Talk:Breast implant/Archive 1

Archive 1

Archive 2

Archive 3

→

Archive 5

Ruptured Implant Photos

The photo shows an extracapsular rupture (black implants). These were removed less than two years ago, from a woman who was very ill. She and I had our implants removed around the same time. We both had (extracapsular) rupture for several years before we knew the implants were ruptured. I also was very sick, having been diagnosed with lupus, multiple sclerosis and Hashimoto's thyroiditis -- all autoimmune illnesses. My implants were yellow. Silicone implants are supposed to be clear, not black or yellow, as these were when removed. No legitimate doctor would suggest that contaminated implants like these would be 'safe' in the body.

The black implants shown in the photo were not double lumen. These were single lumen, but over 20 years old when removed. My implants, however, were double lumen. There was no saline left when they were removed. The silicone gel was yellow, and much of it was gone, presumably in my system. My guess is that mine were also ruptured for several years, because of the timing of a mammogram and when my symptoms appeared.

Also, it is not particularly benign that added antibiotics to saline implants causes them to turn black. Dr. Blais, a biochemist, says that sterilization is still a problem with saline (or double lumen) and sometimes the devices are filled during surgery and may be contaminated then. Another problem occurs with trying to resterilize implants that are reused or if physicians uses additives such as steroids, antibiotics, detergent solutions, etc. Believe it or not, some physicians have actually reused a "perfectly good implant" in another woman.The mixtures and drugs added to the saline may also cause problems as they degrade. Micro-organisms could feed off those nutrients. There are now numerous studies documenting mico-organism can and do grow in the saline while implants and in the capsules surrounding them. ~~MB

Rupture Information

Dr. Lu-Jean Feng published an article worth noting. Analysis of risk factors associated with rupture of silicone gel breast implants.

CITE: Plast Reconstr Surg 1999 Sep; 104 (4): 955-63

http://forums.delphiforums.com/explantation/messages?msg=1271.1 Jeena_el

Adjunct Study

I see that Dr. Zuckerman already corrected the plastic surgeon's erroneous reports of follow-up by Inamed and Mentor. Thank you! The FDA PMA reviewers determined this part of the adjunct study 'fatally flawed'. It seems that several styles of implants did NOT have even 10% follow-up. In addition to the three questions I mention below, it appears also that neither manufacturer answered the FDA's question regarding platinum. The more I learn of what really happened with the PMA, the more appalled I am that the FDA panel accepted either manufacturer's PMA. Indeed, Congress has also been investigating a possible conflict of interest of panel members, although I am unaware of the outcome (if there is one yet). ~~MB

I don't know where the statistics regarding the Adjunct study came from, but they are completely inaccurate. The statistics are difficult to find but they are all available on the FDA website, based on Inamed's and Mentor's own analysis. Here's the FDA website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=593

The letter below, which requests an investigation, provides a good summary of some of the problems with the data. ~~DZ

Excerpts from the letter are also consistent with the statements made to me by an epidemiologist who reviewed the questions asked of Inamed and Mentor, and the data submitted by them. That epidemologist stated that neither manufacturer could adequately answer the three questions:

 1.  What is the rate of rupture (as the surgeon here pointed out, there was inadequate data to model this)
 2.  What is the cause of rupture
 3.  What are the long term ramifications of rupture  ~~MB

Excerpts April 19, 2005

Background On April 13, the Advisory Panel voted to recommend that the FDA put Mentor Corporation'ssilicone gel breast implants back on the market with nine conditions, after rejecting Inamed’s application the day before. In the medical reviews prepared prior to the meeting, FDA scientific staff clearly stated that the applications from both companies had serious weaknesses, finding that the data in both applications was of limited value for responding to questions set out in the guidance for industry that the FDA issued in 2004.

Issues for Investigation Susan Bond, who is Director of Scientific Policy in the Office of the FDA Commissioner, circulated an email (see attachment) to Dr. Daniel Shultz, Director of the Center for Devices and Radiological Health, and to Acting Commissioner Crawford with an attached document, titled, "Backgrounder for Crawford's email explains that this document was written by an outsider who is interested in seeing us come out ok on the b.i [silicone breast implant] issue." Since the document is a biased summary of breast implant research that clearly advocates for FDA approval, this email implies the FDA had a pre-determined interest in approval even before the FDA advisory panel met. Sending a document from an unidentified outsider, rather than specifying the source of information on either the email or the document itself, is especially questionable. Who was the"outsider" who created this document? Did this "outsider", through Susan Bond, exert inappropriate influence over the agency to act in the interest of industry?

Given the clear assessment by FDA scientific staff that the companies had not yet collected adequate data to meet the standard set out in the draft guidance, why did the FDA convene the panel rather than simply informing the companies that the data were inadequate to support approval?

The Guidance Document regarding breast implant research, which was issued by the FDA in January 2004, requested platinum and other toxicology analysis on tissue samples. Neither company provided this. Did the FDA tell the manufacturers that they did not have to comply with that element of the guidance? Why wasn't an expert on platinum appointed to the Advisory Panel? What was the FDA's process for determining the members of the panel, and why did the agency issue a conflict of interest waiver that allowed the participation and vote of Dr. Michael Miller? Dr. Miller had a grant from one of the sponsors which he used to create a promotional/educational CD-ROM for the product he was being asked to evaluate. In the CD-ROM, Dr. Miller reassures patients that silicone breast implants are safe, creating a very clear intellectual conflict of interest, in addition to the financial conflict.

 Why were independent scientific experts inside and outside the FDA not invited to present their data? 

 Why were offers to present scientific information, made by several independent experts, rebuffed? 

 Why was FDA's own research on breast implant rupture, which includes the largest published sample of women with leaking silicone implants, 
 not provided to the panel or discussed in either the written reviews or oral presentations?

