Physicians can access The MemoryGel® Breast Implant Device Access Education video and print their training certificates online to be able to begin using MemoryGel® Breast Implants today. Have more questions? Let us know and we’ll have one of our knowledgeable Mentor Reps contact you.
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What are MemoryGel® Implants?
MemoryGel® is the brand name for all of Mentor’s round silicone gel-filled breast implants. These are the same Implants Mentor has been studying in the Adjunct Study since 1992 for reconstruction and revision patients. MemoryGel® Breast Implants contain a proprietary cohesive gel formulation that acts as a unit rather than a liquid, and holds together uniformly.
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 Pre-market Approval (PMA) 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 US history.