What is a post-approval study, and why did the FDA mandate that Mentor conduct it?
A post-approval study is a clinical study or other investigation included in the PMA approval order to gather specific information to address precise study objectives about an approved medical device. FDA has concluded that both Mentor and Allergan need to provide additional long-term safety data on gel-filled breast implants. Mentor’s post-market study is an effort to continue to evaluate the product over the long-term. The MemoryGel® Post-Approval Study will include approximately 43,000 women and will evaluate their health over 10-years through annual questionnaires and three physician visits. Mentor takes its commitment to science and the health and safety of its patients seriously. To that end, Mentor has agreed to conduct one of the largest device post-market studies in U.S. history.
