The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates. 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. More than 264,000 women had breast implant surgery last year with saltwater-filled devices, whose availability was never limited. Medical experts predict that yesterday's approval will increase that number because silicone-gel implants, which are considered more natural and appealing, will prove popular. The FDA is allowing the devices for breast augmentation for women who are least 22 years old and for all breast-reconstruction patients. Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was "inadequate information to demonstrate that breast implants were safe and effective." A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices.
