In a news release, the manufacturer, Mentor Worldwide LLC, said the implants have been approved outside of the United States for more than a decade. The product is available in a range of sizes and is tear-drop shaped to mimic the natural shape of a breast.
The product, which is very likely to be available in Africa and possibly – Nigeria – has been clinically studied among 955 augmentation and reconstruction patients participating in an ongoing 10-year study.
However, after six years, the study has found a low rate of “adverse events” including rupture/
The FDA said that it’s approval was based on six years of data from 95 women showing a reasonable assurance of safety and effectiveness for this implant. Mentor’s MemoryShape Breast Implant showed similarrates of complications and outcomes as previously approved breast implants.
These complications included tightening of the area around the implant, 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.
According to Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, “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.”
Breast implant surgery should not be performed on women with any
active infection, untreated cancer or who are pregnant or nursing.
With this approval, there are now five FDA-approved silicone
gel-filled breast implants available in the United States manufactured
by three companies: Allergan, Mentor and Sientra.