Talk:IntraUterine System/Archive 1

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Video Talk:IntraUterine System/Archive 1

Pamphlet information

The IntraUterine System or IUS is an IntraUterine Device (IUD or "coil") that has a hormone cylinder that releases levonorgestrel ( on its shaft. The originality is the local release of the levonorgestrel : the systemic dose is very low, the lowest of all hormonal contraceptives (pill, implant, patch, ring)

1)The first generation of IUDs was copper free, with a low contraceptive efficacy. 2)The second generation of IUDs was consisting of copper wire. 3)The IUS is the Innovation of the last 30 years since the pill.

History of the IUS concept : It was developped by the Population Council,the Finnish firm Leiras and the Pr Tapani Luukkainen, thanks to the experience gained with the development of the contraceptive implant in the 60ties. The implant was bringing something very positive (no more daily intake) but the implant was very badly tolerated (sytemic release of the drug, adverse effects, very unregular bleedings and insertion issues in the arm). This Pr Luukkainen had the great idea to put this implant in the uterus, on the structure of a plastic T and to insert it like the classic copper IUDs.

What is the efficacy? The efficacy is excellent, far better than the best copper IUDs,the best OCs, ring and patch, and it is the same as the implant. (Percentage of women experiencing an unintended pregnancy during the first year of use and the percentage continuing use at the end of the first year.(United States of America).Trussel, WHO 2005)

[1]

What does it bring in contraception? The IUS allow the practitioners and the women to keep most benefits of oral contraception (pill) or of Short term contraception without daily intake.

What should know the young woman, befote getting this product? The counselling of the practitioner is essential. Like most modern pills, ring and patch, the IUS reduce the menses in volume and in intensity and sometimes the menses can disappear. The explanation is simple : this is the clear result of the local release of the levonorgestrel at the level of the endometrium. This is the originality of the IUS : the endometrium is prevented from growing, whilst the ovaries are not blocked. That is the reason why, new users should be clearly informed of this bleeding decrease, the specific bleeding profile.

What are the non contraceptive benefits? Like the pills, the IUS decrease dysmenorrhea, by reducing the gynaecological bleedings.

What is the acceptance of this contraceptive method? like most hormonal contraceptives, IUS decrease or stop the bleeding regular or unregular. Women are seeking for low dose hormones and low menses (volume of bleedings, no more acceptance of strong bleedings...). This IUS set this strong change of the minds

IUS and bone mineral density? The ovaries are not blocked by the IUS ; comparative studies and long term use do not have shown any change in the BMD.

Where is it available? The brand available in the UK, US and Canada and also in all the European countries (France, Germany, UK, Spain, Italy....), Russia, Turkey, Israel, in South America (Brazil, Argentina, Mexico...) is Mirena® made by the pharmaceutical firm Schering Health : it is marketed in more 100 countries and it is currently used by more than 9 million women all over the world.

Is it successful? yes, more than 9 millions users worlwide.

Is it for all the women? The IUS is the contraception of the young women and the young mothers, as early as after the first child. After ten years of daily intake or less, the IUS enable the women to keep the benefits of OCs without regular or daily intake.

It is not the first line contraception for the nulliparous teenager. But in second line, in case of adverse effects with OCs ie, it can be used : decision of the practitioner.--The preceding unsigned comment was added by Femme2006 (talk o contribs) 09:59, 11 March 2006 (UTC)

A decision to use or not use a pharmeceutical drug or device suggested by a practitioner is a decision which should be made ONLY by a patient. Patients have a right to informed consent. Practitioners do not make decisions, they provide information and options. Since they do not themselves test the safety of any drugs or devices--or collect information about side effects, etc. from other patients on mass scale--patients should not look upon practitioners as infallible, but exercise "caveat emptor" with regard to the medical/pharmaceutical industry, as it is a colossal for-profit industry, which does not operate in the public interest except by government regulation, which is not adequate.

It is especially crucial for patients to regard the medical and pharmaceutical industries with great skepticism and caution because huge corporations DO offer perks/financial incentives to medical professionals to sell drugs and devices for them... and because the medical professionals, so incentivized, ARE capable of bullying patients into purchasing the drugs/devices. Patients should ask such questions as, who is profiting from this? Is there a less risky alternative, say, something with an expired patent and no marketing budget? How long has this drug/device been on the market, anyway?

See: As Doctors Write Prescriptions, Drug Company Writes a Check By GARDINER HARRIS

Published: June 27, 2004, New York Times

See also: "National Institute of Health: Private Marketer?" by David Willman, LA Times, Dec. 22, 2004

http://www.latimes.com/news/nationworld/nation/la-na-nih22dec22,0,7519657.story?coll=la-home-headlines

See also: http://www.hsph.harvard.edu/bioethics/archives/200104/msg00003.html

Copyright 2001 Burrelle's Information Services CBS News Transcripts

SHOW: 60 MINUTES (7:00 PM ET) April 1, 2001, Sunday

TYPE: Profile LENGTH: 2448 words

HEADLINE: OF MICE AND MEN; CONTROVERSY SURROUNDING TESTING OF NEW DRUGS ON HUMAN SUBJECTS AND THE PROFIT CORRUPT DOCTORS CAN MAKE --The preceding unsigned comment was added by Cindery (talk o contribs) 20:12, 26 July 2006 (UTC)

Maps Talk:IntraUterine System/Archive 1

Proposed Infobox for individual birth control method articles

Let's all work on reaching a consensus for a new infobox to be placed on each individual birth control method's article. I've created one to start with on the Wikipedia Proposed Infoboxes page, so go check it out and get involved in the process. MamaGeek (Talk/Contrib) 12:23, 14 June 2006 (UTC)

src: alphacord.com

Other possible side effects

Hundreds of women have reported severe side effects not reported by the manufacturer of this product.

     * CHRONIC fatigue     * CONSTANT bleeding (up to 9 months)     * Heavy bleeding and clotting     * SEVERE Lower abdominal pain (cramps)     * SEVERE joint and pelvic pain     * SEVERE Acne or other skin problems     * DEBILITATING Back pain     * SEVERE bloating     * SEVERE weight gain     * SEVERE Headache     * SEVERE Mood changes and wood swings     * Constant Nausea     * Loss of hair     * Vaginal Dryness     * SEVERE depression and feeling of hopelessness     * Decreased Libido     * Increased body hair     * Dry skin     * Incontinence and constipation     * Many many more  

www.mirenaclassaction.com --The preceding unsigned comment was added by Cindery (talk o contribs) 21:48, 25 July 2006 (UTC)

Quite aside from what opinion one might have as to manufacture's altruism in reporting side effects - the listed side effects are those required by the regulatory authorities (FDA in US, was MCA in UK but now renamed). Side effects will be included if similar products have exhibited them (hence a slow-release tablet will generally "inherit" the list from a previous short-acting tablet). Post-marketing adverse events reporting ("Yellow card" scheme in UK) are run by the regulators and they will & do insist upon modifications to the data sheets if evidence emerges. All this as it may, to list side effects from claimants in a class action against a drug, does not "prove" the claims - for that one needs cite scientific/epidemiological evidence presented in WP:Reliable sources.

I am still not clear from the talk-page entry above what the precise reason was for tagging the article with neutrality disputed tags (given they were applied to specific sections, I've modified them from article-disputed to section-disputed):

• Neutrality - Is it that the sections are not written in a WP:NPOV style ? Remember even if one group make claims that some information is being missed from the data sheets, one must find a reliable source to cite in order to verify adding in to an encylopedia "additional facts".
• Disputed - Wikipedia is not a soapbox, and so is not the place to discuss whether differing opinions are correct or not. However the fact that there is a dispute may in itself need including under NPOV. (i.e. it is the issue of there being a real-world 'disputing' that is notable and worthy of memtion, rather than whether the actual details of the claim can be verified and cited for)

Hence an article on MMR vaccine needs mention the Wakefield/media issue of claimed links to autism - the controversy undeniably exists and vaccine uptake fell as a result (references can be found for these aspecs), yet MMR-autism has not be proven and thus there is no reference one can provide to justify altering the wikipedia articles to state the one being the cause of the other.

If proof can be found that the group's action is notable (i.e. widespread media coverage and commentary, or similar in medical press) then perhaps a "Controversy" section should be included. But if this remains just claims for a litigation group, then I suspect the neutrality-disputed tags should be emoved from the encyclopedia article. David Ruben ^Talk 01:58, 26 July 2006 (UTC)

Given the number of dangerous drugs and devices approved by the FDA and recalled from the market--Vioxx, Norplant, Serzone, Black Box warnings on anti-depressants, the list goes on and on--it is highly logical not only to be very cautious of similar products, but of the FDA itself. Below is a link to a CBS News article about a poll in which the FDA's own scientists expressed their concerns that drugs are not aqequately tested for safety (or monitored for side effects).

http://www.cbsnews.com/stories/2004/08/26/health/main638721.shtml

I dispute the neutrality of the entire Mirena article on Wikipedia, because it is basically an advertorial for Mirena, not an impartial encyclopedia entry. The side effects reported to the law firm which is handling the class action suit against the manufacturer of Mirena should be included to show a balanced, neutral point of view of this hormonal device--otherwise the article is just a misleading ad for Mirena (written by the company, and probably posted here/disseminated by someone who is in the employ of their marketing or "education" dept. Dr. Reuben, did you receive compensation of any kind from the manufacturer of Mirena for authoring this article? Do you fit pateints with Mirena, and if so, do you receive compensation of any kind from the manufacturer?)

Because the "precautionary principle" is not effectively in place at the FDA, and because the FDA is able to exert so little monitoring control over drugs once they reach the marketplace, dangerous drugs are unleashed on the public, and it can take years--and a great deal of damage--before additonal "side effects" of drugs/devices are well-known.

As long as there is significant concern over the efficacy of the FDA regarding drugs and consumer safety, the early warning system provided by consumers--such as lawsuits of any kind, but especially class action lawsuits--should be made as widely known as possible, and are certainly and inarguably necessary to a "neutral" article which is suppose to summarize/include all "points of view."

Please note also 1) the Health Canada report on uterine perforation caused by Mirena at a much higher percentage than claimed in their "side effects" marketing, and 2) by your logic, early lawsuits against the Dalkon Shield would not have been "reliable sources." --The preceding unsigned comment was added by Cindery (talk o contribs) 06:51, 26 July 2006 (UTC)

src: www.bmj.com

Progesterone a carcinogen?

It is true that progesterone is listed as a carcinogen in the state of California (Prop 65).

This seems to be solely because the small companies that make over-the-counter bioidentical progesterone cannot afford to hire lawyers to jump through the legal hoops California has set up to get off the list.

And manufacturers of synthetic progestins do not have to put the warning on their products, because they are prescription products. Prescriptions are not subject to Prop 65. So the big companies have no incentive to even try to get off the list. [2]

Prop 65's classification of progesterone is completely unsupported by medical research. Progesterone is actually an anti-cancer, protecting particularly against the effects of excessive estrogen. [3]

While there are valid concerns about synthetic progesterone, mention of them in this article will need to cite actual research studies - not prop 65. I support completely deleting the prop 65 reference from the article. Lyrl ^Talk _Contribs 22:48, 25 July 2006 (UTC)

There is no such thing as "natural" progesterone, except the progesterone produced by a woman's own body. This is especially important to note, since there are no regulations whatsoever over the word "natural." I can sell you antifreeze in shampoo and legally put "natural" in big letters on the bottle. I can name it "Nature" if I want.

See the Breast Cancer Fund's "State of the Evidence" report, which clearly outlines the dangers of artificial hormones. Progesterone is also listed as a human carcinogen the in National Toxicology Report. Below are links to two studies cited by the Breast Cancer Fund which link progestin to breast cancer. The Breast Cancer Fund is a nonprofit organization, acting in the public interest, by law. The study you have cited appears to be from a company which manufactures progesterone--not exactly impartial, or acting in the public interest. It is of crucial importance when citing or evaluating a study to investigate who paid for it, and what financial stake they have or may have in it. Studies paid for by industry can be very misleading (and the financial relationships between scientists and companies are often not disclosed). In this case, however, there is an obvious link suggesting bias. (rude, obnoxious newbie use of capital letters removed by author. please accept my apologies.)

51 Holmberg L, Anderson H (2004) HABITS (hormonal replacement therapy after breast cancer-is it safe?), a randomized comparison stopped. Lancet 363:453-455.

52 Von Schoultz E, Rutqvist LE (2005). Menopausal hormone therapy after breast cancer: The Stockholm Randomized Trial. Journal of the National Cancer Institute 97:533-555 --The preceding unsigned comment was added by Cindery (talk o contribs) 07:09, 26 July 2006 (UTC)

On progesterone and progestins, the Breast Cancer Fund's State of the Evidence report cites a single paper reporting on two studies of HRT. That paper found that combined estrogen-progesterone HRT resulted in higher rates of breast cancer than estrogen alone, which resulted in higher rates than no HRT. The State of the Evidence report then goes on for several pages about estrogens and synthetic estrogens.

The U.S. Department of Health's 11th Report on Carcinogens' substance profile on progesterone refers to animal studies, but does not list the type of progesterone or progestin used or the dosage used in these animal studies. The substance profile also notes that progesterone is produced at a rate of "19.58 mg/24 hr in normal adult cycling females."

I fail to see how a study on the interaction of estrogen and progesterone at dosage levels given in HRT is relevant to a low-dose progesterone-only device like Mirena. I also fail to see how animal studies involving presumably high doses of progesterone are relevent to a device that releases the drug at the same rate as what a woman's body naturally produces. Lyrl ^Talk _Contribs 21:48, 26 July 2006 (UTC)

It is relevant because progesterone is a carcinogen--this is why Mirena is not advisable for women with breast cancer, or women who suspect they may have breast cancer. Breast cancer is a "hormone dependent" disease. Cindery 22:17, 26 July 2006 (UTC)

I know the drug manufacturer put that CYA clause in their pamphlet. But a review of the medical literature shows there is NO evidence that levonorgestral, not accompanied by estrogens, at the doses released by Mirena, causes cancer of any sort. Lyrl ^Talk _Contribs 22:31, 26 July 2006 (UTC)

Additonal note regarding your citation from the "Health Science" website regarding progesterone. Health Science makes the following disclaimer:

"Food and Drug Administration Statement

The statements made within this website have not been evaluated by the Food and Drug Administration. These statements and the products of this company are not intended to diagnose, treat, cure or prevent any disease. "

J Steroid Biochem Mol Biol. 2006 Mar;98(4-5):218-27. Epub 2006 Feb 8.Click here to read Links

     Progestin inhibition of cell death in human breast cancer cell lines.  

Moore MR,Spence JB,Kiningham KK,Dillon JL.

Department of Biochemistry and Molecular Biology, Joan C. Edwards School of Medicine, Marshall University, Huntington, WV 25755, USA. moorem@marshall.edu

Previously, we have shown that progestins both stimulate proliferation of the progesterone receptor (PR)-rich human breast cancer cell line T47D and protect from cell death, in charcoal-stripped serum-containing medium. To lessen the variability inherent in different preparations of serum, we decided to further characterize progestin inhibition of cell death using serum starvation to kill the cells, and find that progestins protect from serum-starvation-induced apoptosis in T47D cells. This effect exhibits specificity for progestins and is inhibited by the antiprogestin RU486. While progestin inhibits cell death in a dose-responsive manner at physiological concentrations, estradiol-17beta surprisingly does not inhibit cell death at any concentration from 0.001 nM to 1 microM. Progestin inhibition of cell death also occurs in at least two other human breast cancer cell lines, one with an intermediate level of PR, MCF-7 cells, and, surprisingly, one with no detectable level of PR, MDA-MB-231 cells. Further, we have found progestin inhibition of cell death caused by the breast cancer chemotherapeutic agents doxorubicin and 5-fluorouracil. These data are consistent with the building body of evidence that progestins are not the benign hormones for breast cancer they have been so long thought to be, but may be harmful both for undiagnosed cases and those undergoing treatment.

PMID: 16466914 [PubMed - indexed for MEDLINE]

src: upload.wikimedia.org

Neutrality disputed

The neutrality of this article is disputed because it appears to be an advertorial for Mirena, rather than an impartial encyclopedia entry. It excluded factual information such as 1) Progeseterone, the active ingredient of Mirena, is a carcinogen according to the State of California (Prop 65), the National Toxicology Report, and studies cited by the Breast Cancer Fund. 2)There is a class action suit pending against the manufacturer of Mirena, which lists a large number of side effects not included in Mirena's advertising/marketing campaign. Because the money spent by Big Pharma makes it difficult for the FDA to prevent the approval of dangerous drugs, and to effectively monitor them once they are on the market, harm to consumers and class action lawsuits are the first sign that a drug or device is a human health hazard.

According to an FDA whistleblower, "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx." Graham, a 20-year FDA doctor, before the Senate Finance Committee." http://www.cbsnews.com/stories/2004/12/07/health/main659529.shtml

SUBSTANCE PROFILES REPORT ON CARCINOGENS, ELEVENTH EDITION, NATIONAL TOXICOLOGY REPORT Progesterone CAS No. 57-83-0 Reasonably anticipated to be a human carcinogen First Listed in the Fourth Annual Report on Carcinogens (1985) Carcinogenicity Progesterone is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1982). When progesterone was implanted subcutaneously, mammary carcinomas were induced at a significantly earlier age and at a higher incidence in female mice. Long-term subcutaneous implants induced ovarian granulosa cell tumors or endometrial stromal sarcomas in female mice (IARC 1974, 1979). Subcutaneous injections of progesterone induced increased incidences of mammary tumors in adult female mice and lesions of the vaginal or cervical epithelia and genital tract lesions in newborn female mice. Hyperplastic alveolarlike nodules and other dysplasias were also induced in female neonatal mice (IARC 1979). Long-term subcutaneous injections in female dogs induced endometrial hyperplasia, inhibition of ovarian development, marked mammary hyperplasia, and some fibroadenomatous nodules of the mammary gland (IARC 1979, 1982).

The David Graham testimony didn't touch on progesterone or devices. I don't think it's relevant to this discussion. Allegations of corruption etc are extremely serious but should not be made part of any Wikipedia article until the sources are clear and incontrovertible, and preferably not until there has been affirmation of such allegations in a court of law.

Your data on the carcinogenicity of progestagen is not specifically relevant of IUS, as virtually every contraceptive uses a progestagen. At the doses used in humans, there is very little trial data confirming cancer risk (e.g. breast cancer, uterine cancer). That's because the doses used in the mice and dogs trials were far above human physiologic doses. At such dose equivalences, any beneficial substance may become a carcinogen. JFW | T@lk 23:16, 26 July 2006 (UTC)

My above comments were not intended to lllumine the progesterone discussion, they were a response to femme2006's comment regarding "decision of the practitioner," and Dr. Reuben's general comments. Someone--not me--edited this and moved all of my comments out-of-context. Would you care to move them back to their original location? Cindery 00:17, 27 July 2006 (UTC)

I was the one who moved your comments. It is Wikipedia custom to add new topics at the bottom of the page, and I misread your comments as being new topics, not expecting them to be a reply to a four-month-old statement. Please accept my apologies. Lyrl ^Talk _Contribs 01:41, 27 July 2006

  (UTC)  

I have moved them back to their original location.Cindery 03:05, 27 July 2006 (UTC)

Allegations of general corruption of an industry from such reputable sources as The New York Times--a preferred Wikipedia "reliable source" --most certainly should be included in any discussion of pharmaceutical drugs and devices (especially ones approved for use in the United States after 1995, when the National Institute of Health began to accept "consulting fees" from drug manufacturers).

And I'm sorry, but I am particularly appalled that, as a doctor, you would make such a patently false remark as "virtually every contraceptive uses a progestagen." Barrier methods do not use any hormones. Other IUDs don't even use hormones.

And, given that progesterone is carcinogenic, I am appalled that Mirena was approved for use anywhere without ANY testing of the carcinogeneity of levonorgestrel.Cindery 00:31, 27 July 2006 (UTC)

Progesterone has only been shown to be carcinogenic at high doses in animals. Lower doses of progestins have been used in humans in the form of the pill, minipill, and other hormonal contraceptives for decades without reports of heightened risk of cancer. I have read all the reports you have referred to so far, and I have not found any evidence that the doses of levonorgestrel released by Mirena are carcinogenic. Lyrl ^Talk _Contribs 01:41, 27 July 2006 (UTC)

That is NOT correct--ALL hormonal contraceptives, and HRT, are associated with cancer risk. And like it or not, progesterone, based on animal studies, is listed as a human carcinogen. I am a little disturbed by sweeping non-factual statements you make, such as "progesterone is anti-cancer" and "...hormonal contraceptives (have been used for decades) without reports of heightened risk for cnacer." Both of those statements are flatly false. I am also disturbed that you have not deleted the reference to the Health Science article, which was written by a progesterone manufacturer.

Combined hormonal contraceptives and HRT involve estrogens. Mirena does not contain estrogens, so studies that have linked estrogen exposure to cancer are not applicable to Mirena. Most substances are carcinogenic at very high doses; this does not mean they are carcinogenic at lower doses. Progesterone-only pills and other progesterone-only contraceptives such as Depo have been used for decades without (to my knowledge) reports of heightened risk for cancer. Depo's effects on bone marrow density are well-documented - why would that serious adverse side effect be so well-known, and yet a supposed increased risk of cancer be unheard of? Lyrl ^Talk _Contribs 00:50, 28 July 2006 (UTC)

Depo has a *fast-acting* adverse effect on bone-density. Cancer from hormones is more like smoking--takes time. Worst effects are with "early and prolonged use."

http://www.foxnews.com/story/0,2933,205553,00.html here's a recent citation from fox news.

Interesting to note that this news bit--based on the famous ongoing Nurse's study-- shows a much HIGHER breast cancer risk for women who took estrogen + progesterone than women who just took estrogen. Cindery 07:17, 28 July 2006 (UTC)

And here's NIH, etc:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=PubMed&list_uids=12824205&dopt=medline

http://www.medscape.com/viewarticle/450281

http://mend.endojournals.org/cgi/content/abstract/14/3/348

Content on talk pages is generally not deleted, so that future editors can review the conversations that went on previously. Content on talk pages is also not subject to the same reliability and verifiability requirements as article content is. For these reasons, I have no plans to delete my previous link to the Health Science article. For a less biased source, consider that the Breast Cancer Fund's State of the Evidence report states that progesterone is added to hormonal treatments to lower the risk of uterine cancer. Even this anti-hormonal organization states without dispute progesterone's ability to lower the risk for this cancer. Lyrl ^Talk _Contribs 00:50, 28 July 2006 (UTC)

ok--but I would take it down, if it were me. You seem highly intelligent most of the time, so I don't see why you want to leave that up there. It's ok to make mistakes. I certainly reserve the right to remove anything I no longer have faith in, or any comments related to a dispute which gets resolved.

src: srh.bmj.com

Disadvantages

Accuracy Dispute: Sidebar listing "disadvantages" excludes most of them, per the manufacturer's own site.

The sidebar is meant to be a very brief summary. A more thorough discussion of disadvantages should occur in the article itself, not in the infobox. Lyrl ^Talk _Contribs 01:41, 27 July 2006 (UTC)

Even the briefest mention of disadvantages should include ovarian cysts, as there are experienced by %12 of users, and are therefore listed by the FDA on the short list of "most common side effects."Cindery 14:14, 28 July 2006 (UTC)

src: www.bmj.com

No Studies Done on Mirena and Breastmilk

I have seen no evidence that the amount of progestin transmitted to the infant (7% of the amount present in the mother's blood) causes any harmful effects. Progestin in the form of the mini-pill is very commonly given to breastfeeding women, and has been for decades. I am open to new evidence, but am unwilling to include speculative warnings. Lyrl ^Talk _Contribs 01:41, 27 July 2006 (UTC)

No amount of progestin is recommended for consumption by infants.

