Senators question breast implant data
This article was originally published in The Gray Sheet
Sens. Dianne Feinstein (D-Calif.) and Olympia Snowe (R-Maine) urge FDA in an Oct. 20 letter to consider "all data collected" by silicone gel breast implant developer Mentor, "whether or not it was originally required" for approval, based on allegations from a former Mentor employee that the company withheld or misrepresented data related to gel leaks. Mentor's Memory Gel silicone breast implants are pending FDA approval; the firm received an "approvable" letter in July 2005 (1"The Gray Sheet" Aug. 1, 2005, p. 18). Public Citizen appealed for a criminal investigation into the whistleblower's claims on Oct. 12 (2"The Gray Sheet" Oct. 16, 2006, p. 5)...
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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
Mentor's Memory Gel silicone breast implant moved one step closer to earning FDA approval July 28 with the receipt of an "approvable letter" listing conditions the company must meet to bring the device to market
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