Talk:Breast implant/Archive 5

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Contents 1 Complications 2 Patient characteristics 3 Chart 4 What the FDA stated 5 Misstating studies 6 One such study that is misrepresented 7 Wiki Clin-Med reviewed? 8 Dr. Oliver's mistatements 9 BY DR M (A BOARD CERTIFIED PLASTIC SURGEON) 10 Page protected 10.1 Article authenticity 11 Futility 12 Reverting to an incorrect version is not the answer 13 An/I? Medical Article ? 14 Samir, where are you? 15 Refactored 16 Table 1 17 Comment on protection, revert-wars, and accusation/counter accusations 18 Rupture 19 Alternative Rupture Section 20 Paragraphs, not sections 21 3rd rupture proposal 22 Response to rupture discussion 23 Unprotected 24 rupture section

Complications

We should include SOMETHING regarding these assertions: "the literature offers a number of noteworthy examples of downright unhealthy silicone side effects, some of the scariest of which are presented in an ongoing National Cancer Institute study. Among its findings: Women with implants were two to three times as likely to die from brain cancer and respiratory cancers, and four times as likely to commit suicide, compared to other plastic-surgery patients." http://www.alternet.org/stories/43231/ I didn't find mention of the cancer study anywhere in the wiki article, but it's obviously a part of the debate. 72.244.201.27 17:22, 21 October 2006 (UTC)

Actually, the lung CA issue & suicide rate is referred to in the article. The brain CA issue never panned out on closer analysis. The small increase in lung CA clearly appears to be related to smoking in the particular population studied (scandanavian women) rather then the presence of implants, and this was noted by the authors of the paper as well as in subsequent discussions by the national cancer institute. There is no plausible mechanism or connection for implants and lung CA & this correlation has not been seen on many other large population studies, including a large study from Canada just published which had lower cancer rates of all types as compared to the general population. Suicide rates have been higher (but still small) in 4 or 5 large implant group studies outside of America, which reflects the correlation to higher preexisting psychiatric disease rates rather then implying causation from the implants (as witnessed by no increase in suicide rates among implant based reconstructive patients). This mirrors the observation of slightly higher suicide rates among all comers for cosmetic surgery rather then something specific to implants. I don't believe there has been any study from the US population demonstrating similar phenomena yet, but our follow-up isn't as sophisticated as some of the countries with more centralized databases from their national health servicesDroliver 15:15, 26 October 2006 (UTC)

Studies have been cited in this article that are misunderstood or misrepresented. I urge anyone reading this to please review these. Look at the history. For example, one study cited concluded that the rupture rate of modern devices is - at a MINIMUM - 15% between 3 and 10 years. However, the study was misstated in this article, that the rupture rate was 3 to 8 % in a decade. That is not what the study found.

The lower rupture rate comes from the segregation of 3rd/4th generation implants out of the data which also included 2nd generation implants which have signifigantly higher ruture rates. There are an additional 2 studies of 4th gen. implants with similar observed rates.Droliver 22:49, 24 November 2006 (UTC)

The lower rupture rate was not accurately stated. In fact, the 'best scenario' rupture rate was minimized in the article, and was misleading, The study itself states that this is likely not an accurate rupture rate, because women who had their implants removed because of rupture were excluded from the study. I actually quoted from the first study cited which was stated incorrectly, and Dr. Zuckerman accurately discussed the second study and why it minimized the actual rupture rate. And, of course, these were both small studies, and neither even attempted to estimate rupture rates beyond 10 years, This is because there was not enough data to model rutpure rate beyond 10 years. Similarly, the effects of rupture were also not analyzed long-term. That is why the FDA stipulated what it did, and recommended follow-up MRIs to detect silent rupture. The truth is that we just don't know (in the words of my rheumatologist) what the long term effects of implant rupture are.67.35.126.14 06:12, 30 November 2006 (UTC) jance

Patient characteristics

I feel it would be nice to expand this section by mentioning the women who get augmentation after a masectomy as a consequence of for example breast cancer. Not all women who get implants do it to get bigger breasts. Furthermore i feel that the first sentence desperately needs a citation since íts generalising and unencyclopedic the way it is now. 18:26, 4 November 2006 (UTC)

Good point, I think this: Brinton L, Brown S, Colton T, Burich M, Lubin J (2000). "Characteristics of a population of women with breast implants compared with women seeking other types of plastic surgery.". Plast Reconstr Surg 105 (3): 919-27; discussion 928-9. PMID 10724251.  fits the bill and I have added it. (Could I say, tongue in cheek, that it reflects the careful work done by Plastic Surgeons in assessing the needs, aspirations and characteristics of their patients?) Will TALK 09:51, 8 November 2006 (UTC)

I wonder where the Brighton study found the women. Many women who have had breast implants are highly educated, and more affluent than most. I surely do not fit into Brighton's assessment, since I have post-graduate degrees, and am non-smoking, non-drinking and have no history of rheumatoid arthritis in my family. Oh I know, I am only an 'anecdote'. Perhaps manufacturers and plastic surgeons should advertise this when they try to sell breast implants --

"WOMEN who are prone to using drugs, already have arthritis in their family and those who don't have much education - breast implants are for you!!!"

They surely want to use this stereotype in finding comparison groups for studies. I wonder why? I would really like to examine how those patients were actually selected.67.35.126.14 01:43, 24 November 2006 (UTC)

Chart

This chart that DR Oliver used where he summarized the scientific reviews has been discussed and debated ad nauseum. THe majority then determined NOT to include it, as it is unnecessary. Moreover, ALL of these studies cited were cited seletively and summarized selectively. I specifically pointed this out, wtih examples. Nothing has changed that. I will concede to inclusion that there were scientific studies that concluded this. However, to say these all were independent, when some are still questioned as to their bias, is wrong. Does anyone bother to check some of these things?

What the FDA stated

This is what is actually stated on the FDA page cited in the articl- notwithstanding the recent FDA decision to approve silicone implants for women 22 years old and older, with conditions:.

"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."67.35.126.14 03:07, 24 November 2006 (UTC)

Misstating studies

I changed the rupture section to its correct version. Dr. Oliver reverted what I had written, after I corrected what now looks like Dr. Oliver's deliberate misstatement of the study HE cited. Is it really acceptable to other doctors here to deliberately misstate studies he cites? And if you don't know what is stated in the study, then I urge you to read it. It is vastly different than what he wrote. I also added information from the FDA website and a new study on Patient Characteristics which he simply deleted without explanation. Are the other "medical" doctors here going to support this? 67.35.126.14 23:31, 24 November 2006 (UTC)

Dr. Oliver has a problem with accuracy in his reporting of research findings. As the author of dozens of peer-reviewed medical articles, I have tried to correct his mistatements. However, Dr oliver has a track record of making changes, including adding promotional websites for "information" such as the names of plastic surgeons who are selling their services. That does not belong on wikipedia.

This article is long, and should not include technical information and technical medical terms. Breast implants are not so important that they deserve more details about techniques than heart surgery, for example. Drzuckerman 05:28, 25 November 2006 (UTC)

Dr. Zuckerman, treating this topic as an area to be pointedly edited for political views is a non-starter. If you would like to discuss what you percieve to be misstated studies, please bring it here thru the discussion page. The entry as it read prior was a flat/dry mainstream discussion of the devices, techniques, and commonly associated risks which was previously presented thru the wikipedia clinical medicine peer review. While you most certainly disagree with the current conclusion of every health ministry in the world re. these devices, that is not the lens thru which medical topics should be filtered. There is certainly room to refine aspects of this presentation, but the prolonged re-airing of failed arguments which have been evaluated and dismissed by the FDA, MHRG, Health Canada & others isn't productive or an accurate overview.

I would also disagree with dismissing the technical aspects of the procedure as this in fact is a large part of any discussion between surgeons and their patient. Unlike your example of heart surgery (CABG), there are many aspects of breast surgery that are negotiated during evaluation for breast implants. These distinctions are of immense interest & discussion among patients considering these operations.Droliver 17:06, 25 November 2006 (UTC)

Everyone has a view, Dr. Oliver - and yours is equally as biased as you claim mine and Dr. Zuckerman's are. First please show us the source by which you claim sole authority to edit this article. Also, is this encyclopedia intended to serve as a discussion between doctor and patient? If so, then surely the risks that the "Health ministries of the world" point out should also be included. This includes the accurate studies on rupture, which the FDA states is a primary cause of reoperation. Also, the FDA states a number of causes of rupture, including mammogram, which you deleted. Why? As a patient, I would want to know this. There is no legitimate reason to leave this out.Jance 18:34, 25 November 2006 (UTC)

Dr. Oliver also deleted what I had written here:

Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [1]

Why would he delete this? Don't you think this is important, and something women should know? Or is it only important that women know about the surgical techniques that plastic surgeons use?Jance 19:01, 25 November 2006 (UTC)

One such study that is misrepresented

Dr. Oliver highlights one study as the "only" accurate study of rupture and says this of the study ""The only literature with available MRI data on single lumen 3rd/4th generation silicone implants have reported 5% and 8% device failure rates at a decade."

Please show all of us where this study says that.

The study you cited included women who had had implants for only 3 years. Even those 3 year old implants that were presumably examined after a two year period would be 5 years old. How could this study then determine what the rupture rate was at a decade? In fact, it does not, based on the paragraph below, and even their estimate is much higher than what you stated as fact. I wanted to add that a linear curve is usually not accurate in estimating failure rate of devices over time, and I do speak with formal training and experience in this. This study does imply that the rate is non-linear, although not in these words. Still, I'd like to know what mathematical curve they used to estimate - although I suppose that "minimum" and "between the third and tenth year" include some wobble room. Surely this is not even close to what Dr. Oliver wrote as "reported" by the study, nor is it as enticingly accurate and specific as what Dr. Oliver implied.

The study states, and I quote,

"A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."

Please, other doctors out there, help me out - is there some other way that medical doctors would read this that I am missing?

This is what I wrote that Dr. Oliver deleted,

One of the only published studies with randomized MRI data on single lumen 3rd/4th generation silicone implants concluded that "the risk of implant rupture increases with implant age" and "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."

Please show me where what I wrote quoting the study Dr. Oliver cited below, is incorrect, and his version that the study "ha[s] reported 5% and 8% device failure rates at a decade." is more correct. I do not know if it is the only randomized MRI study. If it is, then surely that should be sourced.

Jance 18:09, 25 November 2006 (UTC)

The objection you have to my characterization of Holmich's data is worth discussing for the length more so then the rates and we can certainly address that. These rates were closer to 6-7 years at the time of publication and result from more specific subgroup analysis in his data. In 2001 Holmich et al. [PMID: 11547138] measured implant rupture prevalence by magnetic resonance imaging in 271 ,women with 533 implants. Ruptures were found in 26 percent of the implants overall and 7 percent of the 183 third-generation implants, which had a median age of 6 years. In the companion to this study you refer to, Holmich [PMID 12794458] in 2003 obtained incidence of implant rupture by magnetic resonance imaging or surgery in 186 women with 317 implants. Of the 145 third-generation implants included in the study, 5 percent were found to be ruptured.

Additional confirmation of this survival rate for devices, 9.2 percent at 10 years, comes from a British study by Sharpe and Collis in data presented before the FDA in 2005 which I did not refer to.

Heden's 2006 data [PMID 16874191] is even more specific with essentially no heterogenity of implants and a tight study group range of MRI reviewed patients with 6% (+2% indeterminate, giving a high-end estimate of 8%) rupture at 11 years median time.

In summary, please explain how you odeally would like to see this treated and we can go from thereDroliver 14:57, 26 November 2006 (UTC)

Certainly. First, I reverted back the article, since your version is NOT Wiki-clinmed reviewed, as you claimed, and you deleted at least two editors' work:

Now, to the issue here.

The fact is, that the Holmich study cannot - and did not - report 5-8% rupture rate at 10 years, as you stated.

Here is what the study stated:

For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years.

CONCLUSIONS: The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.

You may not know this, but the curve (of rutpure with time) is not linear with time. You did not address that, either. I am not going to repeat what I already wrote, but this was a 2 year study (not 6 or 7 or 10), on women with implants 3 years old or more. Even if the median was 6 years, this study alone would not provide enough data to accurately predict rupture rate at 10 years. That is why the authors wrote that they <estimate> a minimum of 15% rupture at 10 years.

We need to leave it as I wrote it, which is correct:

One of the only published studies with randomized MRI data on single lumen 3rd/4th generation silicone implants concluded that "the risk of implant rupture increases with implant age" and "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."

This is absolutely 100% accurate, based on the study you cited. What you wrote was not accurate or true, based on the study.

Heden's study is a smaller study than the Holmlich study. It does report 8%. This is still not what you stated, and I note that if you were looking at both this and the Holmlich study, then the literature would say 8% to 15% or greater. This also is not 5-8% at a decade, that you stated. The implants in Heden's study had an older median age - of 10.9 years. I don't like the conclusion here that based on that, one can determine a rupture rate of 8% at 11 years. The implants that were less than 10.9 years were not followed for 10.9 years, were they?

What really should be done is a large study where the implants were all 10 years or older, say 10-15 years old, and then look at the rupture rate. Do you know of a study that did this?

What about 15-20 years old? There are many many women with implants that are 15 years old, or older. I suppose they would not be the 'newer' implants, though.Jance 17:57, 26 November 2006 (UTC)

I suspect, but cannot speak for Dr. Z, that she meant 'both ruptured' implants here. I would like for her to be able to respond to what she wrote, before it is deleted.

