I basically reverted to the original. Unless Rob Oliver can work with editors and discuss paragraphs, eg work coooperatively, this article will never happen. I am not going to allow him to completely gut everything I did so h e can make it an advertisement. I again suggest we get some other editors to help who will discuss paragraphs, or sections. I will talk to Dr. Laub, and see if he will help start this. Oliver only inflames, because he guts the entire section and writes only what he wants - no discussion, no cooperation. It is outrageous. He has already been requested not to do this in other articles, especially when he added links to his own website. This is not Wiki, and it is also not professional. molly bloom 23:39, 30 April 2006 (UTC)[reply]

David, would you please add what you reduced the "rupture" paragraph to be for the main article? I know this was not it, but I can't find what you originally wrote. We agreed to have the local complications include a comment about rupture, but to expand on the problems in the "Risks and Controversy" section. Rob Oliver removed the whole of local complications except capsular contracture, and I believe we all agreed that was not appropriate.

Also, should "mammography" appear in the main article, as with rupture, and then expand in the "Risks and Controversy" section? Thank you!molly bloom 00:25, 1 May 2006 (UTC)[reply]

The only thing Rob even mentioned was the table, in the edit itself. Most other editors agreed that a table is not appropriate in this section. Also, please discuss changes HERE when editing. Do not gut large sections of text. Given the contentious nature of this article, changes should be SMALL and DISCUSSED HERE. It is also not appropriate to gut large sections of text, given the history of this article. I would ask that Rob cooperate on this article, or I will lodge a complaint about vandalism and POV.molly bloom 01:24, 1 May 2006 (UTC)[reply]

Molly, this was where David suggested hammering out this section rather then the main. As there had been no activity on it (and you were still working on the main entry), I assumed you were not into this and I was in the process of making pretty heavy editing here in the sandbox. This was not meant to antagonize you.

The revised table removed individual studies in response to your feeling I was cherry-picking single studies, and so I just presented the conclusions of all the large Federal appointed reviews. It puts it all into black & white & I think makes it pretty clear where the general consensus is. There was not an outcry among editors that this was out of bounds, and this was originally placed by David Ruben

This is a very simple table for everyone to understand and it's a very effective argument for the safety of the devices. You can quibble with what you & Diane Zuckerman percieve to be any individual studies' biases, design flaw, conflict of interests, or misinterpretation but the sheer weight and volume of these studies put's it into perspective. I've invited you several times to add any various Government or health ministry reviews that have been overlooked - as far as I can tell there hasn't been one that's come out in support of connections to connective tissue disorders. Below is a Pub-med search involving silicone and sytemic disease limited to review articles for nearly a decade with about 40 relavent reviews (I'm sure they're more that didn't get caputures by the search tags). As near as I can tell they run nearly 7 or 8:1 in their review conclusion, and this is on the low side as 3 of the reviews suggesting a connection are by the same author SL Brown.

Some of the studies you cite are also by the same authors. So what is your point? There are also other studies that are there that are not done by Brown. You can have 1000 different articles about the same thing, and it does not make the actual studies any more persuasive or abundant. I picked some of the articles below, by random, and some are essentially editorializing about the existing studies. Why don't we stick to actual studies? I can show you dozens of articles editorializing as well. Because these are in a plastic surgery journal does not lend them any more weight. In fact, I have less respect now for plastic surgery, in general, given their obvious bias in this area. IT seems that where the money is, is the 'weight of the evidence'. This would never fly in court.

PMID 15776068 PMID 15166995 PMID 15156983 PMID 15154572 PMID 15065364 PMID 14563011 PMID 14528500 PMID 12908390 PMID 14770029 PMID 12415977 PMID 12126580 PMID 11932626 PMID 11818862 PMID 11768036 PMID 11710703 PMID 11256005 PMID 10909551 PMID 10866122 PMID 10873241 PMID 10717013 PMID 10191786 PMID 9934002 PMID 9881833 PMID 9816748 PMID 9797723 PMID 9676177 PMID 9629778 PMID 9567202 PMID 9458621 PMID 9388410 PMID 9364829 PMID 9326798 PMID 9308408 PMID 9191755 PMID 9183827 PMID 912899 PMID 9105364 PMID 9499999 PMID 9433399 BTW, nice Dailykos diary on the income tax manuevers of the super-rich. Good stuff. Rob65.89.98.20 18:09, 1 May 2006 (UTC)[reply]

Yes, I like Daily Kos. I contribute to it regularly.

I've replaced the table in the section on systemic disease. If you can convince the community at large that verbatim investigational reviews/reports from western nations is "POV" then go for it. I'll will leave it to the group of editors to decide on this. Presently, there is no indication that any signifigant work in this area of excluding systemic ilness has been done which is ironic for what's been called the most studied device ever presented to the FDA. Molly, you've had a free run for several weeks on editorial control and this article is a confused and alarmist view of what is a fairly simple subject as a result. The inflamatory factoids, quotes, and reports have made the sections on saline/PTU/silicone implants, systemic disease, and complications into an unacceptable narrative. 65.89.98.20 18:33, 1 May 2006 (UTC)[reply]

Rob, it is not that some of that information should not be in the article. Other editors have agreed that the table itself is not the way to present this. If you read what others have said, it woudl be helpful. The subject is not 'simple'. These are not inflammatory factoids. Good God, I have included peer reviewed articles, also. Why don't we leave the addition of this information to other editors who don't find regulation 'lunacy'. The local complications, for example, are not 'inflammatory.' It is very factual, and to the point. You chose to delete all of it except CC. That is unacceptable. Let's see what other editors have to say. I am certainly open to changing it, but not the way you evidently want to do. So let's let someone else work on it.20:06, 1 May 2006 (UTC)

David has asked us not to add any additional studies without discussion. Most of what you added in the table were reviews of existing studies, often funded by Dow Corning. So like you find fault with those studies that I added, I can find fault with those you included - in addition to funding, the study parameters were suspect. The length of time was suspect.

