FDA Revisits Silicone-Gel Implant Controversy

The Institute is a private, nonprofit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences. The report was commissioned as lawsuits and controversy accelerated over silicone implants' safety. The most significant litigation involved Dow Corning, which dropped out of the implant business in early 1992 and filed for Chapter 11 bankruptcy protection in 1995 as a result of a flood of implant-related lawsuits. A U.S. bankruptcy court judge approved the company's reorganization in 1999 as well as a settlement fund for plaintiffs.

Silicone implants reached the U.S. market in 1962, but the FDA wasn't given authority by Congress to regulate them until 1976. Existing products were exempt from stricter demands placed on post-1976 products. In 1982, the FDA began a more detailed review of implants, responding to what the agency says were "some reports of adverse events in the medical literature."

By 1988, all new implants were subjected to the most stringent reviews for medical devices. And since April 1992, all implants, regardless of when they were sold, had to clear FDA review after adequate tests measuring safety and effectiveness. As a result, no silicone gel-filled implant has been approved for elective, cosmetic surgery. A woman can receive a silicone implant now if she is enrolled in a clinical study or an "adjunct study," which allows such implants for breast reconstruction, repair of implants that have failed or to correct congenital deformities of the breast.

The FDA said in May 2000 that certain saline implants were acceptable "despite relatively high complication and failure rates." The agency approved the products after reviewing five clinical studies from two manufacturers, adding that women should be made aware of risks.

Despite the complications, the FDA noted then that a majority of women still in the clinical studies after three years "reported being satisfied" with the implants. An FDA publication issued soon after the agency granted approval noted that saline implants "are believed to be safer than silicone because rupture or leakage will only release salt water -- not silicone gel -- into the body."

"I think FDA approval will occur," says Dr. Mark L. Jewell, president-elect of the American Society of Aesthetic Plastic Surgery. "We have gotten more data; the manufacturers have had more time to answer questions that the FDA has raised."

Jewell, a plastic surgeon from Eugene, Ore., says the key issues are safety, effectiveness and informed patient consent. "The FDA should evaluate the scientific merit of a drug or device and then turn it over to a clinician for ethical use."

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