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Complications

note: just deleted and moved to the bottom of page per protocol...72.244.201.27 17:23, 21 October 2006 (UTC)

Going Forward

Unfortunately, the last month of discussion crashed and is not available in the archives. Can anyone salvage it?

This is what JFW wrote on Rob's talk page:

I've been working on breast implant and seem to have reached the stage where the atmosphere has reached one of intense collaboration. Simply deleting negative material without discussion is now more or less impossible. You may wish to list your objections to particular material on the talk page, and we'll all weigh in. Who knows, we may end up with something neutral at the end! JFW | T@lk 07:22, 11 July 2006 (UTC)

In fact, there was collaboration on at least a couple of points. I removed what I had written (a quote from the summary of the journal article), even after others reluctantly agreed to leave in a version of it. I removed the statement because it was clear after reading the entire article, that the summary misrepresented what the study actually addressed. Also, JFW agreed that another journal article did indeed omit significant findings in its summary, as Diana suggested. This is called collaboration. Hit-and-run editing is not -- and the discussion then soon devolved into a spitting contest. jgwlaw 15:47, 20 July 2006 (UTC)

There was a level of professional collaboration as pointed out by jgwlaw. More importantly, we made headway on the article. Oliver, you continue to breach the professional agreement to "collaborate before making changes." Your posts are predictable..as is what you have to say. The other editors have brought information, data and perspective to the table which has been discussed by all. These are the things that enhance the article. Not you going off individually doing your own thing...just because you can.Sheehs1 03:28, 21 July 2006 (UTC)

The section on platinum in the 'controversies' section is inappropriate. It is not an issue of concern to patients, physician or manufacturers and there have been no sensibly proposed ill effects of platinum catyalysts. The section should be removed. Will TALK 08:12, 21 July 2006 (UTC)

--I don't understand the above comment. Any young woman with implants or considering implants would be concerned about research showing a toxic form of platinum (called platinum salts) in breast milk, and most women would also want to know more about platinum salts in urine, blood etc. Perhaps Mr. Blake is not aware of the latest research on this topic, which is the FIRST study to use a new technology that measures ionized platinum in bodily fluids. Previous researchers did not have the technology to do that. And, since this study was covered in the national media, women will want to know about it.

DZ, What don't you understand about the FDA's & others response response to this? In no certain words this was largley dismissed in their review. You also have a number of chemists saying that the finding is incompatible with contemporary understandings of platinum free radicals.Droliver 18:12, 21 July 2006 (UTC)

The only 'other' was Will. I disagree, and Sheesh1 disagrees. So it hardly is a consensus. As to the FDA....that is discussed in the article.jgwlaw 18:57, 21 July 2006 (UTC)

I certainly do disagree with the comments of both Oliver and Blake. I would like to ask Will if he read the full articles on the most recent research on platinum ionization found in woman implanted with silicone gel implants. If so, how can you deny others the right to this information thru this Wiki article? Need I say yet again that this section is absolutely required under the quidelines of informed consent.Sheehs1 03:12, 22 July 2006 (UTC)

Droliver cites "a number of chemists" but gives no references. I have spoken with several occupational health experts on platinum --platinum is an occupational health issue because of the platinum in catalytic converters, etc. It is NOT surprising to them that platinum in breast implants could become platinum salts when the implants are in vivo. That's why in vivo studies are important. Drzuckerman 05:37, 23 July 2006 (UTC)Drzuckerman

I also want to respond to JFW's concern about my citing FDA's data analysis instead of peer-reviewed publications. I want to ask if he thinks it is ethical for a company to sit on their data for 6 years (or more) because it shows that women with implants have a statistically significant increase in complications and systemic symptoms. If the company won't try to get the data published, it isn't published, and then no matter how important it is, few people will know about it. Since they didn't publish the saline data (completed more than 6 years ago), I assume that they aren't going to rush to publish the even more negative findings on silicone gel breast implants (which are now 3 years old for Inamed). I would respectfully ask JFW if he thinks those data should be ignored because the companies don't want anyone to know about it.