"This study did not report the number of women with ruptured implants, but since most women reported only one ruptured implant, the implications are that at least 30% of women will experience at least one ruptured implant between the 3-10 years after augmentation."

As to your comments to Dr. Z that this is all well settled - Vioxx was well settled too and FDA approved, but it has been taken OFF the market. The fact is and there is no escaping it, Oliver, that there is still controversy about breast implants that should not simply be dismissed. There are still inadequate studies of the rate of rupture (which the FDA has stated itself) and the long term effects of rupture. Yes, implants have been approved - with unprecedented conditions. And yes, it is also political. Congress is discussing bills directly related to silicone implants. For you to simply dismiss all of this is unreasonable. These are not quacks or fringe elements - there are doctors and scientists and yes, politicians, who still think the decision was a bad one. That is WHY Congress is involved. But okay, that is not the "mainstream" now. The Mainstream (FDA) still admits to not having sufficient rupture data to accurately predict rupture 10 years and beyond. The reason they can't is because the rate of rupture is nonlinear. If it were linear, it would be easy. It isn't. That is the problem.

At the very least, the risks as the FDA describes them and the limitations of the studies should be discussed! And sources need to be accurately represented.

Wiki Clin-Med reviewed?

Where is this version Wiki clin-med reviewed? I would also like to ask if it is, I challenge it. Please show me where "Wiki-Med" support alleged facts that are not what the study cited states? I challenge this and would like to know who all reviewed it. 67.35.126.14 17:00, 25 November 2006 (UTC)67.35.126.14 17:04, 25 November 2006 (UTC)

It was not Wiki clin-med reviewed. That is now obvious. Jance 00:40, 26 November 2006 (UTC)

Dr. Oliver's mistatements

Dr. Oliver has asked for examples of his mistatements. I don't have the hours it would take to list them all, but here are a few:

1. His listing of implant generations was incorrect. The 2nd generation started in the mid-1970's (not 1970, as he stated) through the mid-1980's (not 1980, as he stated), the 3rd generation from the mid-1980's, the 4th generation in the early 1990's and the 5th generation (gummy bears) about 6 years ago (not 1993, as he stated).

2. Even his well-documented historical facts were incorrect. Just check the FDA website -- it would take about 10 min. FDA started regulating medical devices in 1976, 10 years later there were efforts within the FDA to require safety studies of breast implants (not "decades later" because of political pressure, as he stated before I revised it again). Oliver deleted all the correct facts I had entered (at least 3 times!) as well as the Congressional report reference that provided all the facts on that.

3. Dr. Oliver stated that FDA approved silicone implants for unrestricted use. Not true. 3 important restrictions: #1 no women under 22 for augmentation, #2 Allergan and Mentor each have to study the safety of implants on at least 40,000 women for at least 10 years, and #3 women must be informed that they should undergo an MRI 3 years after getting implants, and every 2 years after that.

4. Dr. Oliver's misrepresentation of research findings is mind-boggling, but I will go into details if there is a clinical review or monitor who is interested. He deleted numerous peer-reviewed published citations that I had included, even ones conducted by implant makers or funded by Dow Corning, when they showed any problems.

5. He included an old TV program as a link, as well as 2 implant websites that are paid promotional websites for plastic surgeons selling their services.

6. I am tired of Dr. Oliver's slanderous statements about me. He knows full well I was trained as a post-doctoral fellow in epidemiology at Yale Medical School. I was previously on the faculty at Yale and Vassar and directed a major research project at Harvard and I am currently a Fellow at the University of Pennsylvania Center for Bioethics as well as President of the National Research Center for Women & Families. I have published numerous articles on medical issues, including breast implants, in major medical journals and scholarly journals. I am happy to compare my research credentials against Dr. Oliver's any time. Drzuckerman 19:36, 25 November 2006 (UTC)

1. Implant generations is a bit subjective and depending upon your source you may see 3,4, or 5 generations listed. The pedigree as listed is from the 2006 6 volume Mathes Plastic Surgery set which is arguably the standard textbook. This time line is also consistant with a number of presentations in international plastic surgery meetings.

2. The 3 sentence synopsis of the FDA is an accurate and brief thumbnail characterization the events as they existed and is outlined as such in several sources you can find relating to those events.

3. Unrestricted in this context meaning primary cosmetic surgery indications are allowed. The longitudinal follow-up continuation of the adjuct study patients isn't a restriction.The MRI recomendation (which is not a requirement BTW) is not a restriction. Silicone implants may in fact continue to be used in patients <22 y.o. for a variety of indications (which are largely aesthetic), so I wouldn't call that restricted, but if that distinction is important for you I'd understand your POV

4. There is now 100% international consensus on the treatment of these devices. They've been reviewed world-wide with similar conclusions.

5. I don't think I have added any commercial links in this entry. I will review that if you point to the objectionables

6. You are indeed the most prominent political activist around on this and an effective advocate for your cause. Droliver 01:03, 26 November 2006 (UTC)

1. The FDA has not stated that the long term effects of rupture are harmless. This is an issue for many women. The FDA has required a 10 year study (which really is not long enough but it is something.) There are women who have silicone implants now for 20, 25 and 30 years. Many of these implants are ruptured, and surgeons tell them that their rheumatological complaints can't possibly be related to rupture. That is reprehensible.

2. I do not know that plastic surgeons are any more correct than the FDA or other sources on the historical dates of these implants. Since there seems a discrepancy, perhaps each timeframe can be discussed, and cited (assuming the source is not misrepresented.)

3. Dr. Oliver needs to address the factual errors or misstatements about rupture. He has not done that, but rather, is ignoring what I have pointed out -- evidently he accepts that he erred in misquoting studies he cited.

4. He also changed the article on Dr. Zuckerman to call her a "political activist" instead of an expert in her field. That is insulting, Dr. Oliver - and is consistent with the backhanded compliment you gave her here.

5. The use of silicone implants was not unrestricted, without conditions, as was implied in the previous version. That was the issue. They were not unrestricted on women younger than 22 years old, and there WERE conditions placed. One stipulation was that manufacturers inform women implants are not lifetime devices, and at least one reoperation will be necessary.

6. The FDA has recommended MRIs 3 years after getting implants, and every 2 years after that -- which is what I originally wrote, but which Dr. Oliver deleted, inexplicably. I will leave it to Dr. Zuckerman to state whether it is a requirement, since she wrote that. Follow-up will be expensive since most insurances will likely not cover the MRIs (which run over $1000) or the reoperations.

Jance 01:38, 26 November 2006 (UTC)

Your concerns in order

1. We can agree that rupture isn't harmless. It requires reoperation if nothing else. The sequella however are largely confined to the breast/chest wall and (very) rarely the axillae. As fewer 2nd generation implants remain (with less cohesive filler) this is likely to be even more so. As to reumatologic issues, there is still general consensus that there remains no demonstrable relatilonship. The 2001 Brown study is referred to in the context of the FDA (and others) position on this

2. As mentioned, what constitutes a generation is kind of a moving target. The similar characteristics is the key rather then the date. During the transition between 2nd/3rd is especially confusing when you try to make sense of older reports as multiple devices in transitions existed simultaneously. The standardizing terminology emerging has really come from the more recent surgery literature which is why I would push for that. This should not be a big deal to work out.

3. I agree with you on the treatment of the Holmich data as I'd stated it. My mischaracterization had to do with lumping some of the subset of more modern implants (out of his total n) and their slightly shorter median f/u with the longer median f/u of the whole group (which included a number of older implants). Referring to the high-end of the estimate (15%) in the context of these studies likely overstates the true % but parsing this further is more heat then light. Presenting these studies (holmich, heden, collis) together with passing reference to the shorter core data covers the bases of available information

4. Dr. Zuckerman is both an expert and an activist/advocate/what have you. This site is not a political forum however, and the type of presentation that is in a political press release or advocacy website is different then the treatment of medical topics here

5 Again, unrestricted in this context meaning primary augmentaiton and reconstruction without the adjunct study protacols. The labeling and whatnot are largely unchanged from the version we've been giving out for years except they update the core data #'s and a few odds and ends in the text. The age provision is really more for manufacturer advertising purposes then a true restriction on clinical use as it would have been under the core or adjunct study. These are more distinctions without a difference when the mention of the FDA approval deserves about 1 sentence

6 The MRI recomendation is new, but I don't really think that warrants more then passing mention in the rupture section. As exactly one country in the world has recomended this (and this is nominally a world view article) it's inclusion is kind of American-centric. It makes little sense (as health canada concluded) in asymptomatic patients prior to a decade statistically and is not a enforceable mandate for patients. The FDA hasn't really explained themselves on this yet.Droliver 05:12, 27 November 2006 (UTC)

1. No, rupture is not harmless. The problem is that there are not long term studies on the effects of rupture. Period. At the very least, this should be mentioned. Again, you failed to do this. There are still women out there who have implants that are 20, 30 years old. If you want to discuss that the newer implants are less likely to rupture, fine.

2. I agree.

3. Thank you. This is the kind of thing that bothers me. And it would bother me, regardless of whether you 'like' breast implants or 'don't like' breast implants. That is the engineer and mathematician in me, not the breast implant recipient. When it looks like a deliberate shading on either side, it is bothersome.

4. Agreed. But you have treated her as only a political activist, which is untrue. You also have a 'political' agenda.

5. It takes no longer than a sentence to state what I stated, that the FDA approved unrestricted use for women aged 22 and older, with a number of conditions. This is a true statement. Stating only that there is unrestricted use is not a true statement, because it is misleading.

6. I do not agree, totally. First, the MRI recommendation is not that new - certainly the FDA has considered the MRI the 'gold standard' for some time. This must be mentioned, even if it is only stated for the US. If other countries don't suggest this, then that is unfortunate for women who do consider breast implants. Second, it is as important to women considering implants as is the technique of implantation. Women must consider the expense of implants - this is one reason the FDA stated this, and the requirement that manufacturers inform women that implants are not lifetime devices and they face at least one reoperation. It is VERY important, because for years and years women WERE told by either deceitful or ignorant plastic surgeons that implants would last a lifetime. This is particularly important now that more and more women seem to be interested in having implants - even those women who can't afford them. If they can't afford the initial implants, how exactly are they going to afford the follow-up? To gloss over this, "in passing" is not responsible.

Finally, I reverted to the version that two and more people worked on - you did not ask for input when you completely changed the article before this. That was a major contention, if you recall. Instead you just rewrote it to suit your preference, because of what you called "ham-handed" editors. Well, the ham-handed editors are also fully entitled to contribute, and perhaps a negotiated article can be achieved. It certainly won't be if you come back and revert without discussion. So if you want to bring it here, fine. Otherwise, you, Dr. Z and I -- and others who have said they will contribute (including a plastic surgeon) will be locked in a fruitless battle. It isn't worth it. Your 'version' was not Wiki Clin-med reviewed - I checked. It also was not substantially edited (as far as content) by anyone other than you. It would be a miracle if we can all 'get along' but I think it is possible. But you are also going to have to give - and not automatically call an edit you don't like "political". Surprise me - show me that a plastic surgeon can be honest.Jance 20:14, 27 November 2006 (UTC)

—==Facts, not personalities==

I agree with Dr. Zuckerman above. The actual FDA decision should be stated - without omitting an important part of it. And one should accurately represent the content of a source cited - if this article had genuinely been reviewed by non-biased persons, this would not have happened as flagrantly as it has here.

We all have views. We should stick with facts and attempt to come to an NPOV version of the article. One can hardly call objecting to the omission of a major portion of the FDA decision 'not in the mainstream'. Also, no version of this article has been "Wiki Clin-Med reviewed". That is dishonest.

The mainstream view needs to be the predominant text of the article. I agree with that. But the mainstream view includes the conditions of approval, and accurately citing sources, and the risks and shortcomings that do exist in research. Because of the history of implants, it important to discuss the controversy. The fact is that the FDA in 1992 DID determine that there was insufficient SCIENCE to prove safety of the devices. That has been the case until just this month. To portray this as all political without stating the reason the FDA put a moratorium on implants is not honest. Of course there is politics involved - on both sides. Even now, members of Congress are decrying the FDA decision to approve implants, while I am sure others are applauding the decision. The point is that it IS a subject of heated debate and controversy still.

BY DR M (A BOARD CERTIFIED PLASTIC SURGEON)

As a board certified plastic surgeon who has performed over 900 explantations of breast implants in the past 12 years, I am disturbed that fundamentals in the discussion are being lost

There are 3 problems with implants: (1) Rupture (2) encapulation (3) symptoms.

1. If silicone is safe, why then not simply inject it? After all, when rupture occurs, what you have is a giant silicone granuloma. Injection is outlawed, as well it should be. So the claim that rupture is benign is not tenable. In 1998 I confirmed the findings of Robinson et.al. who found over 50% rupture by 10 years, 70% by 15 years and 94% by 20 years.I continue to find the same rupture rates each year.All implants rupture with time. The current "gummy bear" have not been around for long enough to pronounce them "safe" We have had 3-4 generations who each in turn made this claim and were proved wrong over time
2. All implants get encapsulated. This would be a minor problem if you ignore pain, hardness, deformity, 2 "baseballs" in the chest, inability to sleep prone, etc (-I could name a lot more.) As I wrote (in PRS in 1998), after 10 years all implants have alteration in shape size, contour and feel.
3. In a survey I conducted on over 500 explanted women with silicone gel implants, 67% complained to their plastic surgeons about their symptoms. Women who complained say they were dismissed, and discounted their PS who stated "science has shown implants are 100% safe". I wonder how many PS follow up with detailed questionnaires about symptoms?