And they aren't speculative warnings--the burden of proof that it is NOT dangerous is on the drug companies. We're talking about infants--we should not be using them as unwilling test subjects in a mass drug trial to see if a known carcinogen is carcinogenic in a lower dose (which may not actually release in lower dose). Infants, remember, have far lower body weights, and are vulnerable to concentrations of chemical in far, far, far lower doses than adults. (See under: lead.)Cindery 05:12, 28 July 2006 (UTC)

src: srh.bmj.com

FDA a Reliable Source for Wikipedia?

Do you have a web address where we could review the FDA comments? I would like to include more information in the article, but I prefer to read sources myself before agreeing to a certain wording. Lyrl ^Talk _Contribs 01:41, 27 July 2006 (UTC)

I initially posted the FDA link--and someone immediately deleted it. Will post again. The 53 page document is a PDF file, so the link is to the FDA page from which the PDF file can be downloaded. You can also find it without the link by going to the FDA's site.

Stop deleting removing the information from the FDA regarding carcinogenesis, uterine perforation, breastfeeding, ovarian cysts...this has happened in a matter of minutes from the time that I posted this information. The source is the FDA--doesn't get more approved than that...--The preceding unsigned comment was added by Cindery (talk o contribs) 00:39, 27 July 2006 (UTC)

re "source is the FDA--doesn't get more approved than that" - hmmmm, from UK perspective is definitely POV and debatable - it only applies to US, rest of world looks to their own regulatory bodies to assess risks and issue labelling requirements. I might cite FDA refusal to allow over the counter emergency contraceptive pills which included a bizzare statement that might promote teenagers to engage in sex-parties as hardly inspiring confidence in their decission making process and ability not to bow to political pressure vs medical facts - as a result the standing of FDA took big knock amongst other UK doctors I've since met - not a formal study I grant :-) David Ruben ^Talk 02:24, 27 July 2006 (UTC)

I think I've made my highly critical postion towards the FDA very clear. However, it is very highly regarded as a Wikipedia "reliable source," which is my point. Initial hostility towards my inclusion of the side effects reported by the class action-eers came from you, and you made a point of "reliable sources." Your consistent position seems to be to defend Mirena right-or-wrong, "reliable" source or no. I ask you again--what stake do you have in defending this device?

And while I do not sanction any value judgements made by anyone regarding the morality of consensual teen sex, I would not advise anyone to take the morning after pill, because it contains hormones. (I use pennyroyal tea, personally.) Cindery 03:16, 27 July 2006 (UTC)

I made the Canadian citation part of the references for the article. I did not delete it, it is not deleted. It is in the references section. I read the Health Canada article, and it says the manufacturer claimed a 1 per 10,000 perforation rate. The Canadian Health department found a 0.9 per 1,000 perforation rate. 0.9 per 1,000 is the same thing as 9 per 10,000. So I wrote in the article that perforation occurs 1 to 9 times per 10,000.

It is Wikipedia policy to attempt to resolve disputes on the talk page first, and put tags on the article later. We are still discussing on the talk page, so it is premature to add dispute tags.

I am certainly not an advocate for the medical community. I use fertility awareness to prevent pregnancy because of the nasty side effects hormonal contraception gave me. But I am an advocate for citing sources and presenting both sides of an argument. Lyrl ^Talk _Contribs 01:41, 27 July 2006 (UTC)

You cited the Candadian article as a press release-- and it most certainly is not. Can you fix that please? I cannot seem to access the references section for editing.Cindery 14:18, 28 July 2006 (UTC)

src: www.bmj.com

re my Reversion of alarmist pushing of risks (=POV agenda)

(been trying to post this explanation of my revert but repeated edit conflicts as above discussion held)

The issue is less the specific side-effects you are trying to add Cindery, but rather the inappropriate alarmist language used and the failure to give balance to the risks by placing them so prominantly.

I felt compelled to assign prominence to them because so many of them were absolutely absent or downplayed, in the guise of an "impartial" article. If you are impartial, why leave out the risks? the New York Times, The LA Times, and CBS News are not exactly alarmist, fringe publications. I wish the things in those article were merely alarmist dystopian musings. Sadly, they are not. Cindery 02:08, 27 July 2006 (UTC)

Risks need to be included, and total absence I agree is wrong, but the degree of "prominance" is where we disagree. Most wikipedia drug articles are of format Introduction (what it is and what used for, with possibly mention if notable controvesy over its use), method of action, pharmacology details, indications, contraindicateions, side-effects (common, uncommon & rare may be listed separately in that order), history, controversy. Latter last partly because not a bland description of what-it-is, but more a commentary on the real-world existance of the controversy, and far more importantly last because reader needs the previous somewhat dull dry information as a background to what can then be a complicated discussion about risks, studies, eveluations etc. David Ruben ^Talk 04:34, 27 July 2006 (UTC)

Then the article should accurately reflect the findings of the studies conducted by the manufacturer. Perhaps you should read the FDA document, which is based on them. Cindery 05:20, 27 July 2006 (UTC)

If every one agreed with a FDA decision that IUS caused condition Z, does that mean wikipedia need automatcally mention Z ? Certainly not:- this is a general encyclopedia and if the incidence of Z is 1 in 100 million, there really is no need to mention it, however "true". The FDA only ever mentions risks and cautions - it is there role after all - but they are not there to praise how wonderful a drug may be or how many other conditions it may prevent as coincdent benefits. We don't plaster penicillin antibiotic articles with "this drug may cause fatal allergic reactions". People died pre-antibiotics from infections, yet I see no mention in drug sheets of "you might die from the infection this drug is proposed as treating, if the drug is not taken" - the serious but rare allergic risk gets its mention in the articles under the side-effects section without this must cite FDA attitude, or failure to WP:Assume good faith of motives of other editors.

So adding phrases along lines of "However, higher perforation rates have been observed by Canadian doctors." suggests either some great undisclosed risk is being hidden from women to make their informed choice upon, or of some Pharma conspiracy to hide/mislead etc. I have no doubt that differing studies will find differing rates, nor that some studies might suggest risk levels for perforation marginally higher than that found by the drug company's study and equally that some studies might find somewhat lower levels. But none of these risks are that different from each other in absolute terms, so whilst 1-9 cases per 10,000 is a 900% variation, when it comes to advising on risks, we are talking about 99.91% to 99.99% of cases not perforating ! I agree causes of perforation need be understood and best practices applied to minimise such events,

ok, that is one place where we strongly disagree--i do not believe that a perforated uterus is an acceptable risk to take for birth control, when safer methods are available. Under the informed consent principles, doctor are required to explain comparative risks to patients. Any doctor who would say, hey, I think you should check out this snazzy new device which could perforate your uterus instead of using a diaphragm or condoms is just not ok with me. That is my opinion, but ignoring/deleting/refusing to include the long list of risks associated with Mirena--why? I believe it is because if patients are aware of the risks, they will not want to take them. Cindery 02:07, 27 July 2006 (UTC) The risks of uterine perforation are not one in a million.

Depends what one means by "safer methods" - COCP have all sorts of risks (DVTs, breast cancer perhaps best reported) but reduction in ovarian cancers probably outweighs these negative. No comfort of course to a women on the pill who has a DVT, but no one campaigns or appears in the newspaper under heading "Pill prevented me from having ovarian cancer", so complications always easier to identify and report than preventative benefits.David Ruben ^Talk 04:34, 27 July 2006 (UTC)

There is no evidence that the pill has ever prevented a specific person from having ovarian cancer. The best prevention of ovarian cancer is provided by diet, exercise, and avoidance of environmental carcinogens. The idea that anyone should take the birth control pill to prevent ovarian cancer is as idiotic as the idea that anyone should take HRT to prevent oseteoporosis: there are more effective ways to prevent osteoporosis, and the risk/benfit ratio is NOT acceptable. Cindery 05:52, 27 July 2006 (UTC)

No removal of a risk factor can ever be proven to have effect in any one specific index case, but epidemiology gives strong evidence as to alteration in risk rates. A quick search on PubMed came up with "Mortality associated with oral contraceptive use: 25 year follow up of cohort of 46 000 women from Royal College of General Practitioners' oral contraception study." PMID 9880284, which found for current & recent (10yr) users of oral contraceptives relative risk of death from ovarian cancer was 0.2 although from cervical cancer 2.5. This year "Oral contraceptive use and cancer. Findings in a large cohort study, 1968-2004." PMID 16819539, which concludes "Combining data for cancers of the cervix, uterine body and ovary, the age adjusted RR for women ever using OCs compared with those never doing so was 0.7 (95%CI, 0.5-0.8). Beneficial effects of OCs on the gynaecological cancers thus outweighed adverse effects" with the specific cancer relative rates being neutral for Breast cancer (rate ratio) RR=1.0 (95% confidence interval (CI) 0.8-1.1), positive for Cervical cancer RR=6.1 (95%CI, 2.5-17.9), and negative for Uterine body cancer RR=0.1 (95%CI, 0.0-0.4) (77 cases) and Ovarian cancer RR=0.3 (95%CI, 0.1-0.5). David Ruben ^Talk 04:05, 28 July 2006 (UTC)

HRT for osteoporosis prevention is not idiotic, it was the best treatment option of its time. The previous view that women only had significant rates of heart disease similar to that of men after the menopause (a wrong assumption) lead therefore to good grounds for suspecting that HRT might reduce heart disease. Of course the possible effects on coagulopathy, such as DVTs and thrombus formation on a coronary plaque, had not been considered. As studies highlighted the increase cardiac and breast cancer risks of HRT, so studies came in showing the newer biphosphonates to have superior efficacy. So with HRT risk/benefit profile changing and a more effective alternative, HRT fell from its No 1 pedestal. However HRT still has a role for osteoporosis prevention, namely for those women unable to take biphosphonates or the even newer product of strontium ranelate - so about No 4 on the list. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Informed Consent

As for informed consent, differing guidelines exist in differing countries and at different periods in history. In UK it used to be (until perhaps 30 years ago) principle of what the average reasonable person would wish to be informed of - hardly very specific, but was taken to mean risks of 1% or above. Clearly in these less medically patronising times and when patients are active participators in their health & medical care, greater information is expected, especially for serious side effects (a trivial temporary side effect in 0.9% is hardly important to stress, but 0.5% risk of death from a minor cosmetic proceedure is clearly important to stress as a balance for the optional therapy). That said, we generally don't see that a consent form need include every last risk however remote and unlikely (yes there is a measureable death rate during operations from the overhead light fixing breaking free and probably about the same as a light fitting breaking free whilst visiting ones doctor to discuss the risks of the planned operation). So "long lists" are not required in an encylopaedia - that is the job of the product data sheets and wikipedia is not a copy of these but a summaristion of knowlege. David Ruben ^Talk 04:34, 27 July 2006 (UTC)

Regarding informed consent: I think the Nuremberg principles are a good standard to strive for, no matter the country. That pretty much voids the idea of "anthropological exception," morally.

Regarding "medically patronising": Where do you get the idea that these are "less medically patronising times"? There is another NYT article I could cite, by Gina Kolata, "When the Doctor is In--But You wish That He Weren't"--about how the times are as medically patronising as ever. Kolata cites that most people--even other doctors, when they are patients--do not feel comfortable contradicting or complaining directly to doctors when they are treated badly, ignored, condescended to, not given information needed for informed consent, etc.

I said "less" not "non-" patronising - at least it is discussed and medical schools have communication-skills as part of their curriculum (can debate how well this works, but at least there is some effort). David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Regarding whether or not it is important to disclose risks to patients/that a risk from birth control is less important to disclose than a risk from plastic surgery: That is your opinion, not a fact. MY opinion is that ANY risk of uterine perforation is not acceptable for a birth control device, and that patients should absolutely be informed. And I do not believe that a majority of patients--fairly imformed abouthe the risks of uterine perforation, cancer, ovarian cysts, etc. will choose Mirena over less risky methods of birth control. I believe that they are only likely to fall for it if risks are occluded/falsely minimized (on their own, and in comparison to risks of barrier methods). "Informed consent" clearly stipulates that doctors have an ethical obligation to COMPARE risks of alternative treatments, and the benefits of treatment vs. no treatment at all. Being hit with an overhead light bulb during an operation is in no way a comparable risk to the risk of a perforated uterus, ovarian cysts, cancer, etc vs. none of those risks--that is absurd.Cindery 01:38, 28 July 2006 (UTC)

If you believe majority women would not accept IUS (and presumably IUDs given they too have a risk of perforation) if "fairly informed", then presumably you feel that majority women with an IUS/IUD fitted were never "fairly informed" and therefore the majority of doctors/family planning nurses had not obtained proper informed consent. That would be pretty damming of the health care system - is there a reliable source to prove this ? Given you also "do not think ANY hormonal contraception is worth the risk", your assessment of risks seems to leave just natural and barrier methods - that's fine as your assessment of risks/benefits, but not one shared by majority of medical community, health departments or government policy. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

That is not logical--1)the majority of women and 2) the majority of women who have agreed to have Mirena implanted in them are two separate groups. So if I say do not believe a majority of women --fairly informed of all the risks--will not choose Mirena over other, less risky methods, I am talking about the majority of women (And the majority of women have NOT chosen to have Mirena implanted). It does not logically follow that I therefore accuse all the doctors who have implanted this device of not engaging in informed consent. (Although doubtless, some of them did not disclose all the risks). The majority of women don't use IUDs in the first place. When women who have not chosen this device see hoo-ha like %99 efficacy! small risk of PID only at insertion! they are more likely to get a device than if they see the truth. I think conducting a study to prove that would be belaboring the obvious. (Although that has not always stopped people--and hence we have data like the wire monkey study. Would the monkey prefer the snuggly mother-monkey or the wire mother-monkey? Well, duh.)

And that is precisely why it is important to disclose the risks--so women can choose. And it is precisely why the manufacturer/their marketing and pr army do not want women to know the risks/why they downplay them.

I have clearly stated that my bias is in favor of the most natural, lowest risk, hormone-free methods. (I think it's fine to disclose bias and state opinion--this is the talk page. As long as you DO clearly state your bias and opinion. You seem to have trouble disclosing what your biases are--you prefer to state them as if they were not opinion. And you have a very clear bias in favor of hormonal contraception, that I can see in you other wiki pages/comments/edits.)

re lights in operating theatre: except that it occurred to a patient under my team due to have a minor procedure performed under local anaesthetic (sustained minor graze to arm) and nearly resulted in the already anxious patient deciding not to undergo the procedure. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

but whatever level one chooses to quote, this is a rare complication and warrants therefore a small mention in the overall topic. The article is currently unbalanced as an encyclopaedic entry in so many other ways - where is the discussion on its development history, consideration and introduction as a treatment modality for menorrhagia, how it has reduced the rates of hysterectomies being undertaken for menorrhagia by half (so both no need op, nor need risk of post-op DVTs etc), the debate over whether this halving of cases is just at time of first being referred to a gynaecologist or whether a small proportion still proceed to hysterectomy a few years later (?problem of treatment method or just progression of underlying disorder which no longer can be managed by conservative means).

Editing

Most articles get written by editors who see an obvious gap and add a quick short stub of an article - the most import bits are to state what a treatment is and what it is used for (e.g. "a progestagen coated plastic device inserted into a uterus as a method of contraception"). Hopeful that editor, or another, then adds more immediuately pressing issues, such as date of introduction, name of product, worldwide availablity (this english WP is not just for UK or US). As more informationis added, content gets revised and, as here, disputed. The collaborative nature of a wiki (hopefully) means that as consensus s reached a well written encylopaedic artice emergenges with depth & breadth of topic. In general the target level of complexity seems to be high-school to undergraduate, so not all known details can be added (an encyclopedia summarises info after all) David Ruben ^Talk 04:34, 27 July 2006 (UTC)

Oh, I think it varies a great deal. The Paxil discussion page includes a lot of first-person-what-this-drug-did-to-me-accounts. (I recommend that you read some of the first-person accounts of patients who have been harmed by Mirena. They are sobering and heartbreaking. I am haunted by the woman who wrote about having the Mirena embedded in the wall of her small intestine.) The breast implant page you contributed a lot to seemed to be a bunch of doctors. "Everything can't be included..." is rather a cop-out, given your knowledge of the copious, complicated information on that page. Escpecially since we're talking about a short list of 1) risks noted by the FDA based on studies conducted by the manufacturer. 2) a short list of side-effects noted by claimants in a pending class action 3) some information about the larger socioeconimic context in which the 400 billion dollar drug industry sells drugs to the public via doctors. This socioeconomic climate is a VAST change from the very recent past, and very much worth remarking on, and locating all new drug approvals within.

I don't disagree with adding the ovarian cyst/perforation risks - the article was clearly lacking after my initial involvement a year ago (1 August 2005), and over the next 7 months a number of editors added obvious fitting, benefits & disadvantages sections. The issue was over the volumous nature of your inclusion (e.g. this edit sequence) which was poor encyclopaedic style (read other general or drug articles in wikipedia or in other encyclopaedias) and overly POV pushy (in the view of other editors and myself) manner of discussing the risks. As for the Pharma conspiracy, yes sufficiently often cited as to be notable and worthy of inclusion, but the pages of wikipedia form an overall work and information does not need to be duplicated on multiple pages (hence the use of wikilinks or {{see|xxx}} and {{main|xxx}} tags). David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Regaqrding off-label use of Mirena: Mirena has not been approved for use in the US for anything other than birth control. If is is approved for use in the UK for menorrhagia, feel free to state that that is the case.Cindery 01:45, 28 July 2006 (UTC)

Citations given in the menorrhagia article linked to. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Big Pharma in Editing?

Issues of progestagen effects re cancer are not limited to just IUS, so to devote most of the article length to this, or to state that this is a carcinogen is over alarmist. As a topic it would be better mentioned in the one place of progestagen (or progestin - precise term to use and which article to link to here in wikipedia gets regularly disputed). Breast cancer risks of HRT seem largely associated with combined HRT's progestagens, against this the progestagens do protect against endometrial cancers compared to unopposed oestrogen-only HRT. So just calling it a carcinogen is too simplistic and thus is alarmist. Whilst some of the progestagen from IUS does enter circulation and thus cause progestagen symptoms, this is generally lower than POP/Depo-Provera/combined HRTS. Given any effect on breast cancer rates must mirror circulating progestagen levels, the IUS might be expected to cause less breast cancers (if any) than the other more systemic progestagen delivery methods. Against this, the IUS's progestagen is at "full concentration" and effect at the endometrial lining. So one might expect the IUS to show full endometrial cancer prevention as seen in the COCP but far less risk breast cancer. The overall cost/benefit rates for cancers as a whole might therefore be a positive one. Sure studies will actually look into this supposition, and the degree of overall benefit might be very little or even marginally negative (which I would not expect), but it is not going to be entirely negative.

oh, I'll be making my way over to "progesterone" and plenty of other drug sites, believe me. I found this one first, pretty much by accident, because it linked from the Dalkon Shield entry. the Dalkon shield entry read like propaganda from an IUD manufacturer who wanted to mitigate "bad publicity" leftover from the Shield to clear the way for a new IUD. Based on a CNN article from 2000, it is clear to me that that is highly likely what the marketing dept. of Berlex/Schering wanted to do--claim that the Shield made Americans wary of IUDs, to increase profits of Mirena. I have looked over the Paxil and Effexor Wikipedia entries also, and am very very suspicious that the unseen hands of Big Pharma play a role in Wikipedia authorship and editing. (And I am hardly as alarmist as the person on the Effexor site who wrote "a PR company is erasing everything unfavorable about pharmaceutical drugs from Wikipedia" or somesuch. (Someone kept deleting the link to a patient petition about a request to the FDA to chnage the Effexor warning, based on their experience of side effects.) Cindery 02:34, 27 July 2006 (UTC)

Interested parties tweeking articles about themselves is not limited to medical articles - there was quie a stir over US elections and candidates buffing up their biographies and talking down articles on their opponents - suffice to say practice is strictly prohibited in wikipedia and generally results in a prompt ban of the user. However WP:Assume good faith policy means that one must assume editors are working for the same greater good, whatever ones private thoughts might be. David Ruben ^Talk 04:34, 27 July 2006 (UTC)

It is important to note that the petition in question was signed by more than 10,000 people, and successfully submitted to the FDA to require a change in the warning label regarding Effexor. That is hardly "interested parties tweaking information about themselves." That is 1) signifigant 2) factual 3) of great public interest. Who wouldn't want it on there? Pretty much only Wyeth, I think. Cindery 12:23, 28 July 2006 (UTC)

FDA Warnings Relevant?

FDA's warnings have to be taken into context - famous story (?apocryphal) of a disgruntled Pharma having their new product blocked as possible carcinogen following animal testing. Pharma then asked, as an aside, if same ban might be placed on another drug W they were working on which had marginally better kidney cancer rates. With carcinogenicity rates scaled up from rats to humans being some 10 gallons a day, the FDA advised most certainly would ban drug W and insisted be informed of what it was. Pharma gleefully revealed that said drug W was in fact H₂O (Water) and that in high enough quantities it is known to cause kidney cancer due to the chronic overstimulation at that level of daily quantity. Story may or may not be true (told in all seriousness by one of my medical school lecturers, but hardly a reliable source as far as encylopedic writing goes) but it highlights just because something can cause cancer does not necessarily make this a high risk or something that one may be overly concerned about. All methods of contraception have some problem or other (user effort & failure rates in natural methods, DVT/migraine/stroke risks COCPs, intramuscular bruising with Depo-Provera injections, deaths from anaesthetic reactions with sterilisation) - but wikipedia need not alarm readers by pushing these risks at the expense of the overall article.

The FDA warnings need to be INCLUDED in the context.

I do not think ANY hormonal contraception is worth the risk, and am staunchly against all of them. The pill is listed on the "dirty dozen" at The Breast Cancer Fund, along with HRT. Cindery 02:34, 27 July 2006 (UTC)

re "I do not think ANY hormonal contraception is worth the risk", but there again I suspect a Ovarian Cancer Fund might campaign for all women (whetehr or not needing contraception) to be on Combined pill for its halving of ovarian cancer rates. Neither position ob its own is a balanced assessment of risks.David Ruben ^Talk 04:34, 27 July 2006 (UTC)

Don't hold your breath! :-) Breast cancer is a MUCH greater risk than ovarian cancer. Breast cancer is THE cancer women are most likely to get. There is a much, much smaller risk of ovarian cancer. Breast cancer is epidemic in comparison to ovarian cancer (And there are other ways to avoid ovarian cancer than taking a pill`.) Cindery 16:36, 28 July 2006 (UTC)

You are quite open about your viewpoint, and good that you so express it. Strong personal opinions held by editors is of course fine in wikipedia and, if not of the majority opinion, helps ensure balance in articles. However there is a risk of getting too focused in swinging articles towards ones own POV which is not permitted. Strong belief make for committed editors, but risks a rougher ride. Take care in the collaborative process, feelings may get hurst and wikistress ensue :-) David Ruben ^Talk 04:34, 27 July 2006 (UTC)

Perhaps--except I'm not an editor. "Someone" deletes all my edits immediately. What I've actually been very focused on is swinging this article to the middle--away from the POV of the drug manufacturer. I find your accusations rude, patronizing, and obnoxious--especially since you are the one who 1) authored this article 2) has refused to make or permit any changes to it in spite of numerous "reliable sources" which contradict your rehash of the manufacturer's marketing materials. I would say you must have some strong opinions, and a bias to which you are unable to admit, which may render you incapable of a balanced viewpoint.an outside editor/arbitrator may be required.Cindery 01:45, 28 July 2006 (UTC)

Sorry, meant to be supportive, not negative. I had not thought to make any alterations to the multiple edits of some 8 other editors between August 2005 to March this year which radically expanded the breadth of issues covered. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

No one appears to have seriously challenged the bias in any of your birth control entries before. (Nobody made a peep over at Norplant about the lawsuits. Or mentioned breast cancer over at the Mini Pill. But I'm starting...)Cindery 12:36, 28 July 2006 (UTC)

Of course perforation and cancer risks are important enough if they occur as side effects to warrant some mention. Also such mention will be over and above their absolute risk rates (i.e. risk 0.01% perforation need not require us to limit mention to same 0.01% length of the article), but this needs be a small part of overall topic.

