Health Risk or a Woman's Choice?
No scientific consensus on silicone breast implants
Both Carolyn Wolf and Michele Columbo came to the Food and Drug Administration's advisory panel meeting on breast implants last week with strong feelings about the availability of silicone implants. Wolf, now 74, had her implants put in more than 30 years ago after a mastectomy. For the first seven years things went all right. Then, she started getting blisters on her neck and boil-like growths on her forehead. She had chest pains so bad they put her in intensive care. Five years ago she felt intense pain in her left eye. A string of silicone, about an inch long, came out of that eye. Then strings started coming out of her ears. Wolf had her severely ruptured implants removed in 2000, but she still suffers from short-term memory loss that she attributes to the implants. "Please," she told the panel, "do not inflict this on another generation."
Columbo, 35, got implants last year to correct a condition she'd had since birth. Before she did, she researched implants exhaustively to convince herself they were safe. She hasn't had any problems, including when she breast-fed her son. In 1992 an FDA decision had restricted silicone implants to women who've had mastectomies or have a congenital deformity like Columbo's. She testified that she believes that women are competent and educated enough to make their own decisions about what type of implant is right for them. "I don't understand why the FDA can decide they are safe for me or breast cancer patients but not for someone else," she says. "The difference here is a moral one, not a medical one."
The two women's different experiences epitomize last week's emotionally charged hearings, which yielded more questions than answers about whether breast implants should be restricted as a health hazard or offered as a woman's personal choice. The FDA panel voted 7 to 2 to recommend the approval of Mentor's silicone implant and 5 to 4 to reject Inamed's similar implant. Many thought such a split vote was unlikely, and the result makes it hard to predict what the FDA's final decision will be when it considers the recommendations in the months ahead. If it agrees with the panel, silicone implants will once again be available to all American women.
Silicone breast implants were first used in the United States in the 1960s, but the FDA pulled them from the market in 1992, saying there were insufficient safety data. In 2003, Inamed presented an application to the FDA to bring silicone back to the market. That was approved by the advisory panel but turned down by the agency, which asked for more long-term safety studies. Though last week's panel gave silicone implants a vote of confidence, lingering safety concerns prompted it to impose stringent approval conditions to make sure that both patients and surgeons are educated and to ensure that any problems are reported. "We don't have exhaustive knowledge about these devices," Michael Miller, a plastic surgeon and panel member, said at the meeting. "But we have sufficient knowledge to justify their use."
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