BREAKING NEWS: A fairly significant announcement by the USFDA was in the paper today re. silicone gel breast implants (see NYT summary here). Based on testimony and evidence presented, the FDA has finally agreed that the suggestion that patients need routine MRI screening of their implants is no longer one they support. This is bringing the United States into line with the rest of the world on being more pragmatic on the issue and reserving workup for symptomatic patients only.  Recent papers in the surgery literature have been reporting that MRI has been associated with overestimation of rupture rates, particularly when applied to asymptomatic patients. The panel also concluded that no new evidence has been presented to change prior determinations that silicone implants are not causally linked to any known systemic illness.

Rob

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In a not unexpected conclusion, yesterday the United States Food & Drug Administration re-affirmed their 2006 decision to reintroduce silicone gel breast implants into the United States market for cosmetic indications. In statements from the FDA, they explained that no new information has arisen to question the safety or efficacy of the devices for intended use. As has been discussed on Plastic Surgery 101 a number of times, this is not really news and has been accepted world-wide for a number of years now. Hopefully this statement from FDA heralds the availability of the new form stable "gummy bear" silicone implants here in the United States which have been available everywhere else for almost 15+ years.
Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons (ASPS), more than 70,000 others received implants for breast reconstruction.

The most disappointing finding was that only ~60% percent of women enrolled in a 1,000-patient study of one manufacturers implants are still accounted for after eight years. A larger study of 40,000 women conducted has lost nearly 80 percent of its patients after just three years. Diana Zuckerman of the National Research Center for Women and Families, one of the most prominent (and persistent) anti-implant activists, cried foul and suggested that most medical journals would not publish the studies cited by the FDA because of the missing data. I'd agree with her, but for different reasons. She's implying safety issues exist (which they don't by and large), while I'm more interested in outcome data to understand how to reduce re-operations.

Why the relatively poor follow up in the FDA trials?

Dr. Phillip Haeck, president of the American Society of Plastic Surgeons (ASPS)sums it up saying that, "When women are happy with their implants they tend to feel that a regular follow-up is pointless - it becomes a nuisance and an unnecessary expense". I'd agree 100% with that.

It also begs the question of what exactly are we trying to demonstrate with the FDA follow up studies. There is overwhelming world-wide information that suggests safety at this point. It would be nice to have a little more data on longevity so as to better counsel patients on when to consider routine exchange with prior devices, but as we're on the cusp of a major design change in the polymers that make the implant almost impossible to rupture (the "gummy bear" form stable devices) we're going to quickly lose interest in exhaustively studying older devices. This kind of technology advance has always created problems about making conclusions with medical devices, as you end up comparing apples to implants :) (bad pun alert).

Rob

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When the USFDA lifted a nearly 2 decade moratorium on the use of silicone gel breast implants for cosmetic surgery indications in 2006, there were two puzzling things added to the product labeling.

1. The use of silicone gel implants should be limited to women >22 years olds.
2. That women should undergo routine MRI screening of their implants for rupture every 2-3 years.

The first instruction re. an age restriction on women 18-22 is patently absurd and is a nod to the "unique" political history of silicone breast implants in the USA. One more thing we thank lawyers for!


The second suggestion re. MRI was always puzzling, particularly as the rupture rate is so low for modern implants through the first decade where the FDA would otherwise be having patients undergo 5 screening MRI's (at year 3,5,7, & 9). This intuitively is throwing money down the drain as the yield is low and violates what most people consider appropriate in a screening test.

New data and review of the literature from the University of Michagan suggest that while MRI is fairly accurate in detecting implant-related problems, it is 14 times more likely to detect them in women with implant-related symptoms than in women without symptoms.It has been concluded that because most women in the studies had symptoms, the true accuracy of MRI for detecting implant-related problems in asymptomatic women is probably much,much lower and calls into question the whole idea about routine screening for rupture. Beyond the issue of accuracy, the authors comment that screening tests are generally performed to detect diseases with serious consequences-whereas the health risks associated with ruptured silicone implants, if any, are still unknown. To date, there is no single systemic disease or illness clearly attributable silicone gel implants despite them being the most studied medical device in the history of medicine.

Hopefully this will lead to the updating of the current FDA labeling for these devices that causes some confusion for patients and adds significant extra expense for no benefit.

Rob

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