I don't agree--I think cancer is an outrageous, obscene risk to take for birth control, and that it is a crime no testing was done on levonorgestrel carcinogeneity prior to its approval. The fact that NO testing was done, and that progesterone is a known risk, and that the "low" 20mg release of Mirena is misleading--it is "intended, not guaranteed--make it very risky indeed.Cindery 02:34, 27 July 2006 (UTC)

This is your supposition as to "intended, not guaranteed--make it very risky indeed" - unless you can find a WP:Reliable sources to WP:Verify this view then it is banned under WP:No original research.David Ruben ^Talk 04:34, 27 July 2006 (UTC)

"intended," meaning, not guaranteed, is from the 53 page FDA approval document I have already cited. If Mirena could claim absolutely that only 20mg is released, "intended" would not be the required language here. I suspect that the reason some women experience such terrible side effects and others do not, is the unreliability of the dose release. This approval document, by the way, is not based on any new research by the FDA--meaning the studies were conducted in Europe, and all the risks/conclusions were submitted by the manufacturer on the basis of their own European studies. Cindery 05:18, 27 July 2006 (UTC)

Remember wikipedia is not a soap box, NPOV policy requires significant minority opinions to be included but not that granted equal space and finally vast majority of women use most methods of contraception happily with no complications.

Sorry, that is utterly specious--first of all, the vast majority of women do not use most methods of contraception. They generally use one at time. "Happily" is not a word I would use to describe birth control use (and hardly scientific). A great deal of complications have been associated with birth control, especially 1) implants 2) hormonal contraception.

Sorry poorly phrased, what I meant is that women as a whole use the range of methods available (rather than anyone individual trying everything) and the majority are "happy" in as much their individually selected methods are felt by them to be the best choice for them, with negative aspects outweighed by positives (only no-risk method is absinance, buthas negative of hadly being relationships people seek) David Ruben ^Talk 04:34, 27 July 2006 (UTC)

That's pretty outrageous--where is your documentation for the assertions that "women as a whole use the range of methods available and the majority are happy in a smuch as their individually selected methods blah blah..."? I have never seen a study which claims either that women as a whole use the range of methods available or that they are happy with them. There are, however, studies which show serious UN-happiness women have had with a certain spectrum of the range, namely hormonal contraceptives and implant devices. Cindery 05:52, 27 July 2006 (UTC)

Cancer Risk

And the FDA, the New York times, a class action suit--those are not sources of "minority" opinion. (Especially the FDA, for crying out loud. The argument the Times et al make is that something has to be pretty awful for the FDA to sanction it/attach warnings. So if the FDA says, for example, that ovarian cysts are one of the most common side effects of Mirena, that had better be included on the most cursory product information on Wikipedia. If the FDA lists untested carcinogeneity as a WARNING, take note.)

yes but "take note" is not same as should be banned. Iron replacement tablets have warning about not taking with milk, but that is only because milk prevents the iron tablet from being properly absorbed. Cancers and perforations are obviously "bad" events, but if any degree of risk is seen as unacceptable then we are going to end up pressuring patients as to what the "right thing" to do is going to be. If someone has experienced condom falure despite good technique and put themselves through the ordel of an abortion, small risks of an alternative method may be quite reasonably viewed by that patient as a acceptable

That is NOT comparable. A risk presented by a carcinogen is NOT on par with un-absorbed vitiamin tablet. I would say the lack of further testing on intrauterine progestin in Mirena is THE reason the FDA should not have approved it (and it is what I suspect the class action will hinge on, and why Mirena will probably be banned.)Cindery 05:52, 27 July 2006 (UTC)

Conflict of Interest?

Also, I notice that you have refused to answer my questions regarding any compensation you may receive viz Mirena. If you have no financial conflict of interest--why not disclose it? All your arguments will carry more weight. I have had the good faith in you to pose the question as a question. Cindery 02:34, 27 July 2006 (UTC)

WP:Assume good faith. This is a collabrative venture and I'm not obligated to anyone to answer questions on talk pages. Not having responded must not be taken to imply refusal - how dare you. For your information I also read wikipedia articles and contribute to other topics than just IUS. I'm hardly a fast typist, so writing what was a long and detailed explanation of my previous reversion took some time. Individual GP contraceptive service fees were discontined in the Global Sum system of the new General Medical Services contract, so as a UK GP has no financial incentive particularly for any method. IUD/IUS generally inserted by community Family Planning Clinics (ie not within a General Practice surgery) and Mirena awkward in that their higher costs generally not funded for by the health authorities, so GPs often have to prescribe for the patient then to take to the outside clinic - hence Mirena ends up eating into our indicative drug budgets. Suppose it could be argued that a patient with a IUS/IUD does not take up an appointment slot with us every 6 months for a repeat prescription of the pill, but there again such repeat issues are nice quick appointments that allow us to try and keep to time :-) David Ruben ^Talk 04:34, 27 July 2006 (UTC)

What is the "Global sum system of the new general medical services contract"? did you previously receive some sort of per-device subsidy for prescribing Mirena? Do you feel that prescribing the device to patients as part of your paid job exempts you from compensation? (I would say no. Making a living from widgets means one has an investment in the continued sale of widgets.) And do you think that prescribing the device gives you a clear bias, to which you should admit? I admit I am not familiar with UK Tort law, but in the US, you could be held liable in a potential negligence tort case for anything you knew or reasonably should have known about Mirena, if a patient sued you for prescribing it without informed consent. For example, if the manufacturer includes the risk of uterine perforation in their data to you--but you do not pass this on to a patient--and the patient sustains a perforated uterus, you could be sued, not the manufacturer. Admitting in this forum or any other that uterine perforation is a risk of which you are aware--and a risk which may not be acceptable/warranted when safer options are available--could constitute admission of liability for you, as a doctor who has prescribed this device. Same for cancer, levonorgestrel passed to infants in breast milk, ovarian cysts, etc. Do you feel that you are fully capable of assessing the importance of these risks for inclusion in the article, or that perhaps it would be better to recuse yourself, as you may have compelling conflicts of interest? Cindery 05:52, 27 July 2006 (UTC)

UK funding for GPs previously mixture of per capita payment for having patients of various ages registered and per-fee items (e.g. antenatal care, postnatal checks, contraception (same fee for advice as prescribing), IUD fee, childhood immunisations, minor ops etc). New system eliminated the per-item fees for a "Global sum" based just on number patients and Quality Outcome Framework points & money for various targets (eg summarised notes, appointment availability, having recent recording of blood pressure for those with hypertension, reaching a target level of hypertension control). Old and new systems had their pluses and weaknesses. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

You are correct that it is the prescriber in the UK who retains ultimate responsibility for the prescription item, although the IUD/IUS fitter is also responsible for correct fitting technique. Awkwardness also applies to fact that a patient having been to a Family Planning Clinic (FPC) and supposedly counselled by the doctor at the clinic on the method in order to obtain the consent for the insertion procedure, was then asked to request from their GP a prescription. The GP then was responsible for the prescription, yet had not themselves done the counselling or obtaining of consent for the insertion procedure. To overcome some of these issues, the local Primary Care Trust (PCT) health board, who fund their Family Planning Clinics and pay the independently contracted GPs, would often draw up shared care protocol guidelines as to how their commissioned FPC services were to run and then communicate with the local GPs that the required counselling had been undertaken. This transferred some responsibility for appropriate service provision and counselling/consent procedures to the PCTs and the FPC doctor (but not entirely of course, and not to my knowledge ever tested in a UK court). This was a typical UK administrative fudge (an item coming from a GPs drug budget is ultimately paid for by the local PCT, so why they could not do the simpler option of allowing the FPCs to dip directly into the PCTs reserves as they already did for IUDs and pills remains unfathomable to most GPs). In some areas the PCTs have now assessed the funding levels required for IUS and added this to their FPCs budgets, allowing them to prescribe IUS directly and drop the GPs out of the loop. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

re my capability - please be civil. Are no medical articles to be edited by anyone who is a doctor, pharmacist or a patient as all "may have compelling conflicts of interest". If all reasonable risks are mentioned (and yes I do mention rate of perforation, systemic hormonal side effects and irregular spotting amongst others) and the patient after considering the risks (frequency and severity), benefits, other options etc then signs a consent form, then some degree of responsibility lies with the patient (that is partly what "Informed consent" is about). David Ruben ^Talk

I think doctors who prescribe devices can contribute to articles about them--if they disclose thier conflict of interest. This allows readers to take the conflict of interest into account when they read what the doctors say. I also think this means you have to be careful regarding your edits to dissenting edits. I have noticed that after days of sustained debate, you have begun to allow some changes to the article. Thank you.Cindery 13:36, 28 July 2006 (UTC)

As for cancer risks there is reasonable evidence for an overall net benefit of oral hormonal pills ("Oral contraceptive use and cancer. Findings in a large cohort study, 1968-2004." PMID 16819539, amongst others) which failed confirm increased risk previously reported for breast cancer, higher than previous reported rise in cervical cancers, but numbers offset by reduced endometrial & ovarian cancers. And yes I do mention for the pill the changes to these cancer rates, although on finding this study I wonder if previous reciting of a local gynaecologist's advice that risks endometrial & ovarian cancer were halved by COCP was unduly conservative, as this study suggests just 10% & 30% of rates compared to non-use of COCP. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

I still find that preposterous, in comparative terms. You discuss cancer cause/prevention rates for the pill(s) without making any reference to the incidence of these cancers. (Breast cancer is epidemic; the rest are not--preventing breast cancer is therefore more important). You also talk about these pills as if they were the only means of possibly reducing ovarian cancer. Diet and nutrition are very, very important in reducing cancer risk. (Flax, as matter of fact, has been cited in two European studies as being as effective in shrinking breast tumors as tamoxifen. Imagine what it might do for other cancers/risk of cancer.) But my point is a drug should not be the first "treatment" resort for preventing a disease someone does not have! --particularly if it greatly increases the risk of another, worse disease. It doesn't make sense at all.Cindery 16:47, 28 July 2006 (UTC)

Here is a scary pubmed study linking OC use and breast cancer in young women (the generations of OC users we have just barely begun to see come of age into breast-cancer manifestation years..."their tumors are larger, more invasive..."):

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16823161&query_hl=8&itool=pubmed_docsum summary of kumle study: http://www.sciencedaily.com/releases/2002/03/020326073536.htm

Separate Controversy Section?

Might I suggest, by way of compromise, that if those who dispute overall safety (rather than just minor disagreement over values of some of the small risks) are notable in themselves (e.g. million women march or a successful conclusion to a legal class action), then the minority view point might be better included (and thus less liable to POV disputing) under a separate section titled "Controversy" or something similar. Then using appropriate references the fact of there being a dispute (as opposed to carrying out the dispute itself here in wikipedia) is mentioned as required by NPOV. David Ruben ^Talk 01:52, 27 July 2006 (UTC)

Nope--I don't agree, and will bring in reinforcements. First of all, I'm really going to be a stickler about including the full risks described by the FDA, which were not included in the first article, and which someone keeps deleting. As it stands, the entry is still "marketing," not even a "patient insert" (which is what it is designed to emulate. Patient insert minus all the scarier risks= marketing fluff. And progesterone/artificial hormones/carcinogenesis/no testing thereof is a big issue. The only thing I might concede to "controversy" is the larger issues surrounding the for-profit medical/pharmaceutical industry (As long as they are still linked to/a part of this page.) Cindery 02:34, 27 July 2006 (UTC)

No this is an encyclopedia, not a facsimily of data sheets or FDA information - go visit the FDA site for all their information. If you start dumping data-sheet or masses of unabridged FDA discussion documents this will not help the project and will result in WP:RfC on this article, which gets messy for everyone. I basically agree with you - the article needs to discuss risks, progestagen side effects (most commonly minor symptoms of breast discomfort or nausea) and te imprtant but rare risks =. Most editors will agree with this, but add information in stages, don't rush or push as this will just antagonise - make a small change, see how other editors improve teh wording or update a citation with a better or more recent one. But dumping long lits of all risks known is likely to be seen as poor encyclopaedic style (whether or not true) and get revised.David Ruben ^Talk 04:34, 27 July 2006 (UTC)

No, you do not basically agree with me. I do not agree that uterine perforation is acceptable/too rare to be mentioned, given the benefit in exchange). The carcinogenesis warning from the FDA, and the notes regarding ovarian cysts are not minor things, and must be included. Claims for the device, such as that it is good for menopausal or breastfeeding women, are not based in fact. the list of side effects from the class action claimants should be included on the article page as "other possible side effects." Hormonal contraceptive implants have presented clear and present dangers in the past to women. I don't believe this is a safe device--and at the very least the FULL FDA warnings should be listed, as they are directly from the manufacturer's own studies, and because it is so easy for drug companies to obtain approval for drugs/devices hwich are not adequately tested for safety. Cindery 06:06, 27 July 2006 (UTC)

I (partially) disagree - rate of perforation is rare at less than 1 in 1000, else what level would one set for common, uncommon, rare & very rare events ? I would agree that the risk, at whatever frequecy, is of such a major nature if it occurs that it needs be discussed with patients, but it is open to personal assessment of acceptability and cost/benefit analysis.David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Ok--here you might have a deal. Perforation is rare, but *is of such a major nature* that it needs to be mentioned. No, I do not think everyone will agree with me that it is a risk they would not personally take--but it IS unacceptable not to mention it in the article, because it is such a severe possible consequence. Mention of perforation on the article needs also to address consequences associated with perforation--embedment in the uterus or other organs, surgery, infertility. I have already cited the issue of study bias, and the report of higher perforation incidence noticed already in Canada. Also, as someone once said, "there are lies, damn lies, and then there are statistics." There are also different ways of phrasing statistics to make them seem more or less significant. "A woman is killed every four hours by her husband or boyfriend," for example, which has been cited by domestic violence groups. This is 6 women a day. Divided into the number of women in the U.S., the odds are what--one in a million? Statistics look and feel different--and elicit different responses --based on how they are presented. There is some bias in extrapolating them from numbers which do not reflect the number of women actually studied, and in phrasing them in "woman-years," which means nothing to the lay reader. Cindery 13:46, 28 July 2006 (UTC)

Agree - I was always told this quote is from Mark Twain, and yes presentation of statistics is important ("men kill many women" is as alarmist as "insignificant number of women killed" is minimising reductionist) and affects the POV/NPOV of a passage.David Ruben ^Talk 14:10, 28 July 2006 (UTC)

Pending Class Action Aganist Mirena

Regarding the class action url, jfw I did not post it in that format. I posted the list of side effects reported by those people, and someone deleted them. I believe that that person may have included the url as a compromise. I am not affiliated with that attorney, that suit, or those claimants in any way. However, that there is a class action suit is an indisputable fact. If you want to delete the url, I think you need to state elsewhere in the article that there is a class action. (That is also what I initially did, and the statement was deleted, I added the link to cite as proof that a class action exists.)Cindery 00:38, 28 July 2006 (UTC)

re Class action mention - I think most editors would not view a pending legal action as automatically notable in itself as far as inclusion in an encyclopaedia goes; claims can fail in court and reproducing a pending legal claim amounts to using wikipedia as a soap box. Whereas generally a successful class action is notable and should be mentioned in a suitable section, such as history/development/side effects/controversy. David Ruben ^Talk 04:05, 28 July 2006 (UTC)

Nevertheless, it is a VERIFIABLE fact that this suit is pending, and so it should be included. I did not claim that damages were awarded yet. I notice that in your editing of the Dalkon Shield entry, you never saw fit to delete the number of suits filed against the manufacturer/did not quibble about the disposition of the suits--the mere fact that they were filed was fine for you to cite. I suspect bias here--you do not want people to know that a suit has been filed/it is not that you can argue it is irrelevant or not based in fact (and certainly not on the basis of your editing policy.)

I also fail to see the benefit to the article of including the class action suit. The side effects listed on the site are side effects for all forms of hormonal contraception. And while I have problems with the de-emphasis of these side effects by the medical community (as have many other women driven to fertility awareness forms of birth control by unacceptable hormonal side effects - the ovusoft.com forums are an informative community) - the class action suit seems to do a disservice by saying it's somehow the Mirena that causes these problems, rather than all hormonal contraceptives. There are better sources for adverse effects of hormonal contraceptives, such as the recent New York times article on how pill adversely affects sex drive in so many women (abstinence is a highly effective form of birth control, but it's not ususally what a woman has in mind when she starts the pill). Lyrl ^Talk _Contribs 03:27, 29 July 2006 (UTC)

No, the side effects indicate a strong possiblity that 1) the Mirena, which is "intended" to relase 20mg of progestin, may release more, as indicated by more severe hormonal contraceptive side effects in some users and/or 2) As we do not fully understand hormones, some women may be more receptive to progestins-more than is currently known, and may experience more severe side effects from them. (Some of the breast cancer studies recently done focus on whether progesterone-receptors play a role in breast cancer or not--it's not conclusively understood). I personally think that since the class action is an indisputable fact that has to be included, it is less scary to list what appear to be intensified hormonal effects for some women than merley to say "class action pending," as that leaves what it is about to the imagination. For those concerned about "alarmism," the blanker statement could be read as referring to some of the rarer and more serious risks associated with Mirena.

If twice as much progestin is released (compared to intended release), that would make Mirena systemic concentrations equal to that of mini-pill users. If ten times as much is released, that would make Mirena systemic concentrations equal to that of Norplant users. Is there any evidence that Mirena has higher rates of hormonal side effects than other progestin-only contraceptives?

There is also the possibility that some side effects present in some women because of the lower dosage. Different doses of hormones have different effects, and it is entirely plausible that some side effects will be worse at lower dosages than at high ones. In COCPs, for example, breakthrough bleeding is much more common on low-dose formulations.

I don't agree that the Mirena (versus other progestin-only contraceptives) should be singled out for a lawsuit, or that this article should support that mindset by covering the lawsuit. I also do not find existence of a lawsuit evidence that the device has serious malfunctions. Lyrl ^Talk _Contribs 13:24, 29 July 2006 (UTC)

I don't think it matters what anyone's opinion of whether Mirena should be sued is in determining the factual accuracy of whether or not anyone is suing. Stating that a lawsuit is pending does not indicate anything other than that a lawsuit is pending (meaning, it is not written in the article, "A class action lawsuit is pending, therefore the device has serious malfunctions," it is written, "A class action lawsuit is pending"--no conclusions are drawn. People can investigate the lawsuit if they wish, and form their own opinions. It's *beyond* NPOV to give no information about the lawsuit. Cindery 21:11, 29 July 2006 (UTC)

I do not find this pending class action suit to be notable enough to be included in this article. Lyrl ^Talk _Contribs 22:17, 29 July 2006 (UTC)

Then we disagree. Lawsuits are commonly mentioned in Wiki articles.

Regarding progestin, as I said, there is the possibility that some women are more receptive to progestin (have more progestin receptors). For them, a low dose may be a high dose. The reason, as I have also stated, that there is a breast cancer warning is that breast tumors are hormone-dependent. Have you looked at some of the studies on Mirena and endometrial carcinoma? In the one in which Mirena was tested as a possible treatment for endometrial cancer, they specifically tested the carcinoma to see if it had progestin receptors. Since we do not know exactly what role progestin-receptor cells play in carcinoma (and women are not tested for progestin-receptors befcore they get Mirena) signs of increased effect of progestin on some users should be further investigated. Cindery 23:23, 29 July 2006 (UTC)

I would be curious to see other articles that discuss pending lawsuits. I'm aware of abortion-related articles that have them as part of "state of the law" type sections. But I haven't seen any not-yet-resolved sue-for-damages type lawsuits discussed on other pages, and would be interested to see how they discuss it (that single sentence in the lawsuit section looks very lonely).

What does the notation on the class action suit add to the article? Lyrl ^Talk _Contribs 13:31, 30 July 2006 (UTC)

as long as there are no news reports of sepis, death, hysterectomy etc out of this pending lawsuit, i would settle for inclusion of what appear to be intensified hormonal effects of the progestin on thsese women--a list of their symptoms. it will be qualified as not everybody--"other possible side effects reported by some women" (meaning, given study bias and lack of postmarketing/adverse reaction follow up--adequately--they *are* the postmarketing surveillance.) mention of suit could be taken out if mention of "some women have reported much worse hormonal side effects than others." there is an uncited mention of hormonal side effects on younger women, already--what's the difference? and postmarketing surveillance IS sending questionnaires to women who use something...it doen't actually do a product any good--or the cause of contraception itself--for at-risk populations for adverse side effcets to be unadvised not to take it. i read a long thing about progestasert's careful, unaggressive marketing, only to women with no PID, etc, and with long consent forms clearly stating all risks. women who are sensitive to hormones often already know--what is the point of not telling them they could have more dissatisfaction/serious depression etc? claims like, lower hormones than norplant! are therefore misleading--someone will take it, low dose will still have high effect on them, (prob due to more progestin-receptors, not dose of drug) and they'll be miserable, tell all their friends, etc. warning them in the first place is a) the responsible thing to do b) the thing that reduces bad word of mouth re side effects about a drug. Cindery 04:04, 31 July 2006 (UTC)

On the Norplant article; couldn't that comment be made in the intro, where it talks about the manufacturer? Or in the "types of intrauterine systems" section? It seems a little short to have its own sub-section. Lyrl ^Talk _Contribs 03:27, 29 July 2006 (UTC)

Good point--feel free to move/incorporate it with the manufacturer info. Cindery 03:51, 29 July 2006 (UTC)

Broken Link?

Article curently has a link http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist but this seems to be generating a site-error on trying to follow it - is this just my browser or does the URL need amending ? David Ruben ^Talk 11:45, 27 July 2006 (UTC)

I have no trouble with the link.Cindery 18:34, 27 July 2006 (UTC)

Accuracy dispute

1.Regarding the BNF, the link does not go to a citation regarding breastfeeding and Mirena, it goes to a Wikipedia link for a general article about the BNF. I attempted to search for a BNF citation regarding breastfeeding and Mirena, but could not find one. Perhaps this is because it is a subcription-required site, and quotes posted elsewhere on the net regarding Mirena/BNF do not include any info re breastfeeding. If you can find a quote or citation, please post. But please be careful to note that whether or not the BNF advises that is safe to insert Mirena at six weeks postpartum does not indicate that the BNF advises 1) Mirena or any other form of hromonal contraception is the "first choice" line of contraception for breastfeeding mothers 2) that any studies have been done which prove that hormonal contraceptives do not have an adverse effect on breastfeeding infants. (I.e., you cannot claim that they have been proven "safe.")

I do not have access to any document which would constitute the UK equivalent of the FDA documents regarding Mirena. I think it is important to note that there is a difference between product insert information and altered summaries of product insert information which are disseminated as marketing/info to the media, doctors, and patients/consumers. These summaries are significantly different from the info that, for example, patients sign when they have been fully informed and sign informed consent liability releases.

The sources cited in the Mirena article to indicate a difference in labelling requirements for the US/UK appear to be not from an FDA equivalent, but from marketing summaries. They also imply what may be a difference in normative practice, not government safety regulation requirements. (Normative practice, moreover, does not equal proven safety--it is a normative practice to drive like a maniac in France. You would not state in an article on driving that many people drive like maniacs in France, therefore it is safe in France, and may indicate that it is therefore a matter of controversy/cultural difference.)

If the EU or UK govt. regulations significantly contradict the US labelling requirement that Mirena is not the first choice birth control method for nursing mothers, could you provide that information, please?

I would also hope that the newly cited info regarding lactation as a serious risk factor in perforation would inspire changes in US (and the rest of the world) regarding safety labelling for the Mirena during lactation. Cindery 21:28, 29 July 2006 (UTC)

The BNF website does require registration, but it is free. The BNF page on Mirena states: "postpartum insertions should be delayed until 6 weeks after delivery" and has no other comments on breastfeeding with the device. On the BNF site, only combined hormonal contraceptives - and no other types of contraceptives - are contraindicated or recommended against during breastfeeding. The oral progestogen-only contraceptives page states "lactation is not affected."

