Sales Of Silicone Breast Implants To Easily Offset Post-Approval Study Costs
This article was originally published in The Gray Sheet
Executive Summary
Mentor expects to spend up to $45 mil. over the next 10 years on an extensive post-approval study of its Memory Gel silicone-gel breast implants
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Mentor breast implant trial amended
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...
Mentor breast implant trial amended
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...
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