Mentor MemoryShape Silicone-Filled Breast Implants (Premarket application number P060028) (Approved June 2013)
Description and Detailed Information Links:
This breast implant has a silicone outer shell that is filled with silicone gel. The silicone gel in Mentor’s MemoryShape silicone gel-filled breast implant has more cross-linking compared to the silicone gel in their previously approved silicone gel-filled breast implant. Cross-linking refers to the bonds that link one silicone chain to another. The higher concentration of cross-linking in the silicone results in a firmer gel.
There are some other factors unique to the highly cohesive breast implants that women and their health care providers should be aware of. For example, these implants require a larger surgical incision than saline or less cohesive silicone gel-filled breast implants. Also, gel fracture is a new phenomenon that has been identified for the more cohesive silicone gel-filled breast implant and it is defined as a fissure, or crack, in the gel. While no patients were adversely affected by gel fracture in premarket clinical studies, the post-approval studies will investigate this further.
These implants come in different sizes with textured shells and are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
Links to the items listed below will be added as they become available.
- Patient Labeling for Augmentation Patients (2013)
- Patient Labeling for Reconstruction Patients (2013)
- Patient Labeling - Mini Brochure (2013)
- Physician Labeling (2013)
- Approval Order
- Summary of Safety and Effectiveness
- Consumer Information About P060028
- Post-Approval Studies (scroll to P060028)
Post-Approval Studies Summary:
As conditions of approval, the FDA required Mentor to conduct five post-approval studies to characterize the long-term performance and safety of the devices. The post-approval studies for Mentor’s MemoryShape silicone-filled breast implants included:
- Core Cohort Study - To assess long-term clinical performance of breast implants in the 955 women that enrolled in studies to support premarket approval applications. Prior to approval, this study yielded six years of data, and it is designed to follow these women for a total of 10 years after initial implantation.
- US Post Approval Study - To assess long-term outcomes by enrolling more than 2,500 silicone gel-filled breast implant patients and following them for 10-years
- Case-Control Studies - To identify rare adverse events by enrolling 10,750 women in five case-control studies on rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma.
- Continued Access Study - To collect additional safety and effectiveness data from about 350 women who received Mentor’s MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants prior to approval but outside of the Core Cohort Study.
- Focus Group Study - To improve the format and content of the patient labeling.
In addition, explant analysis will be conducted for all Mentor’s MemoryShape silicone-filled breast implants that are removed from patients and returned to the manufacturer.