There was indeed a discussion about the table, if you bother to READ what was written. Even David agreed that it probably is not a good idea. So why don't you write something including some of these studies in a paragraph, and we can all review it. Or, better yet, leave it to a less biased editor to do so. You are even more biased than I am, on your own insistence that these are perfectly safe.molly bloom 20:10, 1 May 2006 (UTC)[reply]

Molly, I think the devices are safe and not "perfectly safe", and this qualifier is common in the conclusions in all these reviews and studies (and is the de facto FDA position as of 2005). I do not dismiss the possibility that very small subsets of patients could be succeptible to auto-immune disease from silicone exposure, but to date there just is not good evidence that this is the case yet, and you can't create that by posing a single outlying study to bolster you which is what you have done for many of the systemic illness topics. It's wreckless to imply that there is more (or less from your view) controversy then there is. The whole topic should be summarized in a few sentences or short paragraphs and outline some of your concerns in the context of the larger body of work. The belabored complication section, narrative about Dr. Jenny in the saline section, elevating Dr. Vessey's view, the Zuckerman talking points,and trumpeting of a few of the smaller studies out of context (don't get me started on the platinum thing) do not serve this well. When the FDA approves these devices (and apparently it's now just negotiating with manufacturers over post-market surveillence) how are you going to be willing to address this with your POV? I for one won't be satisfied until the mainstream view is elevated in toneDroliver 20:32, 1 May 2006 (UTC)[reply]

You dismiss all studies you don't like. These are not Zuckerman's "talking points". Just exactly what do you mean by 'belabored' complication section? I said we should minimize the rupture to a few lines in the "local complications" section. These local complications are true - is that what bothers you? You also wanted to delete the photo of the extracapsular rupture, while leaving your sanitized photo. You really want a breast implant advertisement here, and that is not going to happen.

So why don't you write a paragraph about the 'mainstream' view instead of griping about it? Write it and we can discuss it. The platinum study was peer-reviewed. I don't doubt that you want to dismiss it. And, I expect in short order some Dow funded group will produce a study contradicting it. That seems to be the pattern. Did you read the comments of the other plastic surgeon, who is also a medical professor? He doesn't seem quite as convinced as you are that these are safe. He does agree that we need to include the 'mainstream' view, but also keep the discussion of other studies and the controversy that very much exists. Because you don't want a controversy to exist does not mean it doesn't. The fact is, that the FDA has not yet approved silicone implants. IF and when they do, so be it. I think it will be a mistake, but it will be what it will be. You don't even know what the FDA is doing now, and to say that it is a foregone conclusion is presumptive. The FDA has also been investigating allegations of fraud by Mentor. I think it is a travesty that you have such a closed mind. But that won't translate to the Wiki article - and I will make sure of it.

It is also not the 'de facto' position of the FDA that these are 'safe'. Maybe that will be when and if the FDA approves these. My guess is that silicone implants will be approved, because there is so much money to be had.

I left what you edited about the saline implants, except that I removed the 'newer designs' - that is not pertinent here. And can you provide a citation for the improvement that you mention?

The local complications section is NOT "Belabored". It is now relatively short, and concise. You desire to not have anything on local complications is not acceptable. Other editors agreed that it should not be collapsed to CC and a single sentence.

What exactly are "Dr. Zuckerman's talking points"? And do you dispute that what she said was untrue? I believe as an epidemiologist, she is in a better position than you are to make the comments she made. molly bloom 22:20, 1 May 2006 (UTC)[reply]

Only changed "most plastic surgeons...feel silicone ...is the superior device" to "has a more natural look". molly bloom 23:50, 1 May 2006 (UTC)[reply]

Rob changed this without any discussion, As a result, I reverted back to original. Secondly, there is no need to go into detail about approvable letters. The FDA has not yet lifted the ban,. That is sufficient. When and if the FDA does, then that can be stated. Further, Dr. Kessler did not unilaterally restrict silicone implants. He certainly voiced his concerns, and as the FDA commissioner then, he acted for the FDA. You don't write the names of those who decided to write an approvable letter. This is nonsense. And again, please DISCUSS the changes you make here.molly bloom 00:02, 2 May 2006 (UTC)[reply]

Canada - I did not write this paragraph, Rob. And, you did not discuss your change, IT reverts back to original, which is factual. Your edit gets into controversy which is not what this main article is about. Again, PLEASE DISCUSS YOUR CHANGES ON THIS PAGE. ANY THAT ARE NOT DISCUSSED WILL BE REVERTED.molly bloom 00:10, 2 May 2006 (UTC)[reply]

Local complications and mammography do not need to be in "Risk & Controversy" section. They are already in the main section.molly bloom 03:40, 6 May 2006 (UTC)[reply]

