Device Access Education | MemoryGel™ Implant PAS | MemoryGel™ Implant Starter Kit | Labeling | Forms
Device Access Education | MemoryGel™ Implant PAS | MemoryGel™ Implant Starter Kit | 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.
Mentor is asking all of our physician partners participate in the PAS study to help further the science on these products.
The study officially begins within 90 days post-approval.
The PAS is a condition of silicone gel approval. It is important for the industry to complete this requirement as soon as possible and help further the science on these products.
This study has been designed with physician time requirements and schedules in mind. In order to simplify the follow-up process, the patients will complete the bulk of the follow-up questionnaires online, at their leisure. This makes follow-up much less intrusive than a typical clinical study.
Please see the following flow charts for the process. Click to download in full PDF format
Post-Approval Study Process Flow Chart:
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Post-Approval Study Process Flow Chart:
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Request a copy of the PAS protocol from your Mentor Sales or Clinical Representative. The protocol explains everything you need to know about the study and has samples of the patient follow-up forms.
