FDA Approves a New Silicone Gel-filled Breast Implant
Agency requires post-approval safety studies to assess rare events
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant 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. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.
The FDA's approval is based on six years of data from 955 women demonstrating that there is a reasonable assurance of safety and effectiveness for this implant. Mentor's MemoryShape Breast Implant showed similar rates of complications and outcomes as previously approved breast implants. These complications 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. 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," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.
"The data we reviewed showed a reasonable assurance of safety and effectiveness," said Shuren. "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 MemoryShape Breast 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 subjects 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). The patients 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). These patients 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.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast reconstruction or augmentation. These implants come in different sizes and styles and have either a smooth or textured silicone outer shell that is filled with silicone gel.
Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
With today's 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.
Mentor Worldwide LLC is based in Santa Barbara, Calif.
June 14, 2013
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