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Contents 1 Links 2 Links in dispute 3 Systemic Diseases 4 Complications 5 Rupture 6 Effects on Children 7 Complications 8 Other changes 9 Once again, Samir's suggestion, as a paragraph to discuss 10 Who reverted the complications? See article for more Info on autoimmune symptoms too 11 == 11.1 Previous "off-line" version moved 11.2 Protection 11.3 Editors guilty of continued reversions

Links

We had come to an agreement to delete any links to websites that were paid promotional websites for specific plastic surgeons. We had also agreed to keep links only to recent summaries and research (with the exception of the Institute of Medicine report, which, although completed 8 years ago, is important enough to include). Unfortunately, someone put back some of those links. I removed them, as we had agreed. Drzuckerman 18:42, 8 December 2006 (UTC)

I agree with removing the promotional link for breastimplantsusa.com(I have no idea who put that in). However, the other two are pretty informative and interesting. The monograph by Dr. Rohrich (recent amer. society of Plastic Surgery president & editor of the world flagship plastic surgery journal)is still relevent in that many of the historical aspects of this issue are discussed (and well-referenced) and the discussion of the science is still accurate. The editorial by Marcia Angel provides excellent context for looking at this issue as it was viewed at the time by the editor of the premier world medical journal (New England Journal of medicine) and is an excellent section from her well-reviewed book about the silicone impplant crisis of the early 1990's. Droliver 22:39, 9 December 2006 (UTC)

You mean by Angel as is listed onThe Manhattan Institute website. It is well-reviewed by whom? The Manhattan Institute?Jance 00:28, 10 December 2006 (UTC)

It is important to have the most up to date info available, so I added the latest Inamed and Mentor silicone implant labeling info (from the FDA website) and an FDA consumer booklet. Marcia Angel's article was old, and she has since revised her views regarding industry-funded research -- I have met her and will ask for a more recent article. Since the best studies were conducted in the last 6 years, it's important to link to the newer articles. Brody's is apparently from last year so it should stay, but Rorick's is from 2000. Replaced with an NCI booklet for reconstruction patients. When I checked out all the links, I found another that was promotional (with ads all over the page) that I deleted. Also, there was a paper written by a law student -- obviously not a professional document, so I replaced it with a 2006 report from a legal nonprofit organization. In the spirit of compromise, the links are now devoid of promotionsal websites, balanced, and up to date. Drzuckerman 04:08, 10 December 2006 (UTC)

I reverted this to discuss a few things

• 1. A single link to the FDA information on breast implants is necessary as all that information is laid out there from the implant portal page. Again, this is a world-view article rather then a US-specific one & highlighting several links to what can be achieved with one seems with one belabors the point.
• 2. The inclusion of the political group Alliance for justice & a another self-referential document from your own organization, both of which do not demonstrably hold mainstream positions, is not appropriate.
• 3. The information in Rohrich's summary is still both accurate & relevent. There has in fact been little changes in the science or the interpretation of it since that work. His particular standing in Plastic Surgery makes this notable.
• 4. The LEDA article is about as well-referenced and thorough history on this this as I have seen and I do not think anything about it is "unprofessional". It also is about as neutral & non-judgmental as something like that can be. It is an excellent resource for someone who is unfamiliar with the silicone issue
• 5. Marcia Angel's book on this (from which the essay linked to was an excerpt) is a fairly substancial reference to the political environment that existed around the silicone crisis. Her position as NJOM editor gives her some standing for relevence. If you can find an update from her on this specific topic, I'd be fine with —The preceding unsigned comment was added by Droliver (talk • contribs) 19:53, 10 December 2006 (UTC).

Oliver, I have tried to work with you but this is NOT your article, this is wikipedia. There is absolutely no justification for your reverting to:

1. A website with advertising, when there are so many that don't have advertising.

2. A student paper -- that's just ridiculous.

3. You deleted a National Cancer Institute link. Why? They are the most respected cancer institute in the world.

4. You deleted an FDA link to the most recent information. Why?

5. Alliance for Justice is a very respected nonprofit organization with much more expertise on legal matters than you, me, or a law student. Every time you don't like something, you call it political, but that doesn't make it true.

Samir, I ask for your help. The article, as it is currently written, is almost entirely the product of droliver. He revereted everything to his version. Now he won't even allow an updating of links to more recent reports, even from the most indepedent sources, and insists on including reports published before ANY of the MRI rupture studies were published. And he insists of reports written by plastic surgeons while deleting those that aren't. I hope you can help, and I ask other administrators for help too. Drzuckerman 00:23, 11 December 2006 (UTC)
Dr Oliver, you don't need to revert in order "discuss a few things". That's just a ridiculous excuse for reverting. I encourage discussion of the links and the article content but you have to stop reverting other people's changes to the article. I went through several pages of the history and all you seem to be doing here is reverting changes. It is starting to look like you are asserting ownership of the article. If you cannot discuss edits without reverting, I will reprotect the article. Sarah Ewart 00:38, 11 December 2006 (UTC)

(edit conflict) Whilst I have not looked at any of the specific papers/reports being argued over. I think there is a middle ground as to what to cite. Droliver seems to looking to include initial substantive assessments, and Drzuckerman & Jance point out that the science has progressed since then and therefore so has the interpretation of the evidence. Both stances seem (from the outside of this argument) to be somewhat exclusionist. Wikipedia can report on the history within a field and need not therefore present just the "absolute current truth". I would have thought therefore that if some substantial assessment was published that had a notable effect (e.g. set out medical majority consensus or signified a change in the consensus) then the article should note that opinion (hence I would tend to feel the link (? NJOM) Droliver wishes to include is reasonable). However the article should mention any substantial non-trivial POV that arose from such a paper (citing of course from WP:Reliable sources) and if the evidence has since been improved upon, re-interpreted or re-assessed then these points also should be noted (again stating who made such an opinion and citing the sources) (hence I tend to approve of the wish of the other editors to add additional links).

NB the (italicised opinions) above are based on process rather than any judgement of the "worth" of any specific citations (the relevant paper might be brilliant or awful – I have not checked, but I am discussing general approach rather than specific facts)

Given the recent blocking of this article to bring a halt to edit warring, for Droliver to just revert that which has been discussed in the talk-pages, and which was trying to foster a wiki consensus seems disruptive to the process. I note that Sarah Ewart has therefore quite correctly restored the article back. Further edit warring has to stop, and a deterioration into revert-warring will on principle lead to extended WP:RfC, further blocks to certain editors involved and no doubt a return to article protection (this time it would no doubt be to Droliver's sense of M:The Wrong Version). Droliver you would do well at this point to apologise for your unwise revert and instead rejoin talk-page discussion :-) David Ruben ^Talk 01:13, 11 December 2006 (UTC)

--Thanks to Dr Ruben and Sarah Ewart for your help. I agree that some older reports are important, which is why I had kept in the Institute of Medicine Report and some older reports -- but didn't want most of the links to be to older reports. As an epidemiologist, my goal is to make sure the research findings reported in the paper are accurate, and that the information is NPOV, based on scientific findings. When findings are contradictory, we should say so and try to explain how different studies look at different variables and therefore have different results. Drzuckerman 05:07, 11 December 2006 (UTC)

• David, I think you're going to be begging the question often of what WP:Reliable sources are with this. Are reliable sources to be the detailed reviews of multiple expert panels and the body of literature or are they alternate interpretations of these by small groups which have not been persuasive to governments and medicine at large? This contesting of every single study with "original research" is just reduplicating the hearings on these issues which have all just been repeated in the UK, Canada, & the US in the last few years. The minority view can be succinctly explained without going into the swampDroliver 16:26, 12 December 2006 (UTC)

Links in dispute

1. FDA 2004 Consumer Booklet on Breast Implant Complications and Reoperations
2. 2006 FDA-Required Labeling Information for Silicone Breast Implants
3. Harvard Law School LEDA project:The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention
4. European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) consenus declaration
5. Silicone-Gel Breast Implants - a health and regulatory update by Dr. Rod Rohrich
6. Science On Trial- Medical Evidence and the Law in the Breast Implant Case by Dr. Marcia Angell
7. 2006 Alliance for Justice Report on History of Silicone Breast Implants
8. How Stuff Works: Breast Implants

I can comment on policy in that I don't think that the LEDA project article (even if it is well written), the Manhattan Institute Article (even if it was written by Dr. Angell) and the Alliance for Justice Report can truly qualify as WP:RS. -- Samir धर्म 06:14, 11 December 2006 (UTC)

What about under WP:EL? Sarah Ewart 08:33, 11 December 2006 (UTC)

I'm not an expert on wiki policies, but #1 and #2 are based on recent research, as compiled by the US FDA, so that seems very appropriate. #4 and #5 are outdated and not of sufficient importance to include as a link since #4 is rarely if ever mentioned in other reports or published articles, and #5 never is. #8 is a website with ads, and since it overlaps with other sources, it seems expendable. I agree with Samir re #3 and #6, and I think I understand his reasoning on #7. Drzuckerman 04:59, 12 December 2006 (UTC)

1 & 2 are redundant as they both point to the FDA breast implant page, I'm advocating just linking once to the FDA breast implant portal page where this is all clearly laid out. The EQUAM report (link #4) is relevent as it is still the official E.U. position paper on this, although if you like you could exchange the 2003 STOA update to it, but the conclusions are unchanged. The point being, this is not strictly an American issue, and worldview context is important. Canada, Australia, or other countries health ministries' implant page seem more desrving then 4 internal links to the FDA. Likewise the discussion in Dr. Rohrich's paper (link 5) is still relevent, especially describing the history of the devices to that point. There has really been no science in the interim (as Dr. Zuckerman seems to be suggesting) which has affected the conclusions and accuracy of that monograph. The Marcia Angel essay (#6) is a reprint from her (still in print) book on this & I think deserves consideration giving her standing at the time of the events she was describing as NJOM editor when one of the major systemic reviews was published in her journal. I now understand DZ's issue with the "how things work" link (#8), and while it has really good content and graphics for laypeople, it does accept comercial advertisingDroliver 16:08, 12 December 2006 (UTC)

It's fine with me to delete the first FDA web page, which is merely a portal to many other articles. I think specific FDA articles are more useful than a portal, which is why I added the 2 most recent and relevant and comprehensive FDA publications. Why send readers on a fishing expedition where they have to click everything to find out what's relevant?

