Like millions of American women, Debra Craft wanted bigger breasts. Seven years ago, at 23, she got them by way of foam-covered silicone implants, “I asked a plastic surgeon what the risks were,” she says, “and he told me there weren’t any, aside from possible complications of anesthesia. He said they were a lifetime thing,” But Craft, an insurance claims representative from Orange, Calif., is convinced that silicone leaking from her implants is responsible for a variety of health problems she has suffered for the past six years. She had already decided to have the implants removed–but now she has even more cause for concern. Last week their manufacturer, Bristol-Myers Squibb Co., voluntarily withdrew two brands of foam-coated implants after government studies suggested they might be linked to cancer. The polyurethane foam in these products disintegrates in the body and, the studies found, produces a chemical byproduct, 2-toluene diamine (TDA), that can cause cancer in animals. Craft is angry. “They should have done more research,” she says, “before they started using women as guinea pigs.”
Craft is one of more than 2 million American women with breast implants. Eighty percent just wanted to improve their figures; the others got implants to reconstruct a breast lost after surgery or an accident. Undoubtedly these women assumed their implants had been tested for safety. But the astonishing fact is that breast implants have for almost 30 years enjoyed a completely unregulated history. After Congress passed a law regulating medical devices in 1976, the implants were grandfathered in, placed in a category “assumed to be safe” and not subject to the approval procedures the act provided.
By 1982 the U.S. Food and Drug Administration reclassified implants as potentially risky, but it wasn’t until 1988 that they were put in a new category requiring proof of safety and efficacy. And it wasn’t until this month, prodded by a congressional subcommittee headed by U.S. Rep. Ted Weiss, that the FDA finally told implant manufacturers they had 90 to days to prove their products were safe or remove them from the market.
The most common breast implant is a smooth sac containing silicone gel. In an estimated 40 percent of cases, a hard, painful layer of scar tissue forms around the implant; the polyurethane-coated ones were designed to prevent this. These implants, manufactured by Surgitek (a subsidiary of BristolMyers Squibb), are sold under the brand names Meme and Replicon.
The FDA has known for months about the research questioning the safety of the foam implants, but the agency didn’t acknowledge the troubling findings until last week. Although still exploring what level of cancer risk the implants might pose, the agency said: “It is clear that the cancer risk is very small-certainly too small to warrant removing the implants.” In fact, the FDA contended, removal might be more hazardous than retention, since it can involve delicate excision of breast tissue to which the disintegrated foam has adhered.
Bristol-Myers Squibb also tried to allay the fears of women who have the implants. “Medical literature contains no reported cases of human cancer associated with polyurethane foam,” said a company statement. But many women are worried. Sybil Goldrich and Kathleen Anneken, founders of Command Trust Network, a national information and support group for women with implants, report that their 24-hour hot line has been flooded with hundreds of calls since last week.
Dr. William W. Shaw, chief of plastic and reconstructive surgery at UCLA Medical Center in Los Angeles, believes much too little is known about the risks of both polyurethane and leaking silicone gel. “We’re not sure of the full implications, just as with an oil spill,” he says. “But I’m relieved the problem is out in the open. Maybe now we’ll get better implants and better-informed patients.”
