Mentor breast implant trial amended
This article was originally published in The Gray Sheet
Executive Summary
FDA approves a protocol change May 2 to the firm's 10-year post-approval study for its Memory Gel silicone-filled breast implants to allow patients to receive the implants even if they do not participate in the study. Access to Memory Gel will continue to be available only through physicians participating in the study (1"The Gray Sheet" Nov. 27, 2006, p. 3). Mentor says it has enrolled close to 4,000 patients in the 40,000-patient study since the implants' conditional approval in November...