I completely disagree about there being no major studies in the last 6 years -- that is just not correct. There were only 17 epidemiological studies at the time of the 1999 IOM report and other reports, and almost all of them were badly designed. For example, several of the studies included less than one dozen women with implants, and one was a study of only 250 women, all of whom had implants for less than 2 years. There are now more than 100 epi studies. The IOM study is linked for historical purposes and all the other reports around that time are based on exactly the same 17 studies -- virtually the only studies of women available at the time (the other studies were of animals or cells).

In addition to being redundant to the IOM report, the EU position paper is unnecessary to show international scope because almost all the published studies cited in this wiki article were of European women and by European scientists (albeit funded by Dow Corning).

Your justification for publishing Angell's article makes no sense. The meta analysis of implant studies that was published in NEJM was not the basis of Angell's article, but was in fact based on the same 17 studies as the IOM report. And, as I previously pointed out, Dr Angell's most recent book, published last year, has a different view of industry-funded research than her older book. As I said, I will personally ask her for a more recent article. But again, the goal here is not to provide historical links, but rather a NPOV wiki article that includes a brief history but where the science is up to date.

If you want a history, rather than a history by an individual plastic surgeon who had access only to public documents, we should instead insert a link to the Congressional report, which is based on all FDA documents (official as well as internal scientific documents) and industry documents (many of which were available to Congress but not the public), fully footnoted and available through the Library of Congress. Droliver deleted that link every time it was inserted by me or anyone else. The full Congressional report is available several places on the web -- altho reports of that age are not available on government websites, you can see that these websites have the same report, and I have an official printed version which is identical to these:

http://www.transgendercare.com/surgical/brst_implants_congress102.htm

http://www.breastimplantinfo.org/what_know_3-FDA1992.html

Drzuckerman 05:49, 13 December 2006 (UTC)

So let me get this straight. Just because a 3rd party who has actively lobbied around the world on this declares all widely-accepted research and reviews on this to be either compromised or innacurate, thus it is so. You're proposing continous original re-interpretations of the body of literature in a way not consistant with how this has been evaluated, reported on, and treated by any country in the world. The hundreds (if not thousands) of panelists, researchers, and government officials who've reported/ruled on this were apparently so blinded by DOW-CORNING's subterfuge that they couldn't possibly see how the hundreds of related papers were so clearly flawed as you suggest? It's easier to just present this accurately as reported and state your case succinctly for the alternative view seperatelyDroliver 20:23, 13 December 2006 (UTC)

I do not see anywhere where Dr. Zuckerman was proposing the inclusion of original research, nor do I see in her discussion any suggestion to discount an entire "body of literature", or "hundreds of related papers". If I recall correctly, the 1999 IOM report is already included as a link, and nobody proposes removing it. It is quite appropriate to not include an additional article relying on that study - an article that was written by a doctor who may have altered her opinion since that time. Further, a congressional history is just that - a congressional history. It would be of interest to anyone wanting information on this subject. To deny it exists is revisionism. However, I am only speculating as to your objection, since your comment is a personal attack and not a statement about a specific study or article (and why it should be included or excluded). And what do you mean by calling Dr. Zuckerman a "3rd party"? Jance 22:41, 13 December 2006 (UTC)

Compromise #1

1. FDA 2004 Consumer Booklet on Breast Implant Complications and Reoperations keep
2. 2006 FDA-Required Labeling Information for Silicone Breast Implants remove -- too peripheral to main topic
3. Harvard Law School LEDA project:The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention remove per argument above
4. European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) consenus declaration keep as best EU consensus article
5. Silicone-Gel Breast Implants - a health and regulatory update by Dr. Rod Rohrich remove
6. Science On Trial- Medical Evidence and the Law in the Breast Implant Case by Dr. Marcia Angell remove
7. 2006 Alliance for Justice Report on History of Silicone Breast Implants remove
8. How Stuff Works: Breast Implants remove

• Thoughts? -- Samir धर्म 05:54, 13 December 2006 (UTC)

I haven’t visited this article for a few months, and am shocked at how biased the article now is, compared to before. It seems to be written by and for plastic surgeons, rather than having a NPOV.

As a professional working for a nonprofit health organization, I agree with Samir’s proposal above, except for the EQUAM statement. It is from 2000 and is very outdated. There just isn’t any point in including a very brief research summary with no detailed information, which is based on a summary of a small number of studies on human beings compared to the dozens of studies that have been conducted and published since then. I disagree with droliver’s remarks. He seems to think that everyone agrees with him that silicone breast implants have no risks. That may be the position of most plastic surgeons but it is not the consensus in medicine and public health. In fact, there was a presentation at the American Public Health Association annual meeting a few weeks ago that was entirely consistent with what Drzuckerman, Drcarter, and others have stated above.

I also propose we reinstate the local complications that were deleted by Droliver. These are very well-established and the plastic surgery medical associations and the implant manufacturers all agree that they are complications of all kinds of breast implants. This information should not have been deleted by droliver and suggest his POV. They include:

- ===Hematoma and Seroma===

Two known complications of breast implants include hematoma, the collection of blood inside a body cavity, and seroma, a collection of the watery portion of the blood around the implant or around healing. [1]

- A small scar can form or a rupture may occur if the implant is damaged during draining the incision. Post-operative hematoma and seroma may contribute to infection or capsular contracture.

- ===Changes in nipple and breast sensation=== - Feeling in the nipple and breast can change after implant surgery. [2] - Changes vary from intense sensitivity to no feeling in the nipple or breast after surgery. This altered sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby. - ===Extrusion=== - Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.[3] - Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

- ===Necrosis=== - Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal. [4] - According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implants than saline implants and more frequently for reconstruction patients than augmentation patients. [http: //www.fda.gov] A permanent scar may form. GUHealth 21:49, 14 December 2006 (UTC)

I agree with GUHealth. As a public health professional working with women, the information in this section needs to be updated and accurate for the women who do not have the scientific prowess to read through scientified magazines and studies. LynnMB 20:51, 15 December 2006 (UTC)

I also concur that it's important to include the complications as listed by GUHealth. For those doing research on breast implants and, possibly, making decisions on whether they or someone that they know should have augmentation surgery, it is important that they see the major cons too. DrCarter12

I also agree with GUHealth about adding a few of those well-established complications. There are others, but these seem to be the key ones. Since that would not involve deleting anyone's work, I hope that means we can just proceed to make that addition. Sarah or Samir, will you make those additions? Drzuckerman 21:59, 15 December 2006 (UTC)

• User:GUHealth, What non-profit organization exactly do you work for?
• As to your concerns. Each of these complications you refer to are indeed mentioned already, most of which are not specific or unique to these devices and others are shared by any breast procedure ( be it biopsy, reduction, mastectomy, correction of inverse nipples, and others). Hematoma/Seroma is a rare event in breast augmentation. Extrusion & necrosis are exceedingly rare events in the non-cancer reconstructive groups. If your interest is in accurately presenting what is likely to be an issue, you need to look at the issues we have clearly identified. The rather unique and specific issues to implants are largely the phenomena of capsular contracture and the discussion of what factors drive reoperation rates (which is a group of factors mostly driven by capsule issues, implant/soft tissue changes over time, & size of implant/aesthetic concerns).
• I also find it odd that you would dismiss the review and conclusions of EQUAM, a group representing more countries and a larger market then any such regulatory body in the world. You are unfamiliar with the literature and the subsequent updates to the 2000 report (which have been, "there's nothing new to add")if you believe that the European Union is out of date on this topic. Droliver 00:13, 16 December 2006 (UTC)

The EQUAM article is out of date because it is based on a small number of poorly designed studies (only about 20 studies of humans) that were published before 2000. There have been about 100 studies of women with implants published since then, most of them longer-term and better designed. The EU document is a very short summary, written as a policy announcement, that doesn't specifically review the research. If the EU believes their conclusions would be the same today, that does not negate the fact that the 2000 document is roughly equivalent to a 6-year old government press release. We have not linked to other government press releases from any other countries, not even more recent ones.

In contrast, the 2006 FDA articles on "labeling" links to detailed research-based documents written by the FDA for doctors and patients, based on the most up-to-date research. Even though the FDA aproved silicone implants (as the EU did), these documents are detailed summaries that include the unknown risks, complication rates specific to each companies' implants, etc. Those are very useful documents. Why are you opposed to including them oliver?

Regarding the complications that you deleted and don't want mentioned, they are not rare. For example, 6% of reconstruction patients had necrosis, according to Inamed. Necrosis, as you know, is permanent damage and 6% is a substantial number for such a serious complication. Since this article is about reconstruction as well as augmentation, that information is relevant. Drzuckerman 01:59, 17 December 2006 (UTC)

Diana, if you wish I'll change the EQUAM link to the 2006 update to it IQUAM As you can see, the conclusions have been the same over & over and this is still their position this year. The subsequent literature has done nothing but reinforce the conclusions of the EQUAM, U.K. Independent review group, the IOM, Health Canada, and the FDA. I'm not opposed to listing complications, but I am opposed to belabored descriptions of them, specifically ones that are less unique to implants. Droliver 03:12, 17 December 2006 (UTC)

Oliver, I'm glad you're not opposed to the complications, so I will put them in. But you seem to have missed my point about linking to a very short document (the equivalent to a press release) with little substantive info, most of it outdated. (The IQUAM document is 13 pages long, but less than 3 pages is for breast implants, and their claims of safety provide no details and are footnoted primarily on the 1999 IOM report, which is already in the links.) Let's use links with substantive information that is more detailed than this wiki article. And if you want to use the IQUAM document, use it as a footnote, not a link. And let's cite that interesting new information about titanium-covered implants in the IQUAM article. Drzuckerman 06:52, 17 December 2006 (UTC)

1. these complications are already listed in the article and do not need to be be belabored as they're somewhat generalized. I'm not sure what you're trying to prove with what you are suggesting be readded. Again, as someone who works with these devices and has these discussions with patients frequently, I can tell you the issues you seem intent on going out of you way to highlight, are not the ones you seen as an issue on a day to day patient, certainly not on elective cases. If you want to expand upon the issues involving implant-based reconstruction, the entry on breast reconstruction would seem better suited as that is the scenario and host environment where seroma or tissue loss would be more common.
2. The 2006 IQUAM update was only pointed to as you were implying the 2000 report no longer was accurate, which as you can clearly see is not correct. Droliver 14:25, 17 December 2006 (UTC)

Definately remove the alliance for justice which is a crass political outfit. I've provided the 2006 IQUAM update which should settle the issues with the "obsolete" 2000 refDroliver 03:29, 17 December 2006 (UTC)

Systemic Diseases

It's time to revise the systemic disease section, which is VERY pro-implant, focused on old policy statements (many of which pre-date ANY epidemiological research, and all of which pre-date most epidemiological research. If this is not a political article, it should have disease information based on research, not legal rulings. If it is going to include legal rulings, then it should include Dow Corning's $3.2 BILLION settlement which provided funds to several hundred thousand women in the US and other countries. It should also include the US government's successful settlement against several implant companies which obtained millions of dollars in compensation for women who were harmed by their silicone implants.

