FDA Silicone Implant Ban Is Debated

Pamela Dowd drove her 20-year-old motor home 2,500 miles from Boise, Idaho, to tell a government panel how her silicone breast implants led to health problems that had sapped her vitality and made her medically uninsurable.

Terry Heide took time off from her Pentagon job to urge just as emphatically that women be allowed to make their own decisions about the risks and benefits of silicone implants, which many believe have a more natural look and feel than the available saline-filled ones.

The two women, both breast cancer survivors, testified Monday before a Food and Drug Administration advisory panel that was scheduled to hear more than 180 witnesses on the first of three days of deliberations on making silicone implants available to anyone who wanted them.

Two Santa Barbara companies, Inamed Corp. and Mentor Corp., are asking the FDA to lift restrictions imposed in 1992 that largely limited silicone implants to cancer patients seeking breast reconstruction. The restrictions were put in place after the FDA determined manufacturers had not shown the devices to be safe.

The FDA is under heightened congressional scrutiny because of the way it has dealt with safety concerns that have arisen after drugs were approved for sale.

Monday’s testimony exemplified the wide gap between those who believe that silicone implants can cause severe problems and should be kept off the market and those who contend that women should be able to make a decision on the implants after studying the risks.

“If there is no connection between implants and health problems, why the insurance denial?” said Dowd, who is unable to work. “What is the toxic secret insurance companies know about but aren’t sharing?”

She had her silicone implants removed.

Heide, who is a congressional liaison for the Army, said she researched the risks before choosing silicone for her breast reconstruction in 2003. “Silicone is widely used in medical devices,” she said. “If it had all these terrible side effects, we would be seeing worldwide outrage.

“The only reason this is a women’s health issue,” she added, “is that there is an assumption at work that women are incapable of making sound decisions.”

At stake in the debate are tens of millions of dollars in added revenue for the two companies and an improved market for plastic surgeons, who perform more than 250,000 cosmetic breast augmentations a year -- most of which use implants filled with saline solution.

Like many surgically implanted medical devices, silicone implants can be expected to wear out, and some women may have to replace them. One of the main issues before the panel is whether women can be harmed by silicone gel leaking from ruptured implants.

The hearing marks the second time in as many years that an FDA panel has considered the issue. In 2003, Inamed applied for approval of its silicone implants, and a panel recommended that they be allowed on the market. But that decision was overridden by the agency, which said it needed more information. Mentor did not seek approval for its product in 2003.

The current panel is scheduled to vote today on Inamed’s application and Wednesday on Mentor’s, but the final decision is the FDA’s to make.

Monday’s testimony touched on the personal stories of dozens of women and their husbands and children. Several doctors, academic researchers and health advocates also testified.

Studies have failed to link silicone implants to cancer, connective tissue disease, immune system disorders or other illnesses. But some researchers, doctors and patients suspect a link to fibromyalgia, a condition similar to chronic fatigue syndrome.

A New Jersey plastic surgeon, Dr. Caroline Glicksman, told the panel that scientific evidence indicated that silicone implants could be used safely. And if given a choice, she said, most women preferred them. In Europe, she said, 90% of cosmetic breast surgery patients pick silicone over saline implants.

In an interview, Glicksman said the design and construction of the gel-filled pouches had improved markedly in the three decades since health concerns first surfaced. Surgical techniques have also advanced, she said. She drew a contrast between the FDA’s approval of drugs for male impotence and its reticence on breast implants.

“Drugs for erectile dysfunction are sold to enhance the self-esteem of men,” she said, even though some had risks for men with heart trouble. “A man can drop dead in bed, but it’s his right to choose.”

Another plastic surgeon, Dr. Edward Melmed of Dallas, testified that he had performed hundreds of cosmetic breast surgery operations but now did only a few because he became concerned about how frequently the implants broke.

Of 500 patients whose silicone implants he removed between 1992 and 2004, Melmed said, 50% had suffered a rupture within 10 years of getting the implants and 94% had had a rupture within 20 years.

“No doubt there is a group of women who are sickened from their implants,” Melmed said in an interview. “It’s usually diseases like fibromyalgia, a disease that there is no proof of. But the patients all feel lousy.”

He said most plastic surgeons supported the marketing of silicone implants because “first, it’s a lucrative operation, and second, it’s a lucrative operation.”

Representatives of the American Society of Plastic Surgeons say the doctors are doing a brisk business with liquid-filled implants and do not need to generate more work.

The FDA panel hearing the testimony has come under criticism from both sides. Advocates of silicone implants have complained about the panel chairman, Dr. Michael A. Choti, a cancer surgeon at the Johns Hopkins University medical school in Baltimore, who voted against their position as a member of the panel in 2003.

Silicone opponents have complained about a panel member who was paid for helping to develop a video financed by one of the companies. A third member announced his withdrawal Monday after the FDA questioned his stock holdings in a company that is merging with Inamed.