By Emily P. Walker
An FDA advisory committee is holding a two-day meeting this week to discuss how the agency can better track the safety and efficacy of silicone gel-filled breast implants years after a woman has received them.
FDA’s General and Plastic Surgery Devices Panel on Tuesday and Wednesday will discuss whether current studies that track women who’ve had silicone implants are adequate, how future follow-up studies should be designed, and how to encourage more women to get magnetic resonance imaging (MRI) of their breasts every few years to make sure the implants haven’t ruptured.
Silicone implants became controversial in the 1990s when thousands of women claimed their implants had caused neurological and rheumatological illnesses.
The implants were first marketed in the U.S. in 1962. Thirty years later, in 1992, the FDA requested that manufacturers of silicone implants stop providing them and that surgeons stop implanting them until the agency could determine whether they were safe. Later that year, an advisory committee voted that no manufacturers of silicone breast implants on the market at the time had proved they were safe, and they should be removed from the market.
The FDA decided that women undergoing reconstructive surgery or having their old silicone implants replaced could continue to receive the silicone implants. (Breast cancer patients seem to be happier with breast reconstruction after mastectomy when they choose silicone rather than saline implants, a study found).
More.
[Source: Medpage Today]
