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 monitoringJeffrey 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 requiredIn 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
"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."
Silicone gel-filled breast implantsSilicone gel-filled breast implants are surgically placed under the chest muscle or the breast tissue for augmentation or breast reconstruction. They come in a range of styles and sizes and have either a textured or smooth silicone outer shell that is filled with silicone gel.
Breast reconstruction - this involves building up or replacing breast tissue that was lost when breast cancer tumors were surgically removed, the removal of breast tissue to prevent breast cancer in genetically susceptible women, lost breast tissue due to trauma, or breasts that did not develop properly because of a severe breast abnormality. A studied showed that breast cancer survivors who had a mastectomy prefer silicone gel to saline implants.
Revision surgery to improve or correct the result of a primary breast reconstruction surgery is also a type of breast reconstruction.
Breast augmentation - this means increasing the size of the breasts. Breast augmentation may also include revision surgery to improve or correct the result of a primary breast augmentation surgery.
Dennis Hammond, M.D. of Partners in Plastic Surgery of West Michigan, and lead investigator of the Mentor MemoryShape Breast Implants clinical trial, said "Over the past 25 years, we have been exploring opportunities to improve breast implants. The MemoryShape Breast Implants incorporate several new design features, such as the cohesive gel that allows the implant to be formed into a teardrop shape to fit each individual patient. I am pleased women in the U.S. now have an implant that offers an enhanced yet subtle breast appearance with a proven safety profile."
There are now five silicone gel-filled breast implant products that are FDA-approved in the USA today, including the MemoryShape Breast Implant that was approved this week. They are manufactured by three companies:
- Sientra Inc., Santa Barbara, California - in March this year its portfolio of Silimed-brand silicone breast implants was approved by the FDA.
- Allergan Inc., Irvine, California - in February this year, its Natrelle 410 implants were approved by the FDA.
- Mentor Worldwide LLC, Santa Barbara, California.