Monday, April 11, 2005

FDA reconsiders breast implants with 75% failure

"On Monday, the FDA opens a three-day meeting with its scientific advisers to debate whether some silicone implants are safe enough to re-enter the U.S. market. Inamed and Mentor filed studies with the FDA suggesting that over three to four years, anywhere from roughly 1 percent to 20 percent of implants rupture, requiring patients to undergo additional surgery to remove or replace them.

"But those studies tracked small numbers of women for a short time, FDA scientists cautioned in preliminary analyses posted on the agency's Web site last week. One FDA estimate suggested that up to three-quarters of the devices might rupture within 10 years of implantation.


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