Breast Implants

U.S. Lawmakers Question FDA Decision

Published in Medical Letter on the CDC and FDA, May 30th, 2000

Members of the U.S. Congress on May 11, 2000, questioned health officials' decision to allow saline-filled breast implants to remain on the market after studies found they carried risks of health complications.

The U.S. Food and Drug Administration announced on May 10 that it would permit the two leading implant makers to keep selling the products but stressed that women should be warned about risks, including the possible need for repeat surgeries. Studies by the companies, Inamed Inc.'s McGhan Medical unit and Mentor Corp , found more than 20% of women with implants required surgery to remove or replace them. Other complications included breast pain, leakage or...

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Source: Medical Letter on the CDC and FDA (2000-05-30)

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