FDA panel would allow silicone breast implants

Advisers put conditions on sale of devices, such as education, monitoring


In a 9-6 vote, an advisory panel to the Food and Drug Administration recommended yesterday that silicone breast implants be allowed back on the market after an 11-year hiatus.

But concerned about the dearth of data on the safety of the silicone implants and their durability over a decade or more, the panel said its approval was contingent on a list of conditions, such as education of surgeons and patients and continued monitoring of women who receive implants.

The implant maker, Inamed, had volunteered to meet most of those conditions in seeking the agency's approval.

The FDA usually implements the advice of its expert panels, even when the vote is divided.

Worries about safety

The panel's decision worried those who said they were not convinced that the safety of silicone implants had been established. Some expressed concern that provisions outlined for monitoring women with implants were not enough to make a difference.

"This was a triumph of wishful thinking over science," said Dr. Diana Zuckerman, of the National Center for Policy and Research for Women and Families, an education and advocacy group.

Others said the panel's decision was right.

"There are no serious health risks, and women like them and want to use them," said Dr. Elizabeth Connell, an emeritus professor of obstetrics and gynecology at Emory University. She was the chairwoman of a 1992 FDA panel that recommended a moratorium on the sale of implants while data were gathered on their safety. Connell said she was satisfied with the data compiled since then.

Panel members said they agonized over their votes, pointing to a lack of information on the likelihood of implant ruptures and the complications that might be expected after two years or so.

Yet the FDA generally allows device makers to start selling their products after they complete two years of a 10-year study. Inamed had worked with the FDA to prepare the data the agency requested.

"This was unbelievably difficult, much more difficult than I had ever anticipated," said Dr. Benjamin O. Anderson, a panel member who is director of the Breast Health Center and associate professor of surgery at the University of Washington. He voted in favor of approval, he said, because "ultimately I believe in the right to choose and informed consent."

One panel member, Dr. Nancy A. Dubler, who directs the division of bioethics at Montefiore Medical Center in the Bronx, changed her mind hours before the vote. "I came back from lunch prepared to vote no," she said. But she reversed herself after hearing Inamed's plans to educate women and doctors, to monitor women and to supply data on the device's safety.

If the agency follows the committee's advice, silicone breast implants will have made a remarkable comeback, after a highly public and explosive fall from grace.

The devices have been largely unavailable since 1992, when the FDA asked manufacturers to voluntarily withdraw them from the market, citing concerns that data on their safety were lacking. Implants containing a saline solution remained on the market.

Since 1992, hundreds of thousands of women claimed that their implants made them ill, with disabling diseases that included cancer, autoimmune disease, neurological diseases, chronic fatigue syndrome and cancer.

In the meantime, Inamed began studies that, it hoped, would satisfy the FDA that its implants could be sold. The advisory committee hearings were held to allow a disinterested panel of experts a chance to hear the company and those who had strong opinions about implants.

Divergent opinions

Over two days, starting at 8 a.m. Tuesday and adjourning after midnight, then resuming at 7:30 a.m. yesterday, the panel heard presentations of data from the FDA's staff and from Inamed. It heard often emotional statements from more than 100 people with widely divergent views.

Many women who had had implants told the panel that they were silicone victims, with multiple and serious medical problems that they blamed on their implants.

Others said they were delighted with their implants, including cancer patients who pleaded with the panel to let women have the opportunity to choose the silicone version for reconstructive surgery.

The panel also heard Inamed's assertion that it improved the device over what was sold a decade ago, making it with a thicker shell and filling it with a more cohesive gel. The company said it also has seen a rupture rate that was lower than officials had expected, about 1 percent a year.

"Although that is higher than I would like, it is not the doomsday scenario that many people would have you believe," said Inamed's consultant, Dr. Scott Spear, a plastic surgeon at Georgetown University.

He said the most common device-related complication that leads to additional operations is the formation of painful scar tissue that closes down on an implant, or contracture.

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