Today's entry is kind of an "inside baseball" thought that occured to me reading an article on medicine.

There was a breathless article on the news wire "Participants Left Uninformed in Some Halted Medical Trials" (syndicated from a New York Times story) earlier this week about the fate of patients who were enrolled in clinical trials for devices or drugs that had been discontinued. In many instances these patients (and occasionally their doctor) were apparently unaware of this fact. They used two medical devices as examples - vascular stents used to treat aortic aneurysms and a type of breast implant used in cancer reconstruction.

The stents are a potential big problem in that if they don't perform as designed, the patient will die. The breast implant patients (two women in south Florida) seem to be having much less an urgent issue. From the thumbnail description it sounds like the women were having some degree of capsule pain, which is not terribly uncommon especially in breast reconstruction patients who've been radiated. Capsular contracture is also the way some silicone implant ruptures present.

Implied in the NYT article is the implication that these women are "sitting on a time bomb" with their implants which is really silly and makes the juxtaposition from the stents scenario kind of ridiculous. In this instance, I'm not sure you'd do anything at all different for these women other then checking for rupture. No one would recomend "prophylactic" removal of those implants in the abscence of documented rupture, particularly if the implants were less then 10 years old. We have plenty of information about the treatment of silicone breast implant ruptures, and it's well established that the problems you get are local issues to the chest wall. A capsular contracture or ruptured implant is it's own issue, but to hold it up next to potential life-threatening device failures misses the real serious problems with medical devices and their surveillance.

They don't really go into much detail other then identifying the implant manufacturer, Allergan, and that the particular implant had been discontinued recently (~2005). If I had to guess, it's probably the Inamed "Style 153" implant these women had, which was an anatomically shaped silicone gel device that preceded the more advanced Style 410 "gummy bear" implants. Those implants, which were voluntarily pulled from the market by the manufacturer during their approval process negotiations with FDA for their conventional type of silicone gel breast implants.

The style 153 implant had an innovative "double lumen" core that had an apparent higher failure rate when you studied them on MRI scans (the best test for rupture). Confusing the issue is the resemblance of the double shell for some of the described signs of intracapsular implant rupture which is well described in this full text American Journal of Radiology article. There are a great many surgeons who strongly believe MRI's (or at least the radiologists reading them) have a tendency to over-estimate ruptures, particularly with this specific implant. At the end of the day Inamed made the decision in 2005 to "cut bait" on such a minor product to better their chances of FDA approval for their other products. The style 153 was a good implant for it's time, but it really was just a transitional model to the form-stable devices like the 410.


* Below is an MRI showing the characteristic "double lumen" sign confused for rupture occasionally with style 153 device

Rob

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The November issue of the journal, Annals of Plastic Surgery, features an up to date comprehensive review article on the state of research involving issues of safety surrounding silicone gel breast implants. Researchers from the Vanderbilt University Medical School-Ingram Cancer Center review several hundred related studies to produce this magnum opus. A story interview the lead researchers can be read on the Vandy News Service here.

This "snapshot" is the most thorough review of this topic since the landmark 1999 Institute of Medicine report and addresses the ongoing epidemiology studies thru the Fall of 2007. The body of literature continues to be remarkably consistent in that the weight of the epidemiological evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurological diseases.

From lead author, Dr. Joseph McLaughlin,

“Few implantable medical devices have been investigated for safety hazards more extensively than silicone gel-filled breast implants,” said McLaughlin. “For almost three decades researchers around the world have been conducting in-depth studies on the health of women with implants to determine if there are significant health risks. The evidence is clear that implants are not linked to serious disease.”

An increased suicide rate from patients implanted 20-30 years ago has been the only consistent finding across several large follow-up studies. I've touched on that issue before on Plastic Surgery 101 (read here) on how inferring causation is likely incorrect as epidemiology suggested significantly higher psychiatric co-morbidity among women in those studies from the 1960's to early 1990's (so you'd expect higher suicide rates/attempts). I cannot imagine how you could ever effectively study this subject prospectively, particularly in the United States where medical records aren't centralized. Confusing things even more I'd submit is the recent rise in the United States of pharmacological treatment with mood-altering drugs (Prozac, Daypro, Xanax, anti-depressants, ADHD drugs, weight-loss medicines, etc...) for people who don't have classic or formally diagnosed depressive disorders. I see women (and men) all the time on such medicines prescribed by their family doctor or internist who would not meet strict medical criteria for what they're medicated for.