The article has a source listed, and the BNF site is a second source, for progestogen-only contraceptives sometimes being recommended for breastfeeding women. Is this sentence the source of the NPOV tag? If so, it could be modified to say "offered as an option" or something rather than "recommended." Lyrl ^Talk _Contribs 14:45, 30 July 2006 (UTC)

2.

The claims for effectiveness of Mirena against pregnancy presented in the Wiki entry do not compare to the FDA advisory (which is based on three studies from Finland and Sweden performed by the manufacturer, involving only 2339 women, and submitted to the FDA for review/US approval of the device).

The FDA says, "The reported pregnancy rate may not predict effectiveness with typical use because of limitations in the clinical studies. For example, routine pregnancy testing was not done at the ends of the studies or on patient withdrawal from the study. In addition, %6 percent of women were lost to follow up in the largest efficacy trial. More than %75 of the women in the two largest trials had used IUDs previously. Presumably, women who had experienced IUD problems in the past would be less likely to volunteer for an IUD trial, possibly confounding the results with a bias for improved safety and efficacy."

Hence, the efficacy rate quoted by Wiki is not accurate. At the very least, conditional langauge should be used regarding the statistic quoted. The mere fact that %6 percent of the women were lost to follow up in the largest study is statistically significant.

This is extremely important--important to cite not merely as an unknown in the sidebar percentage regarding efficacy with imperfect use--because of the special risks associated with IUD and pregnancy.

(Regarding the FDA, it is not my opinion that they should even accept clinical trials conducted by the manufacturer. I do not think it is merely opinion to state that trials conducted by a manufacturer can/will be biased by the manufacturer, who has a profit motive. I believe, that for human health and safety, clinical trials of drugs and devices should be conducted by an impartial body--NOT the manufacturer. I do not think that third parties such as the FDA should accept these trials as solely sufficient for safety approval. So, the studies the FDA reviews are already subject to manufacturer bias. If the FDA then cites facts, such as, "%6 percent of the subjects were lost to follow-up," that is MORE significant than if this were the case in trials NOT conducted by the manufacturer. The fact the %75 of the women in the trials had already used IUDs is not only a clear indication bias on the part of the manufacturer, which skews/can skew results, but makes any observations noted by a review body MORE significant. The system of checks-and-balances is already heavily weighted in favor of the manufacturer, not the consumer. "Impartiality" needs to strongly take this into account.

Thank you for adjusting the rates in the sidebar for typical use. However, I don't think the perfect use claim percentage is justified by the data either.

Some other birth control pages (such as fertility awareness and condom) have effectiveness sections discussing how effectiveness is calculated, the problems with effectiveness rates, etc. This would certainly be a relevent section/discussion to have in this article. I'm hesitant to leave the infobox without any information, though. The effectiveness in the manufacturer's studies is at least in the ballpark. Would a more generalized rate such as "less than 1%" rather than the specific "0.2%" be more acceptable? Lyrl ^Talk _Contribs 14:45, 30 July 2006 (UTC)

3. I see strong bias, not impartiality, in the language used to describe menstrual irregularity caused by Mirena. "Causes amennorhea in one fifth of users" vs. "this device is especially suitable to women with heavy periods." The final result should be somewhere in between. Amennorhea is a condition for which treatment is prescribed in other cases--not the ideal outcome for treatment of heavy periods. Menstrual irregularity--even for three or four months--is not a desirable condition, and should be described as what it is--menstrual irregularity.

Thank you for allowing the change to the sidebar which reflects this info in the disadvantages section. However, I do not think it is accurate to list amennhorhea as a general "advantage." It may be/feel like an advantage to some people, but it is not generally considered to be an advantage, across the board, for everyone. It is confusing to have amenhorhea listed in both "Advantage/disadvantage." As I understand it, it is considered an advantage only for those who have heavy periods. (Not the general population, or a general user of birth control.) And even for those with heavy periods, an advantage would be lighter periods, not necessarily no periods. Lighter periods is already listed as an advantage, and the treatment of heavy periods is listed in medical notes, and addressed in the general article.

I believe the concern with amenorrhea in women not using hormonal birth control is infertility (they do not ovulate normally), fear of pregnancy (they do not have menses to confirm non-pregnancy), and danger of hyperplasia (too-thick uterine lining) which increases risk of endometrial cancer. For women using hormonal birth control, particularly progestin-only types like an IUS, infertility does not seem to be a concern (normal pregnancy rate after discontinuation), and the thinning of the endometrium prevents hyperplasia. Fear of pregnancy is something that should be addressed in the article, but appears to be mitigated in some women by knowing they IUS is in place. So the only reason amenorrhea is listed as a disadvantage is because some women do not like it, versus the health reasons of infertility and hyperplasia that are a concern in other amenorrhic women. Lyrl ^Talk _Contribs 14:45, 30 July 2006 (UTC)

Shouldn't an individual woman decide whether she would like lighter periods or not? It does seem reasonable that women with heavier periods would appreciate their reduction more than women with lighter periods, but saying "only those who have heavy periods consider lighter ones an advantage" is somewhat sweeping. Lyrl ^Talk _Contribs 14:45, 30 July 2006 (UTC)

A significant number of IUS (20%) users stop having periods altogether. So 'lighter periods' by itself is not really accurate. I see what is meant about confusion with the current wording, though. Maybe the wording in the periods sections of the infobox could be changed to "changes in bleeding patterns" or something more generic. Lyrl ^Talk _Contribs 14:45, 30 July 2006 (UTC)

Stop deleting the line--direct from the FDA final approved patient insert for Mirena--that "Cysts can cause pain. Sometimes cysts will need surgery." I have posted this--three times today? Every time, it is immediately deleted.

Thank you for finally leaving this in. If you would like to list statistics, please don't list them in "woman years," unless you provide a link explaining what that is for lay readers, and please do not express statistics in super-inflated numbers which do not reflect actual numbers of women studied. I do not think comparisons of cysts with Mirena requiring surgery and cysts in general population are relevant, as it would take too much space to account for all the causal factors in cysts requiring surgery in the general poplulation. (I.e., the general population includes women with ovarian cancer, PCOS--all kinds of factors which do not make them appropriate controls for Mirena comparison.)

Also: "Glucose Intolerance. Levornogestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Mirena."

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist --The preceding unsigned comment was added by Cindery (talk o contribs) 23:24, 27 July 2006 (UTC)

Reliability of Pro-product Medical Sources

http://www.guardian.co.uk/medicine/story/0,11381,1101706,00.html

The concerns of Cindery seem to be getting addressd on the talk page. Is there objection to removing the dispute tag now? Lyrl ^Talk _Contribs 13:48, 29 July 2006 (UTC)

I agree the article has begun to become more accurate, but I still have a number of concerns (still listed under accuracy dispute section). I think inclusion of the fact of class action is essential to accuracy, pehaps with a notice to "see talk page." Also a note to see talk page for breast cancer. Is that possible? Cindery 00:52, 30 July 2006 (UTC)

Wikipedia does not allow references to the talk page. Other sources are allowed to copy/publish/distribute Wikipedia articles under the GNFL, and WikiMedia itself is beginning to release CDs containing selected articles, with plans for more coverage in the future. These copies/distributions have to stand alone, without reference to things that won't get copied such as the talk page. Lyrl ^Talk _Contribs 02:24, 30 July 2006 (UTC)

i didn't know any of that. how about:

1. class action ref stays in 2. cysts stay in sidebar 3. "unknown: cancer" stays in sidebar 4. mirena first use was 1990 5. breastfeeding with Mirena recommended taken out Cindery 06:16, 30 July 2006 (UTC)

Citation Regarding Comparison of Mirena to Dalkon Shield

The citation for the claim "although the Dalkon Shield was associated with higher risk of septic abortion, Mirena is not" is this: 488. ATRASH, H.K., FRYE, A., and HOGUE, C.J. Incidence of morbidity and mortality with IUD in situ in the 1980s and 1990s. In: Bardin, C.W. and Mishell, D.R., Jr., eds. Proceedings from the 4th International Conference on IUDs. Boston, Butterworth-Heinemann, 1994. p. 76-87. (from the bibliography page of the article cited on 17, which cites 488 to support the claim.) However, there is no evidence that Mirena was studied in these articles. (Are there even two?--I can't tell.) This is not sufficient to justify the claim, as linkd to neither of these articles is provided, and there is no evidence that they refer to Mirena at all. --The preceding unsigned comment was added by Cindery (talk o contribs) 03:04, 28 July 2006 (UTC)

The article cited covers both hormonal and non-hormonal intrauterine devices, and its authors seemed comfortable generalizing septic abortion risk over both types. Are you aware of a mechanism by which the hormones in an IUS would increase the risk of septic abortion? I was under the impression it was the physical device/string hanging out into the vagina that created the possibility of risk - in which case the Mirena would carry the same risks as copper IUDs.

Two of the twelve deaths that helped start the whole Dalkon Shield scandal were in users of the Lippes Loop. I read somewhere recently (maybe in that FDA document on the Mirena? History section?) that some now believe the deaths were contributed to by doctors not removing the IUDs after pregnancy was discovered - not necessarily from features of those IUDs.

The "whole Dalkon Shield scandal" didn't really get started with deaths, although it would be hard to pinpoint when it "got started." Death was the *most extreme* negative outcome caused by Shield--not the first, last, or only. I believe perforation, embedment, life-threateningly untenable pregnancy, and severe pain and PID were the most common.

The reason the FDA requires general warnings on septic abortion, sepsis, death for IUDs--whether they ocurred in clinical trials or not-- is that they can occur a number of ways with IUDs. (If the IUDs come loose, they can cause embedment, and/or pregnancy can occur. The risk of pregnancy and therefore infection-- septic abortion--are higher if the IUD is not in place. Embedment and pregnancy can occur at the same time. If either or both occur, the risk of infection and hence PID is likely. PID can result in infertility. Pregnancy is not advised, and requires abortion to avoid risk of infection. Embedment can require surgery which results in infertlity. Infection and/or and surgery can cause death.) The risk of infection is not limited to: germs can travel into the vaginal canal, with or without a little string to climb up on. The greatest risk of infection is if it occurs while the IUD is loose, and complicates pregnancy and/or embedment (both of which require surgery, which is further complicated by infection.) If you get some kind of minor vaginal or cervical infection without an IUD, it will probably be no big deal. If you get some kind of minor vaginal or cervical infection with an IUD in place and become pregnant--that could be life-threatening. If you get some kind of minor vaginal or cervical infection with an IUD that has come loose and is embedded in your uterine wall, that could be life-threatening...

I haven't read any news reports from Finland or Sweden or the UK saying no instance of death, septic abortion, sepsis has occurred with Mirena use. That doesn't mean there haven't been any, and it doesn't mean it can't happen.

The incidences of expulsion and perforation and pregnancy in the clinical trials were rare/low. The study did not involve a lot of people, %75 of them had previously used IUDs. The manufacturer has either not posted the follow-up studies to the FDA, or else the FDA has not posted them. The gravity of the complications which could occur are serious enough that they bear mentioning to women who are deciding whether or not to use Mirena--the FDA certainly thinks so.

I am concerned particularly that the same--or slightly higher--risk of perforation and/or expulsion reported in the clinical trials may have more catastrophic results in a population other than the study subjects--none of whom had a risk for PID, and most of whom had used IUDs already. Perforation/expulsion isn't expected to end there--from there, pregnancy is more likely, and hence infection, sepsis, septic abortion, maybe death. Since safety testing *was* done, I don't expect that the risk will be as high as with the Dalkon Shield, which was basically a plastic gumball machine trinket passed off as a medical device. But the risks are there, and women have the right to be informed, so they can decide if that is a risk they want to take to avoid pregnancy, in spite of the availibily of far less risky options.

I would be curious to see general population statistics on septic abortions, and compare them to the number of known pregnancies with the Mirena. Lyrl ^Talk _Contribs 02:48, 29 July 2006 (UTC)

General population statistics (unrelated to IUD use) on septic abortions should be available. On the IUS, the studies that have been submitted did have a pregnancy rate, and the FDA report discusses thirty-odd term pregnancies that had been reported at the time of the Mirena application. It would be interesting to see how common septic abortion is in non-IUD users, and compare that to the number of Mirena pregnancies that have been reported (i.e. have enough pregnancies been reported to draw any conclusions about increased risk?). Lyrl ^Talk _Contribs 13:06, 29 July 2006 (UTC)

We do not have those--because Schering/Berlex etc have not submitted postmarketing surveillance to the FDA (to my knowledge) or anyone else (to my knowledge).

I agree that in theory use of an IUD/IUS increases risk for infection of the uterus after miscarriage. But recent studies on IUD pregnancies apparently show that with modern management there is not a statistically significant increased risk versus miscarriage in women who did not have an IUD. I'm not aware of any reason the Mirena would be different.

"Pregnancy requires abortion"? I certainly hope women with IUD pregnancies are not pressured into having abortions! The women's forums I visit have a number of women who successfully carried to term after experiencing IUD failure. If a manufacturer recommended abortion as a treatment, I would be afraid it was more a CYA move (to prevent possible litigation over birth defects, etc.) than an actual concern over women's health. I really hope health information is not twisted to pressure women who do not want an abortion into having one. Lyrl ^Talk _Contribs 13:06, 29 July 2006 (UTC)

Sorry--bad phrasing on my part. I meant that "therapeutic abortion" is advised if pregnancy and infection occur, and the device "cannot be removed."

"modern management" is a very good point. it implies "access to good medical care," and the ability to afford it. infection far less potentially serious in that case. i have a general concern about the differences in how contraceptives are marketed/distributed in "first world" viz "developing" countries. and concerns about lack of medical insurance for so many poor americans, too. also, that contraceptives are marketed more heavily via planned parenthood etc. to poorer populations. i'm not sure that is all relevant to this article, but a mention re sepsis/infection that it is usually easily treatable, if access to good medical care and the ability to afford it exist should balance the asssertion that infection+ IUD pregnancy is mitigated by "modern management"? mirena *is* being used primarily in poorer nations, not us/europe. the majority of users are in china, where "family planning authorities" commonly use coercion, including forcible implantation of iuds. female infanticide and abandonment of female babies is not unusual in china, per the one child law. in a country with such human rights abuses viz birth control, can we really expect them to care about "modern management" of an iud pregnancy? Cindery 22:38, 31 July 2006 (UTC)

Very interesting point. I agree discussion of access to medical care to treat complications could help the article. Lyrl ^Talk _Contribs 01:51, 1 August 2006 (UTC)

Is Mirena an Abortificent or a Contraceptive?

There are a lot of (religious) groups/people who were upset that they felt they were not informed that one of the ways in which Norplant seemed to work was not by preventing conception, but by preventing implantation; that is was not a contraceptive but an abortificent. Mirena appears to work in the same way. The marketing-spin on Mirena has been adjusted "we don't know excatly how it works!" to avoid informing people who may have conscientious objections to forms of birth control which are abortificent rather than contraceptive. Cindery 19:50, 29 July 2006 (UTC)

The issue is already mentioned under the 'mechanisms of action' section. Feel free to incorporate a wikilink to the Controversy over beginning of pregnancy article. Lyrl ^Talk _Contribs 22:20, 29 July 2006 (UTC)

Uh, it is not mentioned at all. (Meaning: groups who have conscientious objections to abortificent bc, of which Mirena may be one. the ref to embryos does not equal a ref to this controversy/concern.) I already previously thought to myself that for NPOV the language of "no one single..." blah blah should be changed to what it says in the product insert--"we don't know how it works." Can't really have it both ways for NPOV--can elide the concerns of "contraceptive or abortificent" by saying "don't know how it works," but can't really also claim that how it works isn't therefore speculative (which may give people who are concerned about what is not known about hormones and how progestin birth control works concerns, or alert people who don't know that to the fact that hormonal contraception is not completely understood, and therefore the risks of it aren't completely understood, either). Also, "we don't know how it works" does more clearly state the truth that users are assuming the risk of taking part in an experiment with a device whose function is not understood--and that may not be limited to hormones, it could be a function of IUD + hormones.

(It's important to take into consideration the amenrohhea of the woman in whom the device was intra-abdominally embedded. That means the hormones not only got outside of her uterus, but were sufficient to cause amennorhea even diluted/beyond uterus. Unless there is some other explanation for amenhorrhea with intra-abdominal embedment of Mirena...)Cindery 23:36, 29 July 2006 (UTC)

We know that Mirena has all the effects listed in the mechanisms section. It seems fairly straightforward that having fewer ovulations (a known effect of Mirena) reduces pregnancy risk. Therefore, reducing the frequency of ovulation is one way it protects from pregnancy. Right? Considering that hostile cervical mucus is a major cause of infertility, and the stacks of research on fertility awareness methods involving observation of cervical mucus, it also seems fairly obvious that the known changes in CM caused by Mirena (making it more acid, preventing the ferning patterns needed to guide sperm through the cervix) is one way it protects from pregnancy. These are known ways in which the method works, so it is inaccurate to say that "we don't know how it works." There are other suspected mechanisms, primarily the known changes to the endometrium, but these are in addition to the mechanisms that are known. Lyrl ^Talk _Contribs 02:02, 30 July 2006 (UTC)

Hormones in Mirena normally get outside the uterus. Systemic concentrations of levonorgestral are typically 100-200 pg/mL. Other contraceptives systems using the same progestin (mini-pill, Norplant) can also cause amenorrhea. It doesn't surprise me that the proximity of the device (while located in the abdominal cavity) to the ovaries and uterus caused sufficient local concentrations of the progestin to induce amenorrhea. Lyrl ^Talk _Contribs 02:02, 30 July 2006 (UTC)

Press Release Citations

The citation for the Adverse Reactions newsletter is NOT a press release. Neither is the Mirena product information (which includes all the study info/required FDA warnings). ("medpundit" is a blog, written under a psuedonym. many web sources just reiterate marketing materials word-for-word, and may as well be press releases.) --The preceding unsigned comment was added by Cindery (talk o contribs) 07:22, 28 July 2006 (UTC)

The citation templates are here: WP:CITET

Feel free to change them to whatever you feel is more appropriate. Lyrl ^Talk _Contribs 02:48, 29 July 2006 (UTC)

The information that cites medpundit is that Progestasert was discontinued on 2001. This seems an interesting bit of information, that I feel adds to the discussion of IUS history, but uncontroversial enough to let the blog source slide. If you have another source of information on Progestasert, feel free to replace it. Lyrl ^Talk _Contribs 02:05, 30 July 2006 (UTC)

How FDA Warnings Should be Included in Article

Regarding the FDA warnings, (Lyrl--that was you, right? I am sorry that I don't know how to post comment to you another way) I think they should be listed in the section, under a section heading. I also think there should be a "Study Bias" heading/section, explaining such facts as that 1) only 2339 women were studied, and less than 700 for five years 2) that %75 of them were previous IUD-users 3) that the study was paid for by the manufacturer 4) that not even the "perfect use" statistics on pregnancy-prevention accuracy are "facts," given that no pregnancy testing was done when subjects a) left the studies b) the studies ended c) %6 of them were no followed-up with. --The preceding unsigned comment was added by Cindery (talk o contribs) 03:04, 28 July 2006 (UTC)

You can post comments on my Talk page (here) if you want something to only be seen by me. If it is part of article discussion other editors might be interested in, it is fine to post on the article Talk page.

My concern on the FDA warnings as a section is two-fold. Firstly, duplication of information. Ectopic pregnancy and perforation, for example, have discussion of their topics elsewhere in the article. Why should they be mentioned twice? Secondly, the topics in the side effect/complications section lend themselves to expansion as editors find more information on them. Just copying a list from the FDA seems limiting. Lyrl ^Talk _Contribs 02:48, 29 July 2006 (UTC)

You are right about duplication of information--I will revise the FDA warnings only to include risks that aren't mentioned elsewhere in the article. Cindery 07:55, 29 July 2006 (UTC)

Study Bias in Mirena?

Similar criticisms can be raised for perfect use statistics of all birth control methods. There are no perfect studies. The topic of study bias affects a large number of articles. I would support making a new article on study bias (relating to prescription drugs and devices) and linking to it in relevant articles - this would prevent information being repeated (with varying degrees of accuracy and writing skill) over and over again. This approach seems to be working with Controversy over beginning of pregnancy, which is currently linked to by several hormonal contraception articles and will probably gain more "what links to here" as time goes on and articles are expanded. Lyrl ^Talk _Contribs 02:48, 29 July 2006 (UTC)

Study-bias re Mirena is very specific to this device/the studies done by the manufacturer of this device. (I.e.,%75 of study volunteers had previously used IUDs.) I am also concerned that in their follow-up studies (a questionnare returned by approx 17,000 users to determine why they stopped using Mirena if they stopped using it) the manufacturer learned that the primary reasons users who stopped using Mirena were heavy bleeding and pain. Users were more likely to keep using it if they experienced light bleeding/no bleeding. The manufacturer noted that light bleeding/no bleeding was more likely to occur in older users. This follow-up study was not reported to FDA. It seems possible to me that the manufacturer, upon learning that light bleeding/no bleeding was a selling feature of the device, exaggerated claims that the Mirena lightens bleeding. (My personal anecdotal experience--I know women who have used progestin birth control--is that they all bleed heavily.) Cindery 20:02, 29 July 2006 (UTC)

I have no objections to including results from other studies. Heavy bleeding and pain seem important to note as side effects, especially if there is some indication of how common they are. Lyrl ^Talk _Contribs 01:51, 30 July 2006 (UTC)

IUD/IUS name discussion removed?

This discussion seemed important, as people will be (hopefully) getting information on IUS from other sources; knowing that sometimes they are called by a different name (IUD) seems like it would help a reader interpret information from these other sources. Lyrl ^Talk _Contribs 03:15, 29 July 2006 (UTC)

I think too many names mucks up clarity--the Mirena is known by: "Mirena," "Mirena Coil," "IUS," "Mirena IUS," "IUD," "levornogestrel-releasing intrauterine device,"(how it is usually referred to in pubmed articles), "LNG-IUS," "Mirena IUCD," "MIRENA," and "MirenaTM"...Maybe towards the bottom there could be an "aka" section listing them? It's confusing/not relevant in the first sentence of article?

Cindery 08:02, 29 July 2006 (UTC)

Not all levonorgestrel-releasing intrauterine devices are Mirena. A competitor company is developing Femilis and FibroPlant. The descriptors of Mirena (coil, IUS, etc) vary, confusion can easily be avoided by just writing 'Mirena' without any descriptors; they are just alternative names, not conflicting with each other. However, there is actual source conflict with the IUS/IUD debate, with some stating definitively that an IUS is a type of IUD, and others that it is not. The naming conflict is why I feel IUS/IUD deserves a sentence in the introduction, unlike the coil/IUS/LNG-20 terms not involved in any conflict. Lyrl ^Talk _Contribs 13:11, 30 July 2006 (UTC)

No, I don't think so. Nor do I think there is any "debate." I think the only reason for pushing this in the intro is "branding,"-a form of advertising. It's both an implant device and hormonal contraceptive. Not a "system."Cindery 18:54, 30 July 2006 (UTC)

I have never seen "debate" on the subject, but some sources (which Wikipedia readers may also be reading) provide naming information that conflicts with other sources. I guess I'm not understanding how providing useful information to readers (explaining why they may see conflicting information when reading about hormonal intrauterine devices in other places) is advertising. Lyrl ^Talk _Contribs 21:37, 30 July 2006 (UTC)

I don't think it's a debate, I think it's a simple US/UK difference. In the UK I've always seen it called an IUS, given a separate leaflet at the Family Planning Clinic and so on; that's about as far as I got since I went for a copper IUD. I've never seen the term "IUS" on US-dominated sites, where instead it seems to be regarded simply as another type of IUD (people will say "my IUD just came out" if it's Mirena, for instance). Brand names seem to be used a lot more in the US, so it's generally referred to as Mirena over there, as far as I can tell. I don't think there's controversy, but I think it's important to avoid potential confusion.