As someone who has published in many peer-reviewed journals and served as a peer reviewer for many journals, I admit to my bias: I think the FDA scrutiny of data is usually MUCH more thorough than peer review for medical journals. They actually go back to the raw data, which journals don't do. So, although I don't always agree with FDA's decisions or summaries, I think their scientific summaries reflect scrutiny that is much greater than journal articles do.

I also want to respond to JFW's comments about FDA responding to anecdotal reports and that's why they started regulating breast implants. That is not correct. The FDA had no authority to regulate implants until 1976. At that time, they gave priority to life-saving medical devices, such as heart valves, and allowed breast implants to stay on the market without requiring any safety data at all. Then the FDA scientists and advisory panel became concerned in the late 1980's because of the growing number of published articles citing implant problems in the late 1980's and early 19990's. In the early 1990's, internal documents from numerous implant companies became public, and those documents indicated that plastic surgeons had been reporting problems about leaking silicone implants to the implant companies since the 1970's, and those reports had been widely discussed within the companies. However, the company documents indicated that the concern by company scientists and the plastic surgeon was overruled by company executives. As FDA tried to decide what to do, however, the most important factor was that the FDA law requires implant companies to prove that their products are safe. When the implant companies submitted safety data to the FDA in 1991, NONE of the companies had even one year of data for their samples. Approving silicone implants would have been inconsistent with the law, given those lack of data. Drzuckerman 14:56, 21 July 2006 (UTC)DrZuckerman

Platinum

--Droliver stated that the platinum in implants is stable, not ionized. But as I'm sure some of you will recall from chemistry classes, metals such as platinum can start as a stable compound in the implants, and change as they are exposed to different conditions, such as proteins or other chemicals in the human body. Everyone (including Lykissa and Maharaj) agrees that the catalyst used to make implant shells is a stable form of platinum (I think I have said that at least 3 times in my comments and in the article) but the form can change in vivo. That's why in vivo studies are done, as you know. If you have any doubt about that, read the OHSA and NIOSH articles about workers exposed to platinum in their jobs, or contact the medical professionals and researchers who study them and treat them.

Until very recently (after the UK report) there was no technology to examine whether the platinum in women's bodies was stable or salts, and the implant companies had paid their consultants to publish articles saying it must be stable because the catalyst used was not a platinum salt. However, at least one article (Harbut et al -- he's a physician and occupational health expert) was published describing the symptoms reported by some patients as typical of a reaction to platinum salts. So Lykissa and Maharaj set out to study it FOR THE FIRST TIME (I think I have said that earlier, but perhaps you missed it). This is all new. It is not relevant what a report said in 2004. There is every reason to believe that the technology is accurate and the findings are accurate, since the researchers have every incentive NOT to put their reputations in jeopardy given that there is no money rewarding them and their reputations to lose if they are wrong. But it's fine to be skeptical. Given the level of controversy I agree that a study should be done by government researchers with no biases and lots of scrutiny and with enough funding to do a larger sample size, etc. Drzuckerman 01:08, 23 July 2006 (UTC)DrZuckerman

Although I am new to this, I am a bench researcher in Surgery. It is clear there is a heated debate between Dr Oliver and Molly. This is understandable and occurs in many issues throughout medicine, law, business and life. However, while I appreciate DrZuckerman's notes, if this Platinum article is to remain unbiased within the text of this Wikepedia prose, then I need to repeat my concern about the Platinum issue. 1. Whether it is valid or not, giving this much discussion based upon 1 scientific article is a concern. 2. As stated; if you all wish to keep it in this version, it must be fair to point out the funding and statistical analysis: A) We MUST note just like the Dow funding, that the Platinum article was funded in part by CANDO and B) the sample size is questionable based on lack of power analysis. While the final section notes the FDAs response, this version is taking only the negative aspects of the Platinum article. There were several sections which clearly disclosed that some of the increases were within norms, and were NOT statistically significant (again - how much credence to stats even if NOT significant, is questionable without appropriate numbers) I hope I am making sense. I am coming in unbiased and trying to let you folks see that there is a perceived bias in making sure to state which studies are funded by a pro-implant source, as opposed to those funded by a source that specializes in determing chemicals associated with illness.