The sentence "According to the New York Times, at least three women died when silicone obstructed their blood vessels and lungs.[2]" does not belong in the passing reference to injectable silicone as it does not accurately reflect what you do in fact see. These patiets present with granulomas & silicone "lakes" within the breast & can have some lymph nodes enlarged. There are better references, reviews, and treatment recomendations of this particular problem in the literature if we want to devote attention to this Droliver 12:43, 6 May 2006 (UTC)[reply]

Both the 2005 FDA approvable letters & the current Canadian environment (including the 2005 re-review of safety issues) should be referred to in the intro paragraphs to provide an accurate current snapshot of where things are in North America.Droliver 13:20, 6 May 2006 (UTC)[reply]

We should add the transumbilical approach & endoscopic transaxillary techniquesDroliver 13:20, 6 May 2006 (UTC)[reply]

In the absense of closed-capsulotomy procedures where you used to squeeze a hard capsule unil it 'popped' (which were very common but are no longer done by and large)extra-capsular migration rates are extremely low (something like 1/40,000 from some of the international rupture studies). I think that information should be referenced for context if I can find it in print (it's from a talk by Scott Spear (chief @ Georgetown)on silicone implant safety that's going to be part of the FDA requisites for surgeon training for implanting these devices)Droliver 13:20, 6 May 2006 (UTC)[reply]

We do not yet have rates for this. Please refernce a study if you do. In fact, my implants WERE ruptured by a mammogram. Also, if you change things, you need to find a citation supporting it. molly bloom 17:05, 6 May 2006 (UTC)[reply]

We actually do have some information inferred on rates of extracapsular rupture from several studies which is distinct from the overall device rupture rate, which we do have very good 4 year data to tell people (which has to be prefaced by the fact we have little clue how the failure curve looks at a decade to 15 years which is where older devices sharply increased their failure rate.)Droliver 11:28, 8 May 2006 (UTC)[reply]

While I like the paragraph on this, outlining the Baker Classes in full adds little to help a lay-audience & takes up space. A link to this somewhere on the web would accomplish the same. Also, this area deserves more attention/expansion as it continues to be one of the larger factors in reoperation (after cosmetic revisions, which is #1). In recent years, treatment with Singlair/Accolate (the asthma drugs) has been advocated for tx. with some success which should warrant some reference.

Again, this is not a journal, Rob. There is no need to expand to make it one. I also do agree that the Baker classes could simply be a link -- and that there is no reason to list the four. I have made it a link.molly bloom 18:41, 6 May 2006 (UTC)[reply]

Infection & hematoma/seroma aren't really specific to these devices, and the take home point re. their role in capsule formation (which is somewhat specific to this) is touched on in the preceding paragraph on capsular contracture. Same for chest wall deformity, really that's more of a complication you see from tissue expanders rather then implants. The relationship of the soft-tissue/implant interface and the effects of this over time is very worthy of a paragraph in and of itself. This relationship (and respect for it) has been shown in some people's large series to be the single most effective way to reduce reoperation rate & is front & center in the educational movement [ PMID 15457045] . Droliver 13:20, 6 May 2006 (UTC)[reply]

No, I disagree on hematoma/seroma. It is a factor in cc and should be separately addressed. Chest wall deformity is a complication of implants as well, from plastic surgeons I have asked. Also, the FDA lists it as a complication of breast implants, not just expanders. If you have a study to dispute this, then please produce it.molly bloom 17:08, 6 May 2006 (UTC)[reply]

Again, this is not an educational journal, Rob. It is an encyclopedic article.molly bloom

Molly, I don't need a study to 'dispute' this (it's not really a dispute), rather if you're trying to convey what are the common & real-world complications they are re-ops for size change, asymetry, rippling, capsular contraction, and tissue changes over time. Infection, extrusion, etc... are exceedingly rare. There are dozens and dozens of references on common implant comlications if you really want to reference this. The point being, I think focusing on the most likely is the most relaventDroliver 11:36, 8 May 2006 (UTC)[reply]

The tone of this should reflect breast CA sites like [1][2][3] rather then the melodramatic way it's presented here. Mammography is less sensitive (but signifigantly more specific) in women with implants, but breast cancer is not more advanced in these women when it is diagnosed. Remember that the researchers in the Miglioretti et al.(JAMA Jan 2004) paper that was so publicized concluded that yearly mammograms are effective in detecting breast cancers with a favorable treatment outlook, whether or not a woman has breast implants. 65.89.98.20 16:50, 6 May 2006 (UTC)[reply]

Again, Rob, you distort the very sites you reference. This is a quote from one of your references: "Breast implants may decrease the ability of mammograms to detect breast cancer, because implants can obscure the image of a tumor." Also, this is only one doctor's opinion, who thinks the benefits of mammograms outweigh the risk of rupture. IN my case, it certainly did not.

