WIRED Staff

FDA OKs Silicone Breast Implants

Lifting a ban in place since 1992, the U.S. Food and Drug Administration on Friday approved silicone breast implants manufactured by Mentor and Allergan. “FDA has reviewed an extensive amount of data from clinical trials ofwomen studied for up to four years, as well as a wealth of otherinformation to determine the benefits and risks […]

Lifting a ban in place since 1992, the U.S. Food and Drug Administration on Friday approved silicone breast implants manufactured by Mentor and Allergan.

“FDA has reviewed an extensive amount of data from clinical trials ofwomen studied for up to four years, as well as a wealth of otherinformation to determine the benefits and risks of these products,”
said Daniel Schultz, M.D., Director, Center for Devices andRadiological Health, FDA. “The extensive body of scientific evidenceprovides reasonable assurance of the benefits and risks of thesedevices. This information is available in the product labeling andwill enable women and their physicians to make informed decisions.”

The announcement comes a couple of weeks after Bodyhack editor Kristen Philipkoski's prescient Nov. 6 article on Wired News predicting an end to the ban in the U.S.