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Silicone breast implants

This article was originally published in The Gray Sheet

Executive Summary

Commenting on regulation of silicone gel-filled breast implants during an Oct. 26 interview on a Washington radio show, FDA Commissioner David Kessler said, "I don't think we're at the point yet where we can say the final jury is in. We still need to know how long do these devices last for, what their rupture rate is. We're looking at rupture rates that still are very, very high. How many years do these device last before they rupture?" Referring to recent studies that question the link between the implants and connective tissue disease, Kessler said, "What we care about is that these studies are done...There's still a lot more work that needs to be done before we can give people the kind of reassurance that in fact they are safe." Two studies -- led by Jorge Sanchez-Guerrero of the Harvard Medical School and Brigham and Women's Hospital, and Marc Hochberg of the University of Maryland School of Medicine -- presented last week at the American College of Rheumatology meeting in Minneapolis found no association between the implants and connective tissue disease



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