FDA Advised to Keep Silicone Implant Ban
By a 5-4 vote, an expert advisory panel recommended Tuesday that the Food and Drug Administration not approve silicone breast implants for cosmetic surgery, citing insufficient information about long-term safety and design problems that caused some devices to break within five years.
The FDA does not have to follow the closely divided panel’s recommendation, but in presentations to the advisory group, the agency’s staff was skeptical of manufacturer reports that only a small proportion of implants fail even after 10 years.
The panel’s recommendation came less than two years after a similar panel voted 9 to 6 to approve silicone implants -- only to be overruled by the FDA, which asked for more safety data. One panel member who voted against approval Tuesday had voted in favor of it when he served on that 2003 board.
Some observers said a more cautious climate seemed to be setting in at the FDA after a series of drug safety problems that have brought sharp criticism from lawmakers.
The agency is “probably a little on the conservative side of the curve,” said Dr. Scott L. Spear, a Washington plastic surgeon who serves as a consultant to implant manufacturer Inamed Corp. “People will tell you that when the FDA is criticized, it hunkers down.”
The panel’s decision was a bitter disappointment for Inamed, a Santa Barbara company, which was seeking approval to market its silicone implants for cosmetic surgery patients. It also sought approval in 2003.
The FDA ordered the silicone devices off the market in 1992 amid controversy about health problems experienced by women who had the implants. Since then, silicone gel implants -- which are considered more natural in appearance and feel than the saline liquid-filled alternative -- have been available only to cancer patients having breast reconstruction or to those who agreed to participate in strictly controlled clinical trials.
Inamed Vice President Dan Cohen said he expected that the company would try again. He said a majority of the panel members seemed to concur that there was “reasonable assurance” of the safety of silicone implants over a shorter period of three years or so.
“The decision of the panel seems to be that they want more time,” Cohen said.
The advisory group is scheduled to vote today on the application of another Santa Barbara implant manufacturer, Mentor Corp. Observers predict a similar result.
More than 250,000 American women a year undergo cosmetic breast surgery, and the debate over silicone has been divisive.
Some believe that silicone in the human body can lead to chronic fatigue syndrome and other health problems. Others say they should be able to choose what kind of implant is best for them. They point out that cancer patients receiving silicone implants are in much more precarious health than most cosmetic surgery patients.
Opponents of silicone had worried the FDA advisory panel was moving to approve the implants, but they cheered as the vote was taken.
“Science has won the day today,” said Diana Zuckerman, president of the National Research Center for Women and Families.
Though the FDA is not bound to follow the recommendation, she said, “I don’t think the FDA can afford to do anything embarrassing. Approving this product after this kind of vote would be very embarrassing.”
In the past, the FDA has approved drugs and medical devices against the recommendations of its advisors. One example is the weight-loss drug Meridia; another is Contak CD, an implantable defibrillator for advanced heart failure.
Explaining their votes, members of the panel’s majority cited the lack of information on the durability of implants after many years. Unlike saline implants, which deflate when they break, ruptures of silicone implants are not usually noticeable by look or feel, so panel members were concerned about reliability.
“I feel it was premature,” said Dr. Amy E. Newburger, a Scarsdale, N.Y., dermatologist who offered the nonapproval motion. “I don’t feel secure about safety. I don’t feel at this time that patients can grant informed consent.”
But Dr. Michael J. Miller, a plastic surgeon at Houston’s M.D. Anderson Cancer Center, said he believed that silicone implants could make a big difference in a woman’s quality of life.
“I’m one of the few people on this panel for whom caring for these women is not a theoretical construct,” he said, adding that his experience with patients having reconstructive surgery led him to conclude that the benefits of silicone outweighed the risks.
Stephen Li, president of a Sarasota, Fla., medical devices company, was the panel member who voted no after having previously voted yes. He described himself as “the weakest of the nos” and urged the FDA to continue its analysis of silicone implants.
“I would have voted unequivocally yes if we had [additional] data,” Li said. “We really don’t know why this device is failing when it fails.”
Much of that concern was focused on one of Inamed’s many implant models, Style 153, which is shaped like a teardrop. The company’s own data showed it to be disproportionately prone to rupture and leaks. Inamed said it had submitted a plan for design changes to correct the problem. But even panel members who had no qualms about silicone implants expressed reservations about Style 153.
The timetable for an FDA decision on the recommendation could range from six weeks to several months. The panel’s vote came after the stock market closed for the day. In after-hours trading, Inamed’s shares dropped 11% and Mentor’s stock fell 2%.
Inamed derives 57% of its revenue from saline and silicone implants, but it has been diversifying into skin care and recently announced plans to be acquired by Medicis Pharmaceuticals Corp. of Scottsdale, Ariz.
In testimony to the panel, FDA staffers acknowledged that Inamed supplied the agency with considerably more information than was available two years ago about how and why its silicone breast implants ruptured.
But medical reviewers for the agency said they still lacked enough data to answer some crucial safety questions.
One dealt with what happens to silicone that leaks into the body. It can seep from ruptured implants or bleed from intact ones. Some studies have found silicone in the lymph glands of women with breast implants.
“The FDA believes the answer to this question is crucial with respect to determining the safety of this device,” said Dr. Sahar Dawisha, one of the FDA’s medical reviewers.
Another question involved how implants deteriorated and whether they ruptured at the same rate after years of wear or became more likely to fail.
Dawisha testified that the agency was skeptical of Inamed’s reports that rupture rates would remain fairly constant, in the low single digits, year after year.
To illustrate the uncertainty of the long-range estimates, the FDA prepared a set of mathematical projections for the panel. The probability of rupture by the 10th year ranged from 5% to 29% for cosmetic surgery patients and from 39% to 95% for cancer patients having breast reconstruction.
Dr. Patricia Walker, Inamed’s chief scientific officer, called the FDA’s projections of high rupture rates “highly speculative.” The company said its estimate was that the cumulative rupture rate by the 10th year would be 14%, much lower than any of the FDA’s estimates.
Inamed experts said their current generation of implants had a thicker covering to decrease the risk of rupture and a type of gel that stayed together if the implant covering failed.
Walker said enough was known about the risks and benefits of silicone implants that women could be reasonably confident of their safety. “In the United States, women and their physicians should be able to choose the implant that best suits their needs,” she said.
Times staff writer Denise Gellene in Los Angeles contributed to this report.