However, it seems much more appropriate to include research data. I suggest we include all the information that was in this article for months before droliver deleted it:

==Diseases and Systemic Illness==

Thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Although information from individual reports is considered anecdotal regardless of the numbers involved, peer-reviewed studies indicate that subjective and objective symptoms of many women with implants improve when their implants are removed. For example, in a comparison study, rheumatologists reported that women with rheumatological symptoms who had their implants removed and not replaced experienced limprovement in their health, and women whose implants were not removed or removed and replaced did not. ^[1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

Numerous reports have reported that there is no evidence of increased mortality or classically defined autoimmune diseases among women with silicone breast implants. These include the Canadian Expert Advisory Committee review in 1992, ANDEM in France in 1996, the UK Independent Review Group 1998, and the U.S. Institute of Medicine in 1999, and the Scientific Technical Opinions Assessment (STOA) report commissioned by the European Parliament in 2001 (updated in 2003). Although these reports were independently conducted and funded, they did not conduct new studies and were instead based on the published research available at the time, most of which were funded by Dow Corning at a time that the company was being sued by women claiming illness from their breast implants.

Many of these reports are based on studies with small sample sizes that included women who had implants for just a few months or years. Years later, in 2004, the FDA pointed out that previous studies were not large enough to answer the question of whether or not breast implants increase the risk of connective tissue disease or related disorders. [5] Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. [6] Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made. ^[2] The FDA states: "When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [7]

There is no conclusive evidence linking breast implants to disease diagnosis, but as studies have followed women with implants for a longer period of time, evidence has grown regarding symptoms that are typical of autoimmune diseases. A Danish study, funded by Dow Corning and the Danish Cancer Society, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. ^[3] Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases."

Meanwhile, research on symptoms suggests that even in the short-term, women with silicone implants report more autoimmune symptoms. In data presented to the FDA, Inamed and Mentor both found that women with implants for only two years had a significant increase in auto-immune symptoms such as joint pain and nervous system symptoms. The findings remained significant when the women's age was statistically controlled. [8]

Despite these concerns, it is generally acknowledged that women undergoing breast augmentation or other plastic surgery tend to be healthier than the general population. In a study of several thousand plastic surgery patients, scientists from the National Cancer Institute found that augmented women were healthier than the general population, and yet were twice as likely to die from lung cancer or brain cancer, compared with other plastic surgery patients. ^[4] There were no reported differences in smoking habits that would explain the difference in lung cancer deaths; the authors suggested that more research was needed to determine if implants increase the risk of lung cancer or if undocumented differences in smoking were a contributing factor.

There is no evidence from the National Cancer Institute study or other studies that implant patients have a higher risk of death from breast cancer as compared with either the general population or other plastic surgery patients.

Another large study of nearly 25,000 Canadian women with implants reported lower cancer rates among augmentation patients, which the authors attributed to their higher income and better health prior to surgery. ^[5]

I ask Samir and Sarah for their help with this, and also welcome comments from other health experts. The above summary clearly shows what is known and not known about systemic illnesses, based on the most recent data. It includes the reports that droliver cited, and we can footnote them, without having so much detail on very old reports -- such as a report from the early 1990's, before ANY epidemiological studies were published. Drzuckerman 07:30, 17 December 2006 (UTC)

Absolutely wrong. There is no misinterpreting of the science on this and there's no such thing as "pro implant" data. The history of study of this is what it is. There is no medical or publich health bureau in the world who has accepted a link to systemic illness and many have come out VERY strongly dissmissing it. Attempts to frame this different are innacurate.

If you want to examine different countries' reviews & treatments here in the discussion page, I think this can be productive. Trying to spin this or reimagine the consensus is not Droliver 13:58, 17 December 2006 (UTC)

This is not an accurate portrayal of this & represents a both original research & rearguing of the issues you yourself have raised at a number of hearings both in the US & abroad. This interpretation has been soundly rejected over and over by expert panels and this is easy to show. Make the case for this succinctly rather then trying to reinterpret history. Once again you are trying to greatly expand on something that can be easily explained briefly. Droliver 14:05, 17 December 2006 (UTC)

I am surprised by droliver's comments, since the current version (which he inserted, after vandalizing what was there) is much longer and my proposed version is more succinct. My proposed language, which was in this wiki article for months before oliver deleted it, is a compromise representing a balanced presentation. Everything is footnoted and several of the statements are in quotes or close paraphrases. I can insert quotes to back up everything, just like a college term paper, but that seems unprofessional for wiki or any other encyclopedia.

I realize that one problem may be that droliver apparently does not realize that the EU standards for ALL medical devices, including all implants, is that they can be sold without any clinical trials proving safety. The fact that various countries say implants are not conclusively proven to cause specific diagnosed diseases does NOT mean that they are proven safe to never cause disease or symptoms of disease. Even the US and Canada, which require clinical trials, do not require that implants be proven safe for everyone or for long-term use. My summary is the more nuanced review: there is evidence of potential harm, but there is also evidence that implants do not cause breast cancer, that the women with implants are generally healthy, etc, all of which I included in the proposed section.

Some of this information is in the new FDA labels, which are in the form of booklets for doctors and patients. See http://www.fda.gov/cdrh/pdf2/P020056d.pdf for one example -- there are separate booklets for silicone or saline implants, made by different companies, but some of the language is identical. For example, around page 11 of all the FDA-approved booklets, it clearly states that "Safety and effectiveness [of the implants] have not been established" for women with autoimmune symptoms. The reason that they state this (in the saline labels, as well as the silicone ones) is because the implants were never tested on those women, because of concerns that the implants could harm women susceptible to those diseases (whether they already have been diagnosed or not). It is inaccurate not to mention those concerns -- and the current version does not.

Moreover, an independent Austrian study was just published in a scholarly chemistry journal last week with new evidence regarding women's autoimmune protein reactions to silicone implants. That is another example of why old reports are not appropriate to summarize research findings -- most of the old research is funded by industry, some of it is on rats, but the newer research is usually better designed and sometimes independently funded. Drzuckerman 16:29, 17 December 2006 (UTC)

Dr. Zuckerman, refighting the Health Canada & FDA hearings again is just silly and far beyond the scope of what one subsection of an overview on implants merits. The headline of a discussion on systemic disease in 2006 begins with the fact there is general international consensus that no link to this has been demonstrated. Major reviews of this were just achieved by the US & Canada. Britain & the E.U. have also (in 2006) reiterated their previous reviews. No other country has made any move over concerns on this. This is really simple to explain. There is no new major development that has come out that has changed anything despite the anti-implant movement searching desperately for one. There could in fact one day be some radical new development which causes us to completely rethink this, but that time is clearly not now.Droliver 22:34, 17 December 2006 (UTC)

We need to find a compromise between the current version and this version. Dr. Zuckerman, I agree that the opening of the systemic disease paragraph should reflect that no cause and effect relationship has been found between connective diseases and breast implants. The paragraph should, however, elaborate on the fact that there have been reports of systemic disease in women with silicone gel implants. Let's start with Dr. Zuckerman's first paragraph:

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

• Thoughts -- Samir धर्म 06:12, 18 December 2006 (UTC)

Thanks Samir, I agree with needing to acknowledge both sides. Having been asked by DrZ to comment on complications removal by DrO, I've tidied up the talk page a little and worked on the following posting to try and give some framework for co-operative improvemnt vs antagonistic arguing. Recent talk-page discussion has improved since the article was protected, but still insufficent so....

Latest spat of revert-insertion and reblanking is over some common complications. I feel no further reverting should occur until consensus is reached. Some observations to consider:

• Common complications for all types of operations do not need to be discussed at length for each specific operation article. Hence I would have thought that bruising, post-op infections, surrounding numbness etc would not need to be routinely mentioned.
• Likewise complications that apply generally to operations on a particular part of the body do not need to be mentioned in any great detail for each specific operation in that area (so meningitis with open cranial operations to the head does not need be repeated for pituitary surgery, surgery for epilepsy, surgical management of hydrocephalus)
• But should a particular operation in an area be associated with an unusually high or low risk of a complication, then mention seems appropriate.

re Necrosis

• So if risk of "necrosis occurs more frequently for silicone gel breast implants than saline implant" then this seems important to mention, and certainly is relevant in indicating that the type of implant is associated with differing risks.
• The level of necrosis is described as "reconstruction patients (6% during the first three years) than augmentation patients (1% during the first three years", which leads to 2 issues as to why this seems worthy of including. Firstly as the majority of implants are/were for augmentation and for these patients the cosmetic surgery risk is clearly less than for the reconstruction plastic surgery cases. Secondly 1% risk of a non-minor problem fulfils my understanding of what would be a significant problem to specifically mentioned as part of consent for this specific procedure..

re extrusion

• the risk needs be quantified - merely including because it can occur does seem to be alarmist/anti-implant POV, unless the degree of risk is specified (we don't list having a heart attack during the operation - the risk is so tiny even though it could occur I suppose as for anyone undergoing an anaesthetic).
• The 2nd sentence for this risk of "Surgery needed to correct this can result in unacceptable scarring or breast tissue loss" seems subjective and personal opinion POV. Any surgery can result in what may be perceived by the patient to be unacceptable scarring. It would be more NPOV sounding, as well as briefer encyclopaedically (this is getting to be a long article) to have plainly added on to the end of the 1st sentence ", and requires further corrective surgery".