Elettaria 18:24, 11 September 2006 (UTC)

...the issue with the name pertains to whether mirena/IUS should be in a different category than "IUD"--i.e., if the manufacturer says, it's not like those other IUDS! it's a system! should it therefore be in its own category as a "system" or is merely another kind of IUD? wikipedia has categories for everything, and currently there is both an IUD and and IUS category. which is pointless and confusing, i think. and only serves to legitimize the commerical interest of the manufacturer--i believe that the marketing of mirena as a "system" instead of an IUD was an attempt to evade association with the known history of the problems which are associated with IUDS. using levonorgestrel instead of copper doesn't change an IUD into a "system." that's sort of like saying that cheeze whiz in a spray can is a "cheese delivery system." and moreover, that cheese should be called cheese, but cheese in a can should be called "CDS." i'm sorry, i just find it absurd. but, it's not that IUS is one of the names for mirena that i object to--it's conflating the name to an official separate category that bothers me. Cindery 18:47, 11 September 2006 (UTC)

Perforation rate

The phrase "may be higher" keeps getting added to the discussion of perforation. May be higher than what? Based on what source? The number currently listed (9 per 10,000) is taken directly from the source Cindery posted. If an editor want to use the IUD information (and perforation, being a non-hormonal event, seems like something that could be compared between hormonal and non-hormonal intrauterine devices), that reference cites a study with 16 perforations per 10,000 insertions. I'm not understanding the point of qualifying sourced information with an unsourced "may be higher." Lyrl ^Talk _Contribs 03:15, 29 July 2006 (UTC)

The information about inexperienced providers having a higher perforation rate was deleted. Why? This is sourced information, both from the Health Canada article and from the FDA document. It also seems relevant for the article, as it lets women know the importance of selecting an experienced provided should they choose to use this device. Lyrl ^Talk _Contribs 03:15, 29 July 2006 (UTC)

This is the full text of an article from Contraception (Journal) regarding uterine perforation rate with Mirena. The statistic for the Dutch study is 2.6 per 1000 insertions, but it is noted that this may be too low due to underreporting. Clinician inexperience in comparison to clinician inexperience with the copper IUD is noted, not inexperience in general. That does not seem as salient as other factors as risk for perforation (lactation, inherent risk of device itself). Or noticing perforation before embedment/infection/pregnancy can occur (great pain on insertion may be sign). Intra-abdominal embedment should be mentioned in article as rare but possible risk, as it is grave in nature (and the fact that amenorhea occurred in intra-abdominal embedment). Disturbing how many women with perforation in cited in article did not note 1) pain on insertion 2) notice perforation at all- was discovered by clinician. That has scary implications for "regular" use--use by women who will have it in for five years, but not be checking the string or seeing clinician, or even experiencing pain until a serious perforation-complication occurs, presumably. Cindery 08:09, 29 July 2006 (UTC)

Full Text

I indented your comments (so the flow of the conversation is easier to follow) and made the link clickable. I hope that is OK.

Reading the study, it looks like the reported perforation rate varies from 0 to 1.3 per 1,000 insertions. Based on the study, the estimated perforation rate - which includes underreporting - is 2.6 per 1,000. (Or 26 per 10,0000). If the text of the article notes underreporting and the estimated perforation rate (which accounts for underreporting), can we remove the 'may be higher' comment? Lyrl ^Talk _Contribs 12:51, 29 July 2006 (UTC)

2.6 per 1000 specifically does *not* include underreporting. It states, for one thing, that that number is only accurate if no expulsions occurred. Given an expulsion rate estimated at %4 (and even accounting for some expulsions which were also perforations) it seems highly unlikely. I would say that "at least 2.6 per 1000 and may be higher" should be noted in article. Cindery 20:27, 29 July 2006 (UTC)

I went back and reread carefully, and agree with your interpretation. I'm going to tweak the language somewhat to try to provide more information. Let me know what you think. Lyrl ^Talk _Contribs 02:20, 30 July 2006 (UTC)

thanks for changing. but i don't think 0 is ok as baseline number. perforation rates for other IUDS are around 1-5 per 1000. is there some reason to believe mirena will not be average? i don't think so. 2.6 + may be higher is a favorable percentage, per numbers of other iuds. Cindery 04:11, 31 July 2006 (UTC)

The 2.6 was the highest I remember. Could you post the link to the one that found 5? Lyrl ^Talk _Contribs 01:53, 1 August 2006 (UTC)

Considerable Underreporting of Perforation

"According to the Netherlands Pharmacovigilance Centre

Lareb, which registers and evaluates adverse side effects and complications with drugs, at least 24 LNG IUS-related uterine perforations were reported in the Netherlands (LNG IUSs inserted before 2003) since registration of the LNG IUS in February 1996. None of the 21 uterine perforations reported in the present study had been reported to the Lareb. This indicates a considerable underreporting of this complication. Apparently, a perforation with an IUD is not considered to be an event that has to be reported to the Lareb. After consent was obtained from the doctors who performed the insertion of the LNG IUS, the 21 uterine perforations discussed here were reported to the Lareb by the authors. According to sales figures of the LNG IUS in the region where the study was performed (regional wholesale figures; IMS View), 1189, 2492 and 2941 LNG IUSs were provided in the second half of 2000, 2001 and 2002, respectively. Data on the number of LNG IUSs provided in 1999 and the first half of 2000 could not be retrieved. Assuming that all provided LNG IUSs were inserted, that insertion took place in the region and year of provision, and that no expulsions occurred nor devices removed because of side effects, the estimated incidence of uterine perforations in the studied region is at least 2.6 per 1000 insertions. The actual incidence of LNG IUS-related uterine perforations cannot be calculated because of incomplete data of the provided numbers of LNG IUSs in 1999 and the first half of 2000, failure to recollect all cases and possible negligence in reporting cases." Cindery 18:36, 29 July 2006 (UTC)

Release rate vs. other progesterone-only contraceptives

I understand that the release rate is not exactly 20 micrograms per day, and have no problem with "intended to be" qualifying that numberical release rate. But blood tests on hundreds of women have shown that blood levels of progestin are consistently significantly lower in Mirena users vs. users of other progestin-only contraceptives. Why would that statement (not related to an exact number) need the qualifier? Is there any evidence that some Mirena users have higher blood levels of progestin that users of, say, Norplant? Lyrl ^Talk _Contribs 03:15, 29 July 2006 (UTC)

I'm not sure I understand what you're talking about. Is there a qualifier somewhere not preceding a number?Cindery 08:12, 29 July 2006 (UTC)

I'm referring to the following sentence in the 'systemic side effects' sub-section: "The progestin in an IUS is intended to be released at a lower dose than that used in other progesterone-only contraceptives such as the mini-pill or Norplant (blood levels of levogenestral in Mirena users are half those found in Norplant users and one-tenth those found in users of levogenestral-only pills)." I don't believe the "intended to be" qualifier is accurate in this sentence. Lyrl ^Talk _Contribs 13:09, 29 July 2006 (UTC)

Do you have a citation for blood levels of progestin in all users of progestin forms of birth control? I have said before that a "comparison" section might be a good idea. Comparing Mirena to other forms of birth control--on all issues-- is a good idea, and a comparison section would be a good place to compare it to Norplant, the diaphragm, copper IUD, etc. Specifically regarding Norplant/POP vs. Mirena, the problem with claiming that Mirena releases less progestin is that the progestin release of Mirena varies. Blood tests would have to take that into account and show that they were taken over time (at insertion, at two months, three months, 2 years, etc.Cindery 18:57, 29 July 2006 (UTC)

There is a Comparison of birth control methods article that needs much of work.

The FDA document says on page 12 that "Mean serum levonorgestral concentrations over a 5-year period are approximately 100 to 200 pg/ml (see section 4, table 5)." The table on page 26 shows the results of blood tests at 3, 6, 12, 24, 36, 48, and 60 months. Test results varied from 92 to 249 pg/ml.

A study of Jadelle (the second-generation Norplant) reports: The mean serum concentration of levonorgestrel was 435 pg/mL at the end of the first month and gradually decreased to 279 pg/mL at the end of 5 years. The abstract does not list highs, but the low apparently was 144 pg/mL. Lyrl ^Talk _Contribs 22:57, 29 July 2006 (UTC)

If you think that information could be phrased in lay terms for a comparison section between Mirena and other forms of birth control, why not write a comparison section? Unless your point is that you want to address the dangers of Norplant/POP, and compare Mirena favorably to them. But that would mean a whole section on progestin dangers, including the crucial info regarding proestin-receptor cell variety, and the unknowns therein. Meaning, you can't make the claim that progestin danger is related only to progestin dose, but may have a lot to do with progestin-receptivity and progestin-receptor cells. (Hence the Unknown: cancer, but also breast cancer warning/Mirena cannot be implanted in women who have or suspect they have breast cancer.)

The general problem with selected comparison of Mirena with other forms birth control (the note regarding the copper IUD, etc) is that they are selected--they seem like isolated comparisons to make marketing claims, not comparisons for the purpose of info. I have repeatedly stated that in comparison to other forms of bc, I think there are much safer ones than Mirena, which could be demonstrated by comparison. But I have't included a comparison section because even I agree that would be really unwieldy, and is probably better suited to a separate article.Cindery 23:48, 29 July 2006 (UTC)

I want to remove the "intended to be" qualifier in the following sentence: "The progestin in an IUS is intended to be released at a lower dose than that used in other progesterone-only contraceptives such as the mini-pill or Norplant (blood levels of levogenestral in Mirena users are half those found in Norplant users and one-tenth those found in users of levogenestral-only pills)." Lyrl ^Talk _Contribs 01:47, 30 July 2006 (UTC)

i want the whole thing removed, unless it goes in a comparison section comparing mirena to all other contraceptives. Cindery 01:05, 31 July 2006 (UTC)

After reading your postings under the class action section above, I think I better understand (and agree with) your point. Do you think saying Although the progestin in an IUS is released at a lower dose than that used in other progesterone-only contraceptives, there is no evidence this reduces the risk of side effects. would be helpful? Lyrl ^Talk _Contribs 01:55, 1 August 2006 (UTC)

Fertility section

The Mirena decimates the endometrium. It is reassuring that 1-year post-removal pregnancy rates are comparable to those of women discontinuing other forms of contraception, but I think it important to note that the endometrium (very important for maintaining a pregnancy) may take six months to recover from the effects of Mirena - implying fertility may be impaired for that time. This information on endometrium recovery has been deleted a couple of times, and I'm hoping to find an acceptable way to put it back in. Lyrl ^Talk _Contribs 03:15, 29 July 2006 (UTC)

I did not see or delete anything about endometrial recovery, but I did just now delete the "some women conceive immediately." The actual quote from AFP is "some women may conceive immediately, depending on baseline fertility level." That is speculative. Cindery 19:13, 29 July 2006 (UTC)

Also, the fertility recovery rate noted in sidebar of 2-6 months should be revised to reflect actual data of %80 at 12 months, I think. Cindery 23:03, 29 July 2006 (UTC)

The "STEPS" reference says that it takes two to six months for endometrium changes to reverse. This is information I believe is important to have in the article.

One-year pregnancy rates amoung women who do not use contraception is 80-85%. 80% pregnancy after 12 months just means fertily returned to normal rather quickly after removal. It does not provide the information that the first two to six months post-removal are likely sub-fertile, which I think is important enough to note in the sidebar. Lyrl ^Talk _Contribs 01:06, 30 July 2006 (UTC)

Endometrial Adenocarcinoma and Mirena

i don't have access to the full text of this first article, so i am not sure exactly what they mean by "raises important issues regarding the use of Mirena IUS to treat menorrhagia." Has anyone read it?

Gynecol Oncol. 2002 Nov;87(2):216-8.

Endometrial adenocarcinoma following the insertion of a Mirena IUCD.

Jones K, Georgiou M, Hyatt D, Spencer T, Thomas H.

Ashford and St. Peter's Hospital, London Road, Middlesex, TW15 3AA, United Kingdom.

BACKGROUND: The case histories of two patients who developed endometrial adenocarcinoma with a Mirena intrauterine system (IUS) in place are reported. CASE: Two patients had a Mirena IUS inserted to treat abnormal vaginal bleeding. After 12 and 36 months with the device in place they presented with a recurrence of their heavy, irregular menstrual bleeding. Endometrial biopsies confirmed the presence of endometrial adenocarcinoma, and hysterectomies were performed. In one patient the cancer was localized and below the stem of the device, in the other metastatic disease had developed. CONCLUSION: These cases raises important issues regarding the use of the Mirena IUS to treat menorrhagia.

Publication Types:

Case Reports

PMID: 12477456 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15943993&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=Display&DB=pubmed

Cindery 01:10, 31 July 2006 (UTC)

Sidebar risks

The sidebar currently lists serious risks (PID, perforation) alongside ovarian cysts. While the cysts are very common (one study finding 42% of cycles have cysts), they are almost always not serious (all cysts in that study resolved on their own within 45 days). The risk of serious cysts causing severe pain appears to not be any higher than that experienced in the general population. What is the rational for including a non-serious side effect (compared not only to things like PID and perforation, but also to depression) in the side bar? Lyrl ^Talk _Contribs 13:42, 29 July 2006 (UTC)

If cysts are a common side effect, they are a common side effect--do we need another rationale for listing a common side effect? Additonal info about whether they are serious, how often they are serious, and what that means (pain, possibility of surgery) are discussed in the article, not the sidebar. Cindery 23:06, 29 July 2006 (UTC)

Listing them in the sidebar as common is misleading, especially considering the serious nature of all the other listed side effects. The average user is going to read a term such as 'ovarian cyst' and think it's a common serious side effect. Lyrl ^Talk _Contribs 01:33, 30 July 2006 (UTC)

How do you know what they will think? Would you prefer "benign" cyst? What if they do not require surgery, but are painful--how serious is that? If people are concerned about cysts, the can read the article and look up more about cysts. Cindery 02:18, 30 July 2006 (UTC)

I would prefer benign cysts. Lyrl ^Talk _Contribs 02:47, 30 July 2006 (UTC)

ovarian cysts are practically synonymous with benign--%95 percent of them are benign. how about a link to the wiki ovarian cyst article/the words in sidebar lit up in blue with link?Cindery

The clinical significance of ovarian cysts is not common knowledge. A reader who is not familiar with the term, seeing it for the first time next to serious side effects, is most likely to assume that they are also a serious side effect. I feel it would be much more helpful to readers to note that ovarian cysts are practically synonymous with benign by labeling them (perhaps a parenthetical notation of 'usually benign'), compared to a link that they might or might not click. Lyrl ^Talk _Contribs 12:30, 30 July 2006 (UTC)

That's pretty specious--are readers also to assume that upon seeing "uterine perforation," anything about how common it is, what it is, etc.? No info about how common/serious side effects are can be provided in sidebar. People have to read more to understand how to fit side effects in context. I also don't agree, that of the common side effects, only ovarian cysts should be mentioned. Some ref to hormonal side effects such as depression, acne should be listed. Cindery 19:01, 30 July 2006 (UTC)

What is the objection to adding a notation of 'usually benign' to the listing of ovarian cysts? I feel this would be a good compromise between including/not including the side effect, and was very happy when you suggested it.

What criteria do you propose for inclusion in the infobox?

(List of side effects for convenience of this discussion): mood changes, headaches, changes in sex drive, acne, breast tenderness, nausea, ovarian cysts, pelvic pain, heavy bleeding, PID, uterine perforation, male partner feeling the strings during intercourse, increased risk of miscarriage if pregnancy occurs, higher than normal ratio of ectopic vs. uterine pregnancies if pregnancy occurs.

I'm afraid if they are all included, readers who do not read the entire article will not retain the information in the infobox as well, remembering none of the effects rather than remembering the most important ones. Lyrl ^Talk _Contribs 22:00, 30 July 2006 (UTC)

The sidebar also currently lists breast cancer as a side effect. In the discussion so far, I have not found any evidence linking progestin-only use to breast cancer. A note in the text that progestins increase breast cancer risk when used with estrogen in HRT formulations seems reasonable (as was done in the mini-pill article). But I do not support placement of a speculative risk in the sidebar. Lyrl ^Talk _Contribs 13:42, 29 July 2006 (UTC)

The only reason it is listed as "unknown" is a compromise, not because it is "speculative." Cindery 02:18, 30 July 2006 (UTC)

Someone deleted the orginal way I posted the breast cancer warning (FDA) for Mirena, which was "Unknown: cancer." (The original sidebar listed only "small risk of PID on insertion.") Listing them in the sidebar as "Common: ovarian cysts. /Unusual: Perforation/ Rare: Ecotopic pregnancy, Uterine embedment Unknown: cancer." seems reasonable. (That is how I listed them before, with indications of commone/rare, etc., but someone deleted it.)

Cindery 18:50, 29 July 2006 (UTC)

A risk that is speculative (i.e. breast cancer) should not be listed in the sidebar. There are any number of risks that are unknown. Pick any major disease (heart disease, diabetes, cancer of other organs, etc.) and I bet there haven't been any good studies on Mirena's effects on it. Also consider serious psychological diseases like depression. The topic of 'unknown side effects' is simply too broad to cover in any meaningful way. Lack of information is not worthy of inclusion in an encyclopedia article. Lyrl ^Talk _Contribs 01:33, 30 July 2006 (UTC)

Hormones *have* been studied re cancer, that is why they are of particular concern for hormonal contraception like Mirena. A new tobacco would require studies on lung cancer and heart disease in particular, not focus on non-hodgkin's lymphoma. Cindery 02:23, 30 July 2006 (UTC)

Cancer results on other hormonal contraceptives have been mixed. Combined pills result in a lower overall cancer death rate compared to women not taking the pills. So simply being hormonal does not indicate increased cancer risk. There is no evidence specific to progesterone-only treatment re:breast cancer. So the breast cancer link is speculative. Lyrl ^Talk _Contribs 02:53, 30 July 2006 (UTC)

Listing descriptive terms like 'common' 'unusual' 'rare' is not very informative. What criteria are used to put effects in each category? 1 in 1000? 1 in 10000? 1 in 10? It's not obvious, and I don't like seeing that setup used in the sidebar. Lyrl ^Talk _Contribs 01:33, 30 July 2006 (UTC)

Then list them without qualifiers? They are there because of so much bickering over whether less usual ones should be listed, lest people think they are usual. The solution would be to list them as "unusual." And to give an overview of range. (For diaphram page, cystitus is listed. Is is common? Does it sound scary?) Cindery 02:28, 30 July 2006 (UTC)

I would much prefer that only known serious side effects be listed. Cystitus is a known serious side effect of diaphragm use, and I know a woman who contracted cystitus after diaphragm use. Lyrl ^Talk _Contribs 02:53, 30 July 2006 (UTC)

There is no evidence that Mirena (or any other IUD) causes ectopic pregnancy. Ectopic pregnancy rates in Mirena users are lower than those found in women not using birth control. It seems like what happens is that it does not protect as well against ectopic as against intrauterine pregnancy. While discussing ectopics in the article is informative, alerting users who experience birth control failure to look for symptoms, stating it as a side effect is non-factual. Lyrl ^Talk _Contribs 01:33, 30 July 2006 (UTC)

well, thats *exactly* what iud/ius users are supposed to do in event of suspected or possible pregnancy/any symptoms of ectopic (in order to reduce possibilty of further harm. untreated ectopic can be fatal.) agree it's not a side effect, but it's a serious risk.Cindery 04:16, 31 July 2006 (UTC)

First Use

Is there a citation for 1976? It is my understanding that Mirena was first used in in the 1990s. (I think it is misleading to cite any first use other than first use by the general population of a country/first public release to a country. But if it was used in 1976, can we see that study?) Cindery 22:22, 29 July 2006 (UTC)

Progestasert, the first hormonal IUS, was first marketed in 1976. This is discussed in the 'types of IntraUterine Sytems' section and is footnote number 15. Lyrl ^Talk _Contribs 01:44, 30 July 2006 (UTC)

Yes, but that's still confusing. It makes people think Mirena has been used since 1976, and it has not.Cindery 02:09, 30 July 2006 (UTC)

How about 1976 (Progestasert) 1990 (Mirena)? Lyrl ^Talk _Contribs 02:17, 30 July 2006 (UTC)

Why would we need to talk about Progestasert in the Mirena sidebar? (a place so holy--appropriate for such limited, acutely relevant information--that no side effects are deemed worthy of mentioning in it? :-) Cindery 05:56, 30 July 2006 (UTC)

The article is not titled "Mirena." It is titled "IntraUterine System" which is defined in the introductory paragraph as "a hormonal contraceptive device that is placed in the uterus. An IUS has a hormone cylinder that releases a progestagen." This definition includes Progestasert and other devices currently in development (discussed in the "types" section). The first use of an IUS, therefore, is that of the Progestasert in 1976. Because the Mirena is the only device currently commercially available, I agree that there could be some confusion, and that the first use date of the Mirena should also be noted. Lyrl ^Talk _Contribs 12:34, 30 July 2006 (UTC)

the progestasert was not marketed as an "intrauterine system." And this article is entirely about mirena. Cindery 19:05, 30 July 2006 (UTC)

All progestogen-releasing intrauterine kinds of birth control are inserted the same way, prevent pregnancy the same way, have the same contraindications, and the same kinds of side effects and complications. While research cited is research on the Mirena, it should be applicable to all other progestogen-releasing intrauterine devices.

We're having a dispute over the topic of the article. I see a couple of solutions:

• Rename the article 'Mirena' and absorb the information on other progestogen-releasing intrauterine forms of birth control (Progestasert, Femilis, FibroPlant) into the IUD article, or create a new article for them. This would result in much duplication of information.
• Rename the article 'Progestogen-releasing intrauterine contraceptive device' or 'Hormonal intrauterine contraception' or similar in order to include the Progestasert.
• Something else? Lyrl ^Talk _Contribs 22:10, 30 July 2006 (UTC)

progestasert should have its own page. re duplication of info, that hasn't prevented all the various kinds of pills from having their own page. (which makes total sense.) also, ahve you read anything about varieties of mirena? i just stumbled on that it had a precursor, and an LNG-14 is out/under development already. that would further indicate mirena should have own page not mixed up with progestasert.Cindery 01:19, 31 July 2006 (UTC)

I disagree with the extent to which the combined hormonal contraceptive pages have duplicate info. See my suggestion here.

With various hormonal contraception methods, there is at least a topic-encompassing article hormonal contraception that can in theory be expanded to be the top-level article. If Mirena, Progestasert, and developing hormonal intrauterine contraceptives are spun off, what would be the top-level article to describe the commonalities of the different devices?

I was under the impression that the precursor of Mirena was the Progestasert.

There are actually two LNG-14 devices under development, the Femilis and FibroPlant discussed in the "Types of IntraUterine Systems" section. The Femilis is a T-LNG-14 (it has a T-shaped frame) while the FibroPlant is frameless. (The LNG means 'levonorgestrel' and the 14 means 'intended to release 14 micrograms per day', which describes both the Femilis and FibroPlant. Similarly, the Mirena is described by LNG-20.)

The Femilis and FibroPlant are also marketed as IUS. Creating seperate pages for them would be somewhat problematic unless the current IUS page was renamed 'Mirena'.

