FDA bars marketing of silicone implants

The U.S. Food and Drug Administration has refused to allow a California company to market silicone gel breast implants, continuing a near-ban on the devices because of safety concerns.

After turning down the request of Inamed Corp. to sell the implants in the United States, the FDA also issued new guidelines yesterday suggesting that any manufacturers would have to present significantly more data on the safety of the devices to gain approval.


They will be expected to conduct more testing to determine how long the implants can be expected to last, why they might leak or rupture and how women will know if that occurs. The guidelines note that companies may have to track patients with implants longer than two years, the current minimum, though FDA officials declined to specify how many would be sufficient.

"We need to know when it [leaking or rupture] happens, we need to know why it happens and ultimately we need to know what the consequences are," said Dr. Dan Schultz, director of the FDA's Office of Device Evaluation. "What we want is a picture of the device over the performance of its lifetime."


The agency's action, which could delay a return of the implants for several years, was unusual because the FDA rejected the recommendation of its own advisory panel, which voted 9-6 in October to allow the implants back on the market.

The agency's decision was just the latest step in a 20-year controversy over whether the implants used to enlarge breasts or reconstruct them after cancer or other surgery are safe. Women have complained for years that the implants have caused pain, deformities, fatigue and auto-immune disorders.

Consumer groups commended the agency's action. "The FDA decision ... is a rejection of what would have been the most dangerous, defective medical device ever approved by the FDA despite advanced knowledge of its dangers," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

"At last they've heard us," said Sybil Goldrich, a breast cancer survivor who first complained about implants to the FDA 15 years ago. Goldrich went through four sets of broken implants in the 1980s.

But plastic surgeons were disappointed, arguing that the silicone implants have been exonerated as causes of serious disease and are more natural in appearance than the saline implants that are the only alternative for most women. Some questioned the need for continued study and suggested that factors other than science are clouding the approval process.

"I think what happened here is the bar is being raised constantly and the rules are being changed constantly, and it's because this device is so politically charged," said Dr. Scott L. Spear, chief of plastic surgery at Georgetown University Hospital and a consultant to Inamed. "Suppose this device was a cure for AIDS. It would have been approved in five seconds. It's because of the perception that the benefit of the device is not all that important that people are holding it up to such an incredibly high standard."

The FDA decision was felt on Wall Street yesterday, where Inamed's stock fell $5.80, or 12 percent, to $44. John Putnam, a health industry analyst for Belmont Harbor Capital in Chicago, said he believes no manufacturer could adequately answer the agency's new concerns.

"I don't think any breast implantation product can ever pass that," he said. "How are you going to figure out whether something like that is going to fail?"


Inamed, which learned of the FDA decision late Wednesday, said yesterday that it would continue to seek approval for the implants.

Currently, they are available only to about 40,000 to 50,000 women in clinical studies who require breast reconstruction after cancer surgery, a severe injury or other medical problem. Nearly 250,000 women in the United States underwent breast augmentation in 2002, relying primarily on saline implants. Analysts estimate that consumers spend up to $350 million worldwide on all kinds of implants, with Inamed and Mentor Corp., both of Santa Barbara, Calif., roughly splitting the $250 million U.S. portion.

Breast implants were developed in the 1960s. By the 1990s, so many women complained about problems and had filed lawsuits that Dow Corning, a leading manufacturer of the silicone variety, was forced into bankruptcy protection. The FDA restricted the use of such implants in 1992.

But the debate continued, and in 1999, the Institute of Medicine, a government advisory group, said there is no evidence that rupturing implants could cause problems such as rheumatoid arthritis, lupus or other systemic diseases. Instead, it said implants that ruptured or deflated could cause localized problems, including infections or hardening or scarring of breast tissue.

Inamed had pledged to continue tracking recipients of the implants - an offer that helped sway the FDA advisory panel in October. Ultimately, that wasn't enough for the government.

Dr. Michael Choti, an associate professor of surgery and oncology at Johns Hopkins Hospital, was among the advisory panel members who opposed approving the silicone implants for widespread use. He had concerns, he said, not just about the potential problems they might cause in the breast area but throughout the body.


"We don't really know the long-term effects of having these devices in women, particularly when they rupture or leak," he said. "A woman needs to be able to choose an implant if she wants it. The problem is, in order to have informed consent and to be able to choose, a woman needs to know what are the risks of putting these in the body."

Other physicians are convinced that there is enough evidence the implants are safe.

"I think enough women have had implants for enough years and been studied for enough years that I am quite comfortable placing them," said Dr. Armando D. Soto, assistant director of plastic and reconstructive surgery at Mercy Medical Center in Baltimore.

At the same time, he said, "I tell all my patients to think about their breast implants as essentially fallible, man-made devices. You should not expect your breast implants to last the rest of your life."

Wire services contributed to this article.