My twopence of opinion

Yes specific local complications of particular relevance to those having breast implants needs be included, but No woolly inclusion without incidence rates (to quantify low or high risk) and with just briefest of discussion.

Warning re participation

I think those editors without prior detailed knowledge of Breast Implants are finding this intense edit warring very tedious and frankly boring – it is after all just one article and there are so many more articles we can productively and non-contentiously work on. Consequently few editors are being attracted to start or continue to participate, and the small numbers hinders reaching consensus. Repeated large scale insertion & deletion of text outside of clearly discussed talk-page discussion and consensus is likely to result the article being protected, and a WP:RfC on all editors involved.

• Brevity: Please therefore keep discussions brief (this is not a tribunal nor an FDA hearing)
• Consensus – this means discussing, then waiting for other editors to indicate their views, editing (either way) during the wait is disruptive and just raises the heat.
• Discuss the encyclopaedia entry or improvement to NPOV, not ones own POV. So each side should be able to phrase a section in NPOV terms that acknowledges minority as well as majority opinion.
  • Remember Wikipedia is not a place to carryout a debate and especially not discuss the worth of one paper vs. another - for that is banned personal research, unless of course one can cite an external 3rd party source as holding that opinion of a paper.
  • Also remember that wikipedia explicitly rejects the "truth" of a Scientific Point of view (WP:SPOV), but instead is reporting on currently accepted (i.e. widely held) understanding, even if is thought to be wrong. So if all the papers in favour of implants were shown to be biased, funded directly/indirectly by manufacturers, surgeons are disregarding data etc etc, yet the de facto authorities of the FDA, UK & European regulatory bodies, by extension the relevant governments and medical profession as a whole assert that (older) papers prove safety and lack of any confirmed concerns, then that is what wikipedia must report as the majority POV and also must constitute the majority of the article space (see WP:NPOV re not granting equal space to minority opinions).
  • Now before anyone starts jumping over the last few sentences, I merely phrased them as I did to highlight the process of encyclopaedic development that should be occurring - namely without regard for ones own personal assessment of the various issues. Likewise before anyone suggests that I am dismissing out of hand all concerns, the de facto position is that the regulatory bodies banned/restricted implant usage.
  • So whilst the "established" medical consensus is that there is no proven causation of systemic complications and this needs be clearly stated in the article, equally the quality/length of monitoring failed regulatory body requirements and the products' licenses were revoked and this too needs to be clearly stated in the article. Both aspects are de facto majority viewpoints and need be included.
  • Please don't though take this needing to state what are therefore superficially black/white opposing points (we all appreciate the greys of reality, incomplete research and understanding) as an excuse to engaging in actually carrying out the real life debate. David Ruben ^Talk 06:22, 18 December 2006 (UTC)

There seems to be a misunderstanding of the general consensus re implants and systemic disease. If you look at the current reports and documents, you will see:

1. While there is agreement that there is no conclusive evidence that breast implants cause a UNIQUE DISEASE or a classically defined disease, there is no such agreement on systemic symptoms. On the contrary, there is clear and repeated evidence of significant increases in autoimmune symptoms, such as joint pain.
2. The implant manufacturers are required by regulatory agencies to warn patients that the implants are not proven safe or effective for women with autoimmune symptoms/diseases.

As for complications, a well-documented complication is loss of nipple sensation, sometimes permanently. That is different than complaints for other surgeries, at least to the women. I can add the specific statistics, all of which are now published in the FDA-required documents for patients and doctors. Drzuckerman 18:23, 18 December 2006 (UTC)

Vague symptoms do not equal disease Diane, and individual symptoms are not how auto-immune diseases are diagnosed. There has been no consistancy of patterns of symptoms in 25 years of studies on reproducing this in breast implant patients. This is echoed over & over again in each subsequent systemic review from 1990-2006. In addition the best individual long-term studies [PMID 15220596] continue to find no increases in the totals of loosely defined symptoms which can be manifestations of AI disease.

As to the warning labels, that is more a political legacy from the silicone crisis rather then some recomendation derived from evidence based medicine. It's kind of a gordian knot. That dogma is never going to be formally studied as there's little to be gained by Industry or the feds by doing so, although obviously it's clear (just on chance) that many patients with latent AI diseases have been implanted world-wide over the last 40 years. The persistance of it in the labeling really is better understand in that context rather then as some coded innuendo suggestion an issue

All the complications are already touched on already, and again nipple sensation issues are common to ALL breast surgery. With breast augmentation, it's really felt to be primarily associated with peri-areolar incisions rather then the implant itself. You almost never see it with the way more & more surgeies are being done (inframammory incision with sub muscular implant placement). A more appropriate place for that caveat would be in the incision section next to peri-arelar incisions. Droliver 04:05, 19 December 2006 (UTC)

DrOliver's comment that the labeling is only a "political legacy" seems to be WP:OR. Is it possible for me to ask DrOliver to stop making accusations that an editor is "trying to change history" etc. ? Is this helpful to any resolution of this article? Also, it would be helpful to go back to what David said about the inclusion of necrosis as a complication. Jance 19:18, 19 December 2006 (UTC)

A note on a comment earlier by Dr Oliver: You're too focused on the American process here. Regular MRI screening has been adopted by only the US & was explicitly rejected by health Canada a month prior as not being evidence based. Other countries do not endorse the FDA rec. either. While I'm fine with reference to the FDA position, it needs to be in the context of standard practices... Is it possible that the differences in policy are due to A:the higher fear of lawsuits by hospitals and physicians in the US and B:the differences in healthcare in the US vs countries with socialised or partially socialised medicine? For example, in the US a woman would likely pay for her $3000 MRI ($1500 sounds like a deal!) either out of pocket or by convincing her ins. company, whereas in Canada and the EU, the state (taxes) pay or partially pay for these tests? Having been on both sides of the pond, I've noticed Americans and Europeans (both lay people and policy-makers) have different views on drugs and medicine in general.
The second thing I want to say is, in regards to what Dr Ruben said, we don't have to be too uptight about how current research is— I mean, it's important for sure, but when current ongoing studies finish, we can always add them too; wikipedia will still be around. My €.02 Dikke poes 20:09, 19 December 2006 (UTC)

• The US-FDA MRI recomendation makes no sense to anyone, especially in the first few years after implantation as we know the rupture rates hovers at < 1%. The convetional wisdom is that it was a bone thrown to the activists. They (FDA)can make this statement only because they don't have to fund it, and I think it will be largely ignored by patients. It would make more sense to do this at 8-10 years, but it just isn't a cost-effective test. When you do actuarial #'s on this (as I believe Canada & the UK have done)and compare it to the literture we have on patients with untreated rupture, it's a lot of money for little or no medical benefit. Clinical exam & ultrasound seem likely to be the more common screening modalities with MRI for confirmation (which is Canada's position) will likely be what is advised.Droliver 06:17, 20 December 2006 (UTC)

I would like to reiterate what Samir said. Let's look at a paragraph. All the speculation and generalization will only leave the article POV as desired by one editor. The idea is to come to a compromise - and no, it will not affect accuracy. The issue of implants is not black and white as DrOliver would have people believe. So why not start with the paragraph Samir suggested? It might be more difficult to make personal attacks by generalization and hyperbole, this way.

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

Jance 01:49, 20 December 2006 (UTC)

I'd propose:

The consensus from a number of independent scientific reviews has been that there is no clear evidence of a causal link between the implantation of silicones and connective tissue disease. However, thousands of women have still claimed that they became ill from their implants, with complaints including included neurological and rheumatological problems. Some studies on explantation have suggested that subjective and objective symptoms of women may improve when their implants are removed.[1]

• There is a need to emphacize the systemic reviews when this is introduced, which is why the language should be somewhat stronger like I propose and why the table summarizing these belongs in this subsection.
• There are a number of papers [PMID 11886959] [PMID 15220594] (among others) which seem to disprove the assertion that AI symptoms correlate with rupture status, which is why that add-on should be dropped
• Likewise, improvement after explantation does not happen predictably. I do however think it is an important concept in the case for silicone being toxic and deserves notation & reference. Calling for further research though seems like more advocacy then encylopediaDroliver 06:17, 20 December 2006 (UTC)

Oliver: do you want "connective tissue disease" in the first sentence (are the women complaining of cartilage problems? Or are you saying that's the rheumatoid connection)? (Remove second "included".) The first sentence says there's no clear evidence linking Si implants with connective-tissue disease, then the second sentence says some women claim neurological and rheumatoid problems. For this reason, even though I find your paragraph much cleaner than the one above"Jance" version, yours is more vague when saying there is no causal relationship... then says women complain of (specifically such-and-such). If you were trying to avoid "systemic diseases," I understand, but your workaround ended up weird. And finally: in the "J" version, the pentultimate sentence says "studies suggest... that symptoms improve" and your last says "studies have suggested... that symptoms may improve" Did the studies predict the future (they may improve... implying eventually) or did they say that they improve, that some improve, or that there was uncorrelated improvement? The "some studies on explanation" is awkward. Were the studies specifically done to test whether removal of ruptured implants releived symptoms, or where these merely post-rupture studies looking at other things?

The consensus from a number of independent scientific reviews has been that there is no clear causal link between silicone breast implants and (whichever disease... if it's not AI as your links point out, what was not linked? If conn-tiss, tie in with next sentence). However, thousands (thousands?) of women have ("have still" is awkward...) claimed that they became ill from their implants, with complaints centering on (are these the majority of claims?) neurological and rheumatological problems (tie in with connective tissue??). Some studies have suggested that subjective and objective symptoms (women redundant, or use patients) may improve after the removal of their implants, but more study is needed to verify the correlation.