All the above discussion sadly leaves out the patient, the womem. There IS a problem with implants (if they were so good all these years, why are they changing them?)Dr Rita Kappell in The Netherlands recommended removing implants after 10 years whether it was necessary or not, and replacing them if the patients desired so. There is certainly seems to be a need to look in another direction

—The preceding unsigned comment was added by Edward Melmed (talk • contribs). 03:46, 28 November 2006

-- These are all excellent points. Thanks for your perspective. Dr Oliver has once again deleted every reference he doesn't like. He even insists on including incorrrect dates for FDA and implant generations. I have changed it back at the request of several Wiki readers. Check the FDA website! Drzuckerman 17:31, 28 November 2006 (UTC)

With all due respect, these issues are in fact already addressed in a way consistent with the consensus body of literature in re to rupture data, capsular contracture, and questions about links to systemic illness. If you would like to discuss specifics of any one of these as they relate to how the FDA and others have evaluated these devices, please engage here.Droliver 22:45, 28 November 2006 (UTC)

Whether Dr. Oliver agrees with Dr. Melmed, is irrelevant. The issue is this article. Dr. Oliver continues to revert it to a version he wrote, which totally changed it from what a number of editors had written. If he wants to "take it to the talk page", he should do so. Then we will know that he is actually willing to cooperate wtih other editors. SO far, he has shown he refuses to do so.Jance 03:01, 29 November 2006 (UTC)

Page protected

I've protected the page due to the edit disputes as above. I've reverted to the version closest to the one that was previously reviewed by WP:CLINMED for the purpose of using it as a standard (please see meta: The Wrong Version . Please continue discussing with the goal of achieving as close to consensus as possible -- Samir धर्म 04:49, 29 November 2006 (UTC)

Samir, you know this was not reviewed on Clin-Med. I see you have weighed in, though, to prevent anyone but Oliver from having input. Oliver refuses to work with anyone else - so you are dictating the content here by doing this. You are simply dismissing what Dr. Zuckerman has said, what Dr. Melmed has said, and what I have said, in favor of Oiver's total rewrite.

JFW clearly didn't bother to check the sources and accuracy of what Oliver wrote. Others of us have. Yet you have chosen to strong-arm this article now. Interesting. Jance 06:15, 29 November 2006 (UTC)

A request was made for peer review of the article on WP:CLINMED by User:Droliver with this diff: [2] The page is protected for the purpose of discussion. Despite your assertion otherwise, page protection is warranted in content wars such as this. If you disagree with this action, you're more than welcome to go to WP:ANI -- Samir धर्म 06:31, 29 November 2006 (UTC)

And all of your allegations of "strong-arming" and "content dictation" are wholly unfounded. I suggest that you stop with the same. The purpose of the protection is to promote discussion. You will back up any such claims with evidence, or not make them. -- Samir धर्म 06:33, 29 November 2006 (UTC)

There is a saying, "The thing speaks for itself". That is the evidence - anyone that sees the history can see what happened. When you deleted others' edits in favor of Oliver's, you dictated content. I asked on the Clin med page if this had been reviewed, and nobody said a thing. I did not see it here. How many people reviewed it? Could they all have missed the misstatements that were so immediately clear to me? This was not an opinion, or interpretation - it was a blatant misstatement of the sources. So whatever review was done, did not bother to check the accuracy of the statements, but simply deferred to one editor. We have here an epidemiologist whose edits you deleted. You deleted my corrections to patently incorrect statements. You have ignored Dr. Melmed (another board certified plastic surgeon). But Oliver's edits - all of them - were restored, before you "protected" the article.Jance 07:10, 29 November 2006 (UTC)

I hope that we are going to discuss all concerns about the article over the next little while. But please cease from attacking people who are trying to help accurately represent topics in the article. -- Samir धर्म 07:27, 29 November 2006 (UTC)

--This version of the article is filled with inaccurate statements. I have written a chapter in a new FDA book on medical devices, published by an academic press, and I can assure you that the listing of implant generations is incorrect. The 2nd generation started in the mid-1970's (not 1970, as he stated) through the mid-1980's (not 1980, as he stated), the 3rd generation from the mid-1980's, the 4th generation in the early 1990's and the 5th generation (gummy bears) much more recently than 1993.

Even historical facts are incorrect. Just check the FDA website -- FDA started regulating medical devices in 1976, 10 years later there were efforts within the FDA to require safety studies of breast implants (not "decades later" because of political pressure, as he states). Oliver deleted all the correct facts I had entered (at least 6 times!) as well as the Congressional report reference that provided all the facts on that.

The current article states that FDA approved silicone implants for unrestricted use. Not true. 3 important restrictions: #1 no women under 22 for augmentation, #2 Allergan and Mentor each have to study the safety of implants on at least 40,000 women for at least 10 years, and #3 women must be informed that they should undergo an MRI 3 years after getting implants, and every 2 years after that. AND, the "patient labeling" is actually a booklet of warnings that is more than 40 pages long. Check the FDA website to read what it says.

The current version of this article deleted numerous peer-reviewed published citations that I had included, whether published by National Cancer Institute, FDA, or implant makers.

The current version includes an old TV program as a link, as well as 2 implant websites that are paid promotional websites for plastic surgeons selling their services. So, now Wikipedia is providing free advertising for plastic surgeons. Samir, I'm sure you'll agree that is not a good idea.

I am a Yale-trained epidemiologist, who served on the faculty at Yale and Vassar and directed a major research project at Harvard. I am currently a Fellow at the University of Pennsylvania Center for Bioethics as well as President of a research center. I have published numerous articles on medical issues, including breast implants, in major medical journals and scholarly journals. I would like to talk to Samir about the inaccuracies in this article.

The goal of Wiki has to be accuracy, not consensus. Unfortunately, busy professionals who previously helped with this article have left because of droliver keeps deleting their entries. However, if Samir or another monitor wants to take the time to talk to true experts, we're all willing. Drzuckerman 06:48, 29 November 2006 (UTC)

Well, let's address these issues one at a time. Everyone's opinions are welcome. What is the first issue with the article that we should address? -- Samir धर्म 06:56, 29 November 2006 (UTC)

We can start with both charts, neither of which need to be there. One is redudant, and the other is unnecessary and summarized selectively by Oliver.Jance 07:10, 29 November 2006 (UTC)

Then we can go to the rupture section and discuss that. Dr. Zuckerman added input on the Heden study, that was deleted. I correctly QUOTED the Holmich study, which Oliver misrepresented and misstated.

We can also add the correct statement about the FDA approval, without leaving out a critical part as Oliver did.Jance 07:10, 29 November 2006 (UTC)

The conduct of Droliver (talk • contribs) was reported at WP:ANI and taking a look at his contributions, I found a few very questionable diffs [3] [4] [5] and a strange blanking of his talk page archive. I'm all for assuming good faith but this user seems to be unwilling to uphold our neutrality policies. Note however that I have absolutely no competence to judge the current content dispute. Pascal.Tesson 07:35, 29 November 2006 (UTC)

If you went through all of it (I wouldn't envy you that), you would find far more than a few. There have been consistent problems with Oliver not discussing anything or listening to anyone on the talk page, but simply rewriting or reverting. He has attacked both me and Dr. Zuckerman repeatedly, and vandalized the article on her. I surely cannot address the blanking of his talk page archive. Jance 08:06, 29 November 2006 (UTC)

The unique American history with evaluating silicone implants(in a world-view article) is pretty easily summarized in the 4 sentences devoted to it and I don't see how that brief mention is inaccurate. Trench warfare over the five MRI rupture studies is more disruptive then repeating their actual conclusions with a caveat about the difficulty in long-term projections. Ref. to the fda's recomendation on MRI would seem to belong in the rupture section if anywhere, but keep in mind no other country has taken this position. The other specifics of the FDA position are somewhat unimportant in a world view discussion, but those aren't really controversial to mention as an aside at the end of the sentence noting the FDA reapproved them. The chart outlying all the systemic reviews (these are not cherry picked BTW) is important to reinforce the broad consensus and provide an easy way to go directly to them.Droliver 19:19, 29 November 2006 (UTC)

The chart was summarized by Oliver. The studies were selectively chosen, and selectively summarized. The FDA position is very important to discuss, especially since the decision can be stated in one or two sentences. However, those are parts Olvier wishes to omit. For example, the requirement that manufacturers inform women that implants are not lifetime devices, that a large study be conducted for 10 years, and that the MRIs are recommended to detect rupture (since most ruptures are silent). The MRIs are important because there exist NO studies of the

rupture rate beyond 10 years, and no studies of the effects of same. This may not be an issue for women now choosing implants, who plan to replace every 10 years. It is very much an issue - and an important one - for women who have had implants 20, 25, 30 or even 40 years. To omit this information, or minimize it is irresponsible and most clearly POV in the worst way. The chart of 'systemic reviews' again is not summarized accurately. We went over this at lenght months ago and the consensus was to delete the chart. THOSE studies can be summed up, and also discussed as to the length of time women were studied, etc. We should state the value of the study, as well as the limitations, particularly since many of those are old. The reason the FDA had not previously approved implants is because of the lack of long-term data. Now the FDA has concluded that women can be monitored, with an unprecedented large 10 year study requirement. The rupture has always been and still is a major issue, that women considering implants MUST be made aware of. To skip over this is appalling conduct, especially by a doctor. Also, much of the article reads like a promo or ad, and I will be happy to provide examples.... It reads like a color glossy for Inamed. Jance 07:52, 30 November 2006 (UTC)

Article authenticity

I am a board certified internist who see many women in my practice. I have also been doing outside research on the issue of silicone breast implants and their possible detriment to women's health. I find Dr. Zuckerman's comments to the accepted belief of the medical community and to be particularly impartial. DrCarter12

No, I am sorry. A userid on Wikipedia does not have a board certification especially when it has only made one contribution and is impossible to authenticate. Boards do not certify Wikipedia Userids and only if a real identifable medic emerges from behind it can you claim any credit for your qualifications. Even then I am afraid a practising medic with a commercial interest in a procedure is not neutral point of view. --BozMo talk 17:33, 29 November 2006 (UTC)

The mainstream position on any percieved controversial area is actually quite easy to demonstrate without relying on any individual's expertise or experience and that is how the entry was prepared. The body of comprehensive reviews of this from around the world are available within the article itself. With Canada & the US both releasing silicone implants for wide use, there is 100% concordance in how this is treated world wide. Read the positions of any number of western health ministries and you will see a tone and treatment of this consistant with the current protected versionDroliver 18:50, 29 November 2006 (UTC)

I agree with BozMo - to the extent that someone here has a commercial interest and conflict of interest. The only person here with a conflict of interest is Droliver, since he makes his living putting them in women. And no, it does not take a board-certified doctor to read plain English in the studies. Unfortunately, Droliver has mistakenly read the "comprehensive reviews" he cites and the studies contained in them. The article is a problem. I urge Dr. Melmed and Dr. Carter (I don't know who this is) to show Wikipedia their "credentials" so the same can be verified. I am curious as to whether the other "doctors" such as Oliver or Samir have done so?Jance 19:02, 29 November 2006 (UTC)

Jance 01:12, 30 November 2006 (UTC)

LynnMB 20:23, 29 November 2006 (UTC)As a public health professional who educates women on a variety of issues, I think the back and forth for the "breast implant" definition is just confusing women. Right now, what's posted seems pretty biased towards plastic surgeons. I understand that plastic surgeons perform such operations, but where are other points of view? Why is there nothing up here showing what patients have to say or what the National Cancer Institute says or the Office of Women's Health, or the FDA that just approved the new silicone implants? In order to give the public the best information and to truly HELP WOMEN interested in implants, I think this information should be neutral. I'm personally going to stop referring women to look on this website on this issue.

Lynn, that is wise. I told my daughter to NEVER use WIkipedia as a reference for a college paper. There is good reason for that. A few editors ban together, espeically if one has a financial interest, and protect a "truthiness" version that suits their particular purpose. Like a color glossy, that says "and the newer version is even more (fill in the marketing hype). Ugh. That is not an encyclopedia. And it is surely not reilable. It is tragic that this kind of article is permitted to be written in "color glossy" form. Jance 07:57, 30 November 2006 (UTC)

Futility

I see that mediating this issue is turning futile with the WP:SPA's coming out of left field now. You guys can duke it out and contact any administrator on WP:RFPP when there is a stable version that you agree upon -- Samir धर्म 17:28, 29 November 2006 (UTC)

I see. So it stays with Oliver's version until then, is that what you are saying. Interesting. I don't know who these other people are, but I do not think that a user interested in this article should have to have a long history of posting on Wikipedia to be taken seriously. Unless, of course, it interferes wtih someone's viewpoint.Jance 18:53, 29 November 2006 (UTC)

Oliver always talks about the body of material - but when he misstates those studies, it isn't "mainstream". He has done so, and I have pointed it out. Samir, if you have abandoned mediating, then you should unprotect the page.