I have no opinion on which one is correct - but as scientists (no offense to our attorney friends) we MUST remain equal on both sides of this equation, regardless of our own opinions.

In Summary - I would appreciate noting the funding source for the Platinum article, in the same grammatical format as was done for the Dow funding of other quoted articles.

Thanks (Jocomama 17:33, 23 July 2006 (UTC))

The 'heated debate' is between Oliver and me, Oliver and Dr. Zuckerman, Oliver and Sheesh1 and there have been others, as well. I have a background in science, & take no offense to being called an attorney, since I also have a degree in law. I don't disagree that funding should be added. I did not write this section as it is now, and have not read where CANDO funded this. But yes, it should be added. I added that it was funded in part by a consumer group. You do make sense, which is why Dr. Zuckerman has pointed out on more than one occasion that this study should not be considered conclusive but should be verified (or refuted) with larger studies. The study has been big news, so rightfully should be included.jawesq 22:57, 23 July 2006 (UTC)

Jocomama, well you can see part of the issue in this. This platinum issue, which again has been reviewed by the UK,Canada, & US in the last two years, is being used a political gambit to attempt & delay the presumed reintroduction of the devices (there is every indication the approval of the devices is immeninent if you watch the insiders money). There is no new "crisis" from this Lykissa work & indeed, the FDA responded quickly in print distancing itself from the findings in the paper. Contrast how several would promote this issue, while simultaneously dismissing the gold standard IOM report (and a number if other benchmark reviews) on this topic with nary a mention. It is pointless to go thru and fight issue by issue (paper by paper) on this as it elevates the debate above and beyond where the science and medical mainstream really are when considering the safety of the devices. Droliver 23:38, 23 July 2006 (UTC)

--In response to Jocomama's suggestion, I have shortened the platinum section, removing most of the platinum level info since the sample size is small and the numbers may not be representative. I tried to clarify that the issue is that there are any platinum salts in these women's bodies at all, not the levels -- that's why the sample size is less important than it otherwise would be. I don't have the Lykissa and Maharaj paper with me this weekend, but will check tomorrow to see if other changes are necessary. However, as an epidemiologist I don't think that statistical power is that important in this particular study because it is an issue of type of platinum rather than level of platinum that is of key importance. Therefore, inferential statistics are not so important here -- at power level is only an issue for inferential statistics.

Droliver, you don't know what you are talking about. The IOM report is 7 years old and at least 50 epidemiological studies have been published since then, most of them superior to the studies available for review by the IOM. And, although you keep ignoring the facts, the Lykissa and Maharaj study uses a new technology, never available before, and was published in a very well-respected peer-reviewed chemistry journal. You may not like the findings, but you don't like ANY study that raises questions about the safety of implants. I have yet to see a reasonable comment from you Drzuckerman 23:47, 23 July 2006 (UTC)Drzuckerman

Yes, it would be a pleasant change if Rob would discuss the issue at hand and discuss it reasonably, two things I have not seen him do. (Also, I changed my nickname to jawesq, since yes, I am an attorney)jawesq 00:17, 24 July 2006 (UTC)

DZ, the IOM is still considered the gold-standard for this. The literature & reviews since then nearly unanimously continues to support their conclusions. Do a lit search for yourself, but I know you're already familiar with this. The problem is you dismiss all that work on this en bloc. There are a number of studies that I agree point to issues with implants, however what they point to are local complications and high reoperation rates. They (by in large) do not support the position that there is new evidence of connective tissue issues or oncologic concerns.

If Lykissa's platinum study is so clearly valid, how do you explain the FDA's brisque dismissal of their methods & conclusions? The British also reviewed this theory of reactive oxidative states in 2004 & the Canadians reviwed it in 2005. To date, no one is endorsing this apparently. No?

