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Canada OKs silicone implants

This article was originally published in The Gray Sheet

Executive Summary

Allergan and Mentor receive medical device licenses from Health Canada for their silicone gel-filled breast implants Oct. 20. The licenses for Allergan's Inamed round, smooth and textured implants, Inamed Style 410 shaped and textured implants, and Mentor's MemoryGel round and CPG contour implants come with a number of conditions, including that the firms begin long-term studies of tens of thousands of women and conduct focus groups of patients and plastic surgeons related to product labeling, all within one year. As in the U.S., silicone gel-filled breast implants previously were available only on a restricted basis in Canada. Both firms are still awaiting FDA go-ahead for the products after receiving "approvable" letters in 2005 (1"The Gray Sheet" Sept. 26, 2005, p. 17)...

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