FDA Panel Backs
Made of Silicone
GINA KOLATA / NY Times 16oct03
PROFIT OVER HEALTH
GAITHERSBURG, Md., Oct. 15 — In a 9-to-6 vote, an advisory panel to the Food and Drug Administration recommended on Wednesday that silicone breast implants be allowed back on the market after an 11-year hiatus.
But, concerned about a dearth of data on how safe the implants are and how well they hold up over a decade or more, the panel said its approval was contingent on a list of conditions, like education of surgeons and patients and continued monitoring of women who get implants. The implant maker, the Inamed Corporation, had volunteered most of those conditions in seeking the agency's approval.
The Food and Drug Administration usually goes along with the advice of its expert panels, even when the vote is divided. Kathleen Quinn, a spokeswoman for the agency, said it would decide in "weeks to months," but there was no specific time line.
The panel's decision worried some who said they were not convinced the safety of silicone implants had been established. Some expressed concern that the provisions 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 educational and advocacy group.
Others said the panel's decision was the right thing to do.
"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. Dr. Connell was the chairwoman of a 1992 F.D.A. panel that recommended a moratorium on the sale of implants while data were gathered on their safety. Dr. Connell is now a senior counselor to Citizens Against Lawsuit Abuse, an advocacy group, but said she had no connection to Inamed. She said she was satisfied with the data compiled since 1992.
Panel members said they had agonized over their votes. Women can have saline breast implants, but many say they feel hard and unnatural and can suddenly deflate.
Panel members said they worried about the paucity of information on how likely a silicone implant was to rupture or what sort of complications could be expected after two years or so. Yet the agency generally allows device makers to start selling their products after they complete 2 years of a 10-year study. And Inamed had worked with the government to prepare the data the agency requested.
"This was unbelievably difficult, much more difficult than I had ever anticipated," said a panel member, Dr. Benjamin O. Anderson, the director of the Breast Health Center in Seattle 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," Dr. Dubler 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 after it is approved.
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 Food and Drug Administration asked manufacturers to withdraw them from the market, citing concerns that data on their safety were lacking. In the years that followed, hundreds of thousands of women sued the implant makers, some saying the devices had caused serious ailments like autoimmune disease, neurological diseases, chronic fatigue syndrome and cancer.
"There used to be 10 companies making implants, said Dr. Michael Miller, a panel member who is a plastic surgeon at the University of Texas M.D. Anderson Cancer Center in Houston. "The competition has been destroyed."
Inamed said it hoped its studies would satisfy the government 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.
Over a two-day period, starting at 8 a.m. on Tuesday and adjourning after midnight, then starting again at 7:30 a.m. Wednesday, the panel heard presentations of data from the agency's staff and from Inamed and heard often emotional statements from more than 100 people, with widely divergent views.
Many women who had had implants told the panel they were silicone victims, with serious medical problems. 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 had improved the device in the last decade, making it with a thicker shell and filling it with a more cohesive gel. The company said it had seen a rupture rate of 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 Dr. Scott Spear, a consultant to Inamed and a plastic surgeon at Georgetown University.
He said that the most common device-related complication that led to additional operations was contracture, the formation of painful scar tissue that forms over an implant. Dr. Spear said that over two years, 7 percent of women who had implants for augmentation and about 15 percent of women who had them for breast reconstruction needed more surgery for this reason. But, he said, government-approved saline-filled breast implants also elicit contracture, and at the same rate.
With any plastic surgery, Dr. Spear said, it is common for patients to have operations to improve or repair the original procedures. For example, he said, 20 percent of patients who had nose reconstruction had additional surgery.
"Some members expressed concern that 20 percent of augmentation patients and 45 percent of reconstruction patients have re-operations," Dr. Spear said. "Re-operation and revision is part of what distinguishes plastic surgery from other fields of surgery."
Dr. Dubler said she still worried about the safety of implants over periods of longer than two years.
"So I'm faced with a problem," Dr. Dubler said before she made up her mind to vote yes. "To approve something which doesn't have the data to support its safety seems to me to be irresponsible, but not to expand access seems mean."
Dr. Miller suggested that the panel's problem reflected a deeper issue. Safety, he said, is a ratio of benefit to risk, and when it comes to implants, few agree on benefits.
Some who testified at the meeting felt so strongly that breast implants were unnecessary, and even immoral, that not even a perfect safety record would persuade them that they should be sold. Others saw such an enormous benefit that they were willing to accept substantial risk.
The risks of the device, in contrast, "are pretty clear," Dr. Miller said. There is a short-term risk, primarily of rupture or contracture. As for long-term risks, of diseases like cancer, chronic fatigue, lupus, arthritis and neurological disorders, they have not shown up in large epidemiological studies, he said.
"What we have to avoid is getting into the business of deciding for people what the benefit is," Dr. Miller said. "The person who wants the surgery has to go through the risk-benefit exercise in their own mind. A large amount of latitude has to be given to people to decide for themselves."
source: http://www.nytimes.com/2003/10/16/health/16IMPL.html?tntemail0=&pagewanted=print&position= 15oct03
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