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Breast Implants

FDA Clears Certain Breast Implant Shell of Cancer Risk

Published in Women's Health Weekly, July 10th, 1995

The U.S. Food and Drug Administration (FDA) says women should not have a certain type of breast implant removed based solely on concern that its polyurethane shell causes cancer.

At issue are polyurethane foam-covered implants filled with silicone gel. Approximately 110,000 women have this type of implant.

In 1991, a chemical in the polyurethane was linked to cancer in laboratory animals. The FDA asked manufacturer Bristol-Myers Squibb to study the risk in women, and with that request, the company immediately stopped selling the implant.

The FDA announced June 29, 1995, that those studies show the risk of cancer from the...

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