It would seem to me at this point that the most important issues left to characterize about existing silicone implants would be:

1. Late rupture rates - what can we expect durability-wise at 12-15+ years out?
2. Suicide rates - how to most effectively screen out unstable patients?
   
   

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Found a thought-provoking editorial in The American magazine, titled "Second Thoughts on Breasts." which summarizes some of the history of regulatory issues with silicone implants. The effects of this on the corporation and employees of Dow Corning(which was sued out of existence)are touched upon nicely. It's ironic that if Dow had waited about 15 months (when the first of the large studies not finding links between silicone and disease was published by the Mayo Clinic) they would have not had to pay a dime of the multi-multi billion dollar settlement.

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It's easy to take jabs at trial lawyers and the abuse of the tort system in medical-related topics. What's worse is when physicians facilitate outright fraud involved in these cases. In the United States, several radiologists were fingered in recent years committing wide-spread fraud by collaborating with trial lawyers in the interpretation of chest xrays to certify a persons standing in asbestos and silicosis class-action lawsuits. A New York Times profile of West Virginia doctor, Ray Harron.

Some days, Dr. Harron would review more than 100 X-rays a day, he said during his deposition. He charged $125 an evaluation, but would also charge a flat fee -- perhaps $10,000 -- if he had to travel to a faraway screening site, in California or Hawaii, for example. If he had charged $125 per medical report for the 76,224 claims submitted to the Manville trust, Dr. Harron would have made more than $9.5 million from those claims alone.

Most disturbing, though, was another finding by the judge. ''When Dr. Harron first examined 1,807 plaintiffs' X-rays for asbestos litigation,'' Judge Jack wrote, ''he found them all to be consistent only with asbestosis and not with silicosis.'' But after re-examining X-rays of the same 1,807 people ''for silica litigation, Dr. Harron found evidence of silicosis in every case.''

The diagnoses ''were manufactured for money,'' the judge wrote last summer in an opinion that sent some claims back to state courts and imposed sanctions on one of the plaintiff firms. ''The record does not reveal who originally devised this scheme, but it is clear that the lawyers, doctors and screening companies were all willing participants,'' Judge Jack wrote.

Back in the late 80's and early 1990's a number of doctor's made windfalls on the fears of breast implant patients by repeatedly testifying for money in court about the ills of silicone gel implants (which as we know was later found to unsubstantiated).

It seems like the lawyers in other countries were inspired by our example, as has played out in Great Britain.

In an explosive article in The Lancet (Britain's equivalent of the New England Journal of Medicine) back in 1998, an article was published by surgeon, Andrew Wakefield, associating certain vaccines with autism. This article caused the vaccination rate in the U.K. to fall by almost 1/3 and set of a world-wide ripple of lawsuits against vaccine manufacturers. It later was revealed that Dr. Wakefield received more then $50,000 from lawyers supporting this research which he argued was a donation to the hospital and not to him.

It turns out that aside from that sum of money which has been known about for years, recent investigative reporting has discovered he personally was receiving far greater sums directly from plaintiffs lawyers in excess of $500,000 USD with a number of friends and associates also being paid.

ANDREW WAKEFIELD, the former surgeon whose campaign linking the MMR vaccine with autism caused a collapse in immunisation rates, was paid more than £400,000 by lawyers trying to prove that the vaccine was unsafe.

The payments, unearthed by The Sunday Times, were part of £3.4m distributed from the legal aid fund to doctors and scientists who had been recruited to support a now failed lawsuit against vaccine manufacturers.

Critics this weekend voiced amazement at the sums, which they said created a clear conflict of interest and were the “financial engine” behind a worldwide alarm over the triple measles, mumps and rubella shot.

Dr Evan Harris, Liberal Democrat MP for Oxford West and Abingdon remarked “This lawsuit was an industry, and an industry peddling what turned out to be a myth.”

On a positive related note is this recent article in Business Week "How business trounced the trial lawyers"

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A trend has been identified in several studies of patients with implants which briefly merited some attention last summer, namely that increased suicide rates has been observed among implant patients in some of the large European databases.




Does this suggest that implants actually cause suicide? Absolutely not.