RO, it appears that Dr. Zuckerman is not saying this is 'clearly valid', if you read her comments, Rob (and please sign your comments). This 2006 study has been highly publicized, and it uses a new technology unavailable before, from what I can tell. The point is that this is significant enough to mention, as it has been, and to state that larger studies are needed to either refute or confirm. Surely you are capable of understanding the difference between that statement and making a claim that it was 'clearly valid'. jawesq 16:02, 25 July 2006 (UTC)

The FDA has reviewed this and disagreed with it on the record in the last month. That clearly establishes the context to currently view and refer to this information. Droliver 17:52, 25 July 2006 (UTC)

And indeed that is what is written. It is accurate.jawesq 18:58, 25 July 2006 (UTC)

No that's not what written. What's more this study is now clearly radioactive as the editors of Analytic Chemistry are dustancing themselves from it quickly. Catherine Fenselau, the associate editor who handled the manuscript, says, “The manuscript went through a full review and, as the associate editor who handled it, I am ultimately responsible for the review process. In hindsight, there now seem to be strong arguments that the science in the paper was probably flawed.” Links to the discussion in the journal can be found in that web-link and provide a detailed post-mortem that strongly indicts the whole methodology of the authors. As such, detailing what is now an apparent incorrect or unsubstantiated conclusion, I'm reverting this segment to the previous incarnation which dryly decribes both the claims of the paper and the subsequent FDA review which is about all this topic needs if we feel it merits mention at all anymore.Droliver 01:21, 3 August 2006 (UTC)

--I don't have the time to address every piece of biased misinformation that dr oliver includes on this page, but in this case it is worth noting that the journal decided to "balance" the article with commentaries by a Dow Corning employee and Inamed consultant. Pathetic but true. Dr Zuckerman

DZ, if you read the journal there were a number of other scientest also commenting on this. There is no one coming out and defending what looks more and more like bad (and most likely inaccurate)science. The treatment of this platinum area was flawed from the get go and embraced for the political value rather then putting into into the perspective of the established work in the field.Droliver 13:06, 5 August 2006 (UTC)

People who have had breast implants

Is there any reason to include this?jawesq 16:12, 25 July 2006 (UTC)

No, IMODroliver 17:53, 25 July 2006 (UTC)

I agree.jawesq 18:58, 25 July 2006 (UTC)

Maybe a few extreme examples, specifically what I'm thinking of is people are famous because of their breast implants. i.e. Pamela Anderson. But of course not just any famous people, then the list would be waaaaay too long. Those mentioned must only be included if some of their fame comes from some interesting and relevant aspect of their breast implants. For instance I'd be very interested to know who is the first public figure to acknowledge having breast implants. This would be a very handy thing to know, because breast implants have not always had the same level of acceptances as they do now. Mathmo 07:22, 17 November 2006 (UTC)

Rupture data

I updated the rupture section to

1. Add some saline rupture data for context

2. reflect more accurately the silicone rupture data we have on devices currently being used (rather then those no longer made). These would be the "3rd generation" made since the late 1980's. An article published this month gives us another source to index rupture rates at close to a decade at ~8%. The isolated subset (145 implants out of 317) of 3rd generation implants in this paper also had the rate at 5%. This is as good data as we're going to have for another 5-6 years until the US core study matures

3. place the MRI/clinical detection section at the header

Droliver 02:52, 8 August 2006 (UTC)

If droliver continues to vandalize this article, as he has been doing, I will continue to repair to a NPOV. I understand that droliver is a plastic surgeon who honestly believes that breast augmentation is the best thing to happen to women since Adam. That does not give him the right to delete referenced articles conducted by independent researchers and replace them with articles funded by Dow Corning, the manufacturer of silicone. Drzuckerman 03:28, 9 August 2006 (UTC)Dr Zuckerman

Dr Z, your tone does not reflect NPOV. Try not to be hypocritical Will TALK 09:38, 8 November 2006 (UTC)