I bolded what I would change and italicised my questions. Dikke poes 15:10, 20 December 2006 (UTC)

Edit: The ultrasound suggestion makes more sense than the MRI for early implants, since U/S is usually cheaper. How well does it show silicone rupture? Is it the contour of the implant that changes? In any case, if the statistical relationship of rupture in the first several years is really as low as 1%, then an expensive MRI makes no sense. Has the FDA mentioned anything about regular monitoring of older implants with US? Dikke poes 15:15, 20 December 2006 (UTC)

Excuse me, but the FDA recommends MRI, not ultrasound. The MRI is 86% accurate. And there is not enough data to even get a pattern of rupture with time, which is probably why the FDA made this suggestion - in fact, the FDA specifically mentioned MRI because of its accuracy in detecting rupture. The FDA recommends an MRI three years after implantation, and then every two years. For Oliver to suggest that it was a 'carrot' to the "activists" is WP:OR and I might add, scary. To suggest that the FDA recommendation be changed to the suggestion of an editor here is WP:OR. And Dikke, I believe that paragraph was Dr. Zuckerman's not mine. I agree that there should be something cited for it.Jance 17:35, 20 December 2006 (UTC)

I'ld be a little more accepting of DrOlivers comments above as it raises some interesting issues (even if I don't fully accept his explaination) although perhaps off-topic for this particular article. NOR states "Articles may not contain any unpublished arguments, ideas, data, or theories; or any unpublished analysis or synthesis of published arguments, ideas, data, or theories that serves to advance a position." but that does not entirely hold sway for discussing artices in talkspace and raising possible issues that would need to be encyclopaedically researched into. So yes given the controversy that the subject generates, it would be interesting to compare regulation approaches for these devices around the world. From a sociological point of view, explaining why there are these differences would also be interesting although very off-topic for this specififc article. Of course, unless there can be found reliable sources to WP:Verify the particular explanation given by DrOliver, then the article can not include this. So can anyone find some WP:RS commenting of the pan-global variations of this product's licensing/restriction and why they might exist ?

Whilst the FDA may well have recomended MRIs for their 86% accuracy, that's not terribly impressive accuracy rates. Is MRI more useful at confirming non-rupture (specificity) or rupture (sensitivity) rates ? Are there coresponding figures for ultrasound option? eg I could envisage that if Ultrasound is only 90% as accurate as MRI but just 1/5 the cost, then performing ultrasound scans twice as often as MRIs might practically prove more effective and still cheeper ? David Ruben ^Talk 02:46, 21 December 2006 (UTC)

It is my understanding that the MRI is the "gold standard" for detecting rupture in silicone breast implants, and is superior to other tests. (That is from the many articles and studies I have read). However, I have not seen accuracy rates stated for ultrasound. I did not suggest that discussion on this talk page was WP:ORm, David. It was my understanding that someone suggested not including the FDA recommendation for MRIs, arguing that ultrasounds were less expensive. I presumed he was referring to the article, and not just discussing on the talk page. Certainly, a comparison wtih the recommendations of other countries can and should be included. I do not know what those are. If ultrasound were as accurate as MRIs, then I would think that should be included, while still discussing the FDA recommendation. To omit the FDA recommendation, based on one plastic surgeon's opinion that it was silly, is not appropriate. We do know that mammograms rupture implants (especially as they age). This is a fact - it is not speculation or my opinion. Given this, I have found it odd that mammogram centers only are concerned about obtaining the extra images for cancer detection, at least the one I went to, and not even asking women how old the implants are. Hopefully, that will change in time, especially since the FDA has expressly stated that mammograms can and do cause rupture.Jance 03:37, 21 December 2006 (UTC)

As to the tables, this had already been discussed months ago. The consensus then was that the table was POV. I raised, and still raise the point that the table is not only unduly repetitive, but it is selective in the summaries. I looked at every one of those studies cited. In every case, DrOliver's selections of summaries pull one line out of the whole - that which is most glowing on the safety of implants. Months ago, when I tried to add the *whole* of the conclusion (which was usually one line), he promptly deleted it. If this is not POV, then I don't know what is. It is appalling. And saying there is a need for further research, with the proper citation, is certainly not advocacy. It is a legitimate statement, if it is true and verifiable.Jance 03:44, 21 December 2006 (UTC)

• David: I'm not advocating adding my extrapolative thoughts re. the MRI, that was an explanation for context to Dikke poes about how this is viewed by many who actually work with the devices. I'm not sure an extended discussion about the rest of the world is needed on imaging, other then to point out that no one else has adopted the FDA position re. scheduled MRI exams. The Health Canada panel summary discusses this issue specifically if something needs to be pointed to. MRI is clearly the preferred test, but it's not cost-effective. The Uk & Australian positions on implants in general are linked to thru the systemic review chart as is passing reference to Germany's review of this a decade prior. A number of other countries federally produced patients' handbooks (Ireland for one) can be found online and are consistant with these other countries.
• The table is important for demonstrating the serial evaluation of this that began in the early 1990's and have continued thru the 2005/2006 FDA & Health Canada presentations. These aren't individual studies but a continuous reassment of the body of literture as a whole by expert review panels made of physicians and researchers from many disciplines. It is very effective for presenting an indisputable overview of the world on this and the quotations re. conclusions are self-explanatory and clearly in context.

Droliver 16:17, 21 December 2006 (UTC)

This is the same argument that DrOliver has used consistently, and it does not address the fact that it is (1) repetitive and (2) selective "cherry picking". Each one of those studies made more findings and recommendations than what Oliver picked. He only picked the most positive statement he could find in each review. The implication from his chart is that there is proof that implants do not cause problems. That is simply not true.Jance 23:50, 21 December 2006 (UTC)

Sorry, Jance, I wasn't pointing out whether that was "your" version... I tried saying, "the one above" but since both Oliver's and yours were above, I just figured for clarity it was easier to call it the "Jance" version. And yes, I was just asking Oliver about U/S. I figured he may have run across some mention of it. BTW, I consider the words "gold standard" to sound opinionated -- I'd rather, MRI is the best test available to detect rupture, with an 86%/whatever rate of detection. It's hard to make a gold standard when MRI is constantly improving, and a poor woman in Mississippi might get an old machine and a radiologist from India reading on the night shift (not to disrespect Indian radiologists), and a woman in Cape Cod may get a 7 Tesla magnet (not public yet, this is just an example) with the latest and greatest computer software and a topflight radiologist reading the film with a student going over it with him... I didn't think the U/S thing should be in the article.
For Oliver to suggest that it was a 'carrot' to the "activists" is WP:OR and I might add, scary <-- This is obviously his personal view, (that the MRI thing is a carrot to activists), but that view is NOT in the proposed paragraph. In any case, are there any more ideas/versions of this paragraph that we can use? (note, I'm going to use U/S for ultrasound so it's not confused with America in my posts)Dikke poes 17:19, 21 December 2006 (UTC)

That's ok, Dikke. I wanted to clarify. DrOliver had argued against inclusion of the FDA recommendation, and I thought that was strange. What he or his plastic surgeon friends may think about MRIs does not negate the fact that it is a recommendation. Of course, MRIs are not cost effective. They are very expensive. Unfortunately, there are no long term studies on the rate of rupture of the *new* implants (and there were none on the many old designs, either). But if I were a woman considering implants, at least in the US, I would want to know what the FDA recommendation was. Rupture is a product defect. Of course, nothing lasts forever. But how long do these last? We don't know. What are the long term effects of rutpure in the body? We don't know. (I know what happened in my own body, but I am an anecdote). If I were going to make a decision to implant, I would want to know these things. The FDA now requires manufacturers to tell women that implants do not last a lifetime. Will plastic surgeons tell women this? I suspect those who are honest will. And I suspect (and I know) that some won't, but will instead just hand women a 40 page booklet and tell them this is only a legacy of old "frivolous" lawsuits.) I only wish I had had an MRI (instead of a mammogram) five years before I did. It would be interesting to see the accuracy of an ultrasound in detecting rupture. I do not know what it is, or why the FDA recommended MRIs and not ultrasounds.Jance 23:50, 21 December 2006 (UTC)

• I am not arguing about the cost or utility of MRI's, what the problem has been is the constant presentation of this from a US-centric rather then the world view. No one else has adopted the position the US-FDA took. No one. The rec. on early MRI's on devices with less then <1% failure rates during that period makes no sense to anyone. The standard recomendations in the world are for imaging to correlate with clinical findings. The "carrot" comment reflects an acknowledgement of some of the unique political considerations that have surrounded the evaluation and approval of this stateside.Droliver 19:09, 24 December 2006 (UTC)

Right. And I imagine plastic surgeons have no interest in following up once they put implants in. The FDA has stated that there is not enough data to determine rupture rate. Per your own arguments, a single study or even two short-term is hardly adequate to determine rupture rate. You think everything that remotely smacks of a "risk" is "political". Jance 23:08, 25 December 2006 (UTC)

Complications

Let's first go back to the complications section, since several important complications were deleted by droliver. It is a less complicated (no pun intended) section. Only 2 complications are currently listed, although there are many more well-established complications. And systemic disease is under that heading, whereas it should be a separate heading

I also agree with whoever said that the comments on this page are too long and it a full-time job just to read them. Let's try to be brief.