I just saw a new rheumatologist today. In my history, I wrote that I had 20 year old ruptured silicone implants removed. I did not bring it up at the visit. The rheum. has my medical records, lab tests, etc., and she asked me this question: "Did your lupus symptoms and lab tests improve after you removed the implants?" SHE brought it up. I said yes, but some plastic surgeons seem to think they are perfectly safe so I don't bring it up anymore. Her comment was, and I quote "We do not know what happens after rupture, down the road." She is right (of course, she is also a board certified rheumatologist who went to some of the best schools in the country and has been practicing for over 20 years.) She likened it to cigarette smoking - at least now, she said, women know that there are risks and long term dangers. I pointed out to her that it wasn't the same - plastic surgeons still tell women that silicone implants are perfectly safe. Her response? "Some plastic surgeons will operate on a turnip, too." Disparaging, yes, but I found it interesting coming from a board-certified rheumatologist. And as evidenced from this article, now that silicone implants are approved, women won't even be told of the known risks, and recommendations for follow-up. Jance 18:55, 29 November 2006 (UTC)

Samir, I think it's rather sad that you would so easily give up on trying to mediate here. If you go through the archives, you will find that Droliver has been edit-warring on this article for ever, has been blocked for it a couple of times and has apparently failed to learn his lesson and to engage in constructive dialog. Yeah, I know all about the wrong version principle but as the protecting admin, shouldn't you at least try to help by contacting relevant projects, engaging participants in this dispute one on one, contacting the mediation cabal and whatnot? Pascal.Tesson 23:57, 29 November 2006 (UTC)

The relevant project WP:CLINMED has been contacted. The mediation cabal is a good idea. I'll try again -- Samir धर्म 01:34, 30 November 2006 (UTC)

Reverting to an incorrect version is not the answer

Why does Samir keep reverting to an article that is incorrect? There is no incentive for Oliver to negotiate since he is happy with the version that is protected -- it's his! I have asked Samir to contact me to discuss the specific problems and his response is we should "duke it out." That is not the scientific or medical way to deal with a medical article. I have spent hours giving specific examples of the problems with this article, and they are ignored.

Here's a new example. The Heden et al article that Dr Oliver says is the best study of rupture excluded any women whose implants had broken in the first ten years of use. The authors state on page 307 "Women who had ruptured implants removed before the 9.5-13.2 year post-implantation period covered by our study would not be included in the study, so the rupture prevalance may underestimate the actual rupture rate."

That is a methodological flaw which certainly does cause an underestimate -- and the researchers should have mentioned how many women fell into that category of having removed their implants. A comparable comparison would be: let's do a study on the impact of smoking on lung cancer. Let's study 100 people who started smoking in 1960. Then let's just look at those that are still alive and see how many have lung cancer. Since anyone who died of lung cancer is excluded from the study, and since most people diagnosed with lung cancer die within a year, it would certainly underestimate the link between smoking and cancer.

Here's another example, even more similar. In 2005 let's say we contacted 100 people who bought Corvettes in 1992, 1993, and 1994 (the same year as the implant patients). Let's find out how many of these Corvettes are still running well. But we exclude anyone who sold their Corvette or got rid of it (perhaps it was totalled in a car accident) before 2005. Our evaluation of Corvettes will be based entirely on the 100 cars still owned by those original Corvette owners. Obviously, that is not an accurate evaluation.

Samir, to be fair to the authors and to the integrity of Wikipedia, please either delete the article entirely, or find someone to help make sure it is accurate and that the studies are accurately presented. Or find someone who will. 72.75.6.148 19:08, 29 November 2006 (UTC)

I have a feeling now that the article to Oliver's taste, we won't hear anymore from Samir. I hope I am wrong. However, nothing I say - even deliberately pointing to errors - has made any difference. The "clin-med" review (which was only a couple of people, evidently) clearly didn't bother to look at the accuracy- or lack of it - and does not seem to care. So if an administrator can freeze article to whatever version they choose, and nobody cares, then I don't see what we can do about it. Regardless of how many other doctors, scientists or other editors complain. Jance 19:47, 29 November 2006 (UTC)

An/I? Medical Article ?

I still have trouble believing that most doctors would deliberately condone inaccurate "information" - so the only possibility is that they didn't bother reading it.Jance 22:55, 29 November 2006 (UTC)

Samir, where are you?

I have asked Samir to talk to me about this article several times in the last few days, but haven't heard a word. Samir, where are you? I'd like to point out several factual errors with this article as you locked it in. It isn't the Wiki way to lock in an inaccurate article and then refuse to discuss it. And while you're at it, I would be glad to talk to any of the clin-med folks who you said agreed to this article as is. 72.75.6.148 00:56, 30 November 2006 (UTC)

I've no idea who you are, and you certainly never contacted me -- Samir धर्म 01:20, 30 November 2006 (UTC)

I think, but am not positive, that this is Diana Zuckerman, the epidemiologist. Hopefully, she will clarify this.67.35.126.14 06:04, 30 November 2006 (UTC)

Okay. Make a list of the factual errors and we will discuss them one by one. The goal here is to improve the article -- Samir धर्म 06:26, 30 November 2006 (UTC)

Refactored

I am going to bed now, but I believe Dr. Zuckerman, Dr. Melmed will join this discussion at a more reasonable hour. Jance 07:35, 29 November 2006 (UTC)

From Dr M

Samir is misrepresenting both the facts and Dr Z. It is sad that so much "justification" about a product that clearly has problems is being justified by any means.

I would love to know Dr Oliver and Samir's personal experience in long term evaluation of implants .Putting them in is easy. Have they a personal 10 year + follow up?

I have not misrepresented any facts: all I did was protect the article to the most stable version that I saw, which is well within my rights as an administrator. I'm an academic gastroenterologist with no experience in evaluation of breast implants. -- Samir धर्म 17:28, 29 November 2006 (UTC)

Samir, you don't have to have experience in evaluation of breast implants. All you have to do is to READ the study cited, and you will see where Droliver at times outright misstated and at other times misrepresented what the sources stated. I really don't understand your conduct - whether it is "within [your] rights" or not. I also do not understand why nobody will say who "clin-med reviewed" this article. My guess is that whoever did (if anyone) simply deferred to Oliver's "expertise". Unfortunately, with Oliver, this is not wise.Jance 00:26, 30 November 2006 (UTC)

Table 1

Okay, let's start with Table 1. (1) Is it superfluous? (2) If not, how should it be represented and (3) what are the references for the accuracy of the content therein? -- Samir धर्म 07:21, 29 November 2006 (UTC)

The chart is repetitive. Yes, it is superfluous. It should be represented as it is in text immediately below the chart. However, it should be stated correctly, as Dr. Zuckerman points out.Jance 07:28, 29 November 2006 (UTC)

We should look at the last two versions - the one that Oliver wrote, and the one that Dr. Zuckerman and I wrote, and compare those section by section. Unfortunately, Dr. Melmed has only (so far) written a comment on the talk page. He has operated on thousands of women for many years- inserting breast implants and removing them. I know he is aware of the lack of reliable or long term studies on the rupture rate, and long-term effects of rupture. And rupture is exactly why the FDA is requiring manufacturers to tell women implants are not lifetime devices,and they will need at least one reoperation. The FDA has also recommended MRIS - a very expensive test - for followup, to detect possible rupture. The rate of rupture is not linear with time, yet the miniscule studies on rupture do not follow women over time. NO - absolutely NO - studies analyze rupture beyond 10 years (and precious little information for even 10 years), and certainly have not looked at illness in women with ruptured implants that are older than 10 years old. Dr. Zuckerman explained the one study that Oliver cited, and it should have remained, but was deleted. This issue is probably the single biggest issue the FDA has had (and evidently still does, even wtih approval), and that women face when considering implants. Yet Dr. Oliver misstated the study he cited (which he admits now), and deleted all the information that the FDA found critical, in approving the implants. (This is not a personal attack. It is a fact.) Jance 07:56, 29 November 2006 (UTC)

In approving the "gummy bear" implants, the experts that were relied on for safety were paid by the manufactures. There are NO long term studies. For over 40 years each new batch of silicone as touted as being "safe" with no admitting the old ones were not It is sad that another generation of women will be clinical guinea pigs —The preceding unsigned comment was added by Edward Melmed (talk • contribs) .

I can't resist. You don't think women should be expendable, Doctor? Bravo to you, and I mean this with all sincerity!!Jance 01:58, 30 November 2006 (UTC)

Table one is both accurate and effective for characterizing what we mean when we talk about "generations" of implants. I'm still unclear exactly is being objected to in it. As I've mentioned, what exactly constitutes a generation is a moving target. The table reproduced is consistent with the way this presented in professional meetings and in the 2006 version in the standard textbook of plastic surgeryDroliver 18:40, 29 November 2006 (UTC)

What is objected to in this table was explained aready. It is repetitive - and superfluous. There is no need for a table and then the identical text below it. I would also like Dr. Zuckerman to address her concerns. But this table is minor compared to other misstatements, glaring omissions and the like.Jance 01:44, 30 November 2006 (UTC)

What are the references for Table 1? -- Samir धर्म 01:46, 30 November 2006 (UTC)

References? What references. There were none.Jance 02:00, 30 November 2006 (UTC)

--In response to Droliver's and Samir's question: I would be interested in seeing any evidence that the dates for generations are correct. Here is evidence to the contrary, based on internal implant company documents that were summarized in a Congressional report published in 1993. (Congress had access to documents that had not yet become public, but were in the possession of the Committee and the FDA.) This excerpt shows that the very thin, easily broken 2nd generation implants were from the mid-1970s through the mid-1980s:. This is an EXACT QUOTE from the Congressional report that I had included in the references but Droliver deleted. I had cited the Congressional report for the history of FDA's regulation of breast implants, since it is the authoratative source. You can get the reference by reverting to my last version of this article. Single quotation marks within this material are directly from the internal documents.

"By December 1975, Dr. Thomas Cronin, who designed the original silicone breast implants, wrote a letter to Art Rathjen, senior clinical research specialist at Dow Corning, describing a reconstruction patient who 'produced 100 c.c. of straw-colored fluid daily for one month'. After 1 month, the implant was removed, and he found 'the implant ruptured and gel was free in the cavity'.

"In June 1976, Art Rathjen expressed concerns about a report from Dr. Richard Phares, a plastic surgeon from St. Petersburg, Florida, regarding postsurgical rejections of breast implants that seemed to be caused by 'greasy implants' that prevented healing." Rathjen wrote a memorandum to his colleagues which warned, 'I have proposed again and again that we must begin an indepth study of our gel, envelope, and bleed phenomenon. Capsule contracture isn’t the only problem. Time is going to run out for us if we don’t get underway.'

In January 1977, a Dow Corning salesman from Chicago wrote to Dow Corning in Hemlock, Michigan, to express his concerns about ruptured implants. He wrote that one of his customers, a Dr. Bader, was 'threatening to switch' to a different brand 'after having two consecutive ruptures' with the Dow implants.

"n December 1977, an internal Dow memorandum described rupture problems of four doctors in Ohio and Michigan, ranging from 11 percent to 32 percent of their annual procedures. The concerned salesman wrote, 'I am sure that some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure.' In March 1978, the same salesman wrote another internal Dow memorandum describing 'an excessive number of ruptures in [the Detroit] area over the past six months'. One doctor had reported four consecutive ruptures of the Dow implant to the salesman. The salesman wrote, 'I find it difficult to comprehend that I am the only one experiencing a rupture problem of this proportion. All of the ... doctors have made the same comment: ‘Noticing a difference in our envelope’ ... my question is: ‘Are we making the envelope different, and is it weaker?’ ... I have lost more business recently due to ruptures than I lost last year due to competitors’ sales efforts.'

"n September 1981, Dr. Charles Vinnik, a plastic surgeon in Las Vegas, wrote to Mr. Robert Rylee, the vice president of Dow Corning, about his concerns about "shell failure" of silicone gel implants, which resulted in 'considerable silicone reaction to the extruded material' that was 'as marked a reaction as we ever saw with the silicone injections'. The medical report described an implant that was 'totally disrupted with the implant shell incorporated within the gel mass' and a 'roughly 4x6 cm irregular nodular mass' which was 'an obvious siliconoma.' In November of that year. Gene Jakubczak of Dow Corning described a telephone conversation with Dr. Vinnik during which Vinnik estimated a 5 percent failure rate with Dow silicone breast implants.

"n February 1984, Eldon Frisch, a Dow Corning scientist, wrote a memorandum to his colleagues at Dow Corning about a visit with Dr. Vinnik. He expressed his concern that the breast exercise instructions that Dr. Vinnik and many other plastic surgeons were providing to patients, aimed at preventing capsular contracture, could be causing 'progressive weakening and ultimately rupture.' He also hypothesized that the exercises could cause the gel to break down, 'making it less cohesive.' However, there is no evidence that this information was made available to plastic surgeons, and similar breast exercises were still recommended by most surgeons when the memorandum was made available by Dow Corning in February 1992.

"y September 1985, Dr. Vinnik had written to Dow Corning that he had evidence that silicone gel in ruptured implants could become 'terribly runny' due to 'prolonged contact with tissue fluids and fat.' In the same letter, Dr. Vinnik wrote 'Inasmuch as this is not generally known by my colleagues, I feel that your company has both a moral and legal obligation to make this information available through your representatives and in your literature. I am loathe to publish my series of cases as I feel that it may open Pandora’s Box. I do feel, however, that rapid dissemination of this information is very necessary to protect your company and my colleagues.'

"imilarly, in October 1985, Dr. David Mobley, a plastic surgeon from Jacksonville, Florida, wrote to the president of Dow Corning to inform him that he was 'terminating our consignment agreement for mammary implants' because they had 'recurring problems over the past two years with spontaneous unexplainable rupture.'