Existing mammograms on women with implants do take additional pictures, but do nothing to guard against rupture - this becomes an increasing issue with the age of the implant. Please provide a reference here to dispute this, if you have it, so we can look at it. I would never have mammograms if I had breast implants, after my own experience. My doctor advises women with breast implants to have MRIs, and not mammograms, for the same reason.molly bloom

Molly, I don't think there is any organization NOT advocating mamography in women with implants. MRI may in fact be safer, but given the relative rarity of implant rupture from it & the low cost-benefit at this point, it is not widely advocated yet. What you do see from the breast CA sites & the available literature is the consensus that mammography is harder but that this hasn't had an increase on disease-specific mortality from breast CA. Those are the take home points on breast CA patients have to be educated on. Consideration for preferring submuscular placement is usually also offered if this is a concern to a patient.Droliver 11:47, 8 May 2006 (UTC)[reply]

This section needs to be introduced with a summary of the major reviews on this. I still think the table Molly objects to is the most effective visual aide here, but so be it. I would compromise on the table of the multiple Governmental review panels if we can summarize the common lack of finding associations of systemic illness and attach links where people can be pointed to for the individual systemic reviews.The fda implant page's take is "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"

You will not include the table. It is no compromise. We can discuss what you mention here, as well as the problems with the studies. Also, we will have links to opposing studies.molly bloom 17:13, 6 May 2006 (UTC)[reply]

The IOM study is the benchmark for North America and has to be the lead in any discussion on this in re to systemic illness. I also object to Frank Vasey being quoted at length as he's charitably been described as a highly-paid professional witness in the 1990's tort proceedings and the quote from him seems just thrown in randomly. Dissenting views can be compressed to something like that "... some Physicians and researches still have concerns over questions about X,Y, & Z (cancer, autoimmune dz, platinum, etc...) and attatch references to them for further research. It's appropriate to mention Molly's point about study funding by industry, but again this needs to be mentioned once in a summary view of continued research and surveillence. The #'s from the 2005 PMA data showing complication rates (and complarisons b/w saline and silicone data) seem like they belong somewhere in this section. The rheumatologic,oncologic, & neurologic sections are redundent with systemic illness section and only serves to lengthen the article. Again, I feel those belong summarized briefly in a short summary of concerns with attched links for further reading.

You and those like you do not like Vasey. That is very understandable. I don't mind removing his quote. However, we most certainly need to have some introductory paragraph stating that there is still controversy about the health effects. You m ay not like it, but that is a fact.molly bloom 17:13, 6 May 2006 (UTC)[reply]

The PMA data does not belong in this section. There is no reason to include it, since the FDA has not yet taken action. When and if it does, then it can be included. The FDA also stated that the adjunct studies were flawed (no big surprise there). Also, there are only 2 and 3 years of rupture data, hardly representative when women have implants for many more years. The two implant manufacturers could not answer the question about a pattern of rupture rate since they lacked the data to do so.molly bloom 19:02, 6 May 2006 (UTC)[reply]

The PMA data is extremely relevent b/c its giving us real-time longitudinal data. This is true for both short-term rupture rates (at four years + for Inamed) as well as being able to examine side by side complication rates for silicone device vs. saline devices. The FDA timetable for approval doesn't really have anything to do with the information itself. The ultimate shape the rupture rate curve will take nobody knows, but we do know that for 3rd/4th generation devices it's less then 3% (and well-below 1% with form-stable devices) in the early benchmarks & seems likely to be somewhere b/w 8-11% at a decade if the E.U. data is a predictor. It's appropriate to report the short term data with caveat's about projecting this out reliably. It's also important to explain the difficulty of correlating previous studies which have mixed many different implant styles, generations, manufacturers, and filler materials.Droliver 15:34, 8 May 2006 (UTC)[reply]

As currently written the Brown,et al study is put out on some pedastal like it's the accepted view on fibromyalgia. It's not & in the past the related half dozen or so studies which all disagree have been serially removed by Molly as did a review article of which highlights the Brown study design flaws at length. The FDA's own take on this is "There have been reports of women with fibromyalgia following breast implants, and a preliminary study conducted by FDA found an association between self-reported fibromyalgia and extracapsular rupture diagnosed by MRI. However, this association has not been repeated in a similar study based on a large group of Danish women and the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants." 65.89.98.20 16:50, 6 May 2006 (UTC)[reply]

"Serially removed"? ROFL. Rob, you said this, nobody else did. I pointed out that we need to rewrite it, and never said that the 'other' view should not be stated. IN fact, I asked Dr. Laub if he would help edit, and he said he would. Hopefully he will soon. I trust him more than you to be NPOV. And that is based on my experience of you. The FDA still references the Brown study, and has not disputed its findings. The Danish study was conducted by IRG, which was funded by Dow Corning. It is another typical attempt by IRG and those like IRG to immediately dispute a negative study.molly bloom 17:13, 6 May 2006 (UTC). molly bloom 17:24, 6 May 2006 (UTC)[reply]

I am not the only one objecting to the table, Rob. You need to read the history of this discussion. The consensus is that the table is not appropriate.molly bloom 17:06, 6 May 2006 (UTC)[reply]

The FDA's own web-page on implants (quoted above) does in fact effectively put the Brown study into the context of not being consistant with other work. A 2004 review [ PMID 15156983] goes over these studies in detail & has an extended discussion on Dr. Brown's paper discussing percieved problems with the study (which I've copied for you below as I didn't think you'd have access to the full text), which along with mention of the other studies on fibromyalgia were repeatedly removed by you previously. This same criticism of Brown's study design has also been repeated in the discussion part of the Danish study by Holmich.