And, consistent with wiki rules, I request that droliver show more respect to people he disagrees with, stop calling me "Diane" (which is not my name and seems condescending, since nobody here calls him by his first name), stop questioning my motives, and stop misrepresenting my expertise. Let's call each other by the names we list. Drzuckerman 19:55, 20 December 2006 (UTC)

Unfortunately, I have also asked that Dr.Oliver be more respectful. I don't know how else to stop the rudeness. Also, I will note that "consensus" does not mean 100% agreement, and if consensus is accurate, then it should be acceptable to edit accordingly. Obviously, if the consensus is a false statement, etc, then it should be stopped. But that is the beauty about consensus - usually it does prevent a single editor's POV pushing. At lease, we hope it does. Jance 21:41, 20 December 2006 (UTC)

---

I haven't made a comment in about a week and a lot has happened. I personally believe that viewers of this page have the right to see all complications; not just rupture and capsular contracture, but they also need to know that additional surgery may be needed to fix problems, the possibility of chronic pain/necrosis, loss of sensation, etc... everday women are going to want to know about those type of complications. please include every complication in order to be neutral, yet informative. LynnMB 20:13, 20 December 2006 (UTC)

David also agreed that necrosis was a complication worth mentioning, esp if there is a difference wrt reconstruction v. augmentation. Consensus exists on this, and it should be added. DrOliver does not have to agree for there to be consensus on a legitimate edit.Jance 21:44, 20 December 2006 (UTC)

---

The patient handouts available on line for Inamed and Mentor silicone breast implants for primary augmentation had some glaring statistics. for Inamed 23.5% of women had reoperation within 4 years of the first breast implant surgery; for Mentor it was 15.4% within 1-3 years. Nipple complications were 4.9% for Inamed and 10.4% for Mentor. Breast pain was 8.2% for Inamed and 1.7% for Mentor (but Mentor also has a separate category labeled "breast sensation changes" that was 2.2%). Therefore I think that it is important to specify the complications with their associated rates to give women the necessary information in forming an opinion. DrCarter12

---

Please restore the complication information, especially if consensus exists on this topic. And if there are company-specific statistics available, such as those that DrCarter mentions, I think women have a right to see those, as well. GUHealth 22:22, 20 December 2006 (UTC)

I do not want to add it, since I have had had problems already with DrOliver. However, it is clear that there is a consensus (among doctors and non-doctors alike) and someone should add it.Jance 01:15, 21 December 2006 (UTC)

I read Dr. Ruben's page. He said, list complications if they're significantly special to the particular surgery (as all surgery working with skin has these complications to some extent). So with the statistics provided by Dr Carter (and how big are these two companies? If a significant percentage of the market, we can use them in the article), let's get the statistics for other surgeries that involve skin. Post them here in Talk. If they're like, 1-2%, then what's the deal? Only 2% of patients with (brandname) implants had post-op breast pain? Damn, I wish my oral surgeon were that good. Or are these longterm breast pain? This is important, too. If there's significant breast pain/nipple problems that go beyond post-op, then it should definitely be in the article, because it's relevent info. Just remember that any woman going under the knife is supposed to recieve info about possible complications. Sure, quacks might not, but that's what lawsuits are for :) Dikke poes 17:19, 21 December 2006 (UTC)

I do not know what causes the loss of nipple sensation. However, I would like to see a source on that, and not take the word of any one person. .Jance 23:55, 21 December 2006 (UTC)

• Dikke , the common complications of this are in fact listed both in the context of breast surgery in general and those specific to implants. As David Ruben suggests, if you don't differentiate this, a relevant discussion turns into something akin to the PDR (physicians desk reference) when trying to look up something about a drug. There is so much information included of things uncommon or rare that in sources like the PDR, that it no longer becomes a useful resource for quickly figuring out what is most relevent,most often specific to that drug (or in this case device). There is a 200 page addendum on breast implants to the flagship journal of Plastic Surgery this month covering many aspects of complications & reoperations. Consistant with that, the focus is on what can be done to decrease capsular contracture and reoperation rates. Droliver 19:21, 24 December 2006 (UTC)

Right, Oliver. That was what I meant in my last sentence (that someone actually undergoing the surgery should get a booklet or something with all of the possible effects). So you're wanting main Complications section in the Wikiarticle to be 1: capsular contracture and 2: reoperation. The others want the skin/nipple stuff. So I'm asking them to add numbers here of other skin-involved surgeries and then we can see easily if there's a particular possiblity that we should add under "Complications". For instance, if probablility of nipple numbness were like 72% and for other surgeries numbness is only 20%, then it's obviously a notable complication. If however the probabilities are the same, then it's not notable-- nipples are important, sure, but so are lips. If someone having lip surgery has the same possibility of numbness, than I'd chalk it up to "Bad things that might happen from surgery" and should be left on the surgery page (I'm sure there's a wiki page on it). Dikke poes 20:48, 26 December 2006 (UTC)

Rupture

THe FDA website (2004 consumer booklet) states:

The IOM report20 stated that rupture rates reported in the medical literature across studies ranged from 0.3-77%. This large range of rupture rates is due to the different types and models of implant, varying durations of implantation, different types of groups of women studied, and other factors. The IOM report also stated that extracapsular gel (gel outside the fibrous capsule) was present in about 12-26% of gel-filled ruptures reported in the medical literature. The IOM estimated that less than 10% of modern silicone gel-filled breast implants would have ruptured by five years and that rupture rate would continue to increase over time.

These are relevant, since there is very little data on the newest "style" of implant

And,

Effects on Children

Also from the FDA There are two concerns associated with the effects on children:

1. the safety of the milk from mothers with breast implants for breast feeding children
2. the effects of silicones and other chemicals on children born of mothers with breast implants (second-generation effects).

It is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. There are no current methods for detecting silicone levels in breast milk. The IOM report49 said that there is convincing evidence that infants breast-fed by mothers with breast implants receive no higher silicon (not silicone) intakes from breast milk than infants breast-fed by mothers without breast implants. (Silicon is an element that is one component of the polymer silicone and is one of the most abundant elements on the earth. Everyone is exposed to silicon.)

Concerns have been also raised about the potential damaging effects on children born of mothers with implants. The IOM report said that the information is insufficient or flawed to draw definite conclusions about this issue. In other words, it is not known what effect breast implants may have on an unborn baby (fetus) and the nursing infant. Several studies since the IOM report have suggested that the risk of birth defects overall is not increased in children born after implant surgery.51,52 These studies are comforting, but, because they are small and of short duration, they cannot rule out a very small risk.Jance 21:06, 22 December 2006 (UTC)

Complications

-In response to the agreement and debate on this page, I have re-instated several complications with specific statistics. I did not include hematoma yet, although I would be glad to add it if there is agreement. Other possible additions include breast mass (3% for Mentor augmentation patients) and malposition (4% for Allergan augmentation patients).

In response to the questions -- the manufacturer specifies that these are all long-term serious complications, not short-term pain after surgery, etc. And Allergan/Inamed and Mentor are the 2 major manufacturers worldwide.

In response to Jance's comment, changes in nipple sensation are not specific to incisions around the nipple area (although nerve damage is believed to be more likely with those incisions). Also remember that the statistics given are for the best plastic surgeons that the implant companies could recruit. Presumably the complication rates would be higher for "average" and less experienced plastic surgeons.

With the help of the administrators, I assume that droliver will respect the wishes of the majority on these pages and not delete these well-documented complications.

I also want to remind folks to sign their comments on this page. Drzuckerman 19:41, 22 December 2006 (UTC)

Thanks for answering some of my questions :) Dikke poes 20:54, 26 December 2006 (UTC)

These complications are already in fact mentioned and referred to in both the context of breast surgery & specific to implants. The 4 year CORE data table figure summarizes these rates in a way that clearly speaks to this in a way that makes at length descriptions of less specific complications redundant. Droliver 19:26, 24 December 2006 (UTC)

---

Hello All, As I always state, I believe that all complications should be listed in order to best inform the women/men that read this page. I know that all surgeries have complications, but if I was considering a surgery, I would want to know specifics...so let's include the specifics. Happy Holidays. LynnMB 21:31, 22 December 2006 (UTC)

I know I'm adding this out of place, but a woman looking for surgery info should not rely on Wikipedia or ANY encyclopedia. 'Pedias describe and explain. It's a good START. But listing all complications is not our job. That is the surgeon's job. The surgeon MUST inform you that, before you get your wisdom teeth yanked for example, there's a 2% chance of infection. Is that important? Yes, of course. Does it belong in an encyclopedia? No, other than perhaps a sentence like, Like all surgeries, there is a possibility of etc etc etc'. The especialy notable complications specific to breast implants, though, DO belong here. Dikke poes 20:54, 26 December 2006 (UTC)

• The allergan CORE data complication rates figure for augmentaion cases (the large majority of implants used worldwide) is now added which addresses the issue about people wishing to see data. This should be an acceptable proxy for the devices as a whole. Refs to several of the general complication issues are now attached adjacent to their mention. This would seem to accomplish the agenda without expanding the section to unwieldy lengths for the specific complications that need less expanding.Droliver 18:57, 24 December 2006 (UTC)

Yes, and necrosis was not mentioned in your edit, although several here (including David) thought it was significant enough to mention. There is nothing "unwieldy" about a short discussion of the complications. There is far more unnecessary detail in the generations of implants, for example, or the specfic techniques. And certainly, what you had previously with multiple charts was far more unwieldy than a couple of paragraphs, and was also redundant. Jance 01:08, 25 December 2006 (UTC)

• As per your request, necrosis is incorporated in the context of reconstructive/reoperative surgery.Droliver 20:49, 25 December 2006 (UTC)

I changed back to what a consensus had been on complications. I also removed the unwieldy charts.Jance 23:05, 25 December 2006 (UTC)

Actually, you just reverted back what was an attempt to address the issue of both relevence & brevity to the complications area while incorporating some of your concerns about more serious local complications that primarily involve reconstructive surgery. The list of independent reviews of the literature is also important to communicate the continual & ongoing reevaluation of the literature of this topic & it puts in context the contention that a paucity of study has been done or that there has been much in the way of inconsistancy of the literature. If you can find such systemic reviews that have been overlooked, please bring it to attentionDroliver 16:26, 26 December 2006 (UTC)

I like how the narrative for complications is now displayed. However I am curious as to why the Inamed table is included? Why was this one chosen and not Mentor also? I even feel that the table does not add a great deal to the information. It can always be referred to via a refernce link. DrCarter12 16:46, 26 December 2006 (UTC)

Other changes

I would like others to look at the section on "Systemic Illness" and let us know if it is inaccurate, not mainstream, or any other problem that would warrant major change. I welcome other MDs opinions on this paragraph. Please tell me what, in this paragraph, is inaccurate or even misleading.Jance 02:19, 26 December 2006 (UTC)

I note that rather discuss this, as I requested, DrOliver deleted it and inserted a totally different version. He did not even discuss why he thought what was there was incorrect, or misleading (it wasn't). The "current version" is what DrOliver substituted, and it includes unwieldy tables that are redundant, and the comments are selectively chosen. Jance 18:42, 26 December 2006 (UTC)

current version reads: Droliver 16:39, 26 December 2006 (UTC)

Since the early 1990s, a number of comprehensive (systemic) reviews have been commissioned by various countries to examine the literature and science concerning links between silicone gel breast implants and systemic diseases. A consensus has emerged from these independent reviews that there is no clear evidence of a causal link between the implantation of silicone breast implants and connective tissue disease. The conclusions of these reviews are summarized:

SYSTEMIC REVIEW TABLE SUMMARY (here)

Thousands of women have still claimed that they have become ill from their implants. Complaints include neurological and rheumatological problems. Critics have pointed to the difficulty of effectively studying rare autoimmune diseases (which may take years to develop) and potential conflicts of interest with industry-funded research as reasons to be skeptical of studies finding no correlation to diseases they believe are caused by silicone or saline breast implants.

