Breast Implant Controls Urged
Breast Implant Controls Urged
Dec. 19, 1990
WASHINGTON (AP) _ Scientists and patients told Congress on Tuesday of an array of health problems associated with breast implants, and urged it to enact legal requirements for safety testing and risk disclosure.
''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.''
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 Food and Drug Administration proposed that silicone implants be classified as high risk. That rule was made final in 1988, but another regulation that would require manufacturers to submit safety data or remove their products from the market was still not final. FDA officials testified they expected it would be by March 1991.
Rep. Ted Weiss, D-N.Y., chairman of subcommittee, said he was concerned about the ''inordinate delay'' and ''seven years of the agency dragging its feet,'' especially in light of the unanswered questions about silicone implants.
Walter Gundaker, acting director of the FDA's Center for Devices and Radiological Health, said he has been trying to bring together different groups to agree on the contents of a brochure of patient information.
He said his advice to women who are thinking about breast implant surgery would be ''to discuss the matter fully with your personal physician and the implanting physician. The human body is a hostile environment for any implant, and all surgery involves risks.''
Gundaker said the FDA has received 2,017 reports of adverse reactions from silicone implants, and others at the hearing said many physicians and surgeons don't report the problems.
Dr. Frank Vasey, a medical professor at the University of South Florida College of Medicine in Tampa, Fla., estimated that in up to 75 percent of patients, a fibrous capsule forms around the implant. He said this can be mild, or lead to pain and distortion of the breast. He also said that about 1 percent of women who have the implants wind up with immune disorders.
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.
Several expressed concern about animal studies that indicated silicone was a possible carcinogen. They also said implants reduce the effectiveness of mammographic screening because they may obscure cancer in breast tissue, allowing potential cancers to keep growing.
About 25 percent of silicone breast implants are for breast reconstruction after breast cancer surgery. The rest are for breast enlargement.
Goldrich told the subcommittee that after two silicone-filled implants were put into her chest, she suffered a body rash, pain, fever and eight weeks later her breasts were infected and ''rock hard.''
She had those implants replaced but still had more problems: pain, body aches, fatigue and gynecological problems. The new implants had to be removed also.
She later found a doctor who reconstructed her breasts using her own body tissue, but gynecological problems continued and she had to have a hysterectomy in 1988, she said. A biopsy of her liver at the time found silicone, she said.
''I've gone seven years without a recurrence of cancer, but what will happen from the silicone?'' she asked. ''I shudder when I think about it.''
Another implant recipient, Rosemary Locke, director of a women's support program in the Washington, D.C. area, gave the panel a different perspective. Locke, who also had a double mastectomy and reconstruction, said she had some complications after surgery but explained that ''having my body restored eased away much of the trauma of breast cancer.''
Dow Corning Corp., one of the largest makers of silicone breast implants, distributed a survey by the American Society of Plastic and Reconstructive Surgeons that found 92 percent of women with breast augmentation or reconstruction said they were satisfied with their implant surgery.