from Breast Implants and Fibromyalgia: A Review of the Epidemiologic Evidence Lipworth, et al. "In 2001, Brown et al reported a significant excess of self-reported fibromyalgia among women who had ruptured implants with extracapsular silicone migration (extracapsular rupture) diagnosed by magnetic resonance imaging (MRI; odds ratio 2.8; 95% CI 1.2 to 6.3). However, this elevated odds ratio cannot be meaningfully interpreted, since women with extracapsular silicone were compared with a combined group of women with intracapsular rupture and women with intact implants. There is no biologic or epidemiologic rationale for combining these groups, since women with intracapsular rupture had fibromyalgia rates substantially lower (8.0%) than women with intact implants (14.8%). Thus, the comparison of women with extracapsular rupture with this combined category of women is inappropriate and artifactually inflates the risk estimate for fibromyalgia associated with extracapsular rupture. If the analyses had been conducted appropriately, based on 3 separate categories of implant status (intact, intracapsular rupture, extracapsular rupture), the odds ratio for extracapsular rupture compared with intact implants would be 1.9 (95% CI 0.8 to 4.3), substantially lower than the 2.8 reported by the authors. Similarly, the odds ratio for intracapsular rupture compared with intact implants would be 0.5 (95% CI 0.2 to 1.2), which implies a protective effect of intracapsular rupture against fibromyalgia, an association which is not biologically consistent. Both rupture status and extracapsular silicone were ascertained by MRI, which has been shown to be highly accurate for identification of implant rupture but less so for the classification of rupture as extracapsular (Holmich et al, unpublished observations). Thus, it is likely that some of the women in the intracapsular rupture group actually had extracapsular silicone, and so the observation by Brown et al that the group with intracapsular rupture had the lowest rate of fibromyalgia, rather than a rate intermediate between that of the intact and the extracapsular rupture groups, argues strongly against a causal interpretation of the role of extracapsular silicone in the development of fibromyalgia. It is also noteworthy that even the rates of fibromyalgia reported among women with intact implants or intracapsular ruptures in the study by Brown et al are remarkably high compared with the estimated prevalence rate of 3.4% for US women and with similar or lower prevalence rates reported in many other countries, suggesting a biased selection of women in that study. Finally, the authors found no differences according to rupture status for several symptoms believed to be related to fibromyalgia, including joint symptoms and fatigue, nor could they ascertain if the self-reported fibromyalgia occurred before or after cosmetic breast implantation."Droliver 15:34, 8 May 2006 (UTC)[reply]

This deserves a good bit more attention as it's one of the things both the FDA & Surgeons are most concerned with improving. As mentioned above, educating patients & surgeons on proper device & technique selection has been shown by some authors to reduce this almost 80-90%65.89.98.20 16:50, 6 May 2006 (UTC)[reply]

This is not an educational article for surgeons, Rob. Why can't we just discuss the facts, and not conjecture or a few studies that you want to highlight?molly bloom 17:23, 6 May 2006 (UTC)[reply]

Molly, the facts are that local complications requiring reoperation (and reducing those rates) are what's being most elevated by the FDA in their concerns in recent hearings rather then systemic illness issues. I'm was simply proposing incorporating some of the concepts of this through various parts of the entry before adding them.Droliver 15:41, 8 May 2006 (UTC)[reply]

Ok, then why don't you discuss it here first. And, let's see what others think.molly bloom 04:32, 9 May 2006 (UTC)[reply]

Health Canada says that while some studies have shown a link between silicone implants and autoimmune illnesses, "there is no definite answer to this issue." This is quite different than your conclusion, Rob. Also, the person who wrote that about the silicone implants took it directly off the cited reference. I looked it up, and that is correct. So this was reverted back to what the original editor wrote, AGAIN.molly bloom 17:23, 6 May 2006 (UTC)[reply]

That was, I agree, an accurate quote....from several years ago. It does not reflect current operating conditions & practices which is why it was updated. The 2005 expert review was also accurately characterized as not identifying new issues associated with the devices warranting their removalDroliver 15:45, 8 May 2006 (UTC)[reply]

This is a quote from YOUR source: Recommendation The Panel felt that the questions regarding the potential health effects of any exposure to low molecular weight silicones had not been sufficiently addressed. The Panel recommends to Health Canada that the manufacturers must demonstrate that migrated silicone provides acceptable risks of hypersensitivity and autoimmunity by a critical review of company and literature data and, if necessary, by undertaking studies in animal models.

You misstated the findings. Besides, this is not pertinent to the topic here, which is the current status of regulation.

Furthermore, the facts as previously stated are still correct. You have no citation for anything that says that has changed. Indeed, the regulation has not changed. Here is another (recent) explanation of the same thing.http://www.canadaba.ca/cohesive_gel_implants.html

This is not a paragraph about the recommendations for further research. This is a paragraph about the regulation as it stands today. Your attempt to change this is dishonest, and factually incorrect. molly bloom 04:36, 9 May 2006 (UTC)[reply]

Molly, the panel was indeed accurately characterized. There were no findings that the panel felt warranted increasing restrictions on access to the devices which is all that was added. That report plus the current #'s for Canada give context to the impression that these devices were rarely used

The panel is not a regulatory body. The Canadian regulation is correctly stated. That is what this paragraph is about. Again, it stays.67.35.126.14 21:49, 15 May 2006 (UTC)[reply]

I added a link to a non-profit corporation, since a plastic surgeon's opinion was also linked to here. This provides an alternative view, with links to research.molly bloom 17:38, 6 May 2006 (UTC)[reply]

That "non-profit corporation" is one of the most militant political players in the debateDroliver 15:47, 8 May 2006 (UTC)[reply]

This non-profit corporation is well respected, with links to many studies. It NOT a political link, and is no more biased than the selective articles by plastic surgeons that you chose. On the board of directors of this non-profit are:

