Women and doctors open debate on breast implants

November 13, 1991|By New York Times

IN THE OPENING of what promises to be a three-day marathon of heated debate, women with breast implants and doctors who treat them came before an advisory committee of the Food and Drug Administration yesterday to testify on whether silicone implants should be banned in the United States.

Some women spoke angrily about the health problems they said they had endured because of the implants. Others said they were delighted with their implants; some said they would keep them even if they were a health threat.

And the doctors, plastic surgeons for whom implants are a substantial part of their practice, said the devices should stay on the market.

"I am a gambler," said Wanda Bruce, a 50-year-old woman from Glen Allen, Va., who told the panel she had implants after she lost both breasts to cancer last April. "I'd rather have quality of life than quantity. Not that I think implants will take my life, but I am almost at that point that I'd have them anyway."

Karen Berger, an author affiliated with plastic surgery, said women get implants "to restore what cancer has taken away," and added, "They are motivated not by vanity, even though that is a legitimate reason, so much as by a desire to be whole again and put the cancer behind them."

But Barbara Herzog, 42, a dairy farmer in Pennsylvania, said she has had problems she attributes to the implants she received in 1977. Twelve years later, she said, she began having arthritis-like pain in her joints and ulcers in her mouth, and wondered if her implants had ruptured.

"I went to Johns Hopkins, had an MRI scan and they said no, the implants look fine." she related. "Eight weeks later I had them taken out anyway. The doctor found both had ruptured long ago and silicone was all over the inside of my chest."

She said she bore a child two years ago, "and I breast-fed silicone to my infant daughter." Now, she said, she wants the FDA to "ban silicone gel implants until we get some answers"

The advisory committee is to issue its recommendations tomorrow. The agency is not expected to act on the matter until January; usually, it follows the advice of its such panels.

More than 2 million American women have had breast implants, 80 percent of them for cosmetic reasons. About 150,000 women a year have surgery for breast implants, and the number has been increasing.

The implants can rupture, releasing silicone into the body. But even if they remain intact they can cause a number of problems, including the formation of hard scar tissue. Critics say the implants can also cause auto-immune disorders.

Companies that manufacture the implants say they have been used successfully for more than 30 years. Their studies show they cause few serious problems, they say. But FDA officials have said the studies involved too few patients or lasted too short a time.

"The manufacturers must show these products are safe and effective in relation to their benefits," David Kessler, the commissioner of food and drugs, told the panel at the opening of the hearing. "Simply saying the devices have been used for 30 years without major problems does not meet the standard of proof."

After he spoke, doctors from medical specialties that would be affected by the FDA decision challenged Kessler's statement.

Dr. Edward S. Truppman, head of the American Society of Aesthetic Plastic Surgery, said the burden of proof rests with the FDA as well as the industry.

The hearing, which was held in a ballroom of the Holiday Inn in Gaithersburg, lasted far into the evening. Scores of people packed the hearing room and spilled out into the hallway, where they strained to hear the testimony.

More than 120 women, surgeons and representatives of medical groups have signed up to to speak. Spokesmen for the manufacturers are expected to present their views today, and the committee will discuss the issue and make its recommendations to the commissioner tomorrow.

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