MENTOR MEMORY SHAPE BREAST IMPLANT
On June 14, 2013, Mentor approved its form of a gummy bear silicone gel implant, similar to the 410 highly cohesive Allergan silicone gel implant. These implants are now approved by the FDA and are for women 22 years of age and older for augmentation as well as reconstructive use. The FDA approved the Mentor Memory Shape gel implants after a six-year study of 955 women showing that there was reasonable safety and effectiveness to this specific implant. The most common complications include a capsular contracture, asymmetry and wrinkling. The data show that there was reasonable assurance of safety and effectiveness. They will continue with post-approval studies focusing on long-term safety and effectiveness of this specific implant. The Memory Shape Mentor Breast Implant has thicker cohesive gel associated with more cross-linking compared to previous cohesive gel Mentor implants. There is more chain linking of the silicone to each other which allows for a thicker, firmer and tighter shape to the implant. This will reduce visibility and rippling of this implant, especially in thin-chested women with minimal breast tissue coverage.
The FDA will require that Mentor continue post-approval studies to assess long-term effectiveness and safety of these new memory shape breast implants. They follow approximately 350 subjects who use the CPG style 321 memory shape medium height moderate profile implants and the 955 women who had the memory shape breast implants with the core study and they should be followed until their 10-year evaluation. The FDA also desires a new cohort study of 2500 women that will receive the Memory Shape Breast Implants in order to collect further information on the complications that may include reoperation, implant removal, rupture and capsular contracture and also looking at potential causes of autoimmune diseases, including rheumatoid arthritis as well as breast and lung cancer and reproductive complications.
There are now three cohesive gummy bear implants on the market that have been FDA approved, the Allergan highly cohesive 410 gel, the Mentor Memory Shape Breast Implants and the Sientra Highly Cohesive Silicone Gel Implants.