"The leakage and rupture problems reported to Dow Corning were also apparent to other breast implant manufacturers. The president of Medical Engineering Corporation (MEC), a company whose breast implants were later manufactured by Surgitek, received a letter in September 1977 describing "siliconized" breast tissue; the 'silicone was found in dense pockets that probably streamed out of the original site'. That company’s Scientific Affairs Committee speculated that silicone oil bleeding through the silicone shell into body tissue could eventually cause FDA to remove silicone gel implants from the market. By 1979, the president of MEC sent a memorandum to three colleagues that described the results of a dog study, which showed 'low but definite concentrations of silicon in [selected] organs with the highest concentrations observed in kidney and liver tissue'. One year later, a study that the company conducted to assess the effect of rough handling of gel implants determined that 'Rough handling of any sort will affect the gel cohesion of our mammary implants. However, when left undisturbed for 15 or more days, the gel will return to acceptable limits.' The employee recommended that the implants 'should be processed with the minimum amount of handling' but did not speculate on the implications for women whose implanted prostheses would be constantly in contact with breast tissue."

The problems described in this report resulted in improvements to the implants in the mid-1980's -- which became the 3rd generation implants. Samir, let me know if you need more information. I don't know how to contact you directly, which is why I have tried communicating with you through this discussion page. I have info about the other generation dates being inaccurate also, if you're interested.Drzuckerman 06:41, 30 November 2006 (UTC)

You are absolutely correct, Dr. Z. I did have a 'second generation' which bled and ruptured more easily - and that version was from 1984. So Droliver's timeline is simply incorrect. And yes, it is important to make this distinction. And the correct information can also be stated ONE time, not stated in text and then repeated in a chart. Jance 07:59, 30 November 2006 (UTC)

As there have been an estimated 8000 different styles of implants (from the IOM estimate), exact dates is a tricky thing to nail down with the specificity you're suggesting. This discussion on a report on rupture data which was distinguishing retrospectively on implant rupture by generation in 2000 by Dr. Leroy Young, (arguably the authority on why implants rupture) in Plastic & Reconstructive Surgery distills this confusion: "Generational discussions are confused even more when we consider that different authors use somewhat different dates, and manufacturers introduced their products at different times in various countries. (The generation dates used in the Collis and Sharpe study are unfamiliar to us but probably no more accurate than the dates listed above.)

Accurate categorization of an implant into a certain generation requires knowing the manufacturer and lot number, which would permit discovery of information regarding the date of manufacture and raw materials used. As an example, Dow Corning Silastic I implants are commonly classified as second-generation devices with thin elastomer shells. However, not all Silastic I implants were manufactured with the same material formulations; some had thicker shells than others (the thinnest shells were manufactured in the mid to late 1970s). In reality, each manufacturer probably produced more than three generations of implants.

To complicate matters further, different manufacturers produced breast implants with a thicker shell and barrier coating-commonly referred to as third-generation, low-bleed, or high-performance devices-at different times. Dow Corning introduced the Silastic II in 1981; Mentor/Heyer-Schulte brought out a low-bleed gel implant around 1984; Cox-Uphoff and Surgitek introduced comparable devices around 1986; McGhan developed a low-bleed implant with the Intrashiel shell in 1979, which was followed in 1988 with the thicker UHP (ultra-high-performance) shell. Should we classify all low-bleed implants as third-generation devices? If so, how do we assign a date to this generation? While these low-bleed devices were being sold, older models were still being implanted. It is not unusual for hospitals and large practices to purchase large numbers of breast implants in various sizes at one time; they are then used until the supply runs out or the expiration date is reached. Thus, an implant manufactured in 1982 might not have been placed until several years later.

Based on these multiple complicating factors, the generational classification scheme is inaccurate and greatly oversimplified and sheds little meaningful light on the question of breast implant failure. Unfortunately, reliance on this terminology has proliferated during the last several years. As the previous paragraphs illustrate, the date of implantation may have little relevance to the date of manufacture; the manufacturers changed formulations of materials used in one type of implant, and the dates of product introductions by different manufacturers greatly overlap. It may be time to abandon this approach to implant classification or at least view discussions of generations as having limited usefulness.

• Again, the dates (especially of the transition b/w 2nd & 3rd gen) are ballpark due to this and you're going to see multiple sources which are all valid. The key distinctions are manufacturing. I think we easily can come together on a range on this that you'll accept as "close enough for government work"
• The fifth generation Inamed 410 also was clearly introduced in 1993 by Tebbetts as indicatedDroliver 15:05, 30 November 2006 (UTC)

The discussion on generation needs to be more accurate than what is stated now. Even if it is to say there is overlap, and state generally the time frame. There are second generation implants in the 80s -I know. IN fact, some sources only identify 4 - not 5 - generations. Regardless of how we 'come together' on this, we do not need both a text discussion and a long chart. This is unwieldy and serves no purpose.Jance 17:48, 30 November 2006 (UTC)

Comment on protection, revert-wars, and accusation/counter accusations

Good morning everyone. I just noticed the huge uproar in the talk page, when I looked into the Administrator's noticeboard thread on this. From the history of the page, it seems like there is a big edit dispute going on there, resulting in edit wars. Well, frankly, I don't know who's correct and who is wrong, but I'd like to request the editors to look into the following comments:

• Assume good faith, don't accuse others of having a hidden agenda
• No personal attacks: Please comment on content, rather than the users
• The protected version is always the Wrong version (warning, spoof link here): Someone is bound to create an uproar about the protected version. Believe me, it always happens.
• Edit wars are evil. Please don't engage in it.
• Civility is a virtue, and must be maintained in having a decent, fruitful discussion.

I've looked into the page history and don't see Samir editing it (other than vandalism prevention) in recent months. Therefore, he is fully justified in protecting it without any conflict of interest, as per Protection policy. I request the edit-warring parties to calm down, cool down, and get down to discussion. There are many ways to resolve disputes, for example:

• Start with *this* talk page, discuss among yourselves, try to achieve a consensus.
• If that's not fruitful, try Request for comments
• Try informal mediation from Mediation cabal
• IF that fails, try formal mediation
• As the last straw, try Arbitration

But please, start outlining the points of contention, and discuss without making personal attacks, or being uncivil. Violating any of these policies could be considered disruption and lead to blocking of editing privileges. Don't make Ad hominem attacks, stick to content rather than editors.

I sincerely hope editors of this page will achieve an acceptable consensus by following the above advice. I wish you all the best. Thank you. --Ragib 09:41, 30 November 2006 (UTC)

Well, I am not an editor and do not wish to become one. I guess there are two axis: ethics and risks. Lets talk about where the NPOV of this article should sit. On ethics I guess the extreme anti-implant view would be prominent feminists like Germaine Greer who has written that implants as much of an abuse of women as female genital mutilation in Africa, with psychological coercion aspects. That should be stated (and explained a little) as one end of the spectrum. The other end is a doctor who considers implants as a surgical intervention with proven psychological benefits on a par with other types of surgical comestic procedure (like removing a congenital defigurement). On risks, it should be easier. No medical procedure is without risk and what the risks are should be part of informed consent. In a litigious culture like the USA (where most of these things presumably happen) there must be reviews from both standpoints. But this date argument I don't get. How do you have a POV on dates of things and why does it matter so much? --BozMo talk 11:01, 30 November 2006 (UTC)

I would submit that treatment of breast implants be done as a medical device rather then an extended foray into cross-cultural views adnd politics on cosmetic or reconstructive breast surgeries. A discussion of the attitudes like Greer's are more germaine (pun intended) to the topic entry on breast where the symbolism of breast in re. to fertility/womanhood ,etc.. can be described more fully.

The specific & common risks associated with breast implants are easy to identify and widely identified. Namely rupture, capsular contracture, & traditionally high reoperation rates (which relates to the first two & a few other common causes). The assertion that there exists an identifiedable risk to cancer or auto-immune disease has broad international agreement in the negative, and that's going to be actively disputed but easily demonstrated. The logjam is a dispute over language describing these events and whether you want to passively describe it or aggressively describe it. What I submit (and feel I can pretty easily demonstrate)is a contemporary mainstream view is going to be ridiculed as biased by people who have been lobbying this politically (as Dr. Zuckerman is known for) or have strong feelings on from personal involvement, as apparently Jance has. Alternately I find the relentless editing of Jance & Dr. Zuckerman both innacurate (but not neccesarily false) & deliberately inflamatory.

I've continued to ask all along for input on language we in fact can agree on while resisting editorial changes en masse which resumed recently.

I agree with your confusion over the timeline issue. Please see the discussion under table #1 above. This should be an easy thing to work outDroliver 15:44, 30 November 2006 (UTC)

Hmm. Of course there is a lot of debate on that page too but shouldn't it be treated more like Circumcision with an upfront discussion about what is after all a contraversial societal phenomenon? I am happy with a mainstream view approach provided of course that "mainstream" doesn't mean "mainstream amongst medics who practise the procedure and their publications" any more than it does with say Abortion, it has to include other commentators --BozMo talk 16:17, 30 November 2006 (UTC).

Yes, BozMo. The whole history of breast implants has been extremely controversial. Quite unlike any other "medical" device. It is a sociological issue. But BozMo, I wasn't even asking for as much as you are suggesting - heck, I only wanted the medical controversy to be mentioned, as well as the recent FDA decision to approve silicone implants along with the conditions and the reasons for those conditions.

Oliver keeps asserting that some of us want to focus on something other than what studies have shown. This is untrue. Oliver is framing his discussion in generalities, to portray some of us as fringe or worse. He is claiming that we are all 'political' or operating only from 'personal involvement' as if this is not exactly what he is doing. The dispute is not over whether the risks are passively or aggressively discussed. The issue is misstating studies and omitting critical aspects of the US FDA approval . The issue is putting a positive gloss on everything in the article, as opposed to an objective treatment. Oliver didn't have a 'passive' description of the FDA recommendation on MRIs, or the restrictions - he had NO description. In fact, his description was a misrepresentation. There is a reason the FDA did not approve implants until this year - after over 40 years that implants have been on the market. There is a reason the FDA placed restrictions and conditions on the approval. For Oliver to dismiss everything he does not agree with as 'political' or 'personal involvement' is breathtaking. He should look in the mirror.

I wanted to point out that there are still no studies that can predict or even estimate rate of rupture after 10 years, nor are there any studies that examine the effects of rupture after 10 years. This is one reason the FDA recommends follow-up with MRIs, a very expensive test that ordinarily would not be suggested for regular follow-up of any condition. Also, the one study that shows some actual prediction of the rate of rupture at 10 years excludes women who have already removed their implants because of rupture - the study itself states that it will thus underestimate rupture. But this was reported as fact, and the only accurate study.

This is one of many problems I have consistently objected to. And nobody, but nobody, would even look into this. Instead, Oliver's version was locked because he said it was "clin-med" reviewed. I asked who reviewed it and nobody would say. SInce nobody would admit to it, I could not show them the glaring misstatements and omissions - the ones that should be obvious to anyone who can read. Oliver has shown to be intransigent on this so I do not foresee any way to correct the problems, without help from others who evidently have no interest in this subject. The professionals who do have an interest in this and have studied it are dismissed by Oliver as political. Therefore, I urge you and anyone else who is objective to please participate in this. Othewise, it will remain as it is, without any discussion of the FDA decision (Oliver says it is not necessary since the FDA is only in the US), or placing the studies in context (as I describe above), discuss the recommendations to follow-up (Oliver said other countries don't require it) etc. If the article is intended to be anything other than an advertisement for plastic surgeons (which Oliver is), then it should be more objective. Jance 17:13, 30 November 2006 (UTC)

My board-certifed rheumatologist likened silicone breast implants to cigarettes - she suggested that at least now women know the controversy and if they get implants they know they are "choosing" something that is dangerous or at the least carries high risk. I pointed out that no, it isn't the same, because no doctor will tell anyone with a straight face that cigarettes are safe. And the effects of smoking have now been studied at 20, 30, 40 years. This is not true for silicone implants. Additionally, plastic surgeons tell women implants are safe - especially now, since the FDA and Health Canada have approved them for use. That is when she snidely commented, "Yes, and some plastic surgeons will operate on a turnip." And I suppose this broaches the sociological context of which you speak.

Approval of silicone implants was made not only because of what Oliver calls a "body of literature" but also because of political pressure comparing breast implants to the "Choice" desired by those wanting abortion. That is an interesting parallel - but not the same, since there is much more knowledge about the long term medical effects of abortion, and not so with breast implants. It is amazing that the "most studied device ever" - silicone breast implants -- do not have longer term studies, especially on rupture, since that is what can result in silicone migration to other parts of the body. Implants have been around for over 40 years - of course, there have been many different types, each trying to "improve" on the last to reduce contracture, or rupture or whatever. We now have women who have had 2nd generation implants - the ones that ruptured more readily - for 20, 25 years, and who will have them for many more.

Many plastic surgeons do not tell women their implants are not lifetime devices - they never told women 20 years ago and many do not now.

There are plastic surgeons who will still not tell women they should remove ruptured implants (although this is the recommendation by the FDA and is the medical consensus for obvious reasons). And now, there are young women who will be receiving the "new improved" silicone implants who will not be told any of this. Plastic surgeons will instead give these women a 40 page book and tell tell them that the book is 'just legal requirements' because of the hysteria of the 90s. I guarantee you those kind of plastic surgeons will tell women that implants are completely safe except for the minor risk of local contracture or infection, and will not tell them they should be followed up regularly for the rest of their lives with MRIs to detect rupure. Look at what is happening here --- Oliver is making these very claims on this article, and insisting on omitting the restrictions and recommendations. Wikipedia articles are copied verbatim in numerous online venues.

