FDA panel to hold hearing on silicone implant post-approval studies
What? The FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will conduct a panel hearing on silicone breast implants The hearing will hear from breast implant companies, surgeons, and the public.
When? Aug. 30-31.
Why? The hearing is to evaluate the studies which were mandated when silicone gel implants returned to the market in 2006. (gel implant patients who had breast augmentation when silicone gel implants came back to the market enrolled in the study.)
What are they evaluating? They want to figure out new ways to gather data for these post approval of silicone studies.-approval studies. How do we figure out “effectiveness” of the device?
“The breast implant post-approval studies have provided us with an excellent learning opportunity,” says 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. The 2006 decision by the FDA to allow women to choose between silicone and saline implants was a sound decision supported by science.”
Dr. Haeck further notes that 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.
What may come out of this? As many of you know, the style 410 “gummy bear” implant is not approved in the US. As these “next-generation” silicone implants look for approval, they likely will have their own studies.
Back in June the FDA issued an updated white paper looking at the safety of silicone breast implants. The paper stated “silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled.”