Physicians and patients told a congressional panel yesterday of an array of health problems associated with silicone breast implants, and urged that Congress require safety testing and risk disclosure.
The Food and Drug Administration has received 2,017 reports of adverse reactions from silicone implants, according to Walter Gundaker, acting director of FDA's Center for Devices and Radiological Health.
"We were misled, ill-informed and even sometimes misinformed by people we should have been able to trust," said Sybil Niden Goldrich of Beverly Hills, Calif., who suffered severe complications from breast implants after a mastectomy. "What we needed, what is still needed, is more information," she told the House Government Operations subcommittee on human resources.
Norman Anderson, an associate professor of medicine and surgery at the Johns Hopkins University School of Medicine, said that "despite estimates that 2 million women bear these devices, we cannot even quantitate the short-term risks for these consumers."
Frank Vasey, a medical professor at the University of South Florida College of Medicine in Tampa, estimated that in as many as 75 percent of patients, a fibrous capsule forms around the implant. He said this can be mild, or can lead to pain and distortion of the breast.
Other witnesses testified that implants can rupture, allowing the liquid silicone gel to migrate to other parts of the body, showing up later in organs and in the bloodstream.
Silicone breast implants have been used since the early 1960s. When 1976 amendments to the Food, Drug and Cosmetic Act required regulation of medical devices, breast implants were "grandfathered" into the market, meaning they did not fall under the new regulation.
In 1982, the FDA proposed that silicone implants be classified as high-risk devices. FDA officials said they expect a rule requiring manufacturers to submit safety data or remove their products from the market would be in force by March.