Dr. Pamela Gallin is Director of Pediatric Ophthalmology and Associate Professor of both Ophthalmology and Pediatrics at the Children’s Hospital of New York Presbyterian Medical Center, where she is on the faculty of the Columbia University College of Physicians and Surgeons. Dr. Gallin has an international clinical surgical practice. Amir Pasic, Ph.D. Amir Pasic is Director of Development and Manager of Special Projects at Johns Hopkins University's School of Advanced International Studies (SAIS) in Washington, DC. Arthur L. Caplan, Ph.D. Art Caplan is the Director of the Center for Bioethics, Chair of the Department of Medical Ethics, and Emmanuel and Robert Hart Professor of Bioethics at the University of Pennsylvania Medical Center. Dr. Zuckerman started her career as a psychologist on the faculty of Vassar College and then directed research on the impact of television on children as a faculty member at Yale University. After a post-doctoral fellowship in epidemiology at Yale Medical School, working on studies of depression, domestic violence, and the health of the elderly poor, she went to Harvard to direct the Seven College Study, a project designed to evaluate the life goals and self-concepts of undergraduates at seven liberal arts colleges. molly bloom 04:45, 9 May 2006 (UTC)[reply]

"It NOT a political link" You've got to be ignorant of 15 years worth of FDA panels, press releases, interviews, and lobbying to make that statement. Dr. Zuckerman is herself, the single most active political force working in the United States for banning silicone implants outright.

You are being insulting, again, Robbie. I am well aware of the controversy. It is incumbant on editors to present both sides, not just your favored side.67.35.126.14 21:50, 15 May 2006 (UTC)[reply]

There is no 'side' to this, the systemic reviews on this are what they are. While you may imagine some cabal involving the panels & health ministries of every nation, at the end of the day there has been 100% consistancy in the conclusions -> no evidence to support causal relationships but worth continued studyDroliver 02:59, 22 May 2006 (UTC)[reply]

There has not been 100% consistency. You only wish there were. There have been studies by the FDA and by others that do suggest there are systemic problems. I know there are, since my own history shows it to me - before and after explant. This is also consistent with peer reviewed studies that show women improve after explant - not just subjectively, but objectively as well. Moreover, when you pick and choose what you want out of a study, ignoring the warnings, you are providing slanted information. I have seen you do that, repeatedly. Finally, your comment about cabals is ludicrous. You can try to paint me as crazy all you want, but it won't fly. Sorry. MollyBloom 01:52, 24 May 2006 (UTC)[reply]

Molly, there is not one systemic review that I'm aware of that has ever implicated silicone in any systemic illness. NONE. These are from countries all over the world with physicians & scientests from all different backgrounds. Any discussion on alleged links to disease have to start with that to put this in context & this is especially true if we're to reflect the international perspective. That you've removed/avoided reference to the landmark IOM review while emphasizing small & largely non-reproduced research in this discussion makes this whole segment ridiculous. You're definately not crazy, (I've enjoyed some of your excellent work on dailykos) but you are wrong,wrong, & wrong on how you're attempting to frame this topic as a political campaighnDroliver 00:31, 25 May 2006 (UTC)[reply]

I have discussed some of the studies that suggest problems - from fibromyalgia to lung cancer. Also, there are studies that show increased autoantibodies and rheumatological symptoms. Some of the studies you want to cite have been notorious, and criticized for funding and selection bias. The fact is that there still is a contorversy, Oliver. Yes, we need to discuss the 'postiive' studies, but you want to simply say it is settled - and it is NOT. There are also peer reviewed studies that show women DO improve, after explant - not just subjetively but objectively. Doesn't that at all interest you, or are you simply oblivious to this? I know that I am merely an 'anecdote' but I know hundreds and hundreds of women like me, that had high (not borderline) ANA for years before explant, but by about 2 years after surgery, their blood tests are normal. Does this even make you the tiny bit curious? I could tell you how much better I feel, of course, but that could merely be 'self fulfilling prophecy'. So I'll stick with the objective tests. They are normal now. For 5 years prior to explant, they were not. And I have seen this over and over and over. The other plastic surgeon who came on here, Dr. Laub, who is also a medical professor, agrees with me that this seems to occur. He believes that the dangers will be proven, eventually. A number of plastic surgeons I have spoken with seem to feel similarly. Yes, I know that there are probably many like you - you believe they are safe and are not even going to entertain any evidence to the contrary. That is one of the biggest problems in this whole issue. Because women like me wait until they are very very sick to finally consider their implants might be a problem - I never considered it because I believed people like you. One idiot plastic surgeon told me that removing ruptured implants would not improve my health. He was dead wrong.. And doctors like him, and possibly like you, will end up harming women by your refusal to consider that there might be problems. MollyBloom 01:05, 26 May 2006 (UTC)[reply]

It's a simple challenge Molly: Please show one systemic review that has ever concluded a link b/w silicone and systemic disease Your conspiracy theories nonwithstanding, there is a widely agreed upon lack of evidence at this point to make the connection you take for granted. That's where the story begins.Droliver 02:46, 26 May 2006 (UTC)[reply]

When you can provide a citation that says this, Rob, we will include it. I do not think that you speak for 'most plastic surgeons'. Most plastic surgeons would be a little more circumspect and cautious than you are, in my experience.molly bloom 04:44, 9 May 2006 (UTC)[reply]

If you like, I can bury you references on this but it's really not neccessary.

