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FDA Advised to Keep Silicone Implant Ban

In a panel's 5-4 decision, experts cite insufficient data on the extended safety of the gel devices.

April 13, 2005|Ricardo Alonso-Zaldivar | Times Staff Writer

GAITHERSBURG, Md. — 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."

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