Talk:Breast implant/Archive 4

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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. [Diana Zuckerman response]

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.[1] 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 [PMID 16874191] 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 [PMID 12860765] 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)