September 01, 2011

Silicone Implants Standing Up to FDA Post-Approval Studies So Far

The FDA held hearings yesterday and the day before as part of the long-term post-approval process for silicone gel-filled breast implants, which were approved to return to the market in 2006. The hearings are part of an information gathering effort to evaluate strengths and weakness of the implants and their long-term effectiveness. More will be forthcoming on this topic over time.

What these post-approval studies have shown so far, according to a news bulletin I received this week from the American Society of Plastic Surgeons is that, quoting ASPS President Phil Haeck, MD:
"At roughly the midpoint of the studies, we know that the pre-market data supporting safety and efficacy have been largely verified."

Also of interest from the same ASPS bulletin:
"Numerous studies have demonstrated a high level of patient satisfaction with silicone breast implants and no established relationship between silicone breast implants and connective tissue disorders, one of the primary reasons these studies were implemented."

On June 22, the FDA issued an updated white paper on the safety of silicone gel-filled breast implants, stating that "silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled." The Agency also noted that women who receive silicone gel-filled breast implants for reconstructive or cosmetic purposes will need to monitor the devices over their lifetime.

A report on the hearings will be published in the October/November PSN and