As studies have followed women with implants for a longer period of time, more information has been made available to assess some of these issues. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of classic rheumatic symptoms then control groups.^[3]

A large study of Sweedish plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery, which the authors attributed to possible differences in smoking rates. ^[6]''::Another large 2006 study with long-term follow-up of nearly 25,000 Canadian women with implants reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind.^[5]

A 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. ^[7]. This association has not repeated in a number of studies^[8], and the US-FDA concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants." ^[9]

''

Droliver, your systemic disease section has errors. I included Samir's paragraph and corrected your incorrect description of the Breiting and Brinton articles. Drzuckerman 16:48, 26 December 2006 (UTC)

This is the version that is current (now):

No conclusive causal relationship has been established between silicone implants and classic connective tissue diseases; however, tens of thousands of women have claimed that they became ill from their implants, and an international settlement by six implant manufacturers totalled more than $3 billion for patients who were able to prove they were harmed by their implants. Complaints include neurological and rheumatological problems, particularly associated with ruptured implants. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [46] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

A 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. [47]. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. [48] Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases", thus distinguishing between symptoms and classically defined diseases. Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. [15] According to the US FDA, "When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [16]

Several studies have established that women who undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. A large study of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled, but the authors speculated that there could potentially be differences in smoking that were not evaluated.[49] Another large study of nearly 25,000 Canadian women with implants recently reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind. The study reported a high incidence of breast pain, and higher suicide rates in implant patients. [50]

Hopefully a compromise can be reached.Jance 18:39, 26 December 2006 (UTC)

• DZ, you are attempting original research reinterpretations of this study, ignoring the authors their report & conclusions. Please describe exactly what you submit is innacurately charcterized. You seem to be merely pushing the same interpretation of this and other papers which has been argued to & not endorsed by a number of the review and safety panels.Droliver 18:22, 27 December 2006 (UTC)

Once again, Samir's suggestion, as a paragraph to discuss

We need to find a compromise between the current version and this version. Dr. Zuckerman, I agree that the opening of the systemic disease paragraph should reflect that no cause and effect relationship has been found between connective diseases and breast implants. The paragraph should, however, elaborate on the fact that there have been reports of systemic disease in women with silicone gel implants. Let's start with Dr. Zuckerman's first paragraph:

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms. Thoughts -- Samir धर्म 06:12, 18 December 2006 (UTC) == It is my understanding that actually 200,000 women were involved in the lawsuit so, if anything, Dr. Zuckerman's estimate was very conservative. I also believe that to specifically cite numbers represents a NPOV versus making generalizations as do Samir's suggestions for changing the first paragraph. I think the first paragraph by Dr. Zuckerman should not be altered at all.DrCarter12 19:38, 26 December 2006 (UTC)

What would you propose? My objection was what Droliver had stated, "a number of" - 200,000 plus (many more than that, since many never registered for the class action) is hardly "a number of. "A number of" implies a few. Jance 01:31, 27 December 2006 (UTC)

• The paragraph on this is explicitly NPOV & goes out of it's way to try and touch on the alternative view (which in fact has little standing iin the literature). The section indeed specifically mentions that there have been claims of said association and mentions the overview arguments for distrusting previous work. The number of participants in the DOW settlement is not reflective of people with symptoms but included anyone with implants, symptomatic or not who filed for monetary claims. This unique American settlement is an example of our tort problems stateside where the issue got ahead of the science by a number of years and companies made a decision after being strong-armed via class-action suits on liability at the time. You can find any number revisitations of that. It is clear that such a settlement would not be offered in 2006 by DOW with the overwhelming subsequent research on this Droliver 18:33, 27 December 2006 (UTC)
  • I think the following points need to be addressed in any systemic illness section:
    • No causal relationship exists between silicone breast implant rupture and connective tissue disease
    • Systemic reviews have been conducted to back this up
    • Thousands of women have claimed they have become ill because of breast implant ruptures and that various nonspecific neurological and rheumatologic complaints are common
  • The DOW settlement should not be used as evidence of of causality between rupture and systemic disease. Also, there is no need to make a table of the systemic reviews conducted and quote the findings of each -- Samir धर्म 20:48, 27 December 2006 (UTC)

Yes, although I think it necessary to say there is no evidence of.. (instead of a categorical statement). Other than that, I agree completely. (My issue still is the rupture rate and effects of rupture, which for all these many studies, still do not study.)Jance 01:10, 28 December 2006 (UTC)

Who reverted the complications? See article for more Info on autoimmune symptoms too

Who deleted all the agreed-upon information about complications?

In addition, Droliver you have repeatedly misrepresented the Breiting et al article. If you have the article, I suggest you read it. Although funded by Dow Corning, they reported significant increases in auto-immune symptoms as well as complications. Re complications, they stated "breast pain was reported nearly three times as frequently among women with breast implants than among women with breast reduction" "and 67% of all women with implants reported moderate or severe breast hardness." (pages 220-221). Re autoimmune symptoms, they stated "Compared with general population controls, women with implants reported significant exceeses of fatigue (odds ratio, 2.6), Raynaud-like symptoms (white fingers and toes on cold exposure (odds ratio 2.4) and cognitive symptoms (impaired memory, problems with traffic orientation, difficulties in adding numbers) (odds ratio, 1.9)" (pages 221). They also reported between a "five fold and seven-fold" increase in the use of antidepressants among women with implants (page 221). They found no significant increase in autoimmune diagnosis, but symptoms can be an early sign of disease, as you know.

Describing these autoimmune symptoms is not "original research" -- its in the published article. So if you want to quote the article, it should be NPOV and accurate: no increase in diseases, but significant increases in autoimmune symptoms, use of antidepressants, and two complication (chronic breast pain and breast hardness). Samir, I am happy to try to work with you on the systemic disease section. I don't care whether we mention the law suit or not here-- I only mentioned it because it provides a specific number that seemed NPOV because it is a fact.

But meanwhile, I asked you to restore the complications that were deleted recently, but several hours passed and I figured out how to do it and restored them myself. Please note: EVERYONE agreed to these complications, but droliver removed them without trying for any consensus. Drzuckerman 00:18, 28 December 2006 (UTC) --Thousands of women have not only complained of symptoms with silicone breast implants but many of these women, who have had the implants removed, noted an improvement of said symptoms. I agree with Dr. Zuckerman that to be neutral in this article requires just stating the facts and not deriving conclusions. DrCarter12 21:38, 27 December 2006 (UTC)

I do not think the lawsuit should be mentioned. In fact, we are not sure whether all of those women were ill, or just preserving their rights in a settlement...do we? I can also testify that many more women never registered for the lawsuit but have had ruptures, become ill with autoimmune disease and filed 'late claims'. This, of course, is still occurring, since there are many many women that have implants from 15, 20 or more years ago. No research on the rupture rates and effects of migration on these women, but hey, that's not important! The only issue doctors seem to be concerned about is the widespread use that new and improved implants "enjoy". Regardless, the lawsuit should not be raised. If you want to say "hundreds of thousands", fine by me. I said "thousands" which is minimizing. Droliver said "a number" which is um...well, not the case. Jance 01:13, 28 December 2006 (UTC)

• DZ, Individual symptoms do not equal disease and the study is important in that no increase in # of vague symptoms existed. That's what it finds in black & white. It is in fact more evidence to refute what you're trying to imply. You are trying to turn the results and conclusion of that study 180 degrees on it's head implying something that is not consistant with the decription of that particular study and many others. That is indeed original research on your part. In addition, the complication section was reverted to the previous version rather then the changed one. Both the numerical data and mention of the more severe complications you wished addressed were added with reference. I'm not exactly sure what you're trying to demonstrate? Droliver 00:08, 29 December 2006 (UTC)

Oliver, it might be helpful if you would stop twisting what others say. Jance 05:30, 29 December 2006 (UTC)

--droliver, everyone else agrees that the complications should be listed, except you. If you continue to delete the well-referenced, widely established information about complications, you risk having this entire article deleted because of an editing war. On the complications issue, your view is contradictory to Dr Carter, Samir, Sarah (administrator), Jance, the GW University person, the MPH person, and me. If you want others to work with you on, you need to be more reasonable and stop deleting.

As an epidemiologist, I am certainly aware of the difference between symptoms and disease, but most autoimmune diseases first show up as symptoms. If you are not aware of that fact, then read up about those diseases. You are incorrect about the Breiting article -- I quoted their findings directly, but I am happy to fax the entire article to you if you'd like. I also offer it to Samir, Dr Ruben, or anyone else.

I added the language re systemic disease that Samir had previously approved. I kept the first paragraph as Samir suggested, as a compromise and show of good faith, deleting information about symptoms. I respectfully suggest that droliver review the peer-reviewed published articles in full (not just the abstracts) to see how the government documents are specific to diseases, whereas the studies (by implant makers as well as government researchers) find significant increases in auto-immune symptoms when age and other confounding variables are controlled.

It is time to discuss the newly proposed language that several health professionals have agreed to, as well as Samir, rather than continuing to have droliver delete and replace this. We are willing to be reasonable, droliver, so I hope you'll work with us. Drzuckerman 06:00, 29 December 2006 (UTC) re

I sorry Diana, but you keep ignoring the fact that the complications you refer to are in fact already mentioned with numbers adjavent. You seek to achieve an exagerated edit of that in a way that is not reflective of the way this is seen in clinical practice. Please refer to recent vintage Plastic Surgery journals or meetings if you want to see what what in fact the true concerns with in re. to complications. It is not tissue loss or scarring with primary cases, but addressing capsular contraction & reoperation rates which is why those topics deserve expansion. Excess scarring & tissue loss discussions are really focused on breast reduction/mastopexy & reconstructive patients, which is made clear in this entry.

