Despite lingering safety concerns from some health advocates, the Food and Drug Associaton (FDA) lifted the ban on cosmetic use of silicone breast implants yesterday.
Despite testimony by Dr. Diana Zuckerman, President of National Research Center for Women & Families on the health risks associated with silicone breast implants and despite calls by Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, to start a criminal investigation into Mentor Corporation's apparent failure to send the FDA data showing safety problems with their silicone gel implants, Dr. Daniel G. Schultz, director of the F.D.A.’s Center for Devices and Radiological Health, said that the agency’s review, had determined that their sale is in the best interest of women.
However, the FDA is requiring that manufacturers tell women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government. To read on, click here.
Editor's note [added Nov. 21, 2006]: This NY Times editorial explains that just because the implants were approved means that they are not risk-free.