April 13, 2005 - An FDA advisory panel recommended Wednesday that silicone implants be brought back to the U.S. market for breast augmentation, 13 years after the agency enacted a partial ban on their use because of safety concerns.
Experts backed one company's bid to sell the implantsbecause of concerns about durability and safety.
The panel supported the application from implant maker Mentor by a 7 to 2 vote. But the panel recommended that strict conditions be imposed on the manufacturer, including close patient tracking and informed consent. The panel also called for certification of physicians implanting the silicone-filled devices.
A final FDA approval would give the company access to the more than 340,000 women expected to seek cosmetic breast enlargement surgery this year. The agency ordered the implants off the broad market in 1992, restricting them to women seeking reconstructive surgery following a mastectomy.
Several panel members said they based their support Wednesday on evidence that Mentor's implant appeared less likely to rupture than a similar implant produced by Inamed, a rival firm. Inamed's application for producing implants was rejected by the panel on Tuesday.
But experts also expressed unease with thewhich for years have sparked controversy because of suspicions that they could leak and cause autoimmune diseases and other illnesses.
Mentor officials presented a study showing that their implants ruptured in 1.4% of all cases (enlargements and reconstruction) within three years after surgery, representing about one in every 72 women who used them. The implants broke within three years in one in every 200 women who got them specifically for cosmetic breast enlargement, the company said.
Officials said none of the ruptures resulted in adverse health problems or disease, except for some breast pain and altered shape in a few cases.
The company also presented a small British study suggesting that the implants could be expected to rupture in 5.4% of women within nine years, a much lower rate than the 14% rupture rate projected by Inamed.
On Tuesday, experts rejected Inamed's application in part because the company relied on projections and did not directly study its implants' reliability for longer than three years.
Mentor also did not directly study long-term use, but instead offered laboratory stress testing that the company said was proof that the implants could withstand up to 60 years of wear and tear in the body.
"These are two different devices," said panelist Stephen Li, who supported Mentor's application after opposing Inamed's bid the day before. "They [Mentor] had an extremely low rupture rate."