The MemoryShape Breast Implant, which is used to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age, has been approved by the U.S. Food and Drug Administration.
Approval of the implant, manufactured by Mentor Worldwide LLC, is based on six years of data from 955 women demonstrating that the implant is reasonably safe and effective. The implant showed basically the same rates of complications and outcomes as previously approved devices.
These include tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and wrinkling. Fissures or cracks were observed in the gel of some MemoryShape Breast Implants, a characteristic called gel fracture.
“It’s important to remember that breast implants are not lifetime devices,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential.”
Post-approval studies needed
Shuren says that while the data that were reviewed showed a “reasonable assurance” of safety and effectiveness, “We will be looking at the results from post-approval studies that will focus on the implants’ long-term safety and effectiveness.”
The silicone gel in the MemoryShape Breast Implant contains more cross-linking compared to the silicone gel used in Mentor’s previously approved implant. Cross-linking refers to the bonds that link one silicone chain to another. This increased cross-linking results in a silicone gel that is firmer. The clinical significance of this type of silicone gel is not known.
The FDA requires that Mentor conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. Lessons learned from previous post-approval studies on silicone gel-filled breast implants informed the design of post-approval studies for Mentor’s MemoryShape Breast Implant.
As a condition of approval for the MemoryShape Breast Implants, Mentor must:
- Continue to follow 955 women who received the implants as part of the pre-market core study that provided safety and effectiveness data for the device approval. These patients will be followed until they have completed their 10-year evaluations for long-term device performance;
- Continue to follow approximately 350 patients who were implanted with the MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants as part of a pre-market continued access study (not part of the pre-market core study). They will be followed until they have completed their 5-year evaluations;
- Conduct a new study of approximately 2,500 women receiving MemoryShape Breast Implants to collect information on long-term local complications (e.g., capsular contracture, re-operation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications). They will be followed for 10 years;
- Conduct five case control studies by enrolling 10,750 women to evaluate the potential association between any silicone gel-filled breast implant (including MemoryShape Breast Implants) and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
- Evaluate women’s perceptions of the patient labeling; and
- Analyze the MemoryShape Breast Implants that are removed from patients and returned to the manufacturer.
With this latest approval, there are now five FDA-approved silicone gel-filled breast implant products available in the U.S. manufactured by three companies: Allergan, Mentor and Sientra.