A Food and Drug Administration advisory panel recommended Thursday that silicone gel-filled breast implants be returned to the market under closely supervised conditions and sharply limited availability.
After two days of hearings, the panel unanimously agreed the implants should be made available only to women who agree to participate in tightly controlled, clinical studies that will help determine whether the devices are safe and effective.
The 22-member panel will forward its recommendation to the FDA, which on Jan. 6 placed a moratorium on use of the implants pending a review of new scientific data concerning their safety. The FDA has 60 days to act on the recommendation, although the agency might move sooner, said FDA Commissioner David Kessler.
Advisory panel members quickly dismissed the idea of continuing a total ban on implants. But they disagreed over the level of risk presented by the implants, which in some cases have ruptured or leaked silicone into women`s bodies.
Panel member Dr. Jules Harris, referring to research indicating a higher rate of rupture than previously believed, said, ”I do not find this evidence convincing but it is disturbing.”
During its deliberations, the panel also considered data suggesting that the implants may be linked to diseases that impair the body`s ability to fight off infection.
Several panel members said they believed the risks were minimal, while others insisted even the sketchy data available on effects of the implants indicate an urgent need for further study. Those studies, they agreed, should take place on a nationwide basis and include as many different types of patients as possible, including breast cancer patients and women seeking the implants strictly for cosmetic reasons.
In particular, panel members expressed concern about risks to women seeking the implants to augment their breasts merely for cosmetic reasons and recommended that the availability of the devices be limited to a ”core group” of such patients under closely supervised conditions in clinical studies at research centers or teaching hospitals.
Those women tend to be younger than other implant patients and generally have no other health problems.
Because the possibility of rupture, leakage or adverse side effects increases over time, the risks may outweigh benefits for such women, they said.
The panel emphasized that implants should be made widely available to cancer patients who need them for reconstruction and to women disfigured by burns or congential deformities.
Several panel members warned that the government should not be paternalistic or make moral judgments about patients who want implants for cosmetic reasons.
But Mary Davis, associate professor of toxicology at West Virginia University in Morgantown, said giving women the right to decide for themselves whether to use implants ”assumes women have the information they need to make an informed choice. They don`t have that data.”
The panel did not place specific restrictions on the number of women who may participate in the clinical studies, but left such matters up to the FDA to spell out, should it accept the recommendation.
Estimates on how many women have received silicone implants vary from about 500,000 to 2 million. About 80 percent have chosen them for cosmetic reasons, the rest for cancer-related reconstruction.
Panel members urged that women who have implants should not have them removed as long as there are no symptoms that may signal rupture or autoimmune disorders. Such patients were advised to have regular exams and ask their doctors about X-rays, ultrasound and other imaging procedures to detect rupture or leakage.
Earlier this week, the leading maker of silicone implants, Dow Corning Corp., pledged to conduct more safety tests on the devices and said it would establish a registration system for follow-up on implant patients.
Dow Corning has maintained the implants are safe and that any development of immune-type ailments in women who had them was coincidental.
Kermit Campbell, a Dow Corning group vice president, said he was ”not disappointed” with the panel`s recommendation. He said the company was considering pulling out of the silicone-implant business.
”We expect the market to be smaller. It is not large enough for four manufacturers,” he said.
FDA commissioner Kessler appeared satisfied with the panel`s recommendation, saying its advice ”will be of great importance in reaching a decision.” He said the implant controversy was ”without a doubt the most difficult issue I have faced since becoming commissioner.”
Kessler said the FDA had doubled to 20 the number of phone lines for women to call the FDA toll-free (1-800-532-4440) for information about implants. ”People are having trouble getting through,” he said.
One critic of the panel`s decision, Sid Wolfe, director of the Health Research Group in Washington, called for Kessler to reject it. ”It`s unconscionable to do further human experiments,” Wolfe said. He said the implants should be tested on animals before any further use in humans.
But several women who attended the hearings in support of implants praised the outcome.
”Implants will be on the market, which is good, and they will be controlled, which is good,” said Sue Richardson of Irving, Texas, wearing a button that said ”Women for Implants.”
She added, ”There is still a lot of ambiguity for women who want them. They don`t know where to go or how to get them. Those questions will have to be answered.”