There is a Wikipedia guideline on article forking WP:SS It recommends creating spin-off articles when the main article exceeds 30KB, which the IUS article has not yet exceeded. While there is no recommendation against making smaller articles, I personally prefer to wait to do spin-offs until there is more information on the sub-topic. Articles on obscure subjects (such as a single sub-type of a rarely used birth control method) do not get much traffic, and therefore do not get much editing. Making stubby articles on Progestasert, the T-LNG-14, and the frameless LNG-14 will likely result in them remaining uninformative for a long time, while leaving discussion of them on a (slightly) more trafficed page will result in a higher likelyhood of information being added. Lyrl ^Talk _Contribs 02:13, 1 August 2006 (UTC)

expulsion and perforation

Two issues with recent expandion of 'Side effects' section:

1. It starts with "Potentially serious complications include expulsion and uterine perforation" and continues to switch between aspects of expulsion and perforation. Unless I'm mistaken, surely expulsion refers to the device's migration out through the normal cervical channel into the upper vagina where it either remains or drops out. Expulsion therefore is not medically serious, and its importance is in the loss of contraceptive cover. This is quite disctinct from uterine perforation (either at time of insertion or later migration) as this involves penetration into the myometrium and either remains there or continues into the abdominal cavity (and all that that might entail). Should not the sentances be untangled so that perforation and expulsion are discussed in their own separate paragraphs ?
2. Generally articles discuss the commonly "to be expected" side effects first and then the rarer (and often more serious) side effects. The Side effects section thus has sub-sections for the commonly experienced Hormonal effects (sub divided again into local & systemic). Perforation occurs at far lower freqency that irreg bleeding or breast discomfort from systemic hormonal effects. To place perforation as the first mentioned problem in side-effects section, and certainly without any opening overview of range of side-effects (e.g. being from insertion process, hormonal effects locally & systemically and of the physical presence of the device itself) therefore seems to unduely emphasise this. I suggest placing expulsion and perforation between the hormonal & pregnancy subsections. David Ruben ^Talk 01:17, 30 July 2006 (UTC)

Sounds helpful to me. Lyrl ^Talk _Contribs 01:45, 30 July 2006 (UTC)

I agree expulsion confusing, but my understanding is that expulsion is related to perforation. Every expulsion--instance of Mirena coming out--carries risk of perforation, embedment, pregnancy. From the moment it comes loose, it could result in any of those things. It appears that coming out is more common than perforation/embedment, once it comes loose, but neither expulsion/perforation could occur if the thing didn't come loose in the first place. Maybe we need a fancy term for "comes loose."(A safety enhancing piece of advice might then be to check daily for string. The sooner coming loose is noticed, the more likely perforation/pregnancy/embedment can be prevented.)

Side effects and complications needs work, yes. Cindery 02:07, 30 July 2006 (UTC)

I thought most perforations occured during placement? So those would not be related to expulsion? And expulsion generally comes out cleanly, only rarely resulting in perforation or embeddment? I was under the impression (from what I read) that perforation and expulsion could reasonable be discussed as seperate side effects.

I believe there are doctors who recommend daily string checking. A discussion of the different string-checking recommendations (with cites, ideally) would be useful in the article. Lyrl ^Talk _Contribs 02:16, 30 July 2006 (UTC)

That's one of the points of the large Dutch follow-up study--most perforations do not occur at insertion. Again, coming loose in the first place can result in either perforation or expulsion. Comes loose/comes out are different but related--one cannot happen without the other, and hence coming loose is related to perforation and expulsion. Perhaps section can read, if it comes loose, can result in either perforation or expulsion, both of which increase risk of pregnancy, etc...Cindery 02:35, 30 July 2006 (UTC)

Only advise I have ever heard from UK Family Planning training & other doctors was for a check after end of each period (i.e. after when the menstrual flow might dislodge any "loose" or partial expelled coil). Daily checking seems potentially risky with increased likelihood of introducing infection into the upper vaginal area. David Ruben ^Talk 02:28, 30 July 2006 (UTC)

Is there any disrtinction in the studies talking about perforation risks as to those at time of insertion rather than subsequent migration? One might expect insertional perforation to be the same for IUD as IUS (its the same technique), however does the design of the underlying plastic frame or the presence of progestagen then alter rates of sunsequent migration ? David Ruben ^Talk 02:28, 30 July 2006 (UTC)

The article (PDF) says that "A potentially serious complication associated with the insertion of an IUD is uterine perforation," and "The supposed mechanism for uterine perforation during or prior to the insertion of an IUD is immediate traumatic perforation of the myometrium by the sound, the inserter tube or the IUD itself. Another mechanism might be partial perforation at the time of insertion, resulting in uterine contractions causing complete perforation."

I cannot find any statements about uterine perforation being unrelated to insertion. The concern of the authors, rather, seems to be that perforation goes undetected (several of the patients were asymptomatic and/or had transvaginal ultrasounds in which the techs did not catch the perforation). Lyrl ^Talk _Contribs 03:04, 30 July 2006 (UTC)

It's not that it's totally unrelated to insertion in all cases--it's that I object to--and studies do not support-- the hype-tastic constant citing of "perforation caused only by clinician error," which implies that if your clinician is experienced, this is not going to happen to you. some perforations occur on insertion, and are noticed. some perforations occur on insertion and are not noticed. some perforations occur on insertion, are not noticed, and result in migration. some perforations occur on insertion which caused great pain, and are surmised therefore to have ocurred on insertion. some perforations occur and cannot be associated with insertion--they just happen. (inherent risk of device.) they do or don't result in migration. some expulsions do doubt cause perforation. (perhaps that accounts for the ones that don't occur on insertion?) also, we haven't addressed embedment at all...any occurrence of expulsion or expulsion (and perhaps embedment?) increases risk of pregnancy (and, if infection occurs, PID, etc.) They are related/interrelated in terms of how they occur and why they can become more serious as complications. (That is why i used the language "potentially serious complications..." pregnancy and/or infections make them both more serious, and if *either* expulsion or perforation occur, pregnancy more likely.Cindery 05:37, 30 July 2006 (UTC)

trying to find definition of "expulsion." many articles reference "undetected expulsion," meaning expulsion cannot refer to "comes out of uterus." (but can include that.) the abstract below suggests that a trip to the fallopian tube can be "expulsion"--i suppose that can happen without uterine perforation. it also gives a clue regarding how design style/contruction can influence expulsion, perforation, etc. (an IUD with no frame can go into fallopian tube.)Cindery 05:13, 30 July 2006 (UTC)

1: Acta Obstet Gynecol Scand. 1983;62(2):191-2. Related Articles, Links

A rare case of IUD expulsion through the fallopian tube.

Wikland M, Wilhelmsson L.

This case report describes the expulsion of an IUD (Gravigard) through the Fallopian tube. Such a phenomenon has been suggested earlier but never reported. It is concluded that the shape of the IUD is of importance for such a route of expulsion.

PIP: This case report describes an IUD expulsion through the Fallopian tube of a 31-year old woman with 3 normal births and no history of gynecologic disease. A Gravigard inserted 8 weeks after delivery by an experienced gynecologist could not be located by examination of the string, pelvic X-ray, of hysteroscopy at the 3-month control visit. The patient was admitted to the hospital and the IUD was found in the ampullary part of the right tube. A laparotomy through a Pfannenstiehl incision was made to extract the device. The IUD shaft was found in the ampulla tubae, its distal end having penetrated the tubal wall and its shank embedded in the fimbria tubae. The device was easily removed without surgery. The pelvic organs did not reveal tissue damage and the postoperative period was uneventful. The patient later had a Copper T inserted without complication. The apparent explanation of the IUD's location was expulsion through the uterotubal juncture, since there was no sign of tissue damage in the neighboring organs. The IUD may have been located at the uterine cornua at the time of insertion, and the single-shank Gravigard shape may also have been a factor.

Publication Types:

Case Reports

PMID: 6868972 [PubMed - indexed for MEDLINE]

Expulsion and perforation are dealt with together here, under heading separated by a slash only. This is from one of those so-pro-IUD-it's- propaganda articles (so hardly biased in favor of "alarmist" citing of risks). Cindery 05:25, 30 July 2006 (UTC)

"Perforation/expulsion.

Frequently, perforation during insertion is caused by the failure to properly assess the uterine position and to accurately define the cervical canal. Rarely do such perforations cause injury to the pelvic or abdominal organs. Often, perforation goes undetected until a routine gynecologic examination, when the device is noted to be absent. Unless there is excessive bleeding suggesting laceration of a uterine vessel, removal of the perforating IUD from the abdominal cavity should be done promptly, but it is not an emergency.

If a patient cannot detect an IUD string, this may indicate perforation or expulsion. Generally, the patient should be assured that the inability to feel a string most commonly means that the strings have retracted and not that the IUD has perforated the uterus or been expelled. The inability to visualize the strings in the cervical canal, especially if the retaining string was cut too short, is a common problem at IUD follow-up visits. Gently rotating a cytologic brush within the cervical canal will often help identify the strings. Should this fail to detect the IUD strings, the clinician must suspect either undetected perforation at the time of insertion or undetected expulsion.

The position of the IUD is then best determined by ultrasound or, if that is not available, with anteroposterior, lateral, and oblique films of the pelvis with a radio-opaque marker (ie, a uterine sound) in the uterine cavity. If the IUD is found to be in the uterine cavity, the patient and clinician can be reassured. A partially perforated or embedded IUD should be removed; this can be accomplished via hysteroscopy or with cervical dilation and use of ring forceps under ultrasound guidance. The latter can be done in the office with cervical anesthesia. An IUD that is partially perforated and cannot be removed transcervically or that perforates into the abdominal cavity will require removal by laparoscopy. Adhesion formation in the abdominal cavity will occur within 3 days after the perforation occurs, so prompt attention is needed.[29] Laparotomy is hardly ever necessary except in the rare event of organ damage requiring extensive repair.

While perforation may sometimes be unrelated to insertion (when it occurs in a breastfeeding, woman, for example), it is most commonly related to clinician error. And while less-experienced providers are more likely to perforate the uterus during insertion, more-experienced providers also cause perforations. If a clinician is experienced, perforation is less likely than if they are not. 'Less likely' does not mean 'it won't happen,' however. Surely we can find a way to talk about the most common causes of this complication without implying that they are the only mechanisms? Lyrl ^Talk _Contribs 12:55, 30 July 2006 (UTC)

My problem with "clinician error" is that it too significantly downplays inherent risk of device AS "clinician error." (I.e., it's an inherent risk of the device that it is inserted into a place the clinician must feel/can't see, not everyone's uterus is shaped exactly the same way--in fact there is great diversity, etc.) I also see marketing hype in "clinician inexperience"--actual FDA warnings are to the effect, since IUDs aren't popular is US, more problems could result for women who use one. (An inexperienced inserter and inexperienced follow-up care are two different things--both with impliactions for perforation, but not limited to that.) Only Dalkon Shield warning issued with packaging was "sepsis may result from unclean technique," implying that physician error was the only probable cause of sepsis. (Since they knew device had defects, attempt to blame physicians before-the-fact for the infections they knew would occur.) Clinician error and inexperience are speculative (and complicated subjects perhaps too complicated to address in article about something else.)Cindery 19:21, 30 July 2006 (UTC)

My understanding of unnoticed expulsion was that it could partially expel (i.e. hanging out of the cervix) and the woman would not notice unless she checked for the string. Or, a woman could go to the bathroom, push the IUD out without realizing, and flush it down the toilet. The article on the IUD migrating to the fallopian tube notes that only the one case has ever been found, making me believe noticed expulsions, partial expulsions, and expulsions into the toilet are what usually happens. Lyrl ^Talk _Contribs 12:55, 30 July 2006 (UTC)

no, as i mentioned "undetected expulsions" do not refer to "comes out of uterus." the case cited re fallopian tube isn't cited to address how common expulsion into fallopian tube by frameless IUDs is, but that medical def. of expulsion is not "comes out." (And how design can influence expulsion.) It means movement/displacement of IUD. I haven't seen any "goes into the toilet" citations.--Can you provide? Cindery 19:27, 30 July 2006 (UTC)

I haven't seen any objections to addressing embedment. I would actually very much like to have the article address embedment and birth defect under the side effects section; I feel they would be better covered there than in the current FDA section. Lyrl ^Talk _Contribs 12:55, 30 July 2006 (UTC)

PID, hormones, ectopic pregnancy, IUD

After looking over the common causes of ectopic pregnancy, I think the contraindication for women with PID only in last three months should be changed. I also think there should be at least some brief mention of fact that hormones increase risk of ectopic pregnancy.

As many as 50% of women with ectopic pregnancies have a history of pelvic inflammatory disease (PID).

Other conditions also increase the risk of ectopic pregnancy. They include:

Endometriosis. A condition in which the tissue that normally lines the uterus is found outside the uterus, and can block a fallopian tube.

Exposure to diethylsilbestrol (DES) as a fetus. If a woman's mother took DES (a synthetic version of the hormone estrogen) during pregnancy, the woman may have abnormalities in her fallopian tubes.

Taking hormones. Estrogen and progesterone are hormones that regulate the menstrual cycle and may be in medications prescribed by a doctor for birth control or other reasons. Taking these hormones can affect the interior lining of the fallopian tubes and slow the movement of the fertilized egg down the tube. Women who become pregnant in spite of taking some progesterone-only contraceptives have a greater chance of an ectopic pregnancy. Ectopic pregnancy is also more likely when the ovaries are artificially stimulated with hormones to produce eggs for in vitro fertilization (a procedure in which eggs are taken from a woman's body, fertilized, and then placed in the uterus in an attempt to conceive a child).

Use of an intrauterine device (IUD). These contraceptive devices are designed to prevent fertilized eggs from becoming implanted in the uterus, but they have only a minimal effect on preventing ectopic pregnancies. Therefore, if a woman becomes pregnant while using an IUD for contraception, the fertilized egg is more likely to be implanted someplace other than the uterus. For example, among women who become pregnant while using a progesterone-bearing IUD, about 15% have ectopic pregnancies.

Surgery on a fallopian tube. The risk of ectopic pregnancy can be as high as 60% after undergoing elective tubal sterilization, a procedure in which the fallopian tubes are severed to prevent pregnancy. Women who have successful surgery to reverse the procedure are also more likely to have an ectopic pregnancy. Cindery 01:53, 30 July 2006 (UTC)

The contraindication on PID (three month wait) is sourced from the World Health Organization. If you have a different source, feel free to include that, too. Also be careful with language - IUDs do not increase risk for ectopic pregnancy. They lower risk for ectopic pregnancy. They just lower the risk for intrauterine pregnancy far more - this is a subtle but important distinction.

While doctors used to believe (speculated) that IUDs worked primarily by preventing implantation, research cited in the IUD article has shown the devices to be highly spermicidal/ovicidal. Preventing fertilization is the primary contraceptive mechanism of IUDs. Lyrl ^Talk _Contribs 02:12, 30 July 2006 (UTC)

it's not my language--it's all direct quotes. will go find link i lifted it from. Cindery 02:41, 30 July 2006 (UTC)

oops-- no, you're right, it was in my prefatory remark. but *hormones* increase risk of ectopic...Cindery 02:45, 30 July 2006 (UTC)

Indeed Lyrl - IUD/IUS do not "increase risk of ectopic pregnancy" in absolute terms, but alter relative rates. The absoute number of ectopic pregnancies is same or slightly lower for thse using IUS/IUDs as those who are naturaly trying to have a child. However given that numbers of intrauterine pregnancies are hugely reduced (the intended aim of contraception), of those pregnancies that do occur the ratio of ectopic to intrauterine cases to will seem higher. So a women with contraception failure with IUS/IUD, has a higher chance of this being an ectopic and in need of a prompt ultrasound scan - however the total number of ectopics is same/less than those who are trying for a baby. David Ruben ^Talk 02:18, 30 July 2006 (UTC)

regarding PID ectopic pregnancy, this is from the product insert:

RECOMMENDED PATIENT PROFILE MIRENA is recommended for women who have had at least one child, are in a stable, mutually monogamous relationship, have no history of pelvic inflammatory disease, and have no history of ectopic pregnancy or condition that would predispose to ectopic pregnancy.

that makes it sort of inherently contradictory, then--not recommended for anyone with a condition which would predispose to ectopic pregnancy, yet gives user a condition which predisposes her to ectopic pregnancy (hormones). Cindery 02:55, 30 July 2006 (UTC)

Hormonal contraception does not increase risk of ectopic pregnancy any more than IUDs do. Two considerations: progestin-only contraceptives seem to change the ratio of extrauterine/intrauterine pregnancy by protecting better again intrautering pregnancy than extrauterine pregnancy. Same as IUD. The evidence is sketcier for combined contraceptives, but they might also have the ratio change. This is discussed in the COCP article under the 'Contraception vs Abortion debate' section.

Secondly, women taking hormonal contraceptives are unlikely to be using condoms. Therefore at higher risk for STDs. Therefore at higher risk for PID caused by increased rate of STDs - not caused by hormones themselves. Lyrl ^Talk _Contribs 03:08, 30 July 2006 (UTC)

J Reprod Med. 2002 Nov;47(11):881-5. Links

     Ectopic pregnancy risk when contraception fails. A review.  

Furlong LA.

U.S. Food and Drug Administration, HFD-580, 5600 Fishers Lane, Rockville, MD 20857, USA. furlongl@cder.fda.gov

OBJECTIVE: To alert clinicians to the risk of ectopic pregnancy when certain contraceptive methods fail by summarizing data from trials reviewed by the U.S. Food and Drug Administration (FDA). STUDY DESIGN: The review focuses on 7 contraceptive drug products with an increased risk of ectopic pregnancy when the method fails. Data were extracted from reviews of clinical trials submitted to the FDA to support marketing applications and from the medical literature. Data on 6 other contraceptive drug products and published data for tubal ligations are used for comparison. This review does not include medroxyprogesterone acetate injections because the FDA reviews for this method did not include any pregnancy outcome information. RESULTS: The results are presented in a table and are compared to postmarketing surveillance reports and published literature, when available. The proportion of ectopic pregnancies among all pregnancies ranged from 1:2 to 1:21 for intrauterine devices, tubal ligations, progestin-only implants and progestin-only oral contraceptives. Although the confidence intervals for the proportions were large in trials with few pregnancies, both postmarketing surveillance reports and published literature support proportions calculated from clinical trial data. CONCLUSION: Pregnancies in women using progestin-only oral contraceptives, progestin-only implants, intrauterine devices and tubal ligations are more likely to be ectopic than pregnancies in the general population.

PMID: 12497674 [PubMed - indexed for MEDLINE]

Reversibility

The reversibility note on the sidebar has been changed from "2-6 months" to "2-12 months or more". What is the rationale behind this? Lyrl ^Talk _Contribs 03:23, 30 July 2006 (UTC) I changed it back. Cindery 07:27, 30 July 2006 (UTC)

STD risk / sexual partners

The contraindications section currently lists "Women at risk for certain sexually transmitted diseases (STDs) that can cause pelvic inflammatory disease (PID), or with or at risk for HIV." It then lists seperately "Women who have more than one sexual partner, or whose partners have more than one sexual partner." These are really the same contraindication. Can they be combined? Lyrl ^Talk _Contribs 03:23, 30 July 2006 (UTC)

yes, i think they could be combined. but i think it is important to note that it isn't just STDs which can cause infection/lead to PID, but even just germs from someone else's body. that's the point of citing that bit from the product insert. (and why insertion must be sterile, and why david has cited not checking strings too much...) Cindery 05:53, 30 July 2006 (UTC)

Nulliparous Women

I think there should be some mention that because there is a risk of infertility, it is recommended for women who have already had one child. This is commonly cited for IUDs, and is cited in Schering product insert. The reason manufacturers' typically cite is liability insurance/that "juries are highly sympathetic to otherwise healthy people who suffer a terrible tragedy from a minor complication." Aside from their reasons, it IS a greater tradegy for a woman who would like to be a mother to risk not being able to have any than it is for a woman who has already had one...Cindery 07:26, 30 July 2006 (UTC)

I don't have any objections to including that discussion the article. I would be careful with the wording on nulliparous women (saying "some doctors believe this is a less acceptable risk for nulliparous women" or something along those lines rather than simply stating it as less acceptable, and ideally finding a source with the nulliparous advisory), as not everyone believes it's more acceptable for parous women to risk infertility. Lyrl ^Talk _Contribs 13:01, 30 July 2006 (UTC)

the schering product insert states ideal patient profile is woman who has had at least one child. If you don't want to change advisory regarding women who haven't had children "not a contraindication for use in nulliparous women, blah blah," more emphasis should be given to risk of infertility. Cindery 19:58, 30 July 2006 (UTC)

IUDs and IUSes do not cause infertility on their own. Infertility can occasionally be caused by an IUD/IUS which perforates the uterine wall if it then leads to further complications, but perforation is extremely rare and complications leading to infertility afterwards even rarer, I've only ever heard of one case and it was decades ago. Now, if you get an STI when you have an IUD/IUS in and leave the STI untreated for a long time, it was traditionally thought that the IUD/IUS would "wick" the infection up into the uterus and make it more likely to turn into PID, and PID can cause infertility. This gets discussed on the LiveJournal IUD forum quite a bit, and it's been said that the extra risk is in fact marginal (someone there has references for this). There is also the risk of PID resulting from an infection following insertion, but that pretty much only happens if the insertion is carried out in non-sterile conditions (e.g. in developing countries).

It should be noted that doctors' views on who is a good candidate for an IUD vary enormously, particularly between countries. It seems to be mainly in the US that nulliparous women are sometimes denied IUDs; I've certainly had no trouble in the UK, even getting fitted for an IUD when I'd only known my partner a week. One reason for this is a blanket assumption that because younger women are higher-risk for STIs in general, all of them are going to be high-risk (some doctors will only insert IUDs in married women, for instance, which is making silly assumptions about marital fidelity). To be honest, a lot of it looks like prejudice against unmarried women. I suspect that the older models of IUDs may have been less suitable for nulliparous women because they were larger and thus less likely to fit a nulliparous uterus; with modern, smaller IUDs, the expulsion rates are very similar for parous and nulliparous women. The idea that a woman who hasn't had children shouldn't be permitted to have an IUD because she might end up infertile (extremely, extremely unlikely), and that would be more of a tragedy, even when she has stated that she is aware of the risks and is not high-risk for an STI, is ridiculous. The official recommendations (can't remember from where but can dig it out if you need) used to be that women who were high-risk for STIs shouldn't have IUDs, but it's now been reduced to women who currently have an STI or have had PID within the last few (three?) months.

Elettaria 00:58, 11 September 2006 (UTC)

Breastfeeding and Levonorgestrel

Contraception. 2002 Jul;66(1):57-65. Health and growth of infants breastfed by Norplant contraceptive implants users: a six-year follow-up study.

Schiappacasse V,Diaz S,Zepeda A,Alvarado R,Herreros C.

Instituto Chileno de Medicina Reproductiva, Consultorio de Planificacion Familiar, J.V. Lastarria 29, Depto. 101, Santiago, Chile. icmer@icmer.org

The objective of the study was to evaluate safety to infants whose mothers used Norplant levonorgestrel implants during breastfeeding. A nonrandomized clinical trial design was used. Participants were 220 and 222 healthy breastfed infants of mothers initiating use of Norplant or T-Cu IUD, respectively, at 55 days to 60 days postpartum. Infants were followed from birth through age 6 years. Breastfeeding pattern, infant growth, and disease events were recorded monthly in the first year, three-monthly in the second, and annually thereafter. Most mothers continued use of Norplant (96.4%) and T-Cu (94.1%) during lactation, and 2140 months of infant exposure to levonorgestrel were accumulated. Breastfeeding pattern and infants growth, from admission through age 6 years, were similar in both groups. In the first year, breastfed infants in the Norplant group had higher incidence rates (p < 0.05) of mild episodes of respiratory infections (adjusted RR 1.17, CI 1.08-1.27), skin conditions (adjusted RR 1.46, CI 1.20-1.79), and eye infections (unadjusted RR 1.49, CI 1.03-2.18) than the control group. Later on, a higher proportion of infants in the T-Cu group showed neurological conditions. Although breastfeeding patterns and infant growth is not affected by Norplant use during lactation, the effect on infants' health of steroidal contraception should be further evaluated.

