Device Access Education | MemoryGel™ Implant PAS | Labeling | Forms
Listed below are answers to some of the most common questions about silicone gel implants. In you are considering breast augmentation and have additional questions, feel free to visit www.LoveYourLook.com.
Physicians may contact their Mentor representative.
MemoryGel™ is the brand name for all of Mentor’s silicone gel-filled breast implants. These are the same products we have been distributing under the Adjunct Study since 1992 for reconstruction and revision patients. MemoryGel™ implants contain a proprietary cohesive gel formulation that acts as a unit rather than a liquid, and holds together uniformly.
Mentor’s approval includes the entire family of round MemoryGel™ implants. We offer three styles (Moderate, Moderate Plus and High Profile) in both smooth and textured options. View a full listing of MemoryGel™ breast implants available to physicians for use.
There are several conditions that the FDA has mandated with approval of silicone gel implants that are different from saline implants:
No. The online training courses are company specific and related to labeling, device tracking and patient education—not surgical technique.
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.
Mentor will complete the current silicone breast implant Core Study through 10 years. Mentor and its physicians will also continue to follow patients in the Adjunct study for five years after enrollment, as dictated by study protocol.
As part of the approval of MemoryGel breast implants, the FDA has required both Mentor and Allergan to conduct a post-approval study to help answer some of the long-term health questions raised during the panel hearings.