Then why don't you provide one or two? That would be helpful67.35.126.14 18:32, 13 May 2006 (UTC)[reply]

The two links Rob keeps removing STAY. I would like to hear what others have to say about it. There is no harm in providing both sides, to this discussion, since there is controversy. Also, we should have links to more European information - I have added two that discuss recent EU Parliment decisions..67.35.126.14 18:32, 13 May 2006 (UTC)[reply]

These links STAY, Robbie. You said the IRG summarized the information I included. Could you please explain to us all how that can be, when the IRG publication is older than the links I provided? I would really appreciate it if you would try to be honest in your comments. Otherwise, this whole discussion is pointless.molly bloom 21:54, 15 May 2006 (UTC)[reply]

Once again, the LINKS STAY.molly bloom 21:55, 15 May 2006 (UTC)[reply]

Rob you need to stop deleting links. I will report your vandalism, if it continues. You are not discussing, you are merely deleting.molly bloom 22:32, 17 May 2006 (UTC)[reply]

Oliver, this stays as it was. The reference cited explains the regulation. That is ALL that this paragraph is about. The reference cited and the text ARE ACCURATE. It does not imply anything. IT is a statement of fact. That is still the regulation in Canada. IT STAYS. molly bloom 18:37, 13 May 2006 (UTC)[reply]

Molly, the context of this is important when you discuss Canada. It's important to show what the contemporary environment is there & as you'd like that paragraph to read that is unclearDroliver 18:46, 13 May 2006 (UTC)[reply]

No it is not. You didn't even cite anything for your comments. This is ONLY about regulation. This is FACTUAL about Canadian regulation as it exists now--this IS the contemporary REGULATORY environment. When and if it changes, then we can add the new regulation. Your comments are misleading and factually incorrect. THIS STAYS AS THE ORIGINAL EDITOR (NOT I) WROTE IT, unless or until a consensus of editors decide otherwise. This is not a paragraph about how many surgeries occur, but about the regulation. What is written is still the law of Canada. molly bloom 21:07, 13 May 2006 (UTC)[reply]

Read the article, Rob. Then you can see some of the studies -- the one that you dismiss out of hand. You are the conspiracy theorist, not I. You dismiss out of hand researchers and doctors whose results you don't like, by blaming it on plaintiff's lawyers. IN your opinion, the whole controversy was concocted by plaintiff's lawyers. That is paranoid. And it also conveniently ignores all the women who have had problems that DO NOT litigate. Yes there are studies. Studies that show that women do improve after explant - I cited that. Studies that show an increase in fibromyalgia, and that citation is also in the article. Also, studies showing an increase in lung cancer and an unsafe increase in platinum. You dismiss all of those. You dismiss my experience, and the experience of thousands of other women. You never answered my question. Do you not have any curiosity at all why women's health objectively improves after explant? No, I don't think you do, do you? This is your business, and you have every reason in the world do downplay the risks of breast implants.MollyBloom 00:26, 27 May 2006 (UTC)[reply]

1. Molly, please refer to the IOM,IRG, and other systemic review reports for summaries of the most detailed examinations of this topic

2. try googling tort-reform to find see the hundreds of hits you'll find discussing the abuse of class action lawsuits & silicone implants

3. review the literature on fibromyalgia & witness where the evidence almost exclusively points to & the FDA's position on their website

4. review the existing literature on platinum toxicty & the FDA's own position. This was also reviewed at the FDA & Canadian panels last year BTW. There is also a detailed paper in print this month [ PMID 16483647] examining the implausible platinum paper you're breathless over. Read it before you swallow some brand new claim of an undiscovered health hazzard on an area that has been studied extensively

5. the NCI researchers specifically dismissed the lung cancer issue in their recent press release. There is no plausible mechanism.

6 from surveying the literature, the effect of explantation has been decidedly mixed without clear-cut patterns of symptom improvement. As there are some psychiatric correlations to connective tissue disease and I do believe in mind-body origins of some disease,I don't find it implausible that when some women believe their implants are making them sick they'll feel subjectively (and perhaps objectively) better when you remove them.

xoxo RobDroliver 05:11, 28 May 2006 (UTC)[reply]

Tort Reform

An article on Breast implants is not really an appropriate forum to discuss the sham of tort reform. However, since you bring it up, apparantly you didn't google it enough. The vast majority of cases cited as litigation abuse are usually missing facts and details and are exagerations. As for those infamous verdicts:

Fred Baron, former president of ATLA, says of these infamous multimillion-dollar punitive damages, "I doubt that 10 have ever been paid out." They almost always get settled by the winning plaintiffs, who need a quick settlement to pay their bills and can't wait out the numerous appeals by the corporate defendant. Baron notes that studies show that the overall cost of punitive damages is down since the mid-1990s, despite reports of wild verdicts in "judicial hellhole states." In 2001, punitive damages were only awarded in about 6 percent of jury civil trials, according to the Bureau of Justice Statistics, and the average payout was $50,000.

6% really crys out for for tort reform- Not. The National Center for State Courts figures show tort ligitagion is down as is the median payout. As near as I can tell doctors do not feel any law suit ever is justified and as a consequence believe every cock and bull story sold to them by the insurance industry. The real problem with "tort reform" besides that it is a sham, is that it allows tortfeasors to escape personal responsibility for their actions. Plaintiff's lawyers have become the last resort for citizens due to the deregulation mania of conservatives in their effort to make government "so small they can drown it in a bath tub". They have eviscerated the health safety and welfare laws while decrying the so called nanny state. The net effect of this decades long effort,again is to allow malfeasors to escape personal responsiblity. Corporate profits uber alles.

