Health
FDA OKs silicone breast implants
NEWS IN BRIEF — Posted Dec. 11, 2006
After a contentious history in which their safety was vigorously debated, silicone breast implants regained the nod of the Food and Drug Administration. They were approved Nov. 17 for use in breast reconstruction in women of all ages and breast augmentation in women 22 and older.
The FDA is requiring that the companies conduct a large post-approval study that follows about 40,000 women for 10 years after their receive the implants.
The implants are not lifetime devices, and women likely will need at least one additional surgery. Women also will need regular MRI screenings to determine if the implants rupture.
The first screening should be three years after the implant and then every two years thereafter. In the event of a rupture, the device should be removed, the FDA noted.
The approval was opposed by the Washington, D.C.-based health care watchdog group, Public Citizen. The group's director, Sidney Wolfe, MD, called the implants "the most defective medical device ever approved by the FDA."
Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/12/11/hlbf1211.htm.
