Rockville, Md. — A federal advisory panel has recommended allowing silicone-gel breast implants to return to the U.S. market following a 13-year ban on most uses — but only if manufacturer Mentor Corp. meets strict conditions.
A U.S. Food and Drug Administration (FDA) committee voted 7-2 on April 13 to approve Mentor's bid — one day after the panel rejected a similar bid from rival manufacturer Inamed Corp. by a vote of 5-4. The panel said Inamed had failed to resolve long-term safety concerns.
A Mentor study showed that only 1.4 percent of recipients experience implant ruptures in the first two years after insertion. The company estimated that 9 percent to 15 percent could experience ruptures after 12 years, according to news reports.The FDA panel said implant sales should resume, however, only if prospective patients sign consent forms acknowledging the risks, only if Mentor sells the implants to board-certified plastic surgeons who complete special training, and only if Mentor warns patients to undergo MRI scans five years after insertion and every two years after that.
The FDA previously rejected a 2003 advisory panel recommendation to allow Inamed implants back on the market.