Firmer Silicon Gel Implant Gets FDA Go Ahead
The FDA has approved the firmer MemoryShape Breast Implants for breast augmentation in women aged 22 years or more, and for females of any age who require breast reconstruction.
The MemoryShape Breast Implants are manufactured and marketed by Mentor Worldwide LLC, Santa Barbara, California.
The FDA (Food and Drug Administration) examined six years’ worth of data from 955 adult females that demonstrated that the breast implant is reasonably safe and effective.
The rates of complications and outcomes associated with the MemoryShape Breast Implants were similar to those found in other breast implants that are already on the market. Reported complications included capsular contracture (tightening around the implant), asymmetry (the implant looks uneven), wrinkling, and implant removal. Gel fracture was observed in some cases too.
Breast implants require long-term monitoring
Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health at the FDA, said:
“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.
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 new MemoryShape Breast Implants have more cross-linking than the silicone gel in Mentor’s other previously approved implants. Silicone chains are linked to each other, cross-linking refers to the bonds that hold them together. The more cross-linking there is, the firmer the gel. The clinical significance of more cross-linking is not known, according to the FDA.
Post-approval studies will be required
In order to assess the breast implant’s long-term safety and efficacy outcomes, as well as the risks of rare disease, the FDA requires that Mentor carry out a series of post-approval studies. The FDA wrote “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.”
The approval for the MemoryShape Breast Implants is granted on condition that Mentor..:
- Carries on following up on 955 women who had the MemoryShape Breast Implants as part of the pre-market core study. The follow-up period must last ten years.
- Continues monitoring about 350 women who received the MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants as part of the pre-market continued access study. This was not part of the pre-market core study. 5-year evaluations must be completed on these patients.
- Carries out a new study involving about 2,500 women who will receive MemoryShape Breast Implants. The aim here is to gather data on long-term local complications, such as implant rupture, re-operation, capsular contracture, and implant removal. As well as less common disease outcomes, including reproductive problems, lung cancer, breast cancer, and rheumatoid arthritis.
- Performs five case control studies involving 10,750 women to determine what the potential link might be between any gel-filled breast implant (including the one just approved) and five rare diseases – lymphoma, cervical/vulvar cancer, brain cancer, neurological disease, and rare connective tissue disease.
- Evaluate women’s perceptions of the patient labeling
Analyzes all MemoryShape Breast Implants that are sent back to the manufacturer after being surgically removed from patients
David J. Wilson, Worldwide President, Mentor Worldwide LLC., said:
“We understand each woman has different needs and specific, personal reasons for choosing to undergo breast surgery. As the U.S. market leader in breast aesthetics, Mentor constantly strives to develop products that celebrate a woman’s uniqueness. The FDA approval of MENTOR MemoryShape Breast Implants allows us to meet this need by delivering the perfect balance of shape and feel to obtain the natural and youthful look patients desire.”
Unlike the round implants, the MemoryShape Breast Implants have a teardrop shape. According to Mentor, this provides a natural breast silhouette. MemoryShape Breast Implants have been approved outside the USA for more than ten years. They are filled with a special formulated cohesive gel that enables shape retention. Mentor says that the “combination of teardrop shape and distinct gel formulation creates the optimal balance of shape and feel.”