FDA tells breast implant manufacturers to provide patient information - Food and Drug Administration

FDA Consumer, Dec, 1991

Breast implant manufacturers must provide doctors with easily understandable information about the risks of breast implants, and doctors should give this information to patients considering breast implant surgery, FDA said in a Federal Register notice published Sept. 25, 1991.

FDA gave manufacturers 30 days to provide the patient information, after which any breast implant not providing the patient labeling would be considered mis-branded and subject to regulatory action.

The agency made available to manufacturers an information sheet to use as guidance in developing their own material.

Risks of breast implants include hardening of tissue surrounding the implant, rupturing of the implant, and interference with mammography.

FDA is currently reviewing manufacturers' data on silicone gel-filled implants (the majority of breast implants on the market) and expects to determine by early January 1992 whether there is adequate evidence of their safety to permit them to remain on the market. The agency will soon request similar data from manufacturers of implants filled with saline solution (salt water).

FDA Commissioner David A. Kessler, M.D., said that the agency decided to tell doctors and manufacturers to provide patients with information about the risk of implants while the agency was considering the safety data because some women are unaware that any risks are associated with the implants.

"I recognize that the implants have been beneficial to many women," Kessler said. "But due to the fact that they can hide tiny tumors that might otherwise be visible on a mammogram, women who are at high risk for breast cancer, including women with a family history of the disease, should be especially cautious about electing to use the implants to enlarge their breasts."

Each year, about 150,000 women in this country receive breast implants, 80 percent for breast enlargement and the rest for reconstruction following mastectomy (surgical breast removal due to cancer).

FDA advises that the risk information currently available does not warrant removing an implant from a woman not having any problems with it, especially considering that any surgical procedure carries a risk. A woman experiencing problems she thinks may be associated with her implants, or who is concerned about the possible risks, should consult her doctor for advice.