FDA Rejects Silicone Gel Breast Implants

Steve Sternberg, The Associated Press: January 9, 2004.

Silicone breast implants were dealt a new blow Thursday when the Food and Drug Administration rejected Inamed Corp.’s bid to bring them back on the market a decade after earlier versions were ruled unsafe and banned. […]

“There’s additional information that we think is necessary for this product to pass the threshold of what we consider necessary for open marketing,” said Daniel Schultz, the FDA’s director of device evaluation.

Silicone breast implants are now allowed only for reconstruction after breast cancer surgery and in controlled trials for women who want them for cosmetic reasons. […]

Some women say they prefer silicone-filled breast implants over those made with saline because silicone implants have a more natural feel. Critics worry about the long-term health consequences when implants break and leak. They cite studies linking silicone implants with cancer, immune disorders and crippling fatigue. But a 1999 Institute of Medicine analysis found no proof that silicone implants cause severe health problems. […]

“Even the FDA advisers who recommended approval all agreed that we don’t know the long-term safety (of these devices). It’s terrific that the FDA heard that message,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families, a Washington-based think tank.

Zuckerman hailed a provision in the FDA guidance document calling for the development of new external performance tests that better mimic conditions within the breast. […]

Read the original article here.