The systemic review introduction is clearly consistant with Samir's proposal and is now minus the table. There is no ambiguity in the world view in assessing this.

Your concerns re. Breiting study seem to be in highlighting elements of the data out of context with the study and the way AI diseases are diagnosed. Symptoms don't equal disease. The number of vague symptoms in this and many other studies predictably is consistant with control groups. That is what was demonstrated there again with better/longer follow up then most. Again, you're getting off into the orignal research reinterpretation with this on what is universally agreed to be grade A data further dismissing concerns over systemic illness.Droliver 17:11, 30 December 2006 (UTC)

==

I too would like to see a compromise struck so that this article can be in a version that everyone can live with. We need to remember that many women and their families will look to this article in guiding their decision regarding breast implants and reconstruction. I feel that the version for complications and systemic disease is well researched and cited. However, I would suggest that the location of the section on "systemic illness" follow "complications". I also disagree with droliver's assertion that DrZ is linking causality to having breast implants and systmic systems. When I read the section it just demonstates that women have complained and they also have breast implants. I have had the occasion to treat 2 women with silicone breast implants and rheumatic complaints. This dilemma is real to me and those 2 patients. DrCarter12 20:04, 29 December 2006 (UTC)

I agree with DrCarter. It is important to be extremely careful with the language of this article and to not imply support for the idea of cause and effect between silicone implants and certain illnesses where there is no scientific evidence supporting such a linkage. --Curtis Bledsoe 00:22, 31 December 2006 (UTC)

• Agreed. It is easy to quickly survey the consensus on this & just as easy to describe it in brief. Wikipedia is not the place to rehear at length the failed arguments on this. That's been done systematically for the last 15 years. As Curtis points out, there is deliberate language implying and suggesting conclusions that are not supported by either the data or general international consensusDroliver 10:30, 31 December 2006 (UTC)

I will note that Curtis Bledsoe is making purely malicious edits, after having followed me here. He has already been warned on this type of conduct.Jance 00:11, 31 December 2006 (UTC)

And I will note that your allegations are completely unfounded. My edits are not "malicious" but rather they are both valid and supported by my comments. I haven't "followed" you here, despite your apparent need to believe this. And I'm curious what exactly I've been "warned on" (sic). --Curtis Bledsoe 00:20, 31 December 2006 (UTC)

We need an admin to look at the violations by this user. There are many. Although he is new, he has been warned. He is a SPEJance 00:26, 31 December 2006 (UTC)

Advisory comments by one user to another is surely the preferred method of informing a user of policies, and pointing out guidelines that they might inadvertently (remembering to Assume good faith) be at risk of breaching - such comments I agree already made to both editors. If this results in a positive change to generally accepted collaborative contributing, then no retrospective further action would seem required. However if further disruption then continues, article talk pages is not the place to seek higher level of action, instead follow dispute resolution processes and use WP:3RR or WP:AN/I to set out details of specific breaches.

That all said both Curtis Bledsoe and Jance have engaged in repeat revert warring with 9 reverts over 12 edits between 00:51 and 04:35, 31 December 2006 (no single point reverted more than twice I agree), this seems overall to be disruptive to the wiki process and thus admin opinions sought. David Ruben ^Talk 04:49, 31 December 2006 (UTC)

I would hope that others can see what he has done to NCAHF, that brought him here. I have already opened an An/I. Jance 08:27, 31 December 2006 (UTC)

David's "help" here is not of much help. I don't know what else I should have expected.Jance 09:05, 31 December 2006 (UTC)

Previous "off-line" version moved

Previously I had created subpages to act for editors to use as an "off-line" version. I don't think this has been much used as of late and Sarah recently posted to me a problem with this approach and that she has kindly moved and preserved the page under her userspace as a result:David Ruben ^Talk 04:57, 31 December 2006 (UTC)

The other night I was poking around in the mainspace and I discovered a page you started earlier in the year at Breast implant/Risks and debate. It was labelled as a sub-page and I just wanted to let you know that you can't make sub-pages of mainspace articles. There's some feature in the software that prevents it and if you try to make a subpage, it actually makes it as an article (see WP:SP). So when searching "breast implants," the page "Breast implant/Risks and debate" came up as its own article. I moved the page to my userspace, User talk:Sarah Ewart/Breast implant risks and debate, for now in case it was worth keeping but I just thought I should let you know. Sarah 08:22, 28 December 2006 (UTC)

David, there's another companion to that scratchpad still lingering as breast implant controversy that needs to be put out of its misery Droliver 10:21, 31 December 2006 (UTC)

If you want that one "put out of its misery," you'll have to take it to AFD.Sarah 16:23, 31 December 2006 (UTC)

Protection

The article seems to have descended back into edit warring. I have protected it again. Guy (Help!) 17:47, 31 December 2006 (UTC)

I think the crux of the matter here is the statement "Thousands of women still claim that they have become ill after getting their implants" in the "Systemic illness and disease" section. The problem is that is completely unsupported. The statement may well be true, but there's no citation to support it. A statement like that should contain some supporting citation. However, it is better than the previous version that read "Thousands of women still claim that they have become ill from their implants". It is important to carefully parse such statements. The old way, the implication is created that the women are claiming that the implants caused their illnesses. That requires an entirely different level of supporting documentation. We then have to talk about who these women are and what authority or expertise they have to make such a statement. It is better to say that the illnesses occurred *after* the implants and rely on whatever scientific evidence exists to provide the cause/effect linkage - or, in this case, the lack of it. --Curtis Bledsoe 18:33, 31 December 2006 (UTC)

Actually, hundreds of thousands of women, not thousands, have claimed breast implants caused their illness., SO yes, it is true. We could cite the lawsuits. We could cite that thousands of documents. Which would you prefer, Curtis?Jance 20:24, 31 December 2006 (UTC)

You can cite anything you like so long as it is relevant and verifiable. However, as to the claim that the implants caused the illness, you'll also have to provide scientific evidence to support the claim. But since there is no scientific evidence to support a causual link between implants and various illnesses, you're going to have difficulty doing that. --Curtis Bledsoe 20:39, 31 December 2006 (UTC)

Curtis does not seem to understand the comment he removed. The statement was "hundreds of thousands of women, not thousands, have claimed breast implants caused their illness."

That is a true statement. Also, it is not true to say there is no scientifice evidence to support a causal link. Even Oliver would not say that. I think you need to stop wikistalking.Jance 00:44, 1 January 2007 (UTC)

• "Hundreds of thousands" is overstating it and confuses women claiming money in a class action settlement with women who actually had symptoms. The secondary gain involved has made any useful analysis impossible. I think more telling is how that issue played out singularly in the USA with our class-action lawsuit system, but that's neither here nor there.
• I agree with Jance that is incorrect to say there is no evidence re possible illness. More accurate (I would submit) would be there is little evidence, and when studied rigorously there has consistantly been a lack of a pattern of symptoms or disease when compared to control groups. This has been validated over and over again world-wide. As it's impossible to prove a negative, that's about as definative as we can can declare on this. One day we may make some discovery which in fact does identify some very small subgroup of women with some genetic predisposition to AI phenomena to explain what Jance & Dr. Zuckerman believe, but no such information currently exists (and may never). Droliver 04:46, 1 January 2007 (UTC)

I actually agree with Droliver, on most of this. "No clear evidence" is more accurate. Also, for the reasons I already stated in this talk page, "hundreds of thousands" or citing the lawsuit is probably not a good claim. There may be hundreds of thousands, I don't know. We all agree that there were 'thousands.' Off topic but interesting is that both asbestos and BI litigation had claimants (or litigants) who were attempting to preserve their rights in a lawsuit before either SOL ran or the settlement, and were not necessarily ill. In both cases, some may never become ill. That was the problem with both class actions, imho. (Let's not debate the 'science' which could go on forever). The ABA has addressed the asbestos issue. The BI class action settlement will soon be ending, and I am glad of that. My hope is that more research will be done on rupture, and its effects - there is little evidence one way or the other on this. Most of the many many studies that do exist do not look at these issues. So of course we do not have clear evidence. I personally do not believe we have all the answers. And, we may never. Jance 20:15, 1 January 2007 (UTC)

So truthfully, what source gives us this "thousands of women" or "hundreds of thousands?" Yes, I saw the earlier remark on the 200,000 involved in the class-action lawsuit, but as some here have already said, there is a problem with using that number... so where else do we find them? C'mon, I'm sure that like, TIME or someone has done stories on Breast implants during the whole disease-claim rage during the 90's, and have a number from some expert here or there that we can use. I don't agree with Mr Curtis' removal of the sentence, but I've been bothered by the source for the number for a while now. Comments? Dikke poes 14:10, 3 January 2007 (UTC)

Editors guilty of continued reversions

I would like to see something said to Droliver for his reversion here, and to Curtis for his continued reversions, sarcasm and abusiveness on NCAHF. Jance 20:23, 31 December 2006 (UTC)

Do you mean the one revert by DrOliver on 29th and this sequence the previous day ? Yes Jance I would agree that following previous edit warring, page protection and advice to discuss here on talk pages, to reach consensus and only then to implement changes to the articles, yes this was not a constructive approach. That said, following your raising of concerns for this article, another admin had now protected again and this will force all editors to return to talk page discussion.

CB has had various comments posted on their talk page. NCAHF is off-topic for here, but I see you have already raised this at AN/I and action has been taken.

For what it is not worth, my personal view is that the raised concerns for BI have been previously under commented upon in this article, but equally the scientific proof to confirm the concerns seems currently lacking and both are valid notable points that should be mentioned. That places me I think on neither side, and I generally find myself seeming to agree with DrZ's various comments above. This article does not attract a lot of interest (as measured by number of different editors) and this makes reaching a widely-based consensus harder (vs just a few individuals on either side), so trying to keep cool, being super-civil is really important - an edit war looks bad for all involved parties and is nasty (to both article development and for the wikistress to the involved parties). I hope all editors are able to restart what had seemed more promising discussion and return to Image:wikistress1.png. Have a peaceful New Year David Ruben ^Talk 03:02, 1 January 2007 (UTC)

Thank you. The disruption was a result of a wikistalker. And, I might add, the latest revert was by Droliver. Jance 20:09, 1 January 2007 (UTC)