Inamed Receives Silicone Breast Implant “Approvable” Letter From FDA
This article was originally published in The Gray Sheet
Executive Summary
Inamed's silicone gel-filled breast implants inched closer to the market with the receipt of an FDA "approvable" letter, after the firm removed the controversial Style 153 implants from its PMA application
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Canada OKs silicone implants
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)...
Canada OKs silicone implants
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)...
Public Citizen Seeks Criminal Investigation Of Breast-Implant-Maker Mentor
Public Citizen has asked FDA to begin a criminal investigation into allegations that silicone-breast-implant-manufacturer Mentor failed to disclose potential safety problems with its implants, currently under review by the agency