Talk:Breast implant/Archive 5

message: We should include SOMETHING regarding these assertions:
"the literature offers a number of noteworthy examples of downright unhealthy silicone side effects, some of the scariest of which are presented in an ongoing National Cancer Institute study. Among its findings: Women with implants were two to three times as likely to die from brain cancer and respiratory cancers, and four times as likely to commit suicide, compared to other plastic-surgery patients." http://www.alternet.org/stories/43231/ 
I didn't find mention of the cancer study anywhere in the wiki article, but it's obviously a part of the debate. 72.244.201.27 17:22, 21 October 2006 (UTC)
replies: text: Actually, the lung CA issue & suicide rate is referred to in the article. The brain CA issue never panned out on closer analysis. The small increase in lung CA clearly appears to be related to smoking in the particular population studied (scandanavian women) rather then the presence of implants, and this was noted by the authors of the paper as well as in subsequent discussions by the national cancer institute. There is no plausible mechanism or connection for implants and lung CA & this correlation has not been seen on many other large population studies, including a large study from Canada just published which had lower cancer rates of all types as compared to the general population. Suicide rates have been higher (but still small) in 4 or 5 large implant group studies outside of America, which reflects the correlation to higher preexisting psychiatric disease rates rather then implying causation from the implants (as witnessed by no increase in suicide rates among implant based reconstructive patients). This mirrors the observation of slightly higher suicide rates among all comers for cosmetic surgery rather then something specific to implants. I don't believe there has been any study from the US population demonstrating similar phenomena yet, but our follow-up isn't as sophisticated as some of the countries with more centralized databases from their national health servicesDroliver 15:15, 26 October 2006 (UTC)
replies: text: The lower rupture rate comes from the segregation of 3rd/4th generation implants out of the data which also included 2nd generation implants which have signifigantly higher ruture rates. There are an additional 2 studies of 4th gen. implants with similar observed rates.Droliver 22:49, 24 November 2006 (UTC)
replies: text: The lower rupture rate was not accurately stated.  In fact, the 'best scenario' rupture rate was minimized in the article, and was misleading,  The study itself states that this is likely not an accurate rupture rate, because women who had their implants removed because of rupture were excluded from the study.  I actually quoted from the first study cited which was stated incorrectly, and Dr. Zuckerman accurately discussed the second study and why it minimized the actual rupture rate.  And, of course, these were both small studies, and neither even attempted to estimate rupture rates beyond 10 years,  This is because there was not enough data to model rutpure rate beyond 10 years.  Similarly, the effects of rupture were also not analyzed long-term.  That is why the FDA stipulated what it did, and recommended follow-up MRIs to detect silent rupture.  The truth is that we just don't know (in the words of my rheumatologist) what the long term effects of implant rupture are.67.35.126.14 06:12, 30 November 2006 (UTC)
thread_title: Complications

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

message: This is what is actually stated on the FDA page cited in the articl- notwithstanding the recent FDA decision to approve silicone implants for women 22 years old and older, with conditions:.
"When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made."67.35.126.14 03:07, 24 November 2006 (UTC)
thread_title: What the FDA stated

