FDA Ends Ban on Silicone Implants

The U.S. Food and Drug Administration (FDA) has ended its 14-year ban on the cosmetic use of silicone breast implants, despite lingering safety concerns from some health officials.

After an indepth scientific study, the FDA approved the marketing of silicone gel-filled breast implants made by two manufacturers for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.

Silicone implants were first marketed and widely distributed more than 30 years ago. In 1992, after many women complained of pain and serious illness when the implants ruptured or leaked, the Food and Drug Administration put a moratorium on the product concluding there was “inadequate information to demonstrate that breast implants were safe and effective.” One major manufacturer of the implants Dow Corning Corp. was forced into bankruptcy because of lawsuits filed as result of the problems caused by the ruptured or leaking implants.

Read more from the Washington Post article, dated November 18, 2006, excerpt below.

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.