PMID: 12169382 [PubMed - indexed for MEDLINE]

cutting strings

can we take that out? string is only way to tell if Mirena is still in (and absence of period, normally an indicator of pregnancy, is likely not an indicator of pregnancy with Mirena use, making string not felt *only* early warning of pregnancy). string moved up also sign of expulsion/moving around, so shorter string not good idea. Cindery 00:55, 31 July 2006 (UTC)

I would modify statement given (my previous edit merely corrected the english, but I disagreed with the sentiment being given). If string felt, then generally problem of string left too long at original insertion proceedure (ideally 1-2 inches in length). So it is quite Ok, if say a string was originally cut to say 3 inches, to trim this to an appropriate 1-2" length. As you correctly piont out, cutting further to cervix removes ability of the women to check the position, but even worse may makes coil removal nolonger a routine task most GPs can do (coil removal being very easy in majority cases, unlike special training needed for coil insertion). Instead it becomes a special task for a Family planning unit who have thread-locator devices; these are awkward to use, uncomfortable for the women and may fail to grasp the thread. There is a very small chance therefore that an otherwise correctly positioned coil needing to be removed (either to resume fertility or for a new replacement coil to then be inserted) may requiring a hysteroscopy operation to grasp the coil and remove it.David Ruben ^Talk 00:05, 1 August 2006 (UTC)

I have also seen a reference to "tucking string behind cervix"? So it still hangs out, but is less likely to poke during intercourse? I have seen women on message boards I frequent have strings cut even with cervix, so some doctors do it. Maybe a discussion of the removal complications caused by too-short strings would be in order.

I have also heard that strings "curl" after insertion, and a doctor can accidentally cut one too short - it appears correct length immediately after insertion, but later retracts into the cervix? Lyrl ^Talk _Contribs 02:20, 1 August 2006 (UTC)

Not sure "tucking" would work, would change position as women changes position and causes movements in the vagina (eg on sitting/standing). The coil thread finders have various technical (?brand) names (all of which escape me currently). PubMed search for "iud string lost" found just 7 entries, o this is more a case of practical specilist training than research articles - suspect we need a wikipedian gynaecologist to help out on this, but I will have a go. David Ruben ^Talk 02:42, 1 August 2006 (UTC)

I've got a different type of IUD, but strings are strings. Yes, you can tuck them behind your cervix even though the cervix changes shape and position throughout the cycle (my strings vary in detectable length from about 2 cm to undetectable). Sometimes you have to tuck them back again, but mine seem to be getting trained into the curved shape, whereas with my previous IUD the strings hung straight down, got caught in my menstrual cup one night, and the IUD got yanked out. Not only do they protrude into the vagina less if they're tucked behind the cervix, but the ends of the strings are also pointing away from where the visiting penis will be coming from, as opposed to straight at it. My partner has never managed to feel my strings.

Elettaria 00:44, 11 September 2006 (UTC)

All three authors of article on Berlex speakers' bureau

shulman, nelson, and darney. they are the authors of the 2nd article cited as reference for American Family Physician article: 2. Shulman LP, Nelson AL, Darney PD. Recent developments in hormone delivery systems. Am J Obset Gynecol 2004;190(4 suppl):S39-48. i have removed the afp article as a reference. since the main ref for the article is the berlex product insert, refs used from that can revert to that. any other refs can be cited separately from the bibliography of afp article.

(what's worse, darney is heading the long term study of levornogestrel iud...)

darney and shulman are listed here, where they were required to disclose conflicts of interest:

[PDF] Contraceptive Methods and Sexually Transmitted Infections File Format: PDF/Adobe Acrobat - View as HTML PHILIP D. DARNEY, MD, MSc Grant/Research Support: Pharmacia Corporation. Consultant:. Organon Inc. Speakers' Bureau for Commercial Sponsors: Berlex ...

anita l. nelson is here:

Anita L. Nelson, MD

Professor, Department of Obstetrics and Gynecology, UCLA School of Medicine, Los Angeles, California

Dr. Nelson holds undergraduate degrees in economics, from Occidental College, and in biology, from the University of California at Irvine. Her medical degree was conferred by the University of California at Los Angeles (UCLA) School of Medicine. She completed her residency in obstetrics and gynecology at the Harbor-UCLA Medical Center.

Dr. Nelson is currently a Professor of Obstetrics and Gynecology at both the UCLA School of Medicine and Harbor-UCLA Medical Center. She also serves as Medical Director of both the Women's Health Care Clinic and Women's Health Care Nurse Practitioner Program at Harbor-UCLA Medical Center, as well as for the Research Division of the California Family Health Council. She is also Program Director of Women's Health Care Teams for the Coastal County Health Centers within the County of Los Angeles.

Board certified by the American Board of Obstetrics and Gynecology, Dr. Nelson has written extensively in the areas of contraception, menopause, and gynecologic infection. An author of Managing Contraception and Contraceptive Technology, she is also an Editor for Contraceptive Technology Update. Dr. Nelson is the recipient of many professional awards.

Dr. Nelson is engaged in research for Berlex Laboratories, NIH, NICHHD, Organon, Ortho-McNeil, and Pharmacia. She is a member of the Speakers Bureau of Barr Laboratories, Berlex, Columbia Laboratories, Eli Lilly, 3M Pharmaceuticals, Ortho-McNeil, Organon, Pfizer, Pharmacia, Solvay, Women's Capital Corp., and Wyeth.

here is an example of dr. darney's (undisclosed) flacking for mirena (it is remarkably similar to the press-release-y info repeated in web articles everywhere on mirena; the party line):http://www.kaisernetwork.org/Daily_reports/rep_index.cfm?DR_ID=5188 Cindery 01:55, 1 August 2006 (UTC)

BMI and hormonal BC

In this study, Obstet Gynecol. 2005;105:46-52 lower efficacy of OCs is correlated with higher BMI, with the arguments that steroid hormone metabolism is affected by greater body weight, and/or lipid metabolism. (steroid hormones are lipophilic. I think it is already commonly known that anesthesia drugs are lipophilic, and higher BMI means more drugs are needed??) It seems possible that women with a lower BMI would be more strongly affected by a lipophilic drug like levonorgestrel. (That could at least partly explain why some women have more/more intense hormonal side effects than others?)

Also to consider: genes. Especially genes and activity of enzymes which metabolize progesterone. Variety does exist.

And: levonorgestrel is derived from testesterone, is a "nortestosterone," with high relative androgenic activity in comparison to other synthetic progestins. (Isn't high BMI estrogenic? Might not then women with low BMI and less genetic ability to metabolize testosterone/higher genetic susceptility to testosterone in the form of receptors, be more sensitive to levonorgestrel, explaining heightened effects for a minority?)

I have been reading more about women having intense hormonal side effects from LNG (mirena dose)--all their hair falling out, bad acne, significant weight gain, terrible depression. And other women on LNG (mirena dose) having none. I believe that a minority of women are having these problems, and also that they are the minority. There has to be an explanation. Cindery 07:56, 1 August 2006 (UTC)

Population Council

"The first International Conference on Intrauterine Contraception in 1962 promoted the IUD. The conference was sponsored by the Population Council, a group concerned with curbing worldwide population growth. In his opening statement for the conference, Dr. J. Robert Willson said "We have to stop functioning like doctors, thinking about the one patient with pelvic inflammatory disease [...] how serious is that for that particular patient and for the population of the world in general? Not very [...] perhaps the individual patient is expendable in the general scheme of things" (Perry and Dawson, 23). The Population Council was founded by Rockefeller. Rockefeller had a strong interest in "eugenics," and donated money to the Nazis. Its last CEO was a former VP of J.P Morgan. (This is a "nonprofit organization"--but one with "unsavory origins" and huge financial support from corporations which had/have vested interest in maintaining American financial self-interest in developing countries via "population control.") Cindery 18:32, 1 August 2006 (UTC)

Grimes/Contraception Online

Exec. Editor of Contraception Online also has conflict of interest (which is disclosed there). Without a note indicating that conflict of interest in Mirena article per the reference, this ref. should be removed.

Dr. Grimes is engaged in research activities for Berlex Laboratories, Ortho-McNeil, and Wyeth. He is a consultant for ALZA, Gynetics, GynoPharma, Mead Johnson, Organon, Ortho-McNeil, Schering, Schmid, and Searle. He is a member of the Speakers Bureau for Berlex Laboratories, GynoPharma, Ortho-McNeil, Parke-Davis, Pharmacia Upjohn, and Wyeth.

citations 3, 7, and 14

have conflicts of interest, either they have to go, or mention of the conflict of interest has to cited *whenever* they are referenced. i am all for inspiring readers to think about possible conflicts of interest whenever they read something, but i think that would be clunky/inelegant in the article, and so these references should just go. (if they come from a conflict-of-interest source--and can't be duplicated by another source--that's further proof they don't belong here.)

The "conflicts of interest" issue gets brought up on contentious topics quiet often, and often risks becoming a rather pedantic source of edit-warring over allowable papers to quote; the problem being that if the journal is a WP:Reliable sources then all of its papers are "reliable" in as much as they may be cited (whether a paper is good/bad, innovative/duplicative is a personal opinion). The requirement is of course that the text in the article meets NPOV and a reference is provided from a reliable source. It is not wikipedia's role to pass judgement on any given paper (that's the role of the peer review process undertaken at the Reliable Source itself). So unless one finds a source to cite as stating that a paper had a conflict of interest, this risks being seen as a personal opinion (i.e. WP:NOR). I take a more relaxed view on references, namely I expect the text to be NPOV and refs used to verify a claim is made but not prove "the whole truth" (example: many articles on aspirin reducing heart disease in otherwise well population and any paper could be quoted even if from manufacture. The problem is not if independant researcher or manufacture make such a claim, as effect is true enough, but rather that offset by increase in gastric ulcers and bleeds (i.e. cardiology journals conflict with gastroenterology journals) - in real life, consensus of medical practice is not based on "whole accurate truth" of any given paper, but the integration of knowledge from multiple papers, experience, practicle considerations etc). David Ruben ^Talk 04:07, 2 August 2006 (UTC)

All that somewhat long winded (sorry). As for ref 3, this is a claim for IUS role in reducing need for hysterectomy and thus not fanciful thoughts of an editor (my seeing clinic letters from local gynaecologists advising & doing this can't be cited in wikipedia, but its true enough and such a paper acts as some form of real-world verification). Other refs can be provided showing there may be a problem with the cost-benefit analysis, namely that may prevent need of hysterectomy in short term, but some patients over a longer time frame may still need hysterectomy (not clear if IUS failling to help, or underlying disease gets worse and nolonger can be controlled by medical means). I don't think the Ref 3 is therefore wrong, just that like most topics, no one paper gives whole picture. Or have I missed some terrible feature of that paper ? :-) David Ruben ^Talk 04:07, 2 August 2006 (UTC)

because there has been such a scandal in last ten years or so in terms of pure science polluted by industry (did you read the uk article i posted about 50 percent of med journal articles are estimated to be paid for/ghostwritten/have a financial conflict of interest? even--no, especially-- very prestigious ones?), there is a definite question about whether prestigious=reliable. a reliable source by name does not mean it's a reliable author/article. even the new england journal of medicine etc have noticed too late/admit that ghostwriters got past them/drs names were attached to articles the drs had never even seen.

to counteract *some* of the industry hijack of pure science, authors are *required* to disclose conflicts of interest. (although that is why it is speculated that industry then hides in ghostwriters/payoffs--it's the only way around disclosure of conflicts of interest). anyway, it's pretty much impossible in this medium to do investigative research about who the ghostwriters/payoff/outright theft of name articles are. but when authors *have* disclosed conflict of interest, that IS something that should be noted. it's not an *accusation* of conflict of interest--it's self-disclosure by the authors per the ethical standards of the profession. the problem i have with citing articles in an encyclopedia touted as more accurate/as accurate as previous standard texts, is that even if the assertions they back up are fairly innocuos/not so much the issue, the cumulative effect cheapens the ideas/ethics of pure science, integrity, reason, ethics itself, etc. if you click on one of those sources and read the article without being alerted that there is a conflict of interest, and then another, and then another--they reinforce each other, with a substitution of falsehood/pr for the truth/more rigorous, accurate standards. (that american family physician article is just crappy, for one thing. it's just a rehash of selected text in berlex product insert, with like 12 footnotes, which give the misleading impression that a lot of research backed it up. i found about three times another source was actually necessary, and not for much. it's a piece of fluff dressed up as an article, not an article. that is what i object to more than anything.) darney/shulman/nelson piece is equally rah-rah insubstantial, but freight of pub adds unwarranted credibility. i was not surprised at all to find all three on berlex speakers bureau. did you *read* their piece? do you know what "speaker's bureau" means? they don't give lectures--they flack. they are quoted in press, like in moronic kaiser piece...

anyhow, per professional ethical standards, fine to reference them--but the conflicts of interest have to be noted, per professional ethical standards. as in "darney, shulman, nelson paid to be on berlex speaker's bureau."

the finnish article is not so egregious/sleazy, but all the finnish authors on the menoragghia ref work for leiras oy, and that should be noted if you wnat to use that reference. (i don't have a problem with their conclusions in that paper, except maybe that since i have no access to the fulltext of article on adenocarcinoma in the two users who presented initially with menoragghia, i don't know if that implies that is a risk of mirena for menoragghia. since there haven't been any long-term studies, it seems not so cautious to promote it for that use without them. maybe i am a little disturbed by "alternative to hysterectomy!" hype, but that is quoted elsewhere, not in the leiras oy study. (i thought endometrial resection/acupuncture, some drug ending with "-ex", lots of things were alternative to hysterectomy for heavy bleeding? good for hysterectomy hardly makes it only alternative...) it's actually an article with some substance, so not unworthy like the afp piece, but if the manufacturer/owner of license sponsored the study, readers should be able to take that into account. leiras oy isn't exactly hiding it.

Cindery 09:11, 2 August 2006 (UTC)

Yes I did read the link you gave re "ghost writting" (Guardian newspaper if I recall) - and very alarming. I had only relooked at Ref 3 of those that your querried. Woud this Cochrane review be better (it comapres diferent studies and independantly weighs usefulness of evidence eg study designs, numbers, duration of followups etc) ?

• Marjoribanks J, Lethaby A, Farquhar C (2006). "Surgery versus medical therapy for heavy menstrual bleeding". Cochrane Database Syst Rev: CD003855. PMID 16625593. CS1 maint: Multiple names: authors list (link)

it seems entirely reasonable and unbiased to me. Cindery 19:24, 2 August 2006 (UTC)

Reference on what Mirena does to reproductive system (currently #7)

Is the information itself being questioned? Is there reason to believe Mirena does not actually reduce the frequency of ovulation? Or cause changes in cervical mucus detrimental to fertility? Or anything else in that list?

I guess I'm just puzzled as to why the reference for those particular facts is being questioned. I have seen discussion along the lines of "that's not true, look at this other source that is more reliable than the one that has the non-true statements."

But it's frustrating to spend time trying to find a website with some sort of substance (vs. just a college birth-control infopage or other source that just lists statements), and then be told "nope, what you're saying is true, but we're going to delete it from the article because there's something completely unrelated wrong with the source." Lyrl ^Talk _Contribs 01:03, 3 August 2006 (UTC)

So, let's run potential alternative sources by the editing committee:

• The Mirena IUD on dentalplans.com - It lists three of the effects (ovulation, cervical mucus, changes in uterine environment) rather than just the first two as most websites do. It does not list the changes to the endometrium, which I think needs to be included, so a seperate source would need to be found for those. And dentalplans.com? Doesn't sound like a respectable source.
• Method of Contraceptive Action cites the studies on how copper IUDs change the uterine environment to be spermicidal/ovicidal. If a source was used that only listed the ovulation/mucus changes, this could be used for the uterine environment changes. It doesn't have any mention of hormonal IUDs, so it might be a violation of WP:NOR to use this source to support this effect with Mirena, although it is actually where the terminology of leukocytes and prostaglandins came from.
• Intrauterine device for birth control - This mentions all the effects except for reducing ovulation frequency, so another source would have to be found for that. It also cites Contraceptive Technology, which seems to be a well-respected resource (unless there's something wrong with that publication?). The wording on the uterine environment changes "prevents fertilization by damaging or killing sperm" is very vague, though.
• Contraception - The Mirena IUD - This seems more promising than others, as it lists three effects in clear language. It does not list the effect on the endometrium, so an alternative source would have to be found for that. It is written by a doctor, so doesn't have the facial credibility problems of someplace like dentalplans.org. Of course, that doctor or that website (pregnancy.org) may have some conflict of interest.
• control methods/articles/0,,549123_599845-10,00.html Contraception A-Z lists all four effects (first one I've found since the STEPS article), but the language is very non-scientific and unclear ("suppressing the normal "plumping up" of the womb lining"?) and not entirely accurate ("slowing movement of sperm" rather than "killing sperm" which is what actually happens).

And that was all I got looking at the first twenty pages of a Google search. Anyone else have ideas for alternate sources? Lyrl ^Talk _Contribs 01:03, 3 August 2006 (UTC)

i was not intending to irritate you, and yet i can see how it might have been irritating. i apologize for any irritation you may have felt.

i was actually looking up today what research is *underneath* the website summaries, hoping for good thing to recommend. they all cite the ortiz study below.

(what i learned/didn't know is that all devices (pacemakers, iuds, etc) induce the inflammatory foreign body response. (which sets off the white blood cells, neutrophils, etc --which de-activate sperm/eggs to some degree. not to *enough* of a degree--alone an iud has 18% pregnancy rate. copper or hormones are what bump it up to higher level of efficacy).

(that may go toward explaining a couple things, making them make more sense... the body's natural response to a foreign object is to expel it or incorporate it--hence expulsion/migration/embedment, when body is successful. white blood cells/slightly lowered immunity/neutrophils help infection. i read up on actinomycosis and other biofilms--it seems the most common bacterial colonizations found on iuds removed after infections are staph, not stds. "inflammatory foreign body response" is an inherent risk of the device.)

can we cite ortiz study and something re progestin and cervical mucus/thinner endometrium? (that's the main difference in pregnancy prevention between copper/progestin--the cervical mucus/endometrial changes.)

Mechanisms of action of intrauterine devices.

Ortiz ME,Croxatto HB, Bardin CW.

Instituto Chileno de Medicina Reproductiva, Santiago, Chile.

The major effect of all intrauterine devices (IUD) is to induce a local inflammatory reaction in the endometrium whose cellular and humoral components are released into the uterine cavity. This inflammatory reaction has a variable effect on the reproductive strategy of the species studied. For example, this foreign body reaction can be localized within the uterus of rodents; and in farm animals it can have striking extrauterine effects. Thus, the action of IUDs in humans cannot be discerned from animals. In humans, copper ions released from Cu-IUDs enhance the inflammatory response and reach concentrations in the luminal fluids of the genital tract that are toxic for spermatozoa and embryos. In women using the IUD, the entire genital tract seems affected, at least in part, because of luminal transmission of the fluids that accumulates in the uterine lumen. This affects the function or viability of gametes, decreasing the rate of fertilization and lowering the chances of survival of any embryo that may be formed, even before it reaches the uterus. Studies on the recovery of eggs from women using IUDs and from women not using contraception show that embryos are formed in the tubes of IUD users at a much lower rate compared with nonusers. This is believed to be the major action of IUDs. Therefore, the common belief that the major mechanism of action of IUDs in women is through destruction of embryos in the uterus (i.e., abortion) is not supported by the available evidence. In Cu-IUD users, it is likely that few spermatozoa reach the distal segment of the fallopian tube, those that encounter an egg may be in poor condition. Thus, the few eggs that are fertilized have little chance for development and their possibility for survival in the altered tubal milieu become worse as they approach the uterine cavity.

PIP: All IUDs induce a local inflammatory reaction that disturbs the functioning of the endometrium and myometrium and changes the microenvironment of the uterine cavity. Moreover, these effects alter signaling between uterus and ovary. The entire genital tract seems affected, at least in part because of luminal transmission of fluids accumulating in the uterine lumen. Copper or progesterone-releasing IUDs may attenuate or accentuate the inflammatory response, disturb the physiology of the gametes in the female genital tract, or destroy the viability of the embryos or endometrial receptivity to implantation. Studies on the recovery of eggs reveal that embryos are formed in the tubes of IUD users at a significantly lower rate compared to non-users. This, rather than the destruction of embryos in the uterus, appears to be the IUD's major mechanism of action.

     PMID: 8972502 [PubMed - indexed for MEDLINE]  

Cindery 05:48, 3 August 2006 (UTC)

breastmilk pov

re breastfeeding and "conflicting points of view" needs citation--the conflict seems to be that there are two issues 1) does it affect milk quantity (no, in fact it increases milk quantity) vs. does it affect infants (yes, they get more respiratory and eye infections, short term). no studies of long-term effect. and there is one study in which milk quality was affected by LNG--protein slightly decreased at 10 months, lipid profile changed at 7 mos. the conflicting opinions are obvious: affect on baby vs. affect on milk quantity. what david is citing is uk web sites that confirm milk quantity is not adversely affected. (that doesn't mean the milk quality is necessarily good short or long term for the baby, or that it is the same as without lng.) i don't think it needs a citation, but maybe clarity. Cindery 03:10, 2 August 2006 (UTC)

What I would like to see is a reference that says that effect on infant is not significant, and a second reference that says the presence of progestin in breastmilk is a cause for concern. So a reader can see that yes, there is a conflict.

On milk quantity, there is currently a sourced statement saying that some doctors do not believe quantity is affected, and then a reference to a study finding that quantity might actually be reduced. I think the article would be better if something like that was done to the discussion over effect on the infant.

And however it turns out, I hope the article doesn't end up worded so it discourages breastfeeding - if a woman only trusts/has access to/is able to use hormonal birth control, I wouldn't want anyone choosing not to breastfeed because of possible effect of hormones - benefits of breastmilk far outweigh possible adverse effects of hormones. Lyrl ^Talk _Contribs 01:10, 3 August 2006 (UTC)

well, for "conflict of opinion," here's a ref which cites that planned parenthood and the WHO disagree over the safety of sex steroids in breastmilk/progestin only contraception--in the first six weeks post partum. (although they both agree it's fine after that).

re breastmilk a benefit no matter what--definitely. even though women pass on a lifetime's store of DDT etc in breastmilk, breastfeeding is still beneficial. (but given how much xenoestrogens/pesticide residues/mercury, lead etc are passed on in breastmilk, why would anyone want to add an elective pollutant. women avoid caffeine when they're breastfeeding--steroids certainly seem higher risk...)

also, no long term studies have tracked children breastfed by mothers using progesin only contraception (to see if, say, they have higher risks of cancer, early or late puberty, etc.) one person, sf minkin, has said in a pubmed ref that breastfeeding on depo violates the nuremberg principles on experimentation without consent, as the infants certainly aren't consenting...

but if you want to cite WHO/PP disagreement, i don't mind, as long as other things are not changed in that paragraph.

Lactation

As in the postpartum phase, contraceptive choice during lactation depends on the length of time since childbirth and on the type of hormone selected. WHO advises against hormonal contraception use during the first six weeks postpartum in women who are breastfeeding because of concerns about the potential effects of steroids on liver and brain development in neonates. From six weeks to six months postpartum, the risk of diminished quantity and quality of breast milk may outweigh the benefits of estrogen-containing contraceptives.19 This risk may be more important to women who breastfeed exclusively. After six months postpartum, when infants begin to eat solid food, the benefits of estrogen-containing contraceptives may outweigh their risks.19

Progestin-only contraceptives have been studied more thoroughly in the postpartum setting. Even in the first six weeks postpartum, these contraceptives do not adversely affect milk production or infant growth.20 The Planned Parenthood Federation of America (PPFA) recommends progestin-only methods at any point postpartum.9 However, WHO suggests that the risks of progestin-only methods (i.e., neonatal steroid exposure) may outweigh the benefits during the first six weeks after childbirth. The PPFA and WHO are in agreement that women who are breastfeeding can safely use progestin-only contraceptives after six weeks postpartum.19

Lactation itself prevents pregnancy in the first six months postpartum in women who remain amenorrheic and whose babies get 90 percent or more of their calories from breast milk. However, a recent review of lactational amenorrhea as a contraceptive method found pregnancy rates ranging from 0 to 7.5 percent,21 pointing to the need to explore contraceptive options even with women who are breastfeeding exclusively.

progestasert in sidebar

i think mirena needs its own page; progestasert first use does not belong in mirena sidebar--it's misleading, due to the very different forms of progestin used.

if mirena were grouped categorically with another form of hormonal bc, the closest comparison would be norplant, not progestasert. levornorgestrel is a nortestosterone (a progestin derived from testosterone, with highly androgenic effects) and both mirena and norplant are implant devices which use LNG...

i agree greater clarity could be made in article about "what is it?" it's an iud which uses hormones from the progestin category, specifically: LNG. the differences among the progestins are significant. (the progestin in depo cause bone loss; LNG is androgenic; the spirolactone in yasmin changes blood pressure/potassium levels, etc...) no iud using levo has been around since 1976, and progestasert wasn't called an "ius." Cindery 19:45, 6 August 2006 (UTC)

The oral contraceptive page is not seperated out into the different progestins used. The differences in women's reactions to the different progestins seems to be just as significant as the differences amoung the progestins themselves. I think seperating them could be just as misleading as grouping them together. Lyrl ^Talk _Contribs 15:10, 7 August 2006 (UTC)

Some medical practitioners seem to have grabbed onto the IUS label as a convenient way to differentiate hormone-containing vs. copper-containing intrauterine contraception. While it started as a marketing stratagy (might as well have called it the AntiBaby 5000 or something), the way it is being used seems to have gone beyond that:

[4] Please do not get confused between the IUD and the IUS. The IUS isn't the same thing at all.