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

message: As a board certified plastic surgeon who has performed over 900 explantations of breast implants in the past 12 years, I am disturbed that fundamentals in the discussion are being lost
There are 3 problems with implants:
(1) Rupture (2) encapulation (3) symptoms.
#If silicone is safe, why then not simply inject it? After all, when rupture occurs, what you have is a giant silicone granuloma. Injection is outlawed, as well it should be. So the claim that rupture is benign is not tenable. In 1998 I confirmed the findings of Robinson et.al. who found over 50% rupture by 10 years, 70% by 15 years and 94% by 20 years.I continue to find the same rupture rates each year.All implants rupture with time. The current "gummy bear" have not been around for long enough to pronounce them "safe" We have had 3-4 generations who each in turn made this claim and were proved wrong over time 
#All implants get encapsulated. This would be a minor problem if you ignore pain, hardness, deformity, 2 "baseballs" in the chest, inability to sleep prone, etc (-I could name a lot more.) As I wrote (in PRS in 1998), after 10 years all implants have alteration in shape size, contour and feel.
# In a survey I conducted on over 500 explanted women with silicone gel implants, 67% complained to their plastic surgeons about their symptoms. Women who complained say they were dismissed, and discounted their PS who stated  "science has shown implants are 100% safe". I wonder how many PS follow up with detailed questionnaires about symptoms?
All the above discussion sadly leaves out the patient, the womem. There IS a problem with implants (if they were so good all these years, why are they changing them?)Dr Rita Kappell in The Netherlands recommended removing implants after 10 years whether it was necessary or not, and replacing them if the patients desired so. There is certainly seems to be a need to look in another direction
:—Preceding unsigned comment added by Edward Melmed (talk • contribs)  03:46, 28 November 2006
-- These are all excellent points.  Thanks for your perspective.
Dr Oliver has once again deleted every reference he doesn't like.  He even insists on including incorrrect dates for FDA and implant generations.  I have changed it back at the request of several Wiki readers.  Check the FDA website!    Drzuckerman 17:31, 28 November 2006 (UTC)
replies: text: With all due respect, these issues are in fact already addressed in a way consistent with the consensus body of literature in re to rupture data, capsular contracture, and questions about links to systemic illness. If you would like to discuss specifics of any one of these as they relate to how the FDA and others have evaluated these devices, please engage here.Droliver 22:45, 28 November 2006 (UTC)
replies: text: Whether Dr. Oliver agrees with Dr. Melmed, is irrelevant.  The issue is this article.  Dr. Oliver continues to revert it to a version he wrote, which totally changed it from what a number of editors had written.  If he wants to "take it to the talk page", he should do so.  Then we will know that he is actually willing to cooperate wtih other editors.  SO far, he has shown he refuses to do so.Jance 03:01, 29 November 2006 (UTC)
thread_title: BY DR M (A BOARD CERTIFIED PLASTIC SURGEON)

message: I am a board certified internist who see many women in my practice.  I have also been doing outside research on the issue of silicone breast implants and their possible detriment to women's health.  I find Dr. Zuckerman's comments to the accepted belief of the medical community and to be particularly impartial.
DrCarter12
:No, I am sorry. A userid on Wikipedia does not have a board certification especially when it has only made one contribution and is impossible to authenticate. Boards do not certify Wikipedia Userids and only if a real identifable medic emerges from behind it can you claim any credit for your qualifications. Even then I am afraid a practising medic with a commercial interest in a procedure is not neutral point of view. --BozMo talk 17:33, 29 November 2006 (UTC)
replies: text: I agree with BozMo - to the extent that someone here has a commercial interest and conflict of interest.  The only person here with a conflict of interest is Droliver, since he makes his living putting them in women.  And no, it does not take a board-certified doctor to read plain English in the studies.  Unfortunately, Droliver has mistakenly read the "comprehensive reviews" he cites and the studies contained in them. The article is a problem. I urge Dr. Melmed and Dr. Carter (I don't know who this is) to show Wikipedia their "credentials" so the same can be verified.  I am curious as to whether the other "doctors" such as Oliver or Samir have done so?Jance 19:02, 29 November 2006 (UTC)
replies: text: Lynn, that is wise.  I told my daughter to NEVER use WIkipedia as a reference for a college paper.  There is good reason for that.  A few editors ban together, espeically if one has a financial interest, and protect a "truthiness" version that suits their particular purpose.  Like a color glossy, that says "and the newer version is even more (fill in the marketing hype).  Ugh.  That is not an encyclopedia.  And it is surely not reilable.  It is tragic that this kind of article is permitted to be written in "color glossy" form. Jance 07:57, 30 November 2006 (UTC)
thread_title: Article authenticity

