BETHESDA, Md. (Jan. 27, 2011)—Women with silicone-gel or saline breast implants may face a very small but increased risk of a rare type of cancer, the Food and Drug Administration said in a consumer advisory.
The FDA said it conducted an intensive review of 34 cases of anaplastic large cell lymphoma (ALCL) in breast implant recipients. Scientific literature, agency reports and information from sources including implant manufacturers, international regulatory agencies and scientific experts led the FDA to conclude there may be a connection between ALCL and breast implants.
“But with an estimated 5 million to 10 million breast implant recipients worldwide, agency experts say the know n ALCL cases are too few to say conclusively that breast implants cause the disease,” said the consumer advisory issued Jan. 26.
The FDA and the American Society of Plastic Surgeons are establishing a registry of ALCL patients with breast implants, the agency said. “FDA scientists hope the registry yields enough information to better understand what the risks for developing ALCL are for women with breast implants,” it said.