Is Wikipedia an information resource, or not? Do enough people really take Wikipedia seriously enough to participate in articles out of an interest in public education? In developing a legitimate open-source encyclopedia? I well know in any group there will be cliques and there are here. But I still hope that the larger community will take enough of an interest in health issues like this to actually read and review the article. I urge this of Wiki physicians, too - that includes you, Samir. I appreciate your start at trying to begin discussion of the chart - but then you dismissed it all as futile, although I am not quite sure why. I hope that was temporary and not how you will approach this in the future. Jance 17:37, 30 November 2006 (UTC)

While we want to hear everyone's views, it is extremely frustrating to hear first edits from people who "find" this page and start attacking me for protecting this page. -- Samir धर्म 07:34, 1 December 2006 (UTC)

250 edits since 1st October is just ridiculous however valid any single POV or edit may seem – learn to break the deadlock.

• The excessive editing load on this article has been a strong disincentive to my further involvement, and probably of other editors too - we may feel we can be far more useful working on other articles, accusations of motives for not joining in only further increase editors wariness of getting involved. That said, the temporary locking (which is not a permanent validation of any particular version/POV and would be a breach of WP:AGF to even suggest otherwise) seems to be generating some more useful discussion on how to proceed - remember there is no deadline cut-off for this article to be "complete" and ready for publication. So if the article is for a short while incomplete, unbalanced in the length of the various topics that it discusses, or in need of balancing the various POVs etc etc then quite honestly fine - it would be better that editors pause to discuss and reach consensus on how to develop the article, than the petty (this is only an encyclopaedia article after all ! and wikipedia supposedly does not give medical advice, so no "harm" should befall anyone) bickering, incivility, lack of good faith or, and possibly worse, ignoring of other editors that seems to have been occurring. Edit warring is disruptive, if you feel there is a problem with wiki process disruptiveness then, in sequence, discuss with other editors, WP:RfC or seek WP:Mediation – further continuation with the edit war is in itself disruptive however valid ones own POV or disruptive the other editor has been – find a new method of breaking the deadlock. Again 250 edits since 1st October is just ridiculous however valid any single edit may seem.
• Please do not edit just from your own POV to try and restore to the supposed NPOV position, this can only make this a tug-of-war between editors as they try to pull the rope-marker to the central position. Instead everyone should edit from the same NPOV so that balance occurs without effort (if people jointly cut a hedge with some high and some low to achieve the "average", then the result is an unsightly mess - if every one starts cutting from the outset at the agreed height then no corrective action is required to achieve an aesthetically pleasing result).
• It should be obvious that this article needs to state in its introduction first what the topic matter is and why used. Mention needs be made of it being a developing process since first invented (current devices are not same as in past and regulation, whether right or wrong, has changed), then mention needs be made that number of side effects related to having surgery generally and specific side-effects of these devices (infection, rupture and other non-contentious accepted short-term risks). Finally that there has been controversy over long term risks which has been related to licensing withdrawal and possible reintroduction (fact that there has been controversy is surely not disputed by any party, which is different of course of whether one feels either sides’ position in the controversy valid/justified etc). Finally brief mention of aspects of femininity/womanhood etc seems appropriate in the introduction to alert the reader to fact that there are wider issues (article need not discuss all aspects of cosmetic surgery, women’s & society rights over the female body – one can link to plastic & cosmetic surgery discussion etc).
• The article itself can then follow this introduction outline, expanding on each aspect in turn. Remember, those for or against the devices should, in wikipedia, be able to comment on the position of both sides in the real-world debate without demeaning either side - if you can't yourselves edit in NPOV then you should be working on other topics (this is not an invite to start commenting on the approach of others which would be breach of AGF and quite honestly justification to request for a user ban). So Droliver should be able to suggest reworded phrases that include mention of concerns raised, likewise Jance/Zuckerman of risks not being widely or fully accepted by plastic surgeons, and who knows which POV the various anons have edited from...
• So select a singe topic, resist with all your self-control the temptation to start raising other issues (don’t try raising the temperature), agree on the NPOV and not whether some study interpreted its results correctly or not (that's original research and just plain banned here in wikipedia) but comment and cite in a NPOV where externally others may have disagreed with a study. Agree amongst yourselves how you will indicate to the wider editorialship when you have reached consensus on a particular choice of wording for a particular part of the article, and then ask the admin to unblock the article to implement the change for you. Only then move on to a further topic to agree upon... but this is just my suggestion. (PS if you can’t agree on a date, how about stating "circa xxxx" ?)

Let me repeat, this article has been a sad example of the wiki process and further accusations of wrong version, bad intensions of other editors or ignoring the concerns of other editors would seem to me to apply in varying degrees and emphasis to both sides of this edit warring, and will only warrant more formal intervention and possible wikipedia disciplining.

Move forwards, move in a positive welcoming collaborative inclusive consensus or, sadly, move on :-) David Ruben ^Talk 18:54, 30 November 2006 (UTC)

Thanks, David. If you read what I said above, I didn't refer to Oliver's version as the "wrong version". I asked for contribution. Yes, this article is indeed a sad example of Wikipedia, which is one reason I left for so many months. And when I returned, I saw that the article had been totally rewritten with obvious inaccuracies (misstatements of the very sources the author cited) and a one-sided gloss. Your outline is fine. I will note that there is no debate on the absence of long term data or study on rupture or the effects of rupture. The debate is whether to omit this fact entirely -- a nagging little fact which is the basis for the FDA's recommendation of regular follow-up with MRIs. As you know, MRIs are expensive, and not typically recommended for routine care. To dismiss this as "only" a US recommendation is disingenuous, and a denial of reality. Again, to portray what Jance/Zuckerman state as not widely accepted is unfortunate, and exactly the way Dr. Oliver has attempted to portray us. This is not a simple matter of "mainstream view" versus "the fringe". This is a matter of accurately stating the mainstream scientific view. Maybe there simply is no hope for this article, with one editor willing to hang on forever to force his own gloss. I surely have a life, and it is not Wikipedia. I have to say that this has been a real *learning* experience - it confirms much for me. Jance 19:02, 30 November 2006 (UTC)

Listen Jance, I am really really sorry but I am simply not going to read these very long discussion messages on a subject which personally I am afraid I find a bit dull, and whose dispute history I am just not going to get into however unreasonable people have been. If you want someone to judge history thats not me (or Samir or...). Lets go one step at a time and suggest a NPOV introduction (which should mention the contraversy in a neutral manner). If we can slowly work through the article carefully some of those brought here by the smoke and tears might stay around long enough to try to get the article NPOV. Why don't you try and propose just this one paragraph and we can all discuss it. Then we could do section headings for the article itself. When we've finish all I will promise is to add the article to my watchlist. --BozMo talk 19:41, 30 November 2006 (UTC)

I can't imagine anyone in their right mind wanting to do so. It is unfortunate that the one version was labeled "clin-med reviewed" but nobody will say who reviewed it. But that is past, and there is no point in belaboring it.

I would be happy to propose a paragraph. Let's start with rupture, since that is a major contentious issue. If we can get past that, we will have made progress. If not, I am not going to waste my time any longer, since what I propose here is accurate, relatively short, and not couched in biased language.

This is what I would propose. I do not speak for Dr. Zuckerman, or anyone else. I would like to get her input, as well.

Rupture

First. There were two actual photos of rupture that were simply deleted. One was intracapsular and the other was extracapsular. If the "Wiki community" believes it appropriate to have multiple photos of breasts ("normal", pregnant etc) in the breast article, then space is not a good argument to exclude it. And it follows too that both 'normal' and ruptured implants should be included. I happen to have one actual photo of implants that were removed from a friend, that were single lumen and 20 years old. If desired, I could point out that the extracapsular rupture was a photo of 20 year old implants, and not the newer version.

This is what I propose, in addition to the photos:

---

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7]

The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, for a variety of reasons including difficulty with samples, non-uniform style of implants, testing methodology and the like.

The rate of rupture has not been studied for implants over 10 years old. Predictions for rupture at 10 years or less have had mixed results. One study using MRIs (the 'gold' standard for detecting rupture with 86% accuracy) concluded that "the rupture rate increased significantly with increasing implant age." This study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years. The study concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants. That is, a woman who has two implants will likely have an increased chance of at least one implant rupturing during this time frame.

Another study similarly evaluated the percentage of implants that were ruptured. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] It is therefore not surprising that the rupture prevalence in this small study was 8% at 10.9 years, involving approximately 16% of the women.

When silicone implants rupture they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate to the breast and the lymph nodes under the arm, resulting in granulomas (inflammatory nodules) and axillary lymphadenopathy [21](enlarged lymph glands in the armpit area). [13] WIth the exception of one study which shows an increase in fibromyalgia, short term studies do not show an increased risk of autoimmune or other systemic illnesses in women with ruptured implants. However, it is unknown how often silicone migration occurs or what the health consequences will be if a ruptured implant remains in the body for several years. [22] Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18] Since most ruptures of silicone gel implants are "silent," with no symptoms, the FDA has concluded that MRIs are necessary to most accurately identify rupture. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10]

---

This is relatively short, states the facts accurately - it includes what has and has not been found, without belaboring it. If anyone can make it shorter/tighter or whatever - while still mentioning the issues stated - please discuss. I removed the disclaimer that the study with the lower rate of rupture was funded by Inamed. Most research is, unfortunately, funded by the manufacturers.

I speak for only myself, not "Jance/Zuckerman". Citations for all statements will be included - including the Brown study (fibro) and the FDA webpage which points out other studies did not find an increase in fibro or other autoimmune illnesses. And, for kicks and grins, I want to mention that I am one of those women who had ruptured implants for several years (five years, to be precise). It is true that this has not been studied.

It is true that I have a personal involvement. Is it only a coincidence that my symptoms and objective lab tests radically improved after removing my ruptured implants? Perhaps. Is it? We will never know unless long-term studies are done. I am not even sure how this could be done, since I can't imagine a woman knowingly leaving ruptured implants in her body, unless she can't afford or can't find a plastic surgeon willing to remove them. These problems have occurred, since some plastic surgeons have refused to remove implants, insurance often does not cover it etc. The problem is that women DO have ruptured implants in their body for 3, 5 or 10 years or more. We have no idea how many or what the effects are. And THAT is a good reason to recommend MRIs every two years, which the FDA has done. That leaves only about 14% (give or take a percent) risk that the rupture will not be detected. But we will never know.

I do not subscribe to any fringe or alternative view, but a straightforward facutal explanation of what has and has not been studied, what the regulatory bodies recommend, etc. The FDA decision is clearly important, since it did attach conditions and recommendations to its very recent approval. I do not know what other countries have recommended or not, although I would like to see more reference than Dr. Oliver's word on it.

Also, I do not have any financial interest in the approval of silicone or any implant. Jance 20:20, 30 November 2006 (UTC)

Alternative Rupture Section

I agree that it makes sense to start one section at a time, and we may as well start with an important section: rupture.

I have read every study quoted here, and this is what I suggest. The footnote numbers do not necessarily make sense, but indicate that there are footnotes.

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7]

The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.

Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18] According to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [6] For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10]

In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study {Brown et al 2001} However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. Neither of the two US implant manufacturers have collected longitudinal MRI data on rupture or leakage for women implants for more than 3 years. [11] [12] Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study cited above, which included Mentor and Inamed implants as well as implants made by other companies.

A more recent study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years and at the time of the study (approximately 10 years). The researchers concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] They could not provide a more exact estimate because women whose implants were removed during the first three post-surgical years were excluded from the sample. This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants. Since augmentation patients have two implants and very few of the women had two broken implants, the authors’ estimate would translate to at least 30% of wmen having at least one implant rupturing between 3-10 years after implantation.

In 2006, Inamed published a study of 104 women whose implants were approximately 10 years old, but were the same styles that are currently sold. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] The authors pointed out that this underestimates the rupture prevalence, which was lower than previous studies: 8% at 10.9 years, involving 16% of the women.

When silicone implants rupture they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate to the breast and the lymph nodes under the arm, resulting in granulomas (inflammatory nodules) and axillary lymphadenopathy [21](enlarged lymph glands in the armpit area). [13] There are few MRI studies of women with ruptured implants that were designed to evaluate the impact on health, and the specific risk and treatment of extracapsular silicone gel is controversial. FDA scientists reported an increase in fibromyalgia among women with extracapsular leakage, compared to women with silicone implants that were not leaking outside the capsule. [26]. The FDA points out that the association between fibromyalgia and silicone implants has not been reproduced in other studies [7], but conclude that "studies have not been large enough to resolve the question" of whether or not breast implants increase the risk of autoimmune diseases, adding "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.” [ http://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html#1]

Comments welcome. Drzuckerman 04:52, 1 December 2006 (UTC) ==re. to dr zuckerman's version==

• I have no issues with the tone or content of paragraphs 1,2, or 3 other then that you're on pace to extend a small subsection of the entry to great length.
• Likewise, your 4th paragraph on older rupture studies strings like the brown study [PMID 11000165] out what is already described in one sentence as The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, as most previous reports[18] mixed heterogeneous groups of devices in non-randomized populations.
• Your 5th/6th paragraphs references to to the Holmich & Heden rupture studies is editorially slanted rather then reciting the authors' conclusions. You've omitted the Collis/Sharpe data & core MRI data which are the other relevent data on MRI surveillence. This would be better treated with a one sentence caveat about the difficulty in these kind of studies rather then armed combat over each study.
• The last two paragraphs are again being not so subtly framed from the locked version. 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. [26]. This association has not been reproduced in a number of other studies, and the FDA has since concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants."
• In summary: I encourage you to resist your impulse to editorialize each study and expand this (sub) section to greater & greater length. We otherwise have areas that seem to be in agreement onDroliver 05:34, 1 December 2006 (UTC)

Neither the Holmich nor the Heden studies are slanted, as Diana or I wrote it. (I think ours are close). Your version had been slanted, and included an inaccurate statement of the conclusions. A correct representation of the study is not "editorializing". Just repeating the conclusions without stating how they were arrived at, to help understand these data from the previous study is an omission of important information, This is exactly what I meant by the importance of not omitting critical information - information that is required to make an accurate statement regarding the study. And I repeat that this is NOT editorializing, since the study states this itself.