 Why did the FDA approve the design of Mentor's Core study, despite the fact that it eliminated the data from women whose implants 
 were removed and not replaced?
 The women who had their implants removed without replacement are among the most likely to have experienced rupture, complications, 
 symptoms from the devices.   These are the women who should have been a focus of the research, but Mentor systematically excluded 
 the data on those problems.   The rationale given, lack of consent to gather information from women whose implants were removed, 
 is inconsistent with accepted procedures   for clinical trials and  apparently inconsistent with the analysis conducted by the other implant maker.

 Why did the FDA accept Mentor's PMA for implant styles 4000 and 8000 even though these models were not included in the company's Core study, 
 the primary clinical data set for the PMA?
 Mentor provided some data on Style 4000 from its Adjunct study, but FDA's PMA reviewers pointed out that the Adjunct study was fundamentally flawed 
 because it  lost 90% of its patients in follow-up. 

Furthermore, they pointed out that the Adjunct study's data are of no value in determining the rupture rate due to the absence of an MRI cohort. Style 8000 was not examined in either the Core or the Adjunct studies. In essence, there was no reliable data for 4 of the 6 implant models the Panel recommended for approval.

Now that the Panel has issued this split decision, it is up to the FDA to decide whether to follow the panel recommendations. It is essential that an investigation take place as quickly as possible, so that these questions can be answered before the FDA issues a final decision on the applications from Mentor and Inamed, which is expected in the coming weeks. We would like to meet with you to provide additional background and documentation to support our request for an oversight investigation.

Michelle Nawar will call to follow-up on this request or you can reach her at 202-223-4000 for more information.

Sincerely, Command Trust Network In the Know Our Bodies Ourselves National Organization for Women National Research Center for Women & Families National Women's Health Network

Re: Risks & Controvery

Dear PS,

Despite your political view on the appropriateness of silicone gel, the fact is there is MUCH ongoing debate among epidimiologist and physicians on this topic. For all practical purposes given the recent recomendations for FDA approval with severe restrictions and the fact that the FDA has delayed approval, it is not "settled".

What doctors have you been talking to? Plastic Surgeons? Even some of them know the dangers of silicone rupture -- especially the ones that remove implants and see the shape many of them are in. My implants were grossly ruptured and yellow. My dear friend's silicone implants were black with fungus and mold. That happens with saline implants, too, that have a faulty valve. As the weeks wore on before my 'explant', I grew sicker and sicker, until I was having hives that went into anaphlactic shock. I have been diagnosed with lupus, MS, Hashimoto's thyroiditis and fibromyalgia. I could not walk across my living room before my explant. Now I am walking and able to work part time. I know that my ruptured silicone implants nearly killed me.

I spoke to an epidemiologist the other day about this, who is very concerned about the inadequate tests submitted to the FDA by Mentor and Inamed on rupture rates. Many epidemiologists ARE concerned. More and more doctors are concerned. This may not be true in your profession (let me guess, plastic surgery). EVEN THE FDA SAYS IT IS UNSETTLED. Are you going to call the FDA not 'mainstream'? This issue is far from settled.

"The overwhelming data clearly supports the efficacy and safety of these devices and they have recieved more scrutiny then any other device ever presented to the FDA. " I have heard that line over and over verbatum and it is as untrue this time as the 578 other times I have heard it. You and your buddies need to change your sentences once in awhile. The FDA stated that only ONE study had been done - in 50 years or more - on the effects of rupture. That tells me the studies that were previously done were problematic. Indeed, the FDA pointed out some of the problems with earlier studies. In fact, my neurologist, who received his MD at Northwestern Univ. and did his residency at Mayo, told me about the gross problems with the Mayo study. He also pointed out how heavily funded it was by the manufacturers. He does not believe the results of those earlier studies, because of their now infamous shortcomings. These are the studies unscrupulous PS hype to 'prove' their point. I

The Dow settlement was NOT American class-action lawsuit abuse 101. Asbestos is not the same as silicosis, by the way, in case you didn't know. So before you go mixing all tort actions you need to find out what the hell you are talking about. You probably think asbestos is safe, too, I bet. I'm sure this was discussed in the WSJ editorial and right-wing think tanks. According to some, all lawyers are bad and all litigation is bad. Without litigation, more people would be dying from asbestos.

Your tone that you try to highlight the entire article is biased towards the safety of implants, when in fact, this has not been determined. God knows it should have been, in the decades there could have been accurate, independent studies. Sadly, many of the studies were like the tobacco research institute studies -- all guaranteed to show that smoking is not dangerous. We now know how patently bogus those 'studies' were.

images

Is it necessary to have 4 copies of the picture? Vroman 03:14 12 Jun 2003 (UTC)

these are 4 different images of 2 different proceedures, not the same thing. However, we can pick an choose. If the article were longer, it wouldn't look so bad. MB 03:38 12 Jun 2003 (UTC)

You should provide captions if they really are different. They look like 2 copies each of a monochrome and color version of the exact same thing.Vroman 07:40 12 Jun 2003 (UTC) Why are the only two images on this page showing surgery that has gone wrong? surely there should be images showing good surgery as well?

Because those were public domain images from the FDA. Do they have any public domain images of surgery that worked okay? - David Gerard 12:05, 22 Jul 2004 (UTC)

I'm sure some sex-related site has such pictures and would be delighted to supply some... anyone wants to investigate further? (RNBC)

I guess I can't see so well at my age...what's wrong with the second picture? Are the nipples different sizes?--Feitclub 02:21, Nov 18, 2004 (UTC)

No, the breasts are different sizes and shapes. The left implant deflated and the saline solution was absorbed in the body. NTK 19:38, 9 Apr 2005 (UTC)

Celebs with breast implants

I've removed this list, because it doesn't seem encyclopedic, and is just barely relevant to this article. If someone is truly burning to put this information in Wikipedia, something like List of celebrities with breast implants, with only verified cases, would seem more appropriate. —tregoweth 04:25, Apr 12, 2005 (UTC)

Images of Properly Performed Breast Implants

This article needed a picture, as described in talk long ago, of why hundreds of thousands of women pay many thousands of dollars and undergo a month or more of pain to achieve. The most notable celebrity who received them is Jordan and it was a good picture that demonstrated the perceived benefits without being too revealing. Medical pictures absolutely do not accomplish this goal. --Noitall 14:42, August 24, 2005 (UTC)

