Silicone breast implants on trial.

Silicone breast implants on trial

A Food and Drug Administration (FDA) advisory panel has voted against banning silicone breast implants, at least for now. The advisory group convened Nov. 23 after the Public Citizen Health Research Group (HRG) urged it to ban the implants.

HRG, a consumer group based in Washington, D.C., says the implants may cause cancer, citing animal studies done by silicone manufacturer Dow Corning Corp. In those studies, 23 percent of female rats implanted with silicone developed cancer.

FDA's panel weighed testimony and research presented at its meeting and concluded that current information does not clearly establish a hazard to humans. "It is unlikely that the types of tumors seen in rats would occur in humans," the panel said. The group did recommend that women considering implants "be advised of the possible risks," and suggested FDA set up a patient registry to keep track of possible ill effects of the implants. The panel will meet again in January to consider any new data and discuss the issue further.

Each year, about 130,000 women in the United States get the implants, according to FDA estimates. About 85 percent of the procedures are done to enlarge healthy breasts.

Dow officials contend the implants are safe, a view backed by the American Society of Plastic and Reconstructive Surgeons (ASPRS). "Women with breast implants have been followed for up to 25 years, and the type of cancer found in the study of rodents has never reported in this population," says ASPRS President George Reading of Rochester, N.Y.

HRG Director Sidney M. Wolfe argues that the average follow-up on silicone implants has been only 10 to 12 years, not long enough for cancer to develop in some cases. He says researchers have shown in humans that silicone leaches out of its implant bag into surrounding tissue, raising concerns about cancer development in other parts of the body.