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HOUSE REPORT RAPS FIRMS, FDA FOR INACTION ON IMPLANT RISKS

SHARE HOUSE REPORT RAPS FIRMS, FDA FOR INACTION ON IMPLANT RISKS

A congressional report says misleading claims by manufacturers and government inaction left women uninformed about the risks of silicone gel breast implants. A top health official says the companies are under investigation.

The report praised specialists at the Food and Drug Administration for trying to bring attention to the problem, but it said they were "repeatedly undermined over a period of 15 years by decision-makers within the agency.""When attention was focused elsewhere, it was business as usual at FDA," said Rep. Donald M. Payne, D-N.J., chairman of the House Government Operations subcommittee on human resources, which conducted the investigation that yielded the report.

FDA Commissioner David Kessler disagreed.

In an interview Wednesday, Kessler said, "I think it's patently clear that the action the FDA has taken over the past year has significantly affected the use of silicone gel breast implants and to suggest otherwise is ludicrous."

Asked if manufacturers were engaged in a cover-up, Kessler said, "There are investigations under way." He would not elaborate.

Before the FDA declared a general moratorium on the silicone implants a year ago, 130,000 women were getting the implants annually. That number dropped to 3,500 in 1992, Kessler said.

The House report said people within the FDA were long aware of problems with two kinds of breast implants: those filled with silicone gel and gel-filled implants covered with polyurethane foam.

The agency has received complaints that silicone gel leaking into women's bodies from the implants caused a host of health problems, including soreness and symptoms related to disorders of the immune system.

The polyurethane foam has its own set of problems, breaking down to toluendiamine, or TDA, a compound that causes cancer in animals, the report said.