WASHINGTON - Thirteen years after they were banned because of health concerns, silicone gel breast implants are heading for a comeback - but opposition is also returning, and federal regulators are at the center of the re-emerging controversy.
With momentum building for final approval of the implants, perhaps by year's end, critics called on the Food and Drug Administration yesterday to hold off until completion of further study on the long-term health effects and of a recently launched Senate investigation into the agency's decision-making.
"We can't risk another Dalkon Shield," Cynthia Pearson, executive director of the National Women's Health Network, said, referring to the contraceptive intrauterine device that was recalled in 1975.
Since the FDA banned most use of silicone gel implants in 1992 amid concerns that they can rupture and cause connective tissue, multiple sclerosis and other serious diseases, manufacturers have made a slow recovery to rebuild their case for government approval. Pressure from women interested in the implants - and from those opposed to their return - has also grown.
Breast augmentation surgeries are increasingly popular. Last year, more than 264,000 were performed. Some doctors and patients have been clamoring for silicone gel implants, which they say feel more natural and look better than the saline devices available. Many studies, including a review by the Institute of Medicine at the National Academy of Sciences, have indicated they do not cause major diseases.
But as the FDA began signaling its likely approval this spring, ethical questions have shadowed its decisions.
The FDA's decision late last month to grant Mentor Corp. approval to resume selling the silicone gel implants if it meets certain, undisclosed conditions has drawn the embattled agency into a controversy about its integrity and concern for public safety. Its refusal to release the conditions that Mentor must meet has also sparked criticism.
The Senate Health, Education, Labor, and Pensions Committee is investigating allegations of conflict of interest on the panel of scientists and surgeons who advise the agency on breast implants, said committee spokesman Craig Orfield.
During a news conference yesterday, women's groups and consumer advocates alleged that a member of the advisory panel participated in paid research for a silicone gel implant manufacturer and that Mentor sold defective implants and gave the FDA fraudulent and misleading data.
Calling for further investigation by Congress, the critics displayed graphic photographs of several women who, they said, had been disfigured by defective implants.
"The FDA must not put corporate profits over women's health," said Kim Gandy, president of the National Organization for Women.
FDA spokeswoman Julie Zawisza said the agency reviewed long-term studies submitted by Mentor showing that the implants could be safe and effective. She said the objections would not halt the move toward final approval.
"It's not that we turn a blind eye to public concerns - we absolutely don't," she said. "But at the end of the day, we still have to look at the scientific and technical data to make our decision."
The FDA has not given a timetable for final approval. Mentor has said the conditions set by the agency are similar to those recommended by the advisory panel. Those conditions would have required plastic surgeons to receive certification before using the devices and Mentor to complete a 10-year study on implant safety.
Mentor dismisses health concerns over the implants as unfounded "myths" and says it is seeking to sell the devices because women want the option.
Josh Levine, president and CEO of the Santa Barbara, Calif., company, issued a statement yesterday rejecting the concerns of the women's groups and consumer advocates as "old accusations from parties with agendas that go well beyond the safety and efficacy of these products."
Both the company and the FDA said an agency investigation cleared Mentor of allegations of improper sales and fraudulent reporting.
"There was nothing there," Zawisza said. "I presume we will be passing that on to the Senate, if we haven't already."
The American Society of Plastic Surgeons supports the return of silicone gel implants.
"There's been 13 years of very intensive study, and based on all of the scientific evidence, there's clear evidence that these devices are safe and effective," said Dr. Maurice Nahabedian, an ASPS member who is a Johns Hopkins associate professor of plastic surgery. "Because of that, women should have the right to choose."