FDA advisers cite need for more data on silicone implants
Wednesday, October 15th 2003, 12:00 am
By: News On 6
WASHINGTON (AP) _ Eleven years after safety fears forced a near-ban of silicone-gel breast implants, government advisers struggled Wednesday to decide whether it's time to allow wider sales despite troubling questions about long-term risks and the durability of today's models.
Silicone gel implants were highly popular until the Food and Drug Administration ended routine sales in 1992, restricting them to breast cancer patients in strictly controlled clinical trials because of concern that leaking silicone could cause serious illnesses.
Now Inamed Corp. wants to restart sales, arguing the implants have been exonerated.
Indeed, studies to date show little evidence the implants cause major diseases like cancer or lupus.
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 an FDA panel Wednesday as the last of more than 100 women, plastic surgeons and consumer advocates argued over two days for or against the controversial devices.
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,'' acknowledged 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.''
FDA scientific advisers were scheduled to make their recommendation Wednesday. The FDA won't be bound by the panel's advice, but usually follows it.
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.
``It simply boggles the mind,'' agreed fellow panelist Nancy Dubler, a bioethicist at Albert Einstein College of Medicine _ who also asked why Inamed hadn't solved the problem by making implants more durable in the last decade.
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.
After three years, up to 46 percent of silicone implant recipients in that study 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.
``What is happening to that silicone?'' asked FDA adviser Barbara Manno, a toxicologist at Louisiana State University.
Another adviser, Dr. Ruth Lawrence, a breast feeding expert at the University of Rochester, raised questions about the impact on children whose mothers had an implant. ``The data is not very robust as to the effect on children born to mothers who had implants,'' she said.
A string of women implored the FDA to allow them to make the choice, arguing that silicone implants feel more natural than saline implants, which aren't perfect either.
But dozens of other women told the FDA that implants caused disabling pain and disfigurement _ problems that often struck once they'd had the implants for a decade or more.
In debate that stretched past midnight, the advisers appeared torn on how to settle the concerns _ or if women should be able to choose silicone implants knowing there are still unanswered questions.
``I believe in the right to choose,'' said FDA panelist Dr. Benjamin Anderson, a University of Washington cancer surgeon. But he stressed if that's ultimately the decision, women will need some basic guidelines on how often to check for leaks and when to remove old implants _ information also still up for debate.