Silicone Implants

Mary Romano loves her breast implants -- they're wonderful, she says. When Jackie Clark talks about hers, though, she talks about "silicone nightmares.""Seeing how beautiful these silicone implants can be, I say to other women, 'If you can afford it, go ahead and do it,' " said Ms. Romano, 30. Two years ago, the Arnold woman had one implant inserted after a mastectomy and a second put in the other side -- "saggy and stretched after two children" -- so that it would match.But Ms. Clark, 38, an Alexandria, Va., woman who had her breasts enhanced for cosmetic reasons, later had the implants removed because she was convinced they were causing her serious health problems.

LONDON -- Britain's chief medical officer has told doctors that they can continue to use silicone gel breast implants despite a temporary suspension of the procedure in the United States.Last month, the U.S. Food and Drug Administration recommended a 45-day moratorium on the supply or use of silicone gel implants while new information questioning their safety is evaluated. Concerns focus on the possibility of reactions in the immune system caused by a leakage of silicone."I understand the concerns and anxiety felt by women over silicone gel breast implants," said Dr. Kenneth Calman, the Department of Health's chief medical officer.

WASHINGTON - Thirteen years after they were banned because of health concerns, silicone gel breast implants are heading for a comeback - but opposition is also returning, and federal regulators are at the center of the re-emerging controversy. With momentum building for final approval of the implants, perhaps by year's end, critics called on the Food and Drug Administration yesterday to hold off until completion of further study on the long-term health effects and of a recently launched Senate investigation into the agency's decision-making.

The U.S. Food and Drug Administration has refused to allow a California company to market silicone gel breast implants, continuing a near-ban on the devices because of safety concerns. After turning down the request of Inamed Corp. to sell the implants in the United States, the FDA also issued new guidelines yesterday suggesting that any manufacturers would have to present significantly more data on the safety of the devices to gain approval. They will be expected to conduct more testing to determine how long the implants can be expected to last, why they might leak or rupture and how women will know if that occurs.

Women should not have their breasts enlarged thinking it won't cost them anything beyond money and that it will make their lives better -- it may, and it may not, says Dr. Melvin J. Silverstein, medical director of the Breast Center in Los Angeles."

Despite a federal ruling that makes silicone gel implants widely available to women losing a breast to cancer, the lingering fear left by months of rancorous debate will probably cause most patients to choose other methods of breast reconstruction.That is the view of many plastic surgeons who said yesterday that they doubted the Food and Drug Administration's decision to give cancer patients the right to choose silicone gel would ease fears over the implants' safety.The FDA ruling, announced yesterday, gives cancer patients access to silicone gel implants as long as they enter studies designed to answer safety questions.

WASHINGTON -- Silicone gel breast implants, one of the most popular cosmetic surgeries in the United States, will be available only to a limited number of women who will test their safety, FDA Commissioner David Kessler is to announce today.Breast cancer patients and those disfigured by birth defects or injuries will have the best chance to obtain the implants if their doctor is convinced it is necessary for their well-being, a Food and Drug Administration official familiar with the plan said.

The most definitive study yet of the health effects of silicone breast implants has found no association between the implants and connective tissue diseases.The new study is so compelling and its results so consistent with previous studies, some leading rheumatologists contend, that the issue of whether implants cause those diseases can be considered closed. They maintain that it is time for the Food and Drug Administration to lift the voluntary moratorium on sales of the implants, which it requested in 1992.