I gather from reading your other comments that you have not swallowed hook line and sinker the sham crusade on inheritance tax. I only wish you would do a little more research on the sham of tort reform rather than swallow the industry line, just because you may be personally affected.

Finally, as it pertains to this discussion, your telling someone to google tort reform really doesn't constitute proof that illness resulting from breast implants is actually caused by plaintiff's lawyers. Post hoc ergo propter hoc, I believe. Nice try though.

gfwesq

A quick note on psychiatric correlations to breast implants and disease

Here in South Florida where implants are as common as roofs damaged by hurricanes, I know a few woman who have had breast implant problems, to suggest it is psychsomatic does not comport with what I can observe with my own eyes. They clearly were in deteriorating health before removal and they clearly have improved over time (1 to 2 years) with removal. If it were psychosomatic as you suggest, I doubt it would take 1 to 3 years before their health improves.

gfwesq

Rob, I have read those articles. I also know about the shortcomings of some of those studies.

As to your ridiculous assumption that health improvement is psychiatric...Do you suppose that a change in blood test results from very abnormal to normal is a psychiatric condition? Tell me, Rob, did I 'will' my body to no longer make antibodies as it did, repeatedly and consistently for 5 years? I was actually shocked when my last blood tests were normal. I didn't really believe that removing the implants would affect so many objective lab tests. But it did. I suppose that the many women who had similar experiences psyched themselves into normal blood tests, as well. I hope that there will be many more studies on health improvement - not just subjective, but objective improvement, as well - that cannot be merely psychosomatic.

"Tort reform" is a way for medical doctors to avoid accountability, at the expense of the public good. I can also google "medical malpractice" and find a ton on that. So what is your point? I am well aware of how much you and your buddies hate lawyers, Rob. Probably about as much as I detest plastic surgeons who remain willfully ignorant. You well illustrate what is WRONG with plastic surgeons whose minds are shut on this issue. You would be the one who would dismiss a woman's health complaint, telling her it is in her head...and undoubtedly you would not report it in the adjunct study since it deviates from your apriori belief. That is one of the huge problems with the adjunct study - oh yes, you are a part of that, aren't you? It was made a sham by PS who refused to follow the rules, and who dismissed women's concerns without reporting them. There is a "Murphy's Corollary" about that -- draw the graph, then plot the points. MollyBloom 19:30, 28 May 2006 (UTC)[reply]

Molly, the fact that you're personalizing your own medical history to be the norm is highlighting the problem we have here. Your own experience has entenched your view, while I defer to the consensus expertise of the international experts who have reviewed this area comprehensively. Anecdotes like yours are not how we study medical problems. That's what we use population or (ideally) prospective studies for & that's what we have ongoing in the core & adjunct studies. Those almost unanimously have not identified patterns of connective disease in patients with silicone implants. Observational medicine and case-reports are not invalid, but they are not particulary strong medical evidence when they consistantly fail to be reproduced by better studies.

Also, please do not take psychiatric (in the context I used it) to imply that I think women who believe their implants make them sick are crazy. I was inferring the possibility of a placebo effect because of the unpredictability of clinical response to explantation.Droliver 04:55, 29 May 2006 (UTC)[reply]

Again, you are wrong, Rob. The international experts to which you refer are NOT all in agreement. And even the studies you cited had comments of reservation, which you conveniently ignored. You can condescend all you like, but I find it interesting that you have zero curiosity in women who do seem to have problems from implants.

You know full well that I am not the only woman who has had this experience. The problem we have here is plastic surgeons with closed minds. Furthermore, as you are aware, other plastic surgeons who have visited here and weighed in, do not agree with your conclusions. THe fact is, there is a split, even among plastic surgeons, as to how safe these are.MollyBloom 15:04, 29 May 2006 (UTC)[reply]

The adjunct studies were a sham, and you know it. THe FDA knows it. Every woman who has later found out she was supposed to be a part of the study but wasn't, knows it.It was made a sham by PS who refused to follow the rules, and who dismissed women's concerns without reporting them. There is a "Murphy's Corollary" about that -- draw the graph, then plot the points. Furthermore, you do not need to lecture me on statistics. I daresay that my math background is considerably more than yours, so you need not explain to me the value of statistics. I also know the limitations, especially in circumstances like this. MollyBloom 15:22, 29 May 2006 (UTC)[reply]

Oh, and I will mention to my internist and rheumatologist that you think all my blood tests becoming normal after 5 years of being abnormal is a 'placebo' effect. I'm sure they will get quite a kick out of that one. That is almost as good as one PS's assistant who told a woman that her problems were probably because of the Taliban spiking pepsi. And no, I'm not kidding. MollyBloom 21:50, 30 May 2006 (UTC)[reply]

This is a quote from one of many many women who say the very same thing about their silicone implants : Do you know if there is anything I can do legally? I am outraged that I was never followed up on by M entor or my implanting PS. And when I called and told them I felt I was having problems with them I was ignored. If they really wanted to learn anything from a study not only do they need to follow up but they need to LISTEN to the people in the study. I personally think a class action may be in order.MollyBloom 12:24, 31 May 2006 (UTC)[reply]

It seems pretty clear to me the plastic surgeons and manufacturers do NOT want to learn anything.12:25, 31 May 2006 (UTC)