WASHINGTON, Nov. 17 (UPI) -- The U.S. Food and Drug Administration Friday approved marketing of silicone gel-filled breast implants, ending a 14-year moratorium on the devices.
"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "This information is available in the product labeling and will enable women and their physicians to make informed decisions."
Supporters of the implants hailed the decision.
"For us, it's a triumph of science," Dr. Richard A. D'Amico, president-elect of the American Society of Plastic Surgeons, told The New York Times.
The decision was based on a review of clinical and preclinical studies, a review of studies by independent scientific organizations and testimony taken by advisory panels of outside experts who heard public comment from hundreds of stakeholders, the FDA said.
The approval restricts breast augmentation to women ages 22 and older. Breast reconstruction is available to women of all ages.
The FDA also ordered manufacturers Allergan Corp. of Irvine, Calif., and Mentor Corp. of Santa Barbara, Calif., to conduct post-approval studies for 10 years.