Rather, it likely reflects selection bias (a phenomena where accurate conclusions from statistical analysis is undermined) in the studied patient groups.

What's that in this instance?
An increased incidence of mental illness and depression among prospective patients.

One of the Danish studies reported that the women with breast implants had almost double the rate of psychiatric morbidity as those in the control groups. This data is easier studied in countries with centralized health care as exists in Canada & Western Europe, and is where most of this information comes from.

It has been suggested that a psychiatric condition, body dysmorphic disorder may explain the elevated suicide risk among breast implant recipients. Earlier research from the University of Pennsylvania Center for Human Appearances (Yes, there actually is such a thing!)suggested that as many as 15% of cosmetic surgery patients have the condition, characterized by preoccupation with small or imagined defects in appearance.

About 80 percent of breast implants in the United States are for cosmetic reasons and 20 percent for breast reconstruction after breast cancer surgery. Dr. Leroy Young, a Plastic Surgeon from St. Louis,one of the world's experts on silicone implants and a respected basic scientist speculated a few years ago that the data trickling in may in fact no longer be applicable to today's breast augmentation patient

“In the 1960s and '70s, women in the U.S. who had breast augmentation tended to smoke, drink alcohol, and report other risk-taking behaviors more often than the general population, but our findings suggest that this is no longer the case,”.

A recent survey of 5,000 women in the U.S. who had either received breast implants or were considering them found that the women were less likely to drink alcohol and smoke than the general population. Young says these women had a lower frequency of signs of depression than did the earlier generation of American implant recipients and the women in the European studies.

Is there a plausible explanation for breast implants causing suicide?
Not really. Some anti-implant activists are suggesting something along the lines that implants cause so much psychic or physical pain that it must be driving these women to killing themselves.

Jacques Brisson, M.D., D.Sc., of Laval University in Quebec City and lead author of the largest study which has noted this phenomena had this to say:

"Recently, it was suggested that complications experienced by women who received breast implants could contribute to increased despair, which may increase the chance of suicide," the authors said.

However, our findings to not support this hypothesis because we found no increase in the standardized mortality ratio for suicide with increasing length of follow-up," they said. "Additionally, there were no differences in suicide rates between implant patients and other plastic surgery patients."

The most recent such study, presented by Dr. Brisson, was performed in a population much larger then the others in a group of Canadian women. (see here for a blog entry I did on this last summer) Like the other work, there was an elevated suicide rate. However, the suicide rate was similar to that of women who had other cosmetic plastic surgery procedures which further strengthens the belief that breast augmentation (and indeed all cosmetic surgery) has a correlative relationship to depression/mental illness rather then a causative one to suicide.

Will today's patients have similar such rates or will observations like Dr. Young's ultimately prove correct. Check back in 10-15 years.

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Besides philosophic differences between Republicans & Democrats on Iraq, Social Security, the Economy, abortion rights, and other issues, there is a chance that breast implants (of all things) could be caught up in partisanship.

There's a real interesting drama playing out about the expected FDA approval of silicone breast implants for unrestricted cosmetic surgery indications. By all indications we have expected approval with some strings attached re. long-term surveillance. The approval last week by Health Canada has made this seem even yet more imminent and has the Siliconistas firing up their PR machine.

Sens. Dianne Feinstein (D-Calif.) and Olympia Snowe (Republican in name only-Maine) have now joined the fray in trying to intimidate the FDA into delaying action on their own advisory committee's report from 2005 which recommended approval for major manufacturers, Inamed & Mentor Corp.

Earlier this month Rep. Rosa DeLauro (D-Conn)took an aggressive posture on this issue, siding with activists intent on stopping silicone implants by any means necessary. Mrs. DeLauro is the ranking Democratic member of the House Appropriations Agriculture Subcommittee, a committee which controls in large part the purse strings of the FDA.

Which brings us to this $64,000 question:

With the midterm congressional elections in 2 weeks, does the fate of silicone implants hang on whether Democrats recapture the house and turn Rosa DeLauro overnight into Chairwoman of the House Appropriations Agriculture Subcommittee? It is conceivable that she could an end run around international scientific & medical consensus and tie this up indefinitely if she assumes the leadership position.


tags:
Plastic Surgery
Silicone Breast
Breast Implant

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