Jance 06:33, 1 December 2006 (UTC)

• I added the general world position (as echoed by Canada in the attched link) on MRI screening which is that routine screening is not endorsed on asymptomatic patients. Mention of the 5th generation implant data was restored & the sharpe/collis data was added with the other 4th gen. implant refs. The mention of no data on more modern implants beyond 2-3 years was inaccurate (that was really just the US-FDA "core" data referred to, which is now 3-4 yrs BTW) as evidenced by the discussion on the next paragraph of 3 studies out at a decade or more, so it was trimmed.Droliver 02:56, 17 December 2006 (UTC)

Paragraphs, not sections

Oliver said he would agree to DZ's paragraph 1, 2 and 3. The rupture studies she quoted were the ones you used, Oliver. Are you saying those are obsolete?

This is the paragraph I wrote on this ...

The rate of rupture has not been studied for implants over 10 years old. Estimates for rupture prevalance at 10 years or less have had mixed results. One study using MRIs (the 'gold' standard for detecting rupture with 86% accuracy) concluded that "the rupture rate increased significantly with increasing implant age." This study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years. The study concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants. That is, a woman who has two implants will likely have an increased chance of at least one implant rupturing during this time frame.

A more recent study similarly evaluated the percentage of implants that were ruptured. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] It is therefore not surprising that the rupture prevalence in this small study was 8% at 10.9 years, involving approximately 16% of the women.

This only looks at the two studies you cited, Oliver. And in fact, you only cited these two. So how are they 'obsolete'? It is useful to briefly explain the study, rather then rotely copying the conclusions. This is particularly true of the Heden study, since it underestimates rupture rate by excluding women who removed their implants during the study period. I would like Samir and Oliver to comment on this.Jance 06:48, 1 December 2006 (UTC)

3rd rupture proposal

• as we seem to have no issues with the saline implant rupture I'll ignore that and work outwards from the locked version. I have tried to neuter things that could resemble editorializing statements (from me) while expanding on criticism of rupture data & rosy estimates

Silicone Implant Rupture

The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, as most previous reports[18] mixed heterogeneous groups of devices in non-randomized populations. Preliminary data from the MRI cohorts of the US-FDA proscribed "core" studies of contemporary implants has demonstrated low rupture rates within the first 3-4 years after implantation and will continue to be followed longitudinally.[[Core study]] The only available published literature MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported between 8% to 15% device failure rates on follow-up approaching a decade.[Holmich] [Heden]. An additional unpublished and retrospective series by a single surgeon reporting similar data in breast augmentation patients was also presented in 2005 FDA hearings.[Collis]Evaluation of 5th generation gel implants is currently limited to a single study reporting 0.3% rupture rate at a median of six years.[Heden].

Potential flaws with studies on rupture rates include [selection bias], flawed inclusion/exclusion criteria, false negative/positive MRI evaluation, and extrapolation of single/select surgeon(s) results to other physicians. In addition, a number of studies on older devices initially reporting low rates of rupture have witnessed sharp increases in rupture rates at 12-15 years. [cite ref] which brings caution about projecting long-term rupture rates of modern devices.

Studies have suggested both that most ruptures of silicone gel implants are asymptomatic ("silent") and that clinical exams alone are inadequate to rule out suspected rupture[23]. MRIs have emerged as the prefered way for evaluating potential rupture, and have been endorsed by the US FDA for periodic evaluation of implant integrity in all women with silicone implants. When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate systemically, but most clinical complications have appeared to be limited to the breast and axillae [24] in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy [25](enlarged lymph glands in the armpit area). [6]

The specific risk and treatment of extracapsular silicone gel is still controversial. 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. [26]. This association has not been reproduced in a number of other studies, and the FDA has since concluded the literature does not support an association between fibromyalgia and breast implants. [7] —The preceding unsigned comment was added by Droliver (talk • contribs).

• Dr. Oliver, Dr. Zuckerman and Jance, your thoughts? Is this an adequate representation in your eyes? -- Samir धर्म 06:41, 1 December 2006 (UTC)

I think there was an edit conflict and my comments and signature did not post. Samir, I hope that you will not discount my input. No, the version Oliver wrote is not acceptable, because it is not accurate. It omits important facts about the studies that do need to be explained, and can be explained briefly. Without this, it is misleading. Also, the quote I had used from the FDA is important to include - what causes rupture includes several things including mammograms and capsular contracture. Age and design of implant are major factors...

Please see what I wrote above, that it looks like Samir moved. I would like to discuss this.Jance 06:51, 1 December 2006 (UTC)

note:I have no problem with the sentence you're referring to about mechanical causes of rupture. Don't take this the wrong way, but your "explaining" is editorializing a spin on the authors' conclusions rather then the study speaking for itself. That is going to get us nowhere quick & bog this down into trench warfare defending/attacking individual studies. Droliver 07:01, 1 December 2006 (UTC)

My "explaining' is not just mine. First, Holmich states a "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] . Your statement is simply misleading. Both Dr Z adn I recognize the need to state what Heden's study states, that the 8% is an understatement because of the methadology - excluding women who removed their ruptured implants. You don't think that might just affect the rate of rupture? There surely should be no trench warfare by including what the study authors admitted. So how exactly is it putting a 'spin' on the study when the authors themselves pointed this out?" The way you wrote it is a spin.Jance 07:10, 1 December 2006 (UTC)

What if we added: "This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants." ? -- Samir धर्म 07:36, 1 December 2006 (UTC)

that would be good for a part, Samir. It also needs to be stated that the implants that were removed (from a woman, obviously) were excluded from the study. This is why the Heden study underestimates the rupture prevalence rate.Jance 07:47, 1 December 2006 (UTC)

Jance, that's coming close to the edge of what is allowed under "no original research". Your own analysis of faults is no good: but if you can provide say a literature review with this critique in it say then that's ok. --BozMo talk 15:25, 1 December 2006 (UTC)

No. This is what the study authors report in the study itself! How is this original research? Dr. Zuckerman quoted the page, but I also have a copy of the full study. The authors pointed out that they excluded implants that were removed "so the rupture prevalence may underestimate the actual rupture rate." Pg. 307. The authors further point out that further research is needed to determine the curve (rupture rate with time). Original research would be my using my engineering and math training and experience to say that it is very unlikely the rate is linear. I will be interested to see if any manufacurer-funded study ever tries to make the claim of a linear failure rate, over time. In reality, this is very very unlikely. And this study confirms what I have been saying and what we CAN say in the article, which is "There are no studies that analyze the rupture rate after 10 years." This is for the newer implants. We know the older implants ruptured more frequently, but there are no long-term studies of these, either. Many many women have the older implants now for 20, 25, 30, even 40 years. How many of these are ruptured? nobody knows. How many of these women are ill from autoimmune illness? nobody knows. Nobody cares. The sad thing is that there are no studies looking at rupture rate of the old implants, because that is not what they are marketing now. Rather interesting when you actually look at it -- especially when the manufacturers and plastic surgeons boast that silicone implants are the "most studied device" in the world. The "devil is in the details".

And that goes back to another comment that was deleted in the "reviewed" version (we have no idea who "reviewed" it, if anyone): Because most ruptures are "silent" (without symptoms), the FDA recommends that all women undergoing implantation have an MRI 3 year after surgery, and then every two years thereafter. This is a bit of a problem for most women, since insurance will undoubtedly not cover these expensive tests (approx $1500 each). But if articles like this that are recopied all over the internet do not point this out, maybe the women won't worry about these pesky details. And these women will never be studied beyond 10 years, because (1) the FDA is not requiring it, and (2) by that time there will be a new design of implant, and new studies that boast of the durability (over a short period of time) of the newer version. Jance 17:10, 1 December 2006 (UTC)

Oh, I mentioned my academic and work background. We all have opinions based on our background. Mine is not only that of an involved consumer. I also have training that gives me the ability to look at this particular issue with a critical eye. Of course, since I am not asking to write anything based on my own original research, it shouldn't matter, should it? All I am doing is quoting directly from the study that Oliver cited. Jance 17:24, 1 December 2006 (UTC)

Okay, if the review contains the critique and is credible I stand corrected. --BozMo talk 17:46, 1 December 2006 (UTC)

Yes, the study does. It is not a review, but the report of the study, where the authors state this fact. Where this study is used to highlight the most accurate 'literature', omitting this point is a serious oversight. Here, of course, it is not an oversight since both Dr. Z and I have repeatedly stated this, and Oliver repeatedly omitted it. So, this is exactly why Dr. Z and I both highlighted the page number - to avoid the potential allegation of "original research." It is also why she and I (in different ways) both stated the difference between this study and the other study Oliver cited, which in fact arrives at considerably different conclusions. Jance 02:45, 2 December 2006 (UTC)

In Re:

Holmich in 2001 [PMID 11547138] measured implant rupture prevalence by MRI in 271 women (533 implants). Ruptures were found in 26 percent of the implants total, with 7 percent of the 183 third-generation implants, which had a median age of ~ 6 years. In the 2003 companion study [PMID: 12860765] (from where the quote about "a minimum of 15%" comes from), Holmich obtained a 2-year cumulative incidence of implant rupture by magnetic resonance imaging or surgery in 186 women with 317 implants. Ruptures were found in 10 percent of the implants. Of the 145 third-generation implants included in the study, 5 percent were actually found to be ruptured. The quote you highlight from Dr. Holmich is a projection he was extrapolating rather then the data (rupture yes/no/maybe) at the point in time where the patients were imaged. This estimation is the ballpark ceiling from recent information and referred to in labeling instructions.

In distinction, Heden's paper [PMID 16874191] provides specific data (not projected)farther out with much a much more specific group of implants (one manufacturer, all modern 3rd/4th gen devices)making his #'s easier to look thru. Somewhere b/w 6-8% (indeterminate MRI were counted in the rupture group). Heden's study criteria excluded patients who had had removal/exchange prior to the endpoint, but it's not attributed to those implants being ruptured per se. The discussion (speculating on reasons why his numbers could under or overestimate the true rate) mention that, but we know from other data that this # is low during that period of time anyway.

Collis/Sharpe's unpublished data which is simlar to Heden's, but used similar devices by the other major manufacturer arrived at a 10% rupture rate at a decade.

Long story short: We have 3 studies to point to + the ongoing CORE studies on relevent devices. They're fairly consistant in conclusions and provide a range to describe rates b/w 8-15%. Each can be micro-disected (as I was making an example with Holmich's #'s) to emphasize why they over or understate. They're all provide useful insight. The criticism you mount of Heden's data is over the generalized category of flaws in inclusion/exclusion criteria. It's more productive to summarize potential flaws in studying this briefly as I've proposed rather then getting into slicing the data on each. Droliver 18:34, 2 December 2006 (UTC)

Response to rupture discussion

Since we all seem to agree on the 1st 3 paragraphs that I proposed, I'd like to suggest that those be included in the "locked" article as soon as possible. Please note that they would also replace the now one-paragraph section on saline implants -- there would be only one section on rupture, which would include little about saline rupture and would focus primarily on silicone.

The 3 paragraphs are as follows:

Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7] The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.

Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18] According to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [7] For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10]

I think the common ground we have is that the studies that have been done so far (whether Holmich, Heden, Sharpe/Collis, FDA, etc) all have shortcomings. As a result of those shortcomings, different researchers make different estimates about long-term safety, but there are no solid studies of long-term rupture rates for specific implants.

Regarding the rest of this discussion, I agree that this section is getting a bit long, so I propose we move anything about the health impact of rupture to the systemic disease section, and deal with that later.

That leaves some relatively minor disagreements on the most recent studies. The study shortcomings are inevitable, as I tried to say in my summary, because:

1. Not all rupture studies included MRIs, which are expensive but necessary to accurately determine rupture.

2. The longer-term studies all include implants that are no longer for sale. Those findings are important for the hundreds of thousands of women who still have those implants in their bodies, however. So, although not necessarily relevant to currently sold implants, they are still relevant to this article.

3. Droliver is correctly quoting the percentage of implants that break, but I think he will agree that for the patients, and from a medical point of view, what matters more is the percentage of women with at least one broken implant, which is twice as high since augmentation patients have 2 implants, and usually they break one at a time. That's why FDA uses that statistic, instead of the percentage of implants broken. And those statistics are in the articles, so therefore giving that info is not "original research."

3. The problem with extrapolating from 6-year data, etc, as the FDA has pointed out (and I quoted) is that we don't know what assumptions to make. As Jance mentioned, all products (cars, tires, and all kinds of implants) tend to be fine at first, have problems as they get older, and then finally reach a point where they are all broken. Few people keep their cars more than 12 years, for example, because everything starts to break.

