The U.S. Food and Drug Administration’s General and Plastic Surgery Devices Panel is holding a meeting this week in order to discuss how the agency can more adequately track the safety of silicone gel-filled breast implants. The two-day meeting will allow the advisory panel to further assess the efficacy of current studies that track women who have received silicone implants, as well as to determine how future follow-up studies should be conducted. The panel is also tasked with identifying ways in which it can encourage women to get magnetic response imaging (MRIs) of their breasts every few years, in order to ensure their implants are still intact and that no ruptures have occurred.
Controversy surrounding silicone implants began in the 1990s, following reports from thousands of women claiming their implants caused them to develop a variety of different illnesses. In 1992, silicone breast implants were deemed unsafe by the FDA and were ultimately removed from the market. However, by 2006, the FDA had approved two types of silicone implants, after determining the makers of the implants, Mentor and Allergen, had proven the devices to be safe and effective.
As a part of the FDA’s 2006 approval, the agency mandated that follow-up studies be conducted on the women who received the silicone implants. In fact, these studies are now the focus of this week’s advisory panel meeting. Data from the studies will be examined in order to ensure that the silicone implants do not cause connective tissue disease, neurological diseases or reproductive problems, as well as to ensure the implants themselves have not ruptured.
The FDA recommends that women with implants get a breast MRI three years after receiving them and to continue doing so every two years thereafter.