Time Bombs in the Breasts?

Susan Cox, 49, was horrified. After a death-defying battle with breast cancer and a prolonged recovery that included reconstructive surgery, the Chicago nurse learned last week that the very implant used to repair her breast could raise her risk of developing cancer once again. "It hit me like a club," said Cox. "Am I going to have to lose my breast twice?" She was not alone in her fear. News reports about the risks of certain breast implants set phones ringing in plastic surgeons' offices around the country. In all, 700,000 American women have had implants after cancer surgery, and 1.3 million more have had them for breast augmentation. Though only 10% had received the type of implant being called into question, virtually all were terrified by the news accounts. "It's been chaos," says Dr. T. Roderick Hester, a plastic surgeon at Emory University. "A lot of women are scared to death."

But should they be? The reports were based on studies under way at the Food and Drug Administration. Scientists there had found that the polyurethane foam coating surrounding the Meme and Replicon brands of implants could break down in the body into a substance called 2-toluene diamine, or TDA. This chemical had been shown to cause liver cancer in laboratory rats. The most alarming news reports claimed that TDA could trigger cancer in as many as 4 in 10,000 women who received the implants.

But in an official statement later in the week, the FDA set the record straight. Spokesperson Sharon Snider pointed out that the agency's analysis was not yet complete and that in any case the 4-in-10,000 figure greatly overstated the risk. "We don't know where those numbers came from," she said. Still, the FDA applauded a decision by the implants' manufacturer, Surgitek, a Bristol-Myers Squibb subsidiary, to halt immediately the worldwide distribution of the products until the investigation was completed.

Ironically, the Meme and Replicon implants, which are actually no different from ordinary silicone implants except for an added layer of polyurethane foam, were considered by many surgeons to be the best on the market. The older, smooth-shelled variety tended to cause surrounding tissue to tighten into a fibrous mass, sometimes leaving the breast misshapen and hard to the touch. But the polyurethane foam coating of the Surgitek products prevented this from happening by substantially increasing the surface area of the implant. When the neighboring tissue contracts, it does not become too compact. Surgeons who have used the models -- which came into widespread use only in the past decade -- swear by it, as do many women. Said one recipient: "They feel just like a non-implant pair of breasts."

The problem with the polyurethane is that when left in the body it can be attacked by cells in the immune system that zero in on foreign objects, chewing them up and walling them off. Just how much polyurethane is broken down in this way is not yet known, though Surgitek has estimated that 10% to 30% might disappear within eight years of insertion.

Since silicone breast implants were introduced in the 1960s, many questions have been raised of their safety. Some recipients have complained of discomfort, recurrent infections and even disorders of the immune system. Another worry is that the implants might impede early detection of cancer. Partly in response to these complaints, the FDA ruled this month that manufacturers of all breast implants must demonstrate their safety by July or withdraw them from the market. The FDA's own analysis of the safety of polyurethane-coated implants is due out within a few weeks. "It is unfortunate," noted the FDA's Snider, that the leak of unfinished data "has created a climate of unnecessary fear."

Last week's reports will doubtless add to the number of implant recipients contemplating liability suits. The potential costs are enormous: in one case last month, a 46-year-old New York woman was awarded $4.5 million after she claimed that polyurethane implants gave her breast cancer. The case is under appeal.

For now, however, surgeons are trying to put the potential risks in perspective. Dr. Norman Cole of the American Society of Plastic and Reconstructive Surgeons is referring his patients to last week's statement by the FDA, which asserts that the potential risk of these implants is "certainly too small" to warrant having them removed. Says Emory's Dr. Hester: "Women need to know that they are not walking around with time bombs in their breasts." With any luck, the final FDA report will defuse their anxiety.