May I ask where you got the pic from and by which nature it is under "fairuse"? --Kim Nevelsteen 15:19, 24 August 2005 (UTC)

Also, if the article or caption stated something to that effect there would be some kind of motive for it being here. Plus, even if you changed the caption. Where is the source that states Jordan as being the most notable with verifiably fake breasts? --Kim Nevelsteen 15:24, 24 August 2005 (UTC)

K.Nevelsteen's caption is fine with me. Jordan is not necessarily the most notable, but she is up there. Arguably Pamela Anderson might be higher. They have both discussed them, and Jordan was booted of the Page 3 because of them. --Noitall 21:08, August 24, 2005 (UTC)

But you still don't specify a source and that is a problem.--Kim Nevelsteen 01:24, 25 August 2005 (UTC)

It is only a problem since I met you half way and agreed to your caption, but your real purpose is to delete. You know, agreement and niceties just do not work when people have a one-track mind. Your assertion as to copyrights is incorrect. Further, this is not the page for discussion nor is it proper procedure. This page is a breast implant page. --Noitall 01:41, August 25, 2005 (UTC)

No, actually I am rather impartial since you agreed to the caption change. I think the image works. But when you make a statement, "...of why hundreds of thousands of women pay many thousands of dollars and undergo a month or more of pain to achieve. The most notable celebrity who received them is Jordan...", then I would expect a source. most notable by whom? Who says it is the reason why, maybe women are a rare sort of breed and just like the pain. A source would clarify these things. --Kim Nevelsteen 01:47, 25 August 2005 (UTC)

On notability, I was not trying to insert an edit to make that assertion, because the most notable would be a matter for debate, probably with Google searches or pics in mags or something. It is also somewhat irrelant as long is the subject is quite notable, it is not necessary to be the most notable. Your question deals with psychology of breast implants, which is where we started in a round about way. I suppose more could be written in the article about it, dealing with self image, the low fat fitness phenomenon, celebrities, the right proportions and what not, advertising, push-up bras, etc. It seems like a big job. --Noitall 01:59, August 25, 2005 (UTC)

Indeed maybe a start of a new section.--Kim Nevelsteen 02:06, 25 August 2005 (UTC)

about Breast Implants or Breast Implants available in the US?

Is this article about Breast Implants or Breast Implants available in the US? The section of different types of Breast Implants is heavily biased to the US. After every paragraph it states ... "not currently available in the US". This isn't the Wiki-way. --None-of-the-Above 14:41, 10 October 2005 (UTC)

I agree. I changed some of it. I think there should be a bit of a bias towards the US. It can be argued that breast implants are an "American thing". Whatever that means? --Janto 21:37, 20 October 2005 (UTC)

I've heard that Brazil, not the United States, has the highest cosmetic surgery rate per capita - I'd guess a lot of these are implants. (I can't find a source, but I've heard this more than once, so I'm reasonably confident...) — stillnotelf has a talk page 23:46, 28 October 2005 (UTC)

radiography

I know from a releative who works in a breast cancer unit that impalsnts make mamography harder. Does anyone know the X-ray absroption coeffients for human breast tissue and for silicone. It would be interesting to see the data for these. Normally mamography is done with Mo-K x-rays so I know what wavelength to use for the calculations. If anyone has the data please then get in touch via cadmium's talk page .Cadmium 18:03, 7 November 2005 (UTC). Cadmium has added a reference to a paper written which I have found, it confirms what my relative told me about silicone implants and radiography.Cadmium 22:17, 7 November 2005 (UTC)

Mammograms can also rupture implants (especially old implants). MB

sub muscular

Why are some implants submuscular? (please answer by editing article) --Gbleem 21:19, 25 December 2005 (UTC)

I believe that submuscular implants are less likely to rupture (I am not sure on this). However, it is my understanding that submuscular implants have reportedly posed problems like 'double bubble' appearance. Also, many plastic surgeons say that it is more difficult to remove implants (and the capsules or scar tissue) that are submuscular,

statistics

The article says "In 2002, 236,888 women in the U.S. underwent breast augmentation." Unfortunately, the link is broken. Is this really correct? Since there are about 2,000,000 women per year, and I assume implants are done once in a lifetime, this would mean 12% of all women underwent augmentation. Seems a lot to me, given that it's controversial. Common Man 15:57, 27 December 2005 (UTC)

Implants are inserted more than once in a liftime. Implants do not last a lifetime. Furthermore, there are often complications. I have known women who have had 3, 4, even 7 or 8 surgeries. It is also possible those figures are as accurate as the old 'studies' supporting the safety of silicone breast implants. The prevalence of breast implant surgery is a travesty, in my opinion. MB

I revised the statistics today (3/26/06) to update to 2005. However, they also include men (although presumably the vast majority are women and teenagers). Many of the women have had implants removed and replaced, which is one of the reasons why the number increases every year. The American Society of Plastic Surgeons does not specify how many are first time customers. DZ

famous breast 'implantees'

instead of the removed 'list of celebrities with breast implants', how about a section in this article on celebrities who are in some way linked with breast implants; i.e. they are famous for having them. Jordan (katie price/katie andre), pamela anderson, etc.

Pamela Anderson had implants removed.

String implants

Is there any information as to why these implants were banned? Or when they will be comming back?

Could someone post some info about string implants and how they are different from the other types?

String breast implants, or polypropylene implants, were developed by Dr. Gerald W. Johnson and designed to yield extreme, almost cartoonish breast sizes. The polypropylene in string breast implants absorbs fluids and expands once implanted into the breast. The result is almost continuous breast growth after surgery. Despite the apparent danger and frequent complications, this type of breast implant was popular among adult entertainers. String implants were only available for a very short time before being pulled off the shelves by the FDA several years ago.

My understanding was that the health concern centered on that the body forms connective tissue through the mass of polypropylene string. Essentially, they become very difficult to remove without resorting to complete mastectomy.

Hanging implants

Is there a type of augmentation mammoplasty that tries to simulate the realistic or natural look of large breasts, i.e. a shape that hangs, as opposed to being all completely spherical and artificial-looking.--Sonjaaa 19:56, 16 March 2006 (UTC)

Silicone breast implants that are ruptured somtimes 'hang'.

By and large, patients do not want ptotic (hanging) breasts they usually want an unaturally full upper-pole (the wonder bra look) that doesn't exist naturally. Large implants however do accomplish that as they stretch the lower pole tissue over time. Anatomic implants have a tapered appearence that have more tissue on the bottom, but have been somewhat problematic in practice. The newest high-cohesive form stable gels (which are anatomic) address this most effectively. Droliver 14:15, 25 March 2006 (UTC)

Runaway Tort System?

As long as you citing studies Doctor, it might interest you to know that virtually every study on the subject shows that the rise in medical premiums has more to do with economic cycles and the competitive nature of the insurance industry than runaway juries.

Putting it in layman's terms, when the economy goes south, the insurance companies start raising premiums to help cover the losses from their investments. They then take advantage of the gullibility of some doctors by telling them it's all the lawyers fault. What's truly amazing is that doctors, normally intelligent and well educated, swallow the buncome whole.

Insurance companies profits are not from collecting premiums; its from investing those premiums.

re.

While I'm no fan of insurance companies, that is not an accurate statement. Most insurance co. investments are diversified enough that there is little fluctuation in investment income from routine economic cycles. What does change rapidly and unpredictably are med-mal claim payouts.

It's pretty simple to watch this in play in real life as you can compare the premiums in states with favorable tort-reform (Indiana, California) to their neighbors which don't. Droliver 14:20, 25 March 2006 (UTC)

Data Doesn't Support Plastic Surgeon's Contention

Diversification does not necessarily protect investments in a crash. From the NY Times:

Lawsuits against doctors are just one of several factors that have driven up the cost of malpractice insurance, specialists say. Lately, the more important factors appear to be the declining investment earnings of insurance companies and the changing nature of competition in the industry.

The recent spike in premiums - which is now showing signs of steadying - says more about the insurance business than it does about the judicial system.

"You get these jolts in insurance prices periodically, and they attract a lot of attention," said Frank A. Sloan, a Duke University economist who has been following medical malpractice trends for nearly 20 years. "They're a result of a confluence of many things."

Data compiled by both the federal government and by insurance organizations show costs for the insurance companies climbing steadily over the last decade at an average annual rate of about 3 percent, after adjusting for inflation. Over most of that period, premiums for doctors rose modestly and sometimes even dropped as the insurance companies battled for market share in a scramble to collect more money to invest in strong bond and stock markets. But when the markets turned sour and the reserves of insurers shriveled, companies began to double and triple the costs for doctors. (emphasis added)

If you look at the handy dandy chart with the NY Times article, what you see is premiums increased dramatically in the mid-80s, flattened, and then went up again starting around 2000.

As I recall, the commercial real estate industry tanked in the mid to late 80’s as did the real estate market as a whole by 1990. I also recall a stock market crash on October 19, 1987 . The stock market also tanked between 2000-2002.

Just a coincidence that premiums rise when investment profits fall?

The policy journal, Health Affairs using data from the National Practitioner Data Bank to study the growth of physician malpractice payments found:

The average payment grew 52 percent between 1991 and 2003 (4 percent per year) and now exceeds $12 per capita each year. These increases are consistent with increases in the cost of health care.

If I were I medical doctor I wouldn’t be too happy with the insurance industry either as the conclusion from this report commissioned by the Center for Justice & Democracy demonstrates:

The Annual Statement data for 2004 indicate that many of the leading malpractice insurers have increased their premiums substantially while (1) their actual claims payments decreased, (2) they reduced the amount they projected they would pay out in the future, and (3) their surplus increased substantially. Doctors are therefore paying more for malpractice coverage than either actual payments in malpractice cases or estimated future payments in malpractice cases would justify. (emphasis added).

I think this vindicates my original postulate that medical malpractice premiums have more to do with insurance industry investment losses and that the insurance industry is abusing doctors by using lawyers and lawsuits as a whipping boy. I understand the motivations of both. With the insurance industry its just plain old capitalism to do what you can to increase profits and reduce losses regardless of the veracity of the insurance companies assertions. And nobody likes to be sued, so I understand the doctors' misguided motivation to believe what the insurance industry tells them.

IOM v. the 2001 Study

It does not appear that the plastic surgeon disputes the fact the FDA said the 2001 study is the only study on long term effect of rupture. Rather he rejects it as inferior to the IOM study. This is poor logic. The doctor is basically correct that the two are not equivalent, but not for the reasons the doctor suggests.

Since the 2001 study is the only study on long term effect of rupture, then by definition the IOM study cannot be compared to it. Apples to apples, oranges to oranges, not apples to oranges.

BTW I was not aware that being a plastic surgeon was the same as being a specialist in disease or causation of disease. I would have thought the two were separate fields of study and that an expert in one was not necessarily an expert in the other. Relying on the expertise of a plastic surgeon on issues of causation of disease appears to be a misguided appeal to authority. While we are on the subject, what diseases cause a need for plastic surgery? Phyiscal deformity and scarring from injuries may require the services of a good plastic surgeon to correct, but these are not diseases.

-- Please note that the iOM report was NOT a study. It is a summary of research published before 1999. All IOM reports are a snapshot in time. As more data are published, the conclusions necessarily change. For example, the first several reports of the National Academy of Sciences and the IOM concluded that there was "no evidence" that Agent Orange or dioxin caused health problems. As more data were collected, later reports concluded that Agent Orange and dioxin caused cancer and other diseases. --Diana Zuckerman, PhD

Mainstream veer and veneer

I thought you were a plastic surgeon. That explains why you have edited this prolifically, to demonize lawyers and praise breast implants. The adjunct study is most interesting to me, since I have talked to many women who participated -- or were supposed to have participated. Reports of plastic surgeons dismissing women's complaints of joint pain, or other possible systemic illness are rampant. One woman told me, "My surgeon just told me that silicone implants don't cause these problems, so he would not report it." I wonder how often this has occurred. Other women stated that they never received paperwork for the study. I am compiling a list of how often this occurred. To date, it seems all too frequent.

I must say that you are correct when you suggest that I am suspicious of doctors. I am particularly suspicious of plastic surgeons who benefit financially by the approval of silicone implants. I have about as much respect for most plastic surgeons as you evidently have for attorneys.

The FDA stated that the 2001 study was the only study that addressed the long term effects of rupture. That is significant, regardless of how many studies existed prior to this. Morever, some of the studies the IOM used have been attacked for various reasons -- like the Mayo Clinic was a defendant in a related lawsuit at the time of the study. The neuologist who pointed that out to me did his neurological residency at Mayo. It seems he was correct. Other concerns include removing women who explanted from the study. Furthermore, as you yourself point out, migration of silicone is a concern.

I am thankful you left off the attorney-bashing. I am sure you relish the idea of tort reform. I believe that people should have access to the courts, and when harmed, should have a recourse commensurate with their injury. Furthermore, our tort system does NOT encourage graft & fraud. The federal rules of civil procedure contains a provision for sanction of not just lawyers but law firms for filing a frivolous lawsuit. My guess, however, is that you think most, if not all, lawsuits are frivolous. That is a philosophy, not a reality.

I believe time will 'vindicate' the women who have been harmed by silicone implants. I hope to God there will be some further independent studies in the effects of migrating silicone. I have absolutely no doubt that ruptured silicone implants harmed me. You may call me an 'anecdote' as those in your profession enjoy doing, but I know my body and know what happened. My health was going downhill at breakneck speed before explant. After explant, it has improved. I am not suggesting that policy be guided by anecdotes. I am suggesting that hundreds of thousands of women are not 'anecdotes'.

My editing has been in large part to steer this topic back to what I feel is the neutral and mainstream view rather then a controversial assualt on silicone. Ironically I've enjoyed some of the give and take in editing this and I think the evolution of the entry has become better then we started. Gradually I think we've come to a more balanced view with some of the concerns, but they still should be put in the more limited context of dissent to what is prevailing information.

When I first saw this article, it looked like an advertisement for breast implants. That is hardly neutral - especially when the subject allegedly addressed the risk & controversy. To read the initial article, one would think that everything was settled that implants are completely safe. That is simply untrue.

Your concerns re. self-reporting symptoms(or lack thereof) with the adjunct is valid, but in the context of thousands of participants it likely affect the data very little. Keep in mind that self-reported symptoms is one of the criticims on studies both pro & con.

My concerns about the adjunct study related to the lack of reporting by plastic surgeons, not self-reporting by the women. If you read what I said, women in the adjunct study are often told by their surgeons that their health complaints are not caused by implants. This is what the study is allegedly designed to find out. When apriori beliefs by surgeons intrude on this process, then something is wrong with the process.

BTW I love my attorney! However, what many would call tort abuse was a large player in the Dow settlement & a number of other class-action med-mal cases. Droliver 05:41, 24 March 2006 (UTC)

Glad you love your attorney. The question of 'tort abuse' is also a matter of debate. What "many would call" is a variation on the "some people say" which is a straw man argument hear often in the news of late. Who are these many? The society of plastic surgeons and implant manufacturers? In contrast, many women can tell you that they were subjected to abuse by the manufacturers in this process. The Daubert rule was used by manufacturers to disqualify experts I believe should not have been disqualified. Many of these had bona fide scientific qualifications but their opinion deviated from the 'mainstream'. But that is an entirely different debate.

Furthermore, the DOW settlement was not a med-mal case. It was a products liability case. But on the subject that I know is dear to your heart - med mal -- we disagree here too.

Litigating a med mal case is very expensive. Most lawyers won't want to touch one unless they feel it has merit. In many states, a doctor must certify the case is not frivolous. Further, there are federal (and state) rules of civil procedure to sanction lawyers and law firms for bringing frivolous cases. Someone below addressed the issue of med mal insurance. The number of legitimate cases of medical malpractice has been well publicized in recent years. I have seen more than a few examples of that. And as I said before, if "many" doctors would worry half as much about their patients as they do litigation, there would be far fewer med mal cases.

First of all, please add comments in an orderly manner, with section breaks, indented responses, signatures (simply type four tildes ~~~~) and common conventions of the like. As for povs, notable criticisms and controversies need to be accorded reasonable inclusion, as mandated by npov prescriptions. Simply whitewashing an article of contrarian content is just as objectionable, and contrary to the spirit of npov, as any alleged hijacking of an article by dissenters from mainstream pov. That said, covering alternative perspectives on medical articles is essential and necessary, as majority opinion is often dead wrong, e.g., Galileo. Given that breast augmentation literally has so much to do with aesthetic and cosmetic appearances, this particular article is somewhat symbolic of the politically correct posturing that has grossly undermined scientific analysis of an increasing number of medical issues. Typically, medical articles within the Wiki tend to attract a great deal of attention from editors anxious to delete content that questions the authoritative views of high ranking figures in the medical field. To a point, that is all well and good, as give and take can and should be considered an indicator of a robust debate. On the other hand, there are many examples of medical articles, hijacked by deletionists, that can only be described as beset by arrested development, due to heavy handed attempts to marginalize legitimate concerns about clear and present dangers denied or ignored by the defenders of medical orthodoxy. As organizations grow, the spam of orthodox disinformation, in a process related to stovepiping (retrieval of information from unconnected databases; the situation that exists when it is necessary to climb out of one database in order to climb down into another; sometimes used for protection against wandering hackers [1]), tends to drown out reasonable expressions of concern. The phenomenon has also been observed among other primates.[2] The Wiki's npov guidelines seem to be designed deliberately to avoid this problem, and should serve to ensure that the overall gaze of articles is not limited to simplistic expert worship. Ombudsman 07:33, 24 March 2006 (UTC)

Thank you, Ombud. I agree that the 'dissenting' view (?!) should also be represented, not just the 'mainstream' - especially when the subject is as controversial and important as this one. Expert worship has long been a problem, and I think the monkey parallel is most appropriate.

I told my internist that the difference between lawyers and doctors is that lawyers get purple tassels because they think they are royalty. Doctors, on the other hand, think they are God.

She did laugh at that one. Fortunately, she has known me a long time, and she has a sense of humor.

On another note, it is taking me a little while to figure out the conventions here. I don't do a lot of blogging, so had to figure out the HTML codes and protocol. My apologies for messy formatting.

Deletions & whitewashing

Plastic surgeons do have a financial interest in seeing silicone implants approved. The editing of this article has been anything but neutral.

As an example: Someone edited the article, again, removing my quote from Dr. Frank Vasey. I added it back in, since Dr. Vasey has spent many years researching silicone implants and treating women who have had them. I am well aware that many plastic surgeons do not like him or his position, but that does not change the fact that his opinion is relevant to this discussion.

Further, the person (presumably the plastic surgeon) who discussed the UK blue ribbon panel misrepresented the findings, by not telling the whole story. I changed that, as well, quoting the article itself. In another area, that person deleted a remark about the history of implants, specifically the sentence about the women who died from silicone injections. I reintroduced that, as well, along a link to the article from which it came.

This 'neutral' editing does a disservice to any article about silicone breast implants and the women who are interested in these issues. It is anything but 'neutral'. When I find out how to introduce photos, I am going to add a photo of silicone implants removed about two years ago in Florida. They are black. I think women need to see this, as well as the plethora of information about how 'new and innovative' these implants are. I spoke with a woman this morning who had the newest style of silicone implants removed, after just two years. She started having problems very shortly after her implantation. These problems include fatigue, joint pain and other 'symptoms' often ridiculed as irrelevant by plastic surgeons.

Plastic Surgeon's Reply and Response

What gets edited is your distortions of what the mainstream opinion is on this subject. Referencing a study cited by the FDA on the potential connection to fibromyalgia is proper, aggressive editing to portray widespread dissent which doesn't exist is not. This is an entry on breast implants and not the sounding board for your personal grievence with the medical establishment who has found many of the contentions you believe to not be supported by the data. The way the issues on silicone gel should be presented should be to summarize the major studies (which are favorable), highlight (but not dramatize) some of the concerns, and discuss the importance of the adjunct study which is continually answering these questions.

I will continue editing to show what you call the 'dissenting' view. Your editing is NOT neutral. You misrepresented the UK study. That was patently dishonest.

Also, why did you delete (AGAIN) the history I added, which included a reference? It IS true that women died of silicone injections. Do you just want to edit history as well?

Dr. Vasey's view is not representative of the position of his own professional organization and is not the mainstream position. Create a wikipedia entry on him if you feel like he needs the platform, but he doesn't belong in a neutral POV entry on breast implants Droliver 04:06, 25 March 2006 (UTC)

Dissenting views should be included. You do not want to do that, but I will continue editing to include them. We can have this war as long as you want, but I won't give up. You must have a lot of free time on your hands, to do this? Or are you using Wikopedia to advertise your wares? I suspect the latter.

I will continue editing as long as you mistrepresent studies, which you are doing. You deleted what I wrote QUOTING the UK study which you yourself included. You misrepresented that study.

The mainstream viewpoint is heavily burdened, and thus quite dubious, due to often obscene conflict of interest problems in the medical field, problems that have escalated in direct relation to the growing disparities in wealth and political clout between corporations and mere carbon based life forms. Silicon is hardly conducive to the well being of the latter; pharmaceutical and medical corporations have demonstrated over and over again that their collective immune response --to anything or anyone that might question the often unscrupulous practices leading to the corpulence of their bottom lines-- is profoundly dysfunctional. The fact is, science has taken a back seat to the abusive character assassinations and other cosmetic marketing ploys of many sectors of the medical industry. If you want to trot out painted ladies and choir boys to drown the article in accord with the marketing paradigm that has transformed many medical journals into pimping parodies strewn with little more than propaganda, then the marginalization of an apparently concerned and dedicated whistleblower would make some sense. Otherwise, it would be best to ascertain the credibility of such critics and present a factual account of such concerns in a manner that will allow readers to make a well informed decision about which is more credible. Given that most medical professionals are now specialists, apparently because they are attracted to the greater monetary rewards that go along with specialization, they tend not to understand much about systems biology, much less immune systems (which, surprise, surprise, don't seem too fond of copious amounts of silicon leaking from foreign objects). To tell the truth, dissenting opinions rarely attain high status in rigidly hierarchical corporate cultures like the medical industry, so the argument that this particular whistleblower is not widely recognized basically goes without saying, and is a moot point, but the issue of rankism can be discussed elsewhere. What is important here are the widespread reports of adverse immune responses, which the chronic fatigue syndrome, autism epidemic, and Gulf War syndrome controversies have already demonstrated to be poorly understood by most medical professionals. This is most likely the case with cosmetic surgery specialists as well. So, please don't shoot the messenger, in keeping with the spirit of NPOV. Surely, there are plenty of other messengers, addressing issues like how fibromyalgia is virtually certain to result from silicon leakage, if this one is seriously lacking in credibility. They couldn't all have been silenced yet. Ombudsman 05:31, 25 March 2006 (UTC)

Plastic Surgeon to Ombudsman

I'm sorry but you don't get to replace your suspicions about the medical establishment in a NPOV on this topic. The most and most recent data does not support your or JGlaws view. That is how it should be presented. In a review of this topic putting in a controversial person like Dr. Vasey is not appropriate other then possible as a reference.

Dr. Vasey's discussion is most appropriate. The Ombudsman is the Ombudsman of this site, not you. Go put up your own site on Breast Implants, and advertise there. If you want to advertise on your own site, I would also suggest some spelling lessons. 65.89.98.20 16:00, 25 March 2006 (UTC)

You are not the final arbiter of what 'should' be represented on Wikopedia.

Please note, the Wiki does not have an official ombudsman. The open source format, along with user advocates and the like, provides more than an adequate range of options to ensure viewpoints are at least heard and considered. Ombudsman institutions typically only arise when there is an unduly authoritarian organizational culture, and/or a decided lack of administrative transparancy. NPOV dictates that noteworthy criticisms and concerns must be covered. Period. That is one of the underlying beauties of the Wiki. Ombudsman 17:20, 25 March 2006 (UTC)

Ombudsman is a misleading name which has been remarked on previously. Midgley 02:07, 26 March 2006 (UTC)

Plastic Surgeon & Bias

It doesn't seem to me that the plastic surgeon is the arbiter of this Wikopedia entry. I do appreciate the plastic surgeon acknowledging that his original entry was biased and looked like an advertisement and bashing of litigation.

re

The previous comments by the Ombudsman are disturbing in that it basically dismisses the best data we have in place of his personal bias. To refelct an accurate view of this topic you don't get to dismiss the relavent literture & fire wild conflict of interest charges against medicine on every single review article on this topic. JGLAW's editing is confusing the topic rather then clarifying

My review includes both sides - the claims you want to highlight as well as other claims. You even wanted to edit the history to exclude deaths from silicone injections. That was very telling. 65.89.98.20 16:33, 25 March 2006 (UTC)

This entry isn't an article about silicone injections (which the NYT article is) which is why the reference is not really relavent in this discussion. I think you & I (and most doctors)can agree that that practice is bad. The fact that some dermatologists are talking about resuming the practice as a wrinkle has brought a lot of criticism from Plastic Surgeons

It most certainly is relevant, when silicone injections and their effects were reported as part of the history. You selectively included only those effects you felt were palatable to the discussion. That is dishonest.

:::effects related to the discussion are included which are largly localized. I treat these occassionally. The article in the NYT is not about implants or breast injections of silicone Actually it is. Please accept my apology if I make you feel as if both sides aren't being presented. It's just the context of the dissent is important. There just really isn't equal weight when you survery the literature on this. A fair summary includes concern re. silicone and connective tissue diseases, it just shouldn't be dominated by it. I think a seperate header in the passage (which I've tried to add but you remove) about the dissent, the activist groups, and the competing literature is more appropriate then trying to frame what are largely favorable summaries of the major studies as something that they are not.

I accept your apology. A fair summary in "Systemic Illness" includes concern about silicone v. connective tissue disease, fibromyalgia and other problems. The FDA stated that there was only one long term study on rupture, and that is not enough. If there were multiple long term rutpure studies from 10-20 years that were consistent, then there might be a problem. You keep calling it 'dissent' as if it were a court opinion. There are still conflicting studies. There are still different voices that express concern. The FDA has still not approved silicone implants - maybe they will (especially with this administration that places consumer protection far down on the list of priorities.) Therefore, there is no need to have a "majority" opinion and a "dissenting" opinion. This is a general discussion.

I also have included all the sites and studies you referenced, in an overall context of the discussion. The title of the section is "risk and controversy" so it is totally appropriate.

If you look at the FDA site, for example, the overriding discussion is how there still are not sufficient long term studies. There are problems with previous studies that are now notorious. For example, the Mayo study was both funded by DOW and done at a time when Mayo was a defendant in a relevant lawsuit. My neurologist, who did his residency at the Mayo clinic, first pointed this out to me.

Can we just come to some detente? Droliver 65.89.98.20 17:15, 25 March 2006 (UTC)

The cause of autoimmune disorders is still not well understood. Plastic surgeons certainly do not have an understanding of these disorders, since that is not their field of expertise.

As long as you continue to represent one side, I doubt that we can come to 'detente'. I have included all of the studies that you raised. It is interesting to me that you selectively picked what conclusions you wanted out of those studies.

The Wiki does not have an official ombudsman, but the point is rather moot, since such an institution's degree of credibility is directly related to establishing and maintaining an independent pov. Besides, the majority pov --which recklessly dismisses the serious hazards of silicone gel out of hand-- is hardly something that anyone, much less the Wiki, is going to dismiss or abandon anytime soon. In any case, the fact that silicone gel leakage causes autoimmune dysfunction in a significant number of victims is beyond doubt, though there are many uninformed opinions to the contrary, deriving from the inherent deluge of propaganda and spam that goes along with the marketing of iatrogenic medical products and services. The misleading statement by an anon above is typical of how simplistic marketing propaganda easily dupes those who either have little understanding of immune systems or have other cognitive deficits or political reasons that cause them to sympathize with the tenets of medical orthodoxy. Ombudsman 17:20, 25 March 2006 (UTC)

You are wrong saying "the fact that silicone gel leakage causes autoimmune dysfunction in a significant number of victims is beyond doubt". The evidence to date has largely suggested the opposite, even in ruptures as of recently. Your POV you've outlined in your two comments will turn this place into the Dailykos atmosphere of partisanship rather then a thoughful work on this

65.89.98.20 17:45, 25 March 2006 (UTC)

I see you don't like the Daily Kos. ROFL.

Only that Danish study you reported stated this about ruptures. SO no, he is not wrong. The FDA points out (as well as other studies you raised) that a subset of women do have such problems.

To the Plastic Surgeon

Your original writing on this topic sounded like a breast implant advertisement. It was incredible. It also included extremely biased statements about the litigation, and 'tort reform' which was not fact, but opinion. Why don't you create your own website where you can write only what you want the public to know? Then you could advertise to your heart's content. —Preceding unsigned comment added by [[User:{{{1}}}|{{{1}}}]] ([[User talk:{{{1}}}|talk]] • [[Special:Contributions/{{{1}}}|contribs]])

I think in retrospect you are correct re. the original editorial tone I used on the DOW settlements. While that is still my (and many others) personal feelings, you were 100% correct to reighn that in. There is no personal advocacy going on with my feelings and this and my practice, the only people who win financially with gels are the companies as the margins are higher per unit for them. Most surgeons fees are unchanged and the costs of maintaining IRB approval and costs of the adjuct study participation are largely on me. My dog in this fight is that from my analysis I feel they're safe and that they're superior performing devices

65.89.98.20 17:22, 25 March 2006 (UTC) droliver

Yes, that was your personal feeling, and I suspect that it is the feeling of many plastic surgeons and the implant industry.

After all this time, you are still attempting to make this an advertisement for breast implants. If this is an example of the objectivity of plastic surgeons, I have far less respect for them than I did before I became involved with this article. Your personal attack on me to Ombudsman was inexcusable.

YOU feel they are safe. I do not. I can give you a list of plastic surgeons who do not feel they are safe. I can give you a list of rheumatologists and neurolgoists who do not feel they are safe. And plastic surgeons will most certainly benefit from the increased number of women having implants, if silicone implants are approved. It does not take a statistician do realize this.

I feel they're safe from surveying the best data available. This is also the position of the NIH, ASPS, PSEF, American Rheumatologic Society, every Western Nation's health ministry, and the FDA advisory panels as of late. There are people with concerns, but its the minority view at this point (which BTW doesn't mean its wrong, just not the general concensus). Some unexpected data could come in down the road to turn this upside down, but its been so widely reviewed most people who study feel a blockbuster discovery is unlikely. I don't know why that's so hard to understand.65.89.98.20 18:27, 25 March 2006 (UTC)

You have selectively considered the conclusions of all of these. It is 'hard to understand' because most all of these reports still say there is a need for long term studies. Many studies in the past have been notoriously flawed, in a similar way as the old tobacco studies showing safety were flawed.

How many Polyurethane?

"An estimated 110,000 women or more received this type of implant before it was largely discontinued in the early 1990's." Won't do, will it. Is the estimate 110,000, do we estimate at least 110000, or what? Where does the estimate come from? "Dow Corning/FDA/women's front for frontal liberation estimated that around ..." would all be better. Data? Midgley 17:52, 24 March 2006 (UTC)

This figure is available in the adjacent reference (PMID 11471963) next to the passage 65.89.98.20 19:48, 24 March 2006 (UTC)(indented and linebreak removed for ease of reading thread)

Not available to me without an effort, and something that the artile could reasonably be corrected on, by someone who has pulled that journal from teh library. Midgley 02:02, 26 March 2006 (UTC)

Danish rupture data

The 2003 & 2004 studies on rupture [PMID 15220594] & [PMID 12560693]. should remain in Ruptures segment adjacent to the 2001 FDA study. They provide the most recent study specific to that area. These were also a large part of the evidence the FDA panel used with their recent pre-approval recomendations. 65.89.98.20 17:52, 25 March 2006 (UTC)

I referenced the Danish study in the rupture section. However, a year ago, the industry PMAs were not approved, because of concerns about rupture -- this was after these Danish studies.

It is most unfortuntate that the FDA panel (including plastic surgeons who had a financial interest in the outcome) would weigh this study so heavily.

I do know that Congress was concerned about the conflict of interest on the panel. My personal opinion is that an FDA of this White House administration is more likely to approve silicone implants than a different FDA. Bush has not shown he is interested in consumer safety. On the contrary, the WHite House intervened in court cases, arguing that we should not 'second guess' FDA decisions and that products approved b y the FDA should not be subject to litigation. That would deny access to the courts by; injured consumers. Thankfully, the kabosh was put on this insanity with the reports of Vioxx dangers.

More Whitewashing

I re-added the reasons for removing Meme & Replicon from the market. However, I left in the 1995 FDA assessment, since it does seem like an important finding. I even added also that the FDA found the risk of cancer 'negligible'.

I re-added the information on the Health Canada report. There was more than merely a review of old information. Moreover, there were recommendations that you deleted, because they were not palatable with a certain POV. This has been a very hot issue among Canadian women that I know.

The Danish studies have also been called into question, which a plastic surgeon may not find appealing but nevertheless is true. I will find more information on this, however, before I add it to the article. When I do, it will stay.

RE

The gist and conclusion of the Canada report (I invite you to read it thru)is that there was no compelling new evidence to recommend removal of the device. Their review of each subarea of the science is included in the attached link which basically echo the FDA & others. The conclusion was non-judgemental & recommended further follow up on the same areas of concern as the FDA. Cutting and pasting the way you did was out of context with the tone of the report. Neutral POV with the link provided so readers can explore it is the best for that information. Otherwise it's just redundant with the FDA.

I changed the entry to include the fact that the panel felt the manuf. answered their questions. I still included the recommendations because it was pertinent, especially as related to peer reviewed literature.

The Danish studies are the most recent in the field of peer-reviewed Medicine on this and were extensively quoted in the FDA hearings in 2005. There has been no mass "call into question" of the validity of this data. It's just more data that we have on the natural history of ruptured implants and possible autoimmune dz. and it is mentioned NPOV alongside.

Droliver 19:28, 26 March 2006 (UTC)

I never said there was a mass 'call into question'. However, epidemiologists have criticized this and other studies that exclude women who have had implants removed because of rupture.

One epidemiologist I spoke to on this very subject said it 'defies the very basic rules of epidemiology'. I wlll include it without mention of criticism. However, I will also note that the study excluded women who removed their implants.

Complete Alteration of Vasey quote

You changed the quote from Vasey, by removing the last sentence. Without that sentence, the entire meaning is changed. This is the most dishonest edit you have done on this entry. I prefaced that by stating that this was a quote from Dr. Vasey. That you would change that is just astonishing.

Plastic Surgeon

To Dr Oliver -- are you board certified in plastic surgery? This is one of the requirements the FDA is considering, to prevent dentists and general surgeons from implanting women. I think it is an excellent recommendation, for any plastic surgery. ~~MB

RedDoc

Hey Red Doc, I don't care if you leave that photo in there. Others may, but I don't. It shows how utterly ridiculous fake boobs can look! You might as well stick cantelopes on that poor woman. One wonders why plastic surgeons hate women.  ;-) You should look at the photo of the ruptured implants that were removed, that were black -- that was what happened when they remained inside a woman's body for over 20 years. It isn't nearly as funny as the photo of the cantelope boobs.