MemoryGel® is the brand name for the round silicone gel-filled breast implants supplied by Mentor Worldwide, LLC. Mentor Worldwide, LLC. began an Adjunct Study in 1992 for implants used in reconstruction and revision patients.
FDA Approval and MemoryGel® Post-Approval Study
The FDA required Mentor Worldwide, LLC. to provide long-term safety data on these implants; Mentor Worldwide, LLC. began this post-approval study for Pre-market Approval (PMA) in order to gather specific information to address objectives about an approved medical device.
The MemoryGel® Post-Approval Study included approximately 43,000 women and evaluated their health over a 10-year period using an annual questionnaire and three physician visits. Dr. Jeremy Z. Williams of Park Meadows Cosmetic Surgery partnered with Mentor, participating in this study, which ultimately because one of the largest device post-market studies in US history.
As a result of the study, the FDA approved the pre-market approval (PMA) application for the Moderate Profile, Moderate Plus Profile, and High Profile Smooth and Textured Surface Round MemoryGel® Breast Implants in November 2006. The implants were approved for the following indications:
- Breast augmentation for women at least 22 years old.
- Breast reconstruction
Silicone Gel-Filled Breast Implants
Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. These implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women. They are also used in revision surgeries, which correct or improve the result of the original surgery.
For more information about the FDA approval of silicone-gel filled breast implants, you can visit the FDA website.
Benefits of MemoryGel® Breast Implants
- MemoryGel® Implants are FDA-approved
- Each implant is filled with Mentor’s proprietary cohesive gel
- The gel filler holds together uniformly and looks and feels like natural breast tissue
- The implants have a set fill volume for predictable results
- MemoryGel® breast implants come in three projection options: Moderate, Moderate Plus and High Profile to give you the look you want
- They come in two shell surface options: smooth and textured (Siltex®)
- MemoryGel® implants are covered by Mentor’s Standard or Enhanced Limited Warranty and Lifetime Replacement Policy
The physicians at The Breast Center Park Meadows Cosmetic Surgery use MemoryGel® implants for their breast enhancement and reconstruction procedures. For more information or to schedule a consultation, please call 720-457-4461 or schedule your appointment online.