message: Why does Samir keep reverting to an article that is incorrect?  There is no incentive for Oliver to negotiate since he is happy with the version that is protected -- it's his!  I have asked Samir to contact me to discuss the specific problems and his response is we should "duke it out."  That is not the scientific or medical way to deal with a medical article.  I have spent hours giving specific examples of the problems with this article, and they are ignored.
Here's a new example.  The Heden et al article that Dr Oliver says is the best study of rupture excluded any women whose implants had broken in the first ten years of use.  The authors state on page 307 "Women who had ruptured implants removed before the 9.5-13.2 year post-implantation period covered by our study would not be included in the study, so the rupture prevalance may underestimate the actual rupture rate."
That is a methodological flaw which certainly does cause an underestimate -- and the researchers should have mentioned how many women fell into that category of having removed their implants.  A comparable comparison would be: let's do a study on the impact of smoking on lung cancer.  Let's study 100 people who started smoking in 1960.  Then let's just look at those that are still alive and see how many have lung cancer.  Since anyone who died of lung cancer is excluded from the study, and since most people diagnosed with lung cancer die within a year, it would certainly underestimate the link between smoking and cancer.
Here's another example, even more similar.  In 2005 let's say we contacted 100 people who bought Corvettes in 1992, 1993, and 1994 (the same year as the implant patients).  Let's find out how many of these Corvettes are still running well.  But we exclude anyone who sold their Corvette or got rid of it (perhaps it was totalled in a car accident) before 2005.  Our evaluation of Corvettes will be based entirely on the 100 cars still owned by those original Corvette owners. Obviously, that is not an accurate evaluation.
Samir, to be fair to the authors and to the integrity of Wikipedia, please either delete the article entirely, or find someone to help make sure it is accurate and that the studies are accurately presented. Or find someone who will.  72.75.6.148 19:08, 29 November 2006 (UTC)
replies: text: I have a feeling now that the article to Oliver's taste, we won't hear anymore from Samir.  I hope I am wrong.  However, nothing I say - even deliberately pointing to errors - has made any difference.  The "clin-med" review (which was only a couple of people, evidently) clearly didn't bother to look at the accuracy- or lack of it - and does not seem to care.  So if an administrator can freeze article to whatever version they choose, and nobody cares, then I don't see what we can do about it.  Regardless of how many other doctors, scientists or other editors complain. Jance 19:47, 29 November 2006 (UTC)
thread_title: Reverting to an incorrect version is not the answer

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

message: I have asked Samir to talk to me about this article several times in the last few days, but haven't heard a word.  Samir, where are you?  I'd like to point out several factual errors with this article as you locked it in. It isn't the Wiki way to lock in an inaccurate article and then refuse to discuss it. And while you're at it, I would be glad to talk to any of the clin-med folks who you said agreed to this article as is. 72.75.6.148 00:56, 30 November 2006 (UTC)
replies: text: I've no idea who you are, and you certainly never contacted me -- Samir धर्म 01:20, 30 November 2006 (UTC)
replies: text: I think, but am not positive, that this is Diana Zuckerman, the epidemiologist.  Hopefully, she will clarify this.67.35.126.14 06:04, 30 November 2006 (UTC)
replies: text: Okay.  Make a list of the factual errors and we will discuss them one by one.  The goal here is to improve the article -- Samir धर्म 06:26, 30 November 2006 (UTC)
thread_title: Samir, where are you?

message: :I am going to bed now, but I believe Dr. Zuckerman, Dr. Melmed will join this discussion at a more reasonable hour.  Jance 07:35, 29 November 2006 (UTC)
replies: text: I have not misrepresented any facts: all I did was protect the article to the most stable version that I saw, which is well within my rights as an administrator.  I'm an academic gastroenterologist with no experience in evaluation of breast implants. -- Samir धर्म 17:28, 29 November 2006 (UTC)
replies: text: Samir, you don't have to have experience in evaluation of breast implants.  All you have to do is to READ the study cited, and you will see where Droliver at times outright misstated and at other times misrepresented what the sources stated.  I really don't understand your conduct - whether it is "within [your] rights" or not.  I also do not understand why nobody will say who "clin-med reviewed" this article.  My guess is that whoever did (if anyone) simply deferred to Oliver's "expertise".   Unfortunately, with Oliver, this is not wise.Jance 00:26, 30 November 2006 (UTC)
thread_title: Refactored

