The Food and Drug Administration has approved the MemoryShape Breast Implant (Mentor Worldwide) for breast augmentation and breast reