The Food and Drug Administration has overruled an advisory committee by granting conditional approval to
to sell silicone gel breast implants for cosmetic surgery.
If the agency ultimately approves the Inamed product, the Santa Barbara, Calif.-based company will join
, its next-door neighbor and rival, in selling these implants.
received conditional FDA approval
in late July, but neither the company nor the FDA described the conditions or the timetable for meeting the conditions.
U.S. sales of silicone gel implants have been restricted since 1992 to a few uses, such as for women undergoing breast reconstruction after mastectomies and women whose silicone gel implants had ruptured. The restrictions reflect tougher FDA requirements that manufacturers provide long-term safety data to support applications for their devices.
The FDA's announcement on Wednesday sent Inamed's stock rising $5.96, or 8.4%, to $77.02, a new 52-week high. In the first two hours of trading, more than 3.44 million shares were traded, or nine times the average daily trade for the last three months. Mentor's stock fell $2.38, or 4.5%, to $50.18 in heavy trading.
The FDA offered no details about the conditions or timetable for approving Inamed's implant. "The conditions outlined in this letter are generally in line with our expectations and the discussions that took place at [previous] FDA advisory panel meetings, and we look forward to working with the agency ... in addressing them," said Nick Teti, Inamed's chief executive officer.
The FDA noted that an advisory committee voted 5-4 in April against Inamed's silicone gel implant application. "Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the agency said Wednesday. The FDA said Inamed will no longer make a certain implant that had raised safety concerns among panel members.