FDA approves silicone-gel breast implant from Mentor
The Food and Drug Administration (FDA) on June 14 approved MemoryShapeTM breast implant, an anatomically shaped, highly cohesive silicone-gel implant manufactured by Mentor Worldwide LLC, and which is indicated for breast reconstruction as well as breast augmentation in women at least age 22.
"Breast augmentation continues to be the most popular cosmetic surgery across the United States, so these exciting advances in implant devices mean that women have more choices for a natural result," says ASPS President Gregory R.D. Evans, MD. "FDA approval of this implant signifies that board-certified plastic surgeons now have another safe, new choice to offer women.
"Research shows that patient satisfaction with breast augmentation is an impressive 98 percent, and we will undoubtedly continue to see extraordinary satisfaction rates with these new implant options," Dr. Evans adds. "There are many considerations to discuss when choosing breast implants, and ASPS Member Surgeons have the certification and aesthetic expertise to guide patients through this process."
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 five-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.
In addition to the Society's work with the FDA to establish the PROFILE Study to track cases of ALCL in women with breast implants, the FDA and ASPS are also partnering to establish a National Breast Implant Registry (NBIR). The primary goal of the NBIR will be to create a device surveillance registry for persons with breast implants in the United States. The Registry will focus on collecting information on short- and long-term safety outcomes associated with all types of breast implants.
"In the process of launching PROFILE, it became apparent that the development of a National Breast Implant Registry would be beneficial to monitor the safety and efficacy of these devices in the patients who have used them," says The PSF President Charles Verheyden, MD, PhD. "A cooperative research and development agreement (CRADA) has since been signed with the FDA and weekly progress is being made in reviewing historical data, validating questions, and discussing the mechanics of harvesting and utilizing data."
The FDA's approval is based on six years of data from 955 women demonstrating that there's 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.
"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," says Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.
"The data we reviewed showed a reasonable assurance of safety and effectiveness," says Dr. Shuren. "We will be looking at the results from post-approval studies that will focus on their 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.
This approval makes the Mentor MemoryShape implant the fifth FDA-approved silicone gel-filled breast implant available in the United States.
For more information, go to www.fda.gov/breastimplants.