FDA recommends lifting ban on silicone-gel implants

WASHINGTON -- Eleven years after most silicone-gel breast implants were prohibited, government advisers recommended on Wednesday that the ban be lifted despite lingering questions about safety and durability.

But the Food and Drug Administration's advisers urged that Inamed Corp.'s sales be allowed only under certain conditions, including ensuring that all users get detailed brochures explaining the devices' known risks -- such as a need for frequent reoperations for pain or breakage.

Women will need annual exams to be sure their implants haven't silently begun leaking, the panel stressed. That will be expensive and hard to ensure, the scientists acknowledged, but crucial because implants can break without immediate symptoms and should be removed when that happens.

"This is as important as your annual mammogram," said FDA adviser Barbara Manno, a Louisiana State University toxicologist.

All implant recipients also must be enrolled in a registry to track their health.

The vote was 9-6.

The panel also said Inamed must do more research tracking women's health for 10 years after implants, a time when many say their devices begin breaking and causing painful disorders. So far, Inamed's research tracks women's health for three years.

Still, after two days of debate, the panel ultimately agreed with Inamed's argument that it is not fair to restrict women's access to silicone implants when research suggests they break and cause other problems no more frequently than today's main alternative -- implants filled with salt water.

The decision came after emotional testimony pitting woman against woman: those who say implants broke inside their bodies to leave them permanently damaged and those who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.

If women keep their implants long enough, they all may break eventually, panelists said.

The question is how to tell: Saline-filled implants deflate so fast that women know they've broken, but silicone leaks slowly and may not cause immediate symptoms. Because women may not be able to get all the leaking silicone out of their bodies, "we have to hold this to a different standard," argued adviser Dr. Amy Newburger, a New York dermatologist.

The FDA ended routine sales of silicone breast implants in 1992, restricting them to breast cancer patients in strictly controlled clinical trials.

Seeking to restart broader sales, Inamed Corp. argued that the implants have been exonerated.

Indeed, studies to date show little evidence the implants cause major diseases such as cancer.

But the FDA worries that rare disease issues aren't settled, and that subsets of women -- especially the small proportion who have silicone leaking through scar tissue into the breast or beyond -- might be more vulnerable to painful conditions like fibromyalgia.

"I wanted to be more beautiful. Instead, my breasts became hard, scarred and ugly," Rebecca Smith-Miles, of Michigan, told the FDA panel. She was one of more than 100 women, plastic surgeons and consumer advocates who spoke over the two days.

Susan Schambeck pleaded for women to have a choice.

"I didn't like the feeling of wrinkled water bags in my body," she said, explaining why she exchanged salt-water implants for those filled with silicone gel.

"It is not a perfect device," said Dr. James Wells, president of the American Society of Plastic Surgeons. But, he said, "the procedure significantly improves the quality of life for many patients."

After 16 hours of testimony and debate Tuesday, the advisers cited a problem: Research by FDA and others suggest implants start breaking and leaking after seven years, but Inamed hasn't tracked women's health for nearly that long.

"A decade has passed and we sat here today talking about two- and three-year data. I'm flabbergasted," said Dr. Thomas Whalen of the Robert Wood Johnson Medical School, the advisory panel's chairman.

Silicone implants break no more often and require no more extra surgery than do implants filled with salt water that currently are Americans' main option, argued Inamed executive JoAnn Kuhne.

She pledged that the company will continue to track the health of patients in its key study for another seven years, even if the implants are allowed to sell in the meantime.

The study indicated that after three years, up to 46 percent of silicone implant recipients needed additional surgeries because of painful scar tissue and other complications. Up to a quarter of the women had to have the devices removed or replaced.

And in some women -- about 6 percent of breast cancer survivors, fewer women who get the implants for enlargement -- the implants silently break, leaking without immediate symptoms to signal that they should be removed.