[5] In the 1970s a new approach to the delivery of hormonal contraception was researched and developed. It was suggested that the addition of a progestogen to a non-medicated contraceptive device improved its contraceptive action. An advantage of these hormonally impregnated intrauterine systems (IUS) is that they are relatively maintenance free...

The PubMed article, in particular, by saying that the IUS was developed in the 1970s, supports my impression that the term IUS is now being used to mean 'hormonal intrauterine contraceptive' rather than just being a manufacturer marketing strategy. The use of the term IUS for devices developed by Contrel, a competitor company to Berlex and Schering, also supports this impression. Lyrl ^Talk _Contribs 15:10, 7 August 2006 (UTC)

...in ref #4, it is claimed that the IUS is a hormonal contraceptive "good for period problems"--i.e., it specifically refers to mirena. progestasert was never good for/marketed as good for period problems.

in ref #5, progestasert is referred to as "progestasert," (not an IUS) while lngs are referred to as IUS devices.

for hormonal iuds, only two progestins have been used, and they are markedly different in action--it seems entirely reasonable to distinguish them. i see "hormonal iuds" all over the literature to distinguish copper iuds from hormonal iuds, not "ius." i don't have a problem with saying mirena is an "ius," whether it's branding or not. but categorocally speaking, there is the category of iuds. among the types, there are medicated, copper, hormonal. within the hormonal subtype, there are progesterone and levonorgestrel. the problem with conflating the two hormonal subtypes is that levo stops/lessens periods significantly--as a distinguishing feature, so much so that it is prescribed for menorraghia--and causes androgenic effects. that's not the case with progestasert.levo can be left in for five years, progestasert had to be replaced every year. i think it's too confusing to conflate them, and that "ius" is not a category signifying "hormonal iud"--it's a name attached to mirena. putting progestasert in the sidebar doesn't just imply that mirena has been used since 1976, it also implies that progestasert could be left in for five years, can treat menoragghia, causes functional and benign ovarian cysts, etc--none of those things are true. Cindery 20:11, 7 August 2006 (UTC)

According to Metagenics.com [6], bioidentical progesterone, including Progestasert (if you scroll down to "Usual Dosage" it talks about an intrauterine device that is effective for one year), causes ovarian cysts in more than 10% of users (under "Adverse Reactions - Systemic").

The FDA document at the bottom of page 37 says that There is precedence for cyst formation with progestins when they are used at levels that do not consistently inhibit ovulation, such as in the Norplant and the progestin-only birth control pills. Implying this is a side effect of ALL progestagens, not something specific to levonorgestral.

According to the Emory University webpage on Progestasert [7]: Women who use the Progestasert IUD experience decreased menstrual cramping and decreased menstrual blood loss. (Though you may bleed for more days, the overall blood loss is less.) and Some women stop having periods completely. Which, to me, sounds very similar to Mirena effects, so touted as menoragghia treatment.

Page 11 of the FDA document implies the only major difference between Mirena and Progestasert is the 5-year effectiveness (vs. 1 year).

How long they are effective, as far as I can tell, is the only major difference between Mirena and Progestasert. I'm reluctant to start a stub on Progestasert (that would probably remain a stub forever, since the device has been discontinued), when this difference could be addressed by putting 5 years (Mirena) in the Duration effect box. Lyrl ^Talk _Contribs 22:09, 7 August 2006 (UTC)

The link 5, above, has as its only selection criteria: SELECTION CRITERIA: All randomised controlled trials comparing IUSs with other forms of reversible contraceptives. Therefore, it did not include trials that did not contain an IUS. The study did include trials that compared Progestasert to copper IUDs. Therefore, the study authors consider Progestasert to be an IUS.

On what basis would the link 4 say that the IUD and IUS are completely different? The only thing I can think of is the hormonal component, meaning the authors of that page consider all intrauterine hormonal contraceptives to be IUSs.

The use of the term IUS for devices developed by Contrel [8] also supports this use of the term IUS as being all intrauterine hormonal devices.

I agree that there is source conflict over this usage of the term IUS. I even support discussion of this conflict in the article: #IUD/IUS name discussion removed? But this is the way some medical sources are using the term (so there is precedent for grouping Progestasert/Mirena/future devices from Contrel), I believe any possible areas of confusion (such as how long the device remains effective) can be overcome, and I do not see any benefit to having a stub of a Progestasert article. Lyrl ^Talk _Contribs 22:09, 7 August 2006 (UTC)

the study below points out a few things--progestin dose in progestasert much higher than mirena (and yet lessening of bleeding not as great). it looks like only one study was performed on progestasert as a treatment for heavy bleeding, and it wasn't concluded that it would be good for that (was never prescribed.) also, progestasert not as effective in preventing pregnancy as mirena (2.5 vs 1.1?) and that's why it had to be replaced yearly--couldn't mainatin a doubly less effective rate than mirena after one year.

i haven't researched cysts, but will take you at your word.

i still think there are too many differences for conflation to make sense (pregnancy efficacy, length of time used, off-label menorraghia use--all things pointing to a difference in the type of progestin.) there's also the matter that levonorgestrel can function as an estrogen as well as an androgen and progesterone--i haven't seen that for progestasert.

if you're concerned that progestasert would be a stub, why don't we work on making it better than a stub (under the category "hormonal iuds" or "progestin iuds" instead of making the mirena article confusing? the sidebar is supposed to be "most important info" about mirena -- details about another --a defunct-- iud just don't seem to fit that criteria...

(article below also refers to both mirena/progestasert as "progestin iuds," not "intrauterine systems." i really haven't seen "ius" used as a standard, and i think it's confusing. "hormonal iud" or "progestin iud" make sense.)

[9]

In looking at other contraceptive articles, it seems common to group devices. Diaphragm covers both rubber and silicone diaphragms, despite different care instructions and allergenicity. Intrauterine device covers inert, first-generation copper, and second-generation copper devices, despite wide differences in effectiveness, duration of effectiveness, and seriousness of side effects. Condom covers condoms made of latex, rubber, polyurethane, nitrile, and animal intestine, again despite widely differing effectiveness and side effects. To me, the differences encompassed in the other birth control articles are just as large as the differences between Progestasert and Mirena.

I really like having a top-level article on hormonal IUDs, vs. having a couple of articles on specific versions but no unifying discussion. While the NHS article uses "progestin IUD" rather than "IUS" - it still groups Progestasert and Mirena together, in the same category. I would be open to changing the name of the article to "hormonal IUD" or "progestagen IUD" or similar, if it is believed that would lessen reader confusion.

It looks like we both view Progestasert as unnoteworthy. We just disagree on how to deal with an unnoteworthy device - I don't think it deserves its own article, and you don't think it deserves a date in the infobox.

Is 'date of first use' part of the most important information about a contraceptive option? To me, it looked more like a curiosity field. And I was certainly curious about when someone first had the idea of delivering hormones directly into a woman's uterus. Not so much about when a particular name brand was first marketed. Of course, I've done work on the history section in the birth control and condom articles, and wrote the history sections in the IUD and spermicide articles. Maybe I'm unusual?

The infobox itself (Template:Infobox Birth control) is very new - only about six weeks old, so not alot of discussion on it.

We could propose deletion of the "date of first use" field as not being in the same category as the medical-type information found in all the other fields. Lyrl ^Talk _Contribs 02:30, 9 August 2006 (UTC)

well, yes, you are sort of unusual in that you have a refined, rigorous curiousity and intelligence about how fertility/conception/contraception work--but that's why articles you have contributed to in the bc category are so much better than ones you haven't had a hand in, in my opinion. so being unusual is one of your good points...

i'm not sure what you are proposing re the date of first use--delete it from sidebar entirely? i don't think that makes sense...isn't it a "required" field?

there is already info about other hormonal iuds at the bottom the mirena page, and that seems like where info about progestasert should go (with or without a link to its own stub or article...) we could note that is was the first hormonal iud used, and that it released a "true," 21 carbon progestin that was not as effective as levo, which is being used for all the other hormonal iuds? (femilis and fibroplant are levo, too...)

now that i know a lot more about progestins, i am really reluctant to ok their conflation. for a casual reader, progestasert=mirena means all the progestins are alike, and they're not...(i think this is less of an issue for the pill, because all the pills use 19 nortestosterones. but it may come up more with the advent of yasmin, with its "fourth generation" spirolactone-derived progestin...)

here is something from our old pal p. darney on the androgenicity of progestins that might make things more clear:

Am J Med. 1995 Jan 16;98(1A):104S-110S. Links The androgenicity of progestins.

Darney PD.

Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.

All steroid hormones are structurally similar, but relatively minor differences cause profound alterations in biochemical activity. The 21-carbon series (pregnane nucleus) includes the corticoids and the true progestins (e.g., medroxyprogesterone acetate). The 19-carbon series (androstane nucleus) includes all the androgens, among them the progestins used in most oral and parenteral contraceptives. The removal of carbon 19 from testosterone changes the major hormonal effect from androgenic to progestogenic, but these "19-nor" steroids retain varying degrees of androgenic activity. (They can also have limited estrogenic activity, but this is insignificant at the low doses used for contraception.) Some of the 19-nortestosterone progestins are metabolized to other compounds (e.g., norethynodrel, ethynodiol diacetate, and lynestrenol to norethindrone), and some (levonorgestrel, desogestrel) are active unchanged. The lingering androgenic effects of 19-nor progestins are dose-related, opposed by estrogen, and are manifested metabolically (e.g., glucose tolerance, lipoprotein synthesis) and symptomatically (e.g., acne, weight gain). The effect of 19-nortestosterones on lipoproteins prompted the development of less androgenic compounds, but the obvious benefit of the new progestins (desogestrel, gestodene, norgestimate) is a reduction in the symptoms associated with the androgenicity of the older compounds. Mitigation of androgenic effects on lipoprotein and carbohydrate metabolism could have long-term benefits, especially for women who are at risk of arteriosclerotic vascular disease; however, these effects remain to be epidemiologically demonstrated.

PIP: This paper reports the results of a review of current literature on progestin androgenicity and any progress made to reduce androgenicity. Structurally synthetic, steroid hormones are similar. The 19-carbon structure series includes all the androgens, including the progestins used in most oral and parenteral OC formulations. Some 19-nortestosterone progestins are metabolized to other compounds and some are active as they are. Androgenic effects of 19-nor progestins are dose-related, opposed by estrogen, and are manifested metabolically or symptomatically. Effects on lipoprotein and carbohydrate metabolism may play a role in the development of vascular disease. This has lead researchers to develop safer, less androgenic compounds characterized by fewer androgenic side effects.

PMID: 7825629 [PubMed - indexed for MEDLINE]

and here's something else:

Comparative evaluation of androgen and progesterone receptor transcription selectivity indices of 19-nortestosterone-derived progestins.

Garcia-Becerra R,Cooney AJ,Borja-Cacho E,Lemus AE,Perez-Palacios G,Larrea F.

Department of Reproductive Biology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Quiroga No. 15, Mexico City 14000, Mexico.

Synthetic 19-nortestosterone-derived progestins show affinity for the androgen receptor (AR) and retain varying degrees of androgenic activity. In this study, AR- and progesterone receptor (PR)-dependent transcriptional activation induced by norethisterone (NET), levonorgestrel (LNG) and gestodene (GSD), and their 5alpha-reduced derivatives, including limited trypsin digestion of AR in the presence of natural and synthetic progestins were investigated. The results confirmed the progestogenic activity of the three 19-nortestosterone derivatives, which decreases after reduction of the 4-ene-double bound. These compounds were able to activate AR-dependent reporter gene expression, LNG and GSD being the stronger activators. 5alpha-Reduction of LNG and GSD did not change their androgenic transcriptional activity; however, the activation of AR by 5alpha-NET was four-fold higher than NET. The highest selectivity transcriptional index, as a measure of progestogenicity versus androgenicity, was obtained for NET. The 5alpha-reduced derivatives had values significantly lower than those of their parent compounds. Non-reduced and 5alpha-reduced 19-nortestosterone progestins induced virtually identical proteolysis fragmentation patterns of the AR to those observed with DHT.

PMID: 15261304 [PubMed - indexed for MEDLINE]

the main point being, i think, that 19 nortestosterone progestins are derived from testosterone molecules, not progesterone molecules, and thus bind to androgen receptors as well as progesterone receptors...

(there is no "bioidentical" progesterone, by the way...synthetic progesterone molecules have the same chemical structure as progesterone made by the body, that's all. depo is considered a "true" progestin. the presumption that because the molecules are the same, external progesterone is "natural" or guaranteed to act in the body as if the body had made it is not correct/hasn't been proven. there's a very complicated conversation amongst the cells--all the PR and ER and AR receptors and the genes they activate...it's not just the progestin itself that is or isn't natural, it's the dynamic...)

other notes on "first use" in bc articles...for cervical cap and lea's shield, there is no first use date listed (meaning no one decided diaphragm first use date was the same for these). for progestin-only pill, first use date is blank--not the same as cocp...

Cindery 20:57, 9 August 2006 (UTC)

The "date of first use" is currently a required field. But I could post on the talk page of the infobox (Template talk:Infobox Birth control) and ask if they're OK with changing it to an optional field. The format of the box is just as mutable as everything else on Wikipedia.

Would deleting the date altogether be a workable compromise? Lyrl ^Talk _Contribs 22:17, 9 August 2006 (UTC)

Sorry, I don't quite follow, what's wrong with having a date ? Just because not listed for some of the pages does not mean such information is not of interest and so needs filling in. If Progestasert was discontinued in 2001, then the main focus of the article is going to be on the currenly marketed product (Mirena), so why not add date and qualify for which product.

  Hence: 1976 Progestasert<br>1990 Mirena  Gives: 1976 Progestasert         1990 Mirena  

Let me know what you think David Ruben ^Talk 23:36, 9 August 2006 (UTC)

progestasert used synthetic progesterone, and mirena uses levonorgestrel, which is derived from synthetic testosterone. the 21 carbon and 19 carbon sex steroids are different enough that they shouldn't be conflated for devices using different ones. listing both progestasert and mirena in the mirena sidebar implies that all the rest of the sidebar info for mirena was also true for progestasert, which is not the case. instead of adjusting the pregnancy efficacy rate to .01-2.5 from .01, and the length of time usable from 5 yrs. to 1-5 years, and deleting the off-label use for menoragghia or adding "mirena only," it makes more sense to talk about progestasert at the bottom of the article with the rest of the other hormonal iuds. Cindery 00:22, 10 August 2006 (UTC)

Very sensible - will so change "dates" to be just that of Mirena and given, as you correctly point out all of the details of the infobox apply just to the currently available formulation, we can qualify the infobox's title with the optional name parameter. David Ruben ^Talk 02:23, 10 August 2006 (UTC)

I guess my disappointment is that I find it significant that hormones were first delivered directly into a woman's uterus in 1976. I do not find it so significant that a second-generation hormonal IUD was marketed in 1990. And now there's no way to prominently display the 1976 number.

Very similarly, in the IUD article, I put the date that a contraceptive device was first inserted into a woman's uterus, despite all the other parameters only applying to 2nd-generation copper IUDs. I suppose we need to change the first use field to the date of marketing of the first 2nd-generation IUD. Oh, well. Lyrl ^Talk _Contribs 22:31, 10 August 2006 (UTC)

"bioidentical" progesterone

i can't find the word "bioidentical" in any dictionary. (but i didn't check the OED.) it is used in a few very recent pubmed articles, but it is used in quotes, as in, so-called "bioidentical." the only places it seems to be used as a word are in ads for progesterone cream. my conclusion is that it is not a commonly accepted term/a word in general usage.

as far as i understand: progesterone is synthesized in labs, from plant steroid compounds like stigmasterol. (which comes from soy.) it has to go through many synthetic steps to ferment and bio-convert it, and be treated with solvents like acetate. at the end of the process, it can be left at as it is, micronized for easier absorption, or a molecule can be added to make it more bioavailable (that's MPA, aka, depo). all the progesterone is exogenous and synthetic. (pfizer doesn't get their soy stigmasterol from a different source than "natural" progesterone creams do. it's the same stuff: soy. has to be highly chemically processed to be usable by the human body.)

for a while, it seems that wild yam was believed to be a "natural" progesterone, but that proved to be false. wild yam contains the plant steroid diosgenin, which chemists can break down into progesterone--as with stigmasterol-- but which the human body can not break down into progesterone. there is no natural source from which the human body can make it own extra progesterone. all progesterone used by the human body is manufactured in chemical labs.

in addition to not being a word in general usage, "bioidentical" is misleading, i think. or meaningless. USP progesterone is a synthetic chemical derived from plants, which can have the same chemical structure, after processing, as human progesterone. that's all. Cindery 23:06, 12 August 2006 (UTC)

The word progesterone has been conflated with progestin (as in the common usage 'progesterone-only pill' when the pill actually contains a progestin). When one is talking about progesterone, as in a molecule with an identical chemical structure to that produced in the human body, it is useful to have some identifier to distinguish from progestins. Some sources use 'bioidentical', others use 'natural'. Lyrl ^Talk _Contribs 00:03, 13 August 2006 (UTC)

http://www.inchem.org/documents/iarc/suppl7/progestins.html

this link contains the list of synonyms for progesterone from IARC (progestasert is included here.) progesterone is classified as a 2B progestin by IARC, with all the other progestins.

(also, at no time was progestasert marketed by alza as "natural" or "bioidentical"--those are claims made solely by recent hrt progerserone manufacturers...no source ever called progestasert "natural" or "bioidentical," including alza.)

the IARC conflation of synthetic progesterone with progestin seems to be seconded by dictionary/medical definitions, and pub med--a search of"progestasert + progestin" gets about 20 hits; a search for "progestasert + natural progesterone" or "progestasert + bioidentical progesterone" gets zero.

for example: PMID: 7704726 Cindery 01:08, 13 August 2006 (UTC)

HIV

Could the information on HIV be integrated into the earlier warnings on other STDs (under contraindications)? It seems awkward to have information on this topic in two places. Also, could a different article ([10], for example) be used? The current article says the increased risk in monkeys was because of endometrial changes, which is not true (HIV and SIV are believed to be transmitted through the vaginal walls, not through the endometrium). Lyrl ^Talk _Contribs 00:15, 16 August 2006 (UTC)

1) i think hiv is important enough to stand on its own, as it is a lethal std and a global health problem. a %500 increase in risk transmission is pretty horrifyingly significant..

2. i have no objection to both refs being used. i'm not aware of any studies which claim that hiv is only transmitted vaginally and cannot be transmitted through the uterus. it can be transmitted orally and anally, why not throught the uterus? i'm also not sure if levo thins the vaginal walls or not. Cindery 01:37, 16 August 2006 (UTC)

...this article does state that progestins thin the vaginal walls (and also quotes a different statistic, based on same number of monkeys--"7 times more likely" rather than %500.) http://www.aegis.org/news/ap/1996/AP960508.html Cindery 01:45, 16 August 2006 (UTC)

Two points relevent to the importance of the HIV information to this article. First, women get HIV mostly by having unprotected sex with HIV-positive men. The relative per-intercourse risk to these women of using progesterone-only contraceptives vs. other non-barrier methods (or no method) is kind of a moot point - if they persist in this behavoir, they will almost certainly get HIV regardless of their non-barrier contraceptive choices. HIV prevention gets the most results when women are encouraged to use condoms at every act of intercourse.

Second, the studies in humans do not seem to line up with the original monkey study:

• Progesterone-HIV link questioned by new studies. Studies in the U.S. and Thailand do not show any progesterone-HIV link. Also, examination of human vaginal thinning shows that it is less than that observed in the monkeys in the progesterone-SIV study.
• Progesterone and STDs: selected studies. A study in Kenya finds no progesterone-HIV link. A study in Rwanda shows no progesterone-HIV link when the protective effect of condoms is accounted for.
• Hormonal contraceptive use and HIV-1 infection in a population-based cohort in Rakai, Uganda. This study in Uganda found no link between use of any hormonal contraception and acquiring HIV.

Lyrl ^Talk _Contribs 01:16, 17 August 2006 (UTC)

can we note that vaginal thinning has been observed to be less in humans than monkeys, and that the biggest risk for hiv is unprotected sex with an infected partner, not a thinned uterus/vagina?

i'm reluctant to chuck the whole finding out as irrelevant, and would rather qualify it with the mitigating factors you mention. (it is possible to be exposed to stds and not contract them, and other transmission-enhancing factors have been noted re hiv--cuts/tears/abrasions in skin, depressed immunity to begin with, etc...)Cindery 02:33, 17 August 2006 (UTC)

some exculpatory evidence for "natural" progesterone

Here is a study which asserts it is possible that only MPA and the nortestosterones are the bad actors in breast cancer risk (because they are androgenic (MPA and nors) and estrogenic (just nors), while synthetic exogenous progesterone which is chemically identical to endogenous progesterone does not have androgenic/estrogenic effects.

[11] this one also:[12] Cindery 22:38, 18 August 2006 (UTC)

clinical uses

...that paragraph seems so fuzzy with fresh eyes, but want to check in before reworking/maybe someone else would rather do it. the main clinical use is contraception, but we don't start off by saying that, we say it thins the endometrium...kinda confusing. then we list the secondary uses, then we list what it is not used for. maybe the contraceptive mechanism of action/the main clinical use as contraceptive should be focus of first paragraph, with second paragraph detailing secondary uses, and non-uses go somewhere else further down? Cindery 00:32, 4 September 2006 (UTC)

Edit 8-October

• I moved the "Removal" section to below the "Mechanisms" section. Reading about fitting -> contraception -> removal seems to be a logical order.
• I moved the "Location" section to the top of the side effects section.
• I fixed the url in a citation of Planned Parenthood (PP had redesigned their webpage), and combined the duplicate ref of that webpage.
• I changed the wording of the string discussion per #cutting strings discussion.
• I made a new sub-section "Pelvic inflammatory disease and sexually transmitted diseases" and removed the sentence on that from the "Contraindications" section. I combined the information in the "HIV" section into the new "Pelvic..." section and modified the information per #HIV discussion.
• I made a new sub-section "Postpartum and Postabortion insertion" and removed that sentence from the "Contraindications" section.
• I broke out the discussion of cancer into its own subsection and removed that sentence from the "Contraindications" section.
• Benign trophoblast disease was the only thing left in the "not usually recommended" portion of the "Contraindications" section, so I put it below the "may not be inserted" list. As malignent trophoblast disease is at the end of that list, the readability seems to be improved.
• I made "Bone density" a sub-section of "Side effects".
• I made the references small.
• Minor spelling and grammar changes.
• Re-add citetemplate for FDA patient insert that was accidently deleted several edits ago.

Lyrl ^Talk _Contribs 01:20, 9 October 2006 (UTC)

Good edit - yes seems to improve the flow of the article. David Ruben ^Talk 01:47, 9 October 2006 (UTC)

Source of the article : Wikipedia