message: First.  There were two actual photos of rupture that were simply deleted.  One was intracapsular and the other was extracapsular.   If the "Wiki community" believes it appropriate to have multiple photos of breasts ("normal", pregnant etc) in the breast article, then space is not a good argument to exclude it.  And it follows too that both 'normal' and ruptured implants should be included.  I happen to have one actual photo of implants that were removed from a friend, that were single lumen and 20 years old.   If desired, I could point out that the extracapsular rupture was a photo of 20 year old implants, and not the newer version. 
This is what I propose, in addition to the photos:
-----------------------------------
Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7]
The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, for a variety of reasons including difficulty with samples, non-uniform style of implants, testing methodology and the like.  
The rate of rupture has not been studied for implants over 10 years old.  Predictions for rupture at 10 years or less have had mixed results.  One  study using MRIs (the 'gold' standard for detecting rupture with 86% accuracy)  concluded that "the rupture rate increased significantly with increasing implant age."  This study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years.   The study concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants.  That is, a woman who has two implants will likely have an increased chance of at least one implant rupturing during this time frame.
Another study similarly evaluated the percentage of implants that were ruptured.  Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] It is therefore not surprising that the rupture prevalence in this small study was 8% at 10.9 years, involving approximately 16% of the women.
When silicone implants rupture they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate to the breast and the lymph nodes under the arm, resulting in granulomas (inflammatory nodules) and axillary lymphadenopathy [21](enlarged lymph glands in the armpit area). [13]  WIth the exception of one study which shows an increase in fibromyalgia, short term studies do not show an increased risk of autoimmune or other systemic illnesses in women with ruptured implants.  However, it is unknown how often silicone migration occurs or what the health consequences will be if a ruptured implant remains in the body for several years. [22] 
Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18] Since most ruptures of silicone gel implants are "silent," with no symptoms, the FDA has concluded that MRIs are necessary to most accurately identify rupture.   Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10]
-----------------------------------
::This is relatively short, states the facts accurately  - it includes what has and has not been found, without belaboring it.  If anyone can make it shorter/tighter or whatever - while still mentioning the issues stated - please discuss.  I removed the disclaimer that the study with the lower rate of rupture was funded by Inamed.  Most research is, unfortunately, funded by the manufacturers.  
 I speak for only myself, not "Jance/Zuckerman".  Citations for all statements will be included - including the Brown study (fibro) and the FDA webpage which points out other studies did not find an increase in fibro or other autoimmune illnesses.  And, for kicks and grins, I want to mention that I am one of those women who had ruptured implants for several years (five years, to be precise).  It is true that this has not been studied.  
It is true that I have a personal involvement.  Is it only a coincidence that my symptoms and objective lab tests radically improved after removing my ruptured implants?  Perhaps.   Is it?  We will never know unless long-term studies are done.  I am not even sure how this could be done, since I can't imagine a woman knowingly leaving ruptured implants in her body, unless she can't afford or can't find a plastic surgeon willing to remove them.  These problems have occurred, since some plastic surgeons have refused to remove implants, insurance often does not cover it etc.  The problem is that women DO have ruptured implants in their body for  3, 5 or 10 years or more.  We have no idea how many or what the effects are.   And THAT is a good reason to recommend MRIs every two years, which the FDA has done.  That leaves only about 14% (give or take a percent) risk that the rupture will not be detected. But we will never know.
I do not subscribe to any fringe or alternative view, but a straightforward facutal explanation of what has and has not been studied, what the regulatory bodies recommend, etc.  The FDA decision is clearly important, since it did attach conditions and recommendations to its very recent approval.  I do not know what other countries have recommended or not, although I would like to see more reference than Dr. Oliver's word on it.
Also, I do not have any financial interest in the approval of silicone or any implant.  Jance 20:20, 30 November 2006 (UTC)
thread_title: Rupture

message: I agree that it makes sense to start one section at a time, and we may as well start with an important section: rupture.
I have read every study quoted here, and this is what I suggest.  The footnote numbers do not necessarily make sense, but indicate that there are footnotes.
Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7] 
The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.
Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18]  According to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs    For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10]
In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study {Brown et al 2001}  However that study included women whose implants dated from  before 1990, and many of the implants were 2nd generation. Neither of the two US implant manufacturers have collected longitudinal MRI data on rupture or leakage for women implants for more than 3 years. [11] [12] Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study cited above, which included Mentor and Inamed implants as well as implants made by other companies.
A more recent study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years and at the time of the study (approximately 10 years). The researchers concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19]  They could not provide a more exact estimate because women whose implants were removed during the first three post-surgical years were excluded from the sample.   This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants. Since augmentation patients have two implants and very few of the women had two broken implants, the authors’ estimate would translate to at least 30% of wmen having at least one implant rupturing between 3-10 years after implantation.
In 2006, Inamed published a study of 104 women whose implants were approximately 10 years old, but were the same styles that are currently sold. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] The authors pointed out that this underestimates the rupture prevalence, which was lower than previous studies: 8% at 10.9 years, involving  16% of the women.
When silicone implants rupture they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate to the breast and the lymph nodes under the arm, resulting in granulomas (inflammatory nodules) and axillary lymphadenopathy [21](enlarged lymph glands in the armpit area). [13] 
There are few MRI studies of women with ruptured implants that were designed to evaluate the impact on health, and the specific risk and treatment of extracapsular silicone gel is controversial. FDA scientists reported an increase in fibromyalgia among women with extracapsular leakage, compared to women with silicone implants that were not leaking outside the capsule. [26]. The FDA points out that the association between fibromyalgia and silicone implants has not been reproduced in other studies [7], but conclude that "studies have not been large enough to resolve the question" of whether or not breast implants increase the risk of autoimmune diseases, adding "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made.” [  http://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html#1]
Comments welcome. Drzuckerman 04:52, 1 December 2006 (UTC)
replies: text:  Neither the Holmich nor the Heden studies are slanted, as Diana or I wrote it.  (I think ours are close).  Your version had been slanted, and included an inaccurate statement of the conclusions.  A correct representation of the study is not "editorializing".   Just repeating the conclusions without stating how they were arrived at,  to help understand these data from the previous study is an omission of important information,  This is exactly what I meant by the importance of not omitting critical information - information that is required to make an accurate statement regarding the study.  And I repeat that this is NOT editorializing, since the study states this itself.  
Jance 06:33, 1 December 2006 (UTC)
thread_title: Alternative Rupture Section

message: Oliver said he would agree to DZ's paragraph 1, 2 and 3.
The rupture studies she quoted were the ones you used, Oliver.  Are you saying those are obsolete?
This is the paragraph I wrote on this ...
::The rate of rupture has not been studied for implants over 10 years old. Estimates for rupture prevalance at 10 years or less have had mixed results. One study using MRIs (the 'gold' standard for detecting rupture with 86% accuracy) concluded that "the rupture rate increased significantly with increasing implant age." This study examined women over a two-year period, from 1999-2001, who had intact implants at 3 years. The study concluded that "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation."[19] This study did not examine the number of women with ruptured implants, but rather looked at the percentage of ruptured implants. That is, a woman who has two implants will likely have an increased chance of at least one implant rupturing during this time frame.
A more recent study similarly evaluated the percentage of implants that were ruptured. Unlike the previous study, it excluded women whose implants were removed within the first 10 years. [20] It is therefore not surprising that the rupture prevalence in this small study was 8% at 10.9 years, involving approximately 16% of the women.
This only looks at the two studies you cited, Oliver.  And in fact, you only cited these two.  So how are they 'obsolete'?  It is useful to briefly explain the study, rather then rotely copying the conclusions.  This is particularly true of the Heden study, since it underestimates rupture rate by excluding women who removed their implants during the study period.
  I would like Samir and Oliver to comment on this.Jance 06:48, 1 December 2006 (UTC)
thread_title: Paragraphs, not sections

message: Since we all seem to agree on the 1st 3 paragraphs that I proposed, I'd like to suggest that those be included in the "locked" article as soon as possible.  Please note that they would also replace the now one-paragraph section on saline implants -- there would be only one section on rupture, which would include little about saline rupture and would focus primarily on silicone. 
The 3 paragraphs are as follows:
Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[7]
The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. Rupture is one reason for reoperation.[8] Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms. [9] The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time.
Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture.[18] According to implant makers, only 30% of ruptures are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [7] For that reason, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes. [10] 
I think the common ground we have is that the studies that have been done so far (whether Holmich, Heden, Sharpe/Collis, FDA, etc) all have shortcomings.  As a result of those shortcomings, different researchers make different estimates about long-term safety, but there are no solid studies of long-term rupture rates for specific implants.
Regarding the rest of this discussion, I agree that this section is getting a bit long, so I propose we move anything about the health impact of rupture to the systemic disease section, and deal with that later.
That leaves some relatively minor disagreements on the most recent studies.  The study shortcomings are inevitable, as I tried to say in my summary, because:
1.  Not all rupture studies included MRIs, which are expensive but necessary to accurately determine rupture.
2.  The longer-term studies all include implants that are no longer for sale.  Those findings are important for the hundreds of thousands of women who still have those implants in their bodies, however.  So, although not necessarily relevant to currently sold implants, they are still relevant to this article.
3.  Droliver is correctly quoting the percentage of implants that break, but I think he will agree that for the patients, and from a medical point of view, what matters more is the percentage of women with at least one broken implant, which is twice as high since augmentation patients have 2 implants, and usually they break one at a time.  That's why FDA uses that statistic, instead of the percentage of implants broken.  And those statistics are in the articles, so therefore giving that info is not "original research."
3.  The problem with extrapolating from 6-year data, etc, as the FDA has pointed out (and I quoted) is that we don't know what assumptions to make.  As Jance mentioned, all products (cars, tires, and all kinds of implants) tend to be fine at first, have problems as they get older, and then finally reach a point where they are all broken.  Few people keep their cars more than 12 years, for example, because everything starts to break.
Every breast implant study so far has found that after 20 years, any that are not broken are likely to break within a year or 2.  Will that be true for the silicone implants now approved in the US, or the gummy bear implants sold in other countries?  Nobody can say until those implants are in the human body for 20 years.  A ten-year study is better than a 5-year study, but doesn't tell us about what happens after 15 years.
4.  I agree with Droliver that women who had their implants removed prior to 10 years did not necessarily have a broken implant.  I agree with him we don't know why they had their implants removed.  However, since most women don't get their implants removed so quickly unless there is some kind of problem, I agree with the study authors that their numbers are underestimates.  What we don't know is how much of an underestimate it is.  
The researchers also stated in the article that many of the women selected for the study could not be reached, because they had moved since going to the plastic surgeon.  Since those women were no longer "current patients" we don't know how many of them also had their implants removed because of rupture.  That contributes to the underestimate, but again, we don't know by how much.
In summary, I propose we go with the text I suggested because:
1.  The language is less technical, more for a general audience.
2.  It talks about ruptures per patient rather than per implant, a more meaningful statistic for a general audience.  (Just as an example, can you imagine talking about breast cancer rates per breast instead of per woman?)
3.  It more clearly explains, in less technical language, what is known and not known about implant rupture rather than concluding that there is nothing to worry about.  Probably the fibromyalgia comments should be moved to the systemic disease section, and we can discuss them there. 
In my proposed text I had already incorporated some of droliver's language.  I am willing to compromise but this article should be less technical and more accurate -- for example, the section criticizing some studies for using "non-randomized samples" is not only more technical than necessary, it is also misleading because one can NEVER use a randomized sample for these kinds of studies.  A random sample would require a random sample of all women in a particular country or group, tell half of them that they are getting breast implants whether they want them or not, and then not allow women who have implant problems to remove them.  ALL the studies done have been on nonrandomized samples.  Some samples are more biased than others, some are more representative than others, but none are random.
Droliver and Jance, since you have no objection to the 1st 3 paragraphs, can we adopt them and focus on these other paragraphs? And, would you agree to moving the fibromyalgia and health impact of rupture section to the systemic disease section?  That way we have less to deal with here. 
I would welcome comments from others as well.Drzuckerman 17:54, 3 December 2006 (UTC)
replies: text: That is fine with me.  I am glad to see that Dr. Oliver at least changed the number he had for the percentages of implants that break.  He had cited 5-8% and quoted Holmich (which states a "minimum of 18".  Now the statement is only misleading, but not simply wrong.  —The preceding unsigned comment was added by Jance (talk • contribs).
* I do not agree on the specific language of your paragraphs, moreso on the general themes. I think the fact that implants can rupture make it implicit that they're not necessarily permanent devices. Speciifically the sentences these sentence are more wordy and editorial then the present version "In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study. [19] However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. Neither of the two US implant manufacturers have collected longitudinal MRI data on rupture or leakage for women implants for more than 3 years. [11] [12] Therefore, it is impossible to determine if the implants that those companies currently sell have a different 11-year rupture rate or likelihood of leakage compared to the implants in the FDA study cited above, which included Mentor and Inamed implants as well as implants made by other companies."'Italic text
* You're too focused on the American process here. Regular MRI screening has been adopted by only the US & was explicitly rejected by health Canada a month prior as not being evidence based. Other countries do not endorse the FDA rec. either. While I'm fine with reference to the FDA position, it needs to be in the context of standard practices. I'll leave it up to you to treat that accurately in your paragraph
* I again think you're turning a small subsection into an overly extended dissection of what are only 3 relevent studies (Holmich/Heden/Sharpe) + the CORE data. The issues with the accuracy of this data (which can under or overstate rupture) and the trouble with historical overly rosy projections (at 12-15 years was an example with older devices) is incapsulated in the two sentence on error with this already. 
* You make an excellent point re. reporting per patient rates along side the standard way this is reported (per device). This puts the ballpark rupture range between 6% (Heden's established low end) to 15% (Holmich's projection) per device or between 15-30% by patient at around a decade.
* In re. to your thought #4 about why implants are removed/exchanged early. We actually do know why in large part, namely capsular contracture issues & aesthetic issues/size changes. It clearly is not rupture rates driving that group of reoperations, but that's a area touched on elsewhere
* The issue of fibromyalgia seemed to go with the rupture section as that was the original assertion ie. rupture caused fibromyalgia. We know that to likely not be the case (as you know) and it's treatment as is should remain. This specific issue would likely be swamped in the discussion on systemic disease which is going to focus on the generalized area rather then the specific 
* In re. to the "randomized" critique, a more accurate way of describing would be studying "unselected" patients
70.148.62.250 19:17, 4 December 2006 (UTC)
thread_title: Response to rupture discussion