Every breast implant study so far has found that after 20 years, any that are not broken are likely to break within a year or 2. Will that be true for the silicone implants now approved in the US, or the gummy bear implants sold in other countries? Nobody can say until those implants are in the human body for 20 years. A ten-year study is better than a 5-year study, but doesn't tell us about what happens after 15 years.

4. I agree with Droliver that women who had their implants removed prior to 10 years did not necessarily have a broken implant. I agree with him we don't know why they had their implants removed. However, since most women don't get their implants removed so quickly unless there is some kind of problem, I agree with the study authors that their numbers are underestimates. What we don't know is how much of an underestimate it is.

The researchers also stated in the article that many of the women selected for the study could not be reached, because they had moved since going to the plastic surgeon. Since those women were no longer "current patients" we don't know how many of them also had their implants removed because of rupture. That contributes to the underestimate, but again, we don't know by how much.

In summary, I propose we go with the text I suggested because:

1. The language is less technical, more for a general audience.

2. It talks about ruptures per patient rather than per implant, a more meaningful statistic for a general audience. (Just as an example, can you imagine talking about breast cancer rates per breast instead of per woman?)

3. It more clearly explains, in less technical language, what is known and not known about implant rupture rather than concluding that there is nothing to worry about. Probably the fibromyalgia comments should be moved to the systemic disease section, and we can discuss them there.

In my proposed text I had already incorporated some of droliver's language. I am willing to compromise but this article should be less technical and more accurate -- for example, the section criticizing some studies for using "non-randomized samples" is not only more technical than necessary, it is also misleading because one can NEVER use a randomized sample for these kinds of studies. A random sample would require a random sample of all women in a particular country or group, tell half of them that they are getting breast implants whether they want them or not, and then not allow women who have implant problems to remove them. ALL the studies done have been on nonrandomized samples. Some samples are more biased than others, some are more representative than others, but none are random.

Droliver and Jance, since you have no objection to the 1st 3 paragraphs, can we adopt them and focus on these other paragraphs? And, would you agree to moving the fibromyalgia and health impact of rupture section to the systemic disease section? That way we have less to deal with here.

I would welcome comments from others as well.Drzuckerman 17:54, 3 December 2006 (UTC)

That is fine with me. I am glad to see that Dr. Oliver at least changed the number he had for the percentages of implants that break. He had cited 5-8% and quoted Holmich (which states a "minimum of 18". Now the statement is only misleading, but not simply wrong.

—The preceding unsigned comment was added by Jance (talk • contribs) 19:09, 3 December 2006 (UTC).

• I do not agree on the specific language of your paragraphs, moreso on the general themes. I think the fact that implants can rupture make it implicit that they're not necessarily permanent devices. Speciifically the sentences these sentence are more wordy and editorial then the present version "In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study. [19] However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. Neither of the two US implant manufacturers have collected longitudinal MRI data on rupture or leakage for women implants for more than 3 years. [11] [12] Therefore, it is impossible to determine if the implants that those companies currently sell have a different 11-year rupture rate or likelihood of leakage compared to the implants in the FDA study cited above, which included Mentor and Inamed implants as well as implants made by other companies."'Italic text
• 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. I'll leave it up to you to treat that accurately in your paragraph
• I again think you're turning a small subsection into an overly extended dissection of what are only 3 relevent studies (Holmich/Heden/Sharpe) + the CORE data. The issues with the accuracy of this data (which can under or overstate rupture) and the trouble with historical overly rosy projections (at 12-15 years was an example with older devices) is incapsulated in the two sentence on error with this already.
• You make an excellent point re. reporting per patient rates along side the standard way this is reported (per device). This puts the ballpark rupture range between 6% (Heden's established low end) to 15% (Holmich's projection) per device or between 15-30% by patient at around a decade.
• In re. to your thought #4 about why implants are removed/exchanged early. We actually do know why in large part, namely capsular contracture issues & aesthetic issues/size changes. It clearly is not rupture rates driving that group of reoperations, but that's a area touched on elsewhere
• The issue of fibromyalgia seemed to go with the rupture section as that was the original assertion ie. rupture caused fibromyalgia. We know that to likely not be the case (as you know) and it's treatment as is should remain. This specific issue would likely be swamped in the discussion on systemic disease which is going to focus on the generalized area rather then the specific
• In re. to the "randomized" critique, a more accurate way of describing would be studying "unselected" patients

70.148.62.250 19:17, 4 December 2006 (UTC)

Unprotected

We seem to have made some progress here. Hopefully the cycle of reverts will end. I will unprotect the article and, provided all parties are okay with the above, we should add Dr. Zuckerman's 3 paragraphs and move from there -- Samir धर्म 05:11, 4 December 2006 (UTC)

I'm glad DZ's 3 paragraphs will be added and moving the last paragraph to the systemic diseases section makes sense to me. I do believe the paragraphs should be fairly short, but still have the facts. Most people that read these are lay people and need it to be understandable. Thanks. LynnMB 16:09, 4 December 2006 (UTC)

I find it interesting that the board certification credentials of Dr.Melmed were not questioned by BozMo.

Sorry I have genuinely never heard of Dr. Melmed, who is that? --BozMo talk 22:51, 4 December 2006 (UTC)

He is a (board certified) plastic surgeon with many years of experience. He is also a vocal critic of silicone implants. I well remember his statement that "One day plastic surgeons will look back and say 'what on earth did we do to women'". Dr. Melmed no longer implants women with silicone breast implants. I don't know if he still uses saline. Proponents of silicone implants dismiss him as being a shill for lawyers, and the like, because he has testified against these implants. Of course, plastic surgeons and manufacturers who criticize him also have a financial interest. So I am not sure why one is acceptable, and the other is not.Jance 23:21, 4 December 2006 (UTC)

However I agree with Jance and DrZ that describing our credentials is not to place the value of our comments above others- they are only being used to illustrate a viewpoint that we may possess that is different from a layperson's. When I say that I am a board certified internist (which is true) it is to demonstrate that I have a certain level of education and speak from a perspective of a primary care physician. Suffice it to say that I glad the additions DrZ has written are being placed onto the breast implant site. Her discussion articulates the authorative information that is in the medical community very accurately and without bias. DrCarter12 16:40, 4 December 2006 (UTC)

Thanks Samir, DrCarter and LynnMB. I inserted the 3 paragraphs (the 1st one replaced the paragraph on saline implants). I also broke the existing 4th paragraph into 2 -- the first from my version (which talks about the long-term FDA study) and the 2nd from the droliver version (which talks about the newer, shorter studies.

I'd like to revise the rest of the section by adding the following to droliver's existing text on the Holmich study:

The researchers could not provide a more exact estimate because women whose implants were removed during the first three post-surgical years were excluded from the sample. This study evaluated the percentage of ruptured implants, rather than the percentage of patients with at least one ruptured implant, as the FDA study had done. Since augmentation patients have two implants and very few of the women had two broken implants, the comporable statistics are at least 30% of women having at least one implant rupturing between 3-10 years after implantation.

In 2006, Inamed published a study of 104 women whose implants were approximately 10 years old, but were the same styles that are currently sold. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] The authors pointed out that this underestimates the rupture prevalence, which was lower than previous studies: 8% at 10.9 years, involving 16% of the women.

Comments welcome! 72.75.6.148 16:46, 4 December 2006 (UTC)

• I would object to this proposed characterization by Dr. Zuckerman as it's veering into commentary and keep it dry, with mention of the per patient rates alongside the standard way of reporting this (per implant). The patients in Heden's paper who had implant exchanges/removal were not attributed to rupture per se (we know ruptures during that period of time to be very,very low) but was a speculation on sources of underestimation. What clearly was a source of possible rupture overestimation was just counting the inderminants in the rupture group as they choose to. I use this as an example as I want to avoid refighting the FDA hearings over the course of this. I would propose as follows:

The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and have reported implant rupture rates between 8% to 15% on follow-up approaching a decade. This represented between a 15-30% rupture risk for individual patients. (Unsigned by Droliver).

The rupture rates as now stated by Oliver are not quite accurate still. The Holmich study concluded that a minimum of 15% of the imlants could be expected to rupture in 10 years. Further, to not state the study's own conclusion and caveats (in Heden/Inamed, that it likely underestimates rupture) is slanting the context of the discussion. Obviously, the detail of every study's methadology etc. is not appropriate for a general article, BUT where the authors of the study showing the lowest rupture rate state that it is likely underestimated, this should be added. Oliver's contention that the authors were incorrect or speculating, and in fact the exclusion was a source of overestimation, is not only "original research", but it misstates the clear language of the study.Jance 21:55, 4 December 2006 (UTC)Jance 21:55, 4 December 2006 (UTC)

• Holmich's data & his projections were indeed 15%, the "minimum" comment is in the context of his discussion on possible errors and the diffficulty in projections. Likewise Heden's paper has this similar discussion (this isn't really "original research" as it's his thoughts) & lays out briefly sources of potential error which over or underestimate. The actual rupture rate (not a projection) was 6% by MRI criteria, throwing indeterminates in with this was a manuever to avoid underestimating and clearly is going to slightly overestimate some ruptures as he points out. The excluded patients who fell out of the study in the early years would be expected to have rates of approaching (but not quite) <1%. Discussing neither of these is as productive as the blanket caveat about sources of error and how predictions about rates are difficult.Droliver 15:35, 5 December 2006 (UTC)

I think DZ's "4th paragraph" into 2 different areas is needed, but I do also like Droliver's more layman's terms. however, I do believe that Jance is correct when she says that the correct rupture rates do need to be presented. LynnMB 21:59, 4 December 2006 (UTC)

I did change the "6-15%" to "8-15%" since nobody had disagreed with the 8%, which was the Inamed reported figure, less the comment about underestimation and my comment that Holmich conclusion was also misstated.

Is there any reason to not include any rupture studies on older implants (older than 3rd generation)? Are there any studies following these women? And if not, why not? Many women still have these implants, and have them now for 20 or more years. It is not only young women who read Wikipedia. Is this age discrimination (just joking). Jance 22:22, 4 December 2006 (UTC)

Dr. Zuckerman already touches on this somewhat with her proposed treatment. Making sense out of the information on those older studies is hard other then the general conclusions about the 2nd gen. implants. What are the points you wish to make that aren't touched on by DZ's passing ref. & the information on problems with 2nd generation implants in a earlier segment?Droliver 15:35, 5 December 2006 (UTC)

I understand your point. It would be interesting to compare rupture rates on 2nd generation with later generations. Why would it be difficult to find older studies on these implants? Especially, since so many women still have them. I understand the techniques may not be the same in identifying silent rupture, but what did the studies find? Or were there any? What about the number of confirmed ruptues? Were these women followed? IT would just be an interesting point, and certainly useful to readers who still have those implants.Jance 21:56, 5 December 2006 (UTC)

rupture section

I deleted a couple of sentences from the rupture section that had previously been stated in the same section, about MRIs as the gold standard.

As we discussed, I moved the fibromyalgia paragraph from the rupture section to the systemic disease section of the article. I strongly disagree with that paragraph but did not edit it until it is discussed.

Regarding the most recent rupture studies (Holmich, Heden, etc) I agree with Droliver that less detail is probably better (here and in many other parts of this very lengthy article). I agree with other comments that we should mention the researchers' own descriptions of their estimates as underestimates. My one disagreement with Droliver is when he seems to say that selection bias is not a problem because rupture/removal rates in the first 10 years are very low. The problem is we don't know what they are, and Inamed and Mentor reported removal rates in the first 3 years that are not all that low (perhaps Droliver meant rupture is low during the first 3 years, which I would agree with).

I also agree with Jance that older implant rupture rates are worth including, as long as we say that they are previous generations. And I agree with Droliver that my previous insertion in the article does that.

I think we can solve the different points of view on the Holmich and Heden studies by calling these studies silent rupture studies. Women who knew they had problems already had their implants removed, so what's left are the women who thought they were ok but had silent ruptures. I could be persuaded to go along with the following slight modification of droliver's proposed paragraph to replace my 2 proposed paragraphs: "The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe, and have reported silent rupture rates of at least 8% to 15% at about 10 years. This represented at least a 15-30% silent rupture risk for individual patients."

Drzuckerman 16:38, 5 December 2006 (UTC)

I continue to say that less detail is probably better as long as less isn't leaving out important statistics. So I think it's good that the study above does include the silent rupture rates and the risk for individual patients. That is what people need to know. Everything needs to be put into context for the possible patients or people considering breast implants.LynnMB 23:10, 6 December 2006 (UTC)

DZ, I have no problem with that sentence.

As a rhetorical point (only) with asserting selection bias in Heden's paper during those years prior to the study date underestimating rupture, I actually asked Dr. Heden by email about the size of this group of patients excluded prior to the study period and his reply was "The number of ruptured implants that we have removed throughout the years, is to my knowledge, only three implants and this is in relation to the 7000 that we have implanted." This just reinforces the evidence from the CORE data & Sharpe/Collis' (no rupture thru 7 years in any of the study patients) that the #'s in that early period approach rates as close to nothing as we likely can achieve with that implant design and that this group as a source of error in rupture rate studies seems to be insignifigant.Droliver 00:23, 7 December 2006 (UTC)

OK, I made the change as discussed. I find Heden's comments interesting but of course he has no way of knowing if women who had implant rupture or other problems requiring removal went to other plastic surgeons, not him. We hear from many women who seek a new plastic surgeon when problems arise. But obviously the best way to answer that question is to keep track of all the patients and find out if they still have their implants or not.Drzuckerman 20:54, 7 December 2006 (UTC)