Clinical images

Image:1200cc Breast Implants.jpg Most of the images are clinical. Shouldn't there be another image included? --evrik 02:39, 3 September 2006 (UTC)

External Links

Other articles have external links organized alphabetically. IT becomes problematic when a controversial article has links organized by 'relevance'. According to JFW, for example, all links that question the safety would be least relevant. In fact, Fumento's article, which is on a libertarian political site, would be more relevant than the NOW letter or The Center for Women's Health. I think not. And according to JFW, Alliance for Justice Releases Important New Study; Silicone Implant Saga Illustrates Vital Importance of the Civil Justice System is not relevant and he removed it entirely. It most certainly is relevant and appropriate as an external link. Leonard60 21:32, 14 September 2006 (UTC)

NPOV is frequently cited by those who are NOT NPOV. Here, Fumento's article is on a Libertarian political site. Hardly NPOV. The Alliance for Justice is a political site, and clearly as relevant as Fumento. But it was deleted entirely. Leonard60 21:41, 14 September 2006 (UTC)

I agree with Leonard60. NPOV should be balanced or neutral. The Alliance for Justice report is footnoted and referenced, which Fumento is not. I also want to suggest that since this article is already long, we should be judicious about new additions. For example, the funny story about an implant stopping a bullet is not important enough or appropriate. Drzuckerman 02:11, 15 September 2006 (UTC)DrZuckerman

Yes, Fumento has a long checkered history as a right wing political writer. Hardly 'relevant' for a NPOV article and certainly not more relevant than The Alliance for Justice. Similarly, the Manhattan Institute is also an extremely political organization, and does not merit a 'relevant' status.Leonard60 04:45, 15 September 2006 (UTC)

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)

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.{{cite journal}}: CS1 maint: multiple names: authors list (link) 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.

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 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. 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 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 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

— Preceding unsigned comment 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: 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 Misplaced Pages 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 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)

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)

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?

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

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)

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)

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 Misplaced Pages does not have a board certification especially when it has only made one contribution and is impossible to authenticate. Boards do not certify Misplaced Pages 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. Evidently, Droliver cannot. Unfortunately, Droliver has blatantly misstated the "comprehensive reviews" he cites and the studies contained in them. Droliver has attacked any statements other than his own (including, evidently, some of the studies he has misrepresented - that is fact, not disparagement). Now it appears that Samir has abandoned the article, after "protecting" it to the version that Oliver wrote. Samir disregarded the edits of the most recent editors (more than one). This is a problem, and hardly seems even-handed, especially when I showed that statements Oliver made were NOT what the study HE cited said. And, as usual, he omits the conditions, recommendations for follow-up, and the like. I urge Dr. Melmed and Dr. Carter (I don't know who this is) to show Misplaced Pages 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)

I might also point out that Droliver has not verified his credentials - I have asked him repeatedly to show he is a board-certified plastic surgeon, to no avail. And since when do you automatically dismiss an editor's comment - is BozMo calling Dr. Carter a liar? Would it help if Dr. Carter proved his /her credentials? Hah. I doubt it. And I doubt that any of Droliver's buddies have proved their credentials, either. Frankly, I would worry about any medical doctor who claims to be an expert in his field, who appears so biased and intellectually dishonest.Jance 20:52, 29 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.

Sorry, Lynn - you are new, so your voice doesn't count (read BozMo's and Samir's comments below). In fact, according to BozMo, we should not believe you are who you say you are.

It seems to be the only voice allowed here is that of Oliver and his buddies. This is despite various people pointing out errors in Oliver's version and PROVING them. Jance 20:44, 29 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 Misplaced Pages 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)

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 Misplaced Pages, 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 Malpractice?

It appears evident that Samir "cut and ran" - he locked the article on what he wanted, and found any excuse to avoid any real attempt at resolution. I hope someone will take this to An/I, and someone will bother to actually read the article and the sources which are misstated. It seems clear that the "Wiki doctors" haven't bothered to do so, before "taking sides". 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)