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.
