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Higher silicone breast implant rupture rate shown in recent data, FDA tells Rep. Shays.

This article was originally published in The Gray Sheet

Executive Summary

SILICONE BREAST IMPLANT RUPTURE RATE APPEARS "SIGNIFICANTLY HIGHER" than previously has been reported, FDA says in a May 25 response to an inquiry from House Government Reform/Human Resources Subcommittee Chairman Christopher Shays (R-Conn.). In a May 10 letter to FDA Commissioner David Kessler, Shays asked the agency to comment on recent clinical studies on the safety of silicone breast implants. Based on a review of recent epidemiological studies, FDA concludes, "There is now data to suggest that the failure rate due to implant rupture may be significantly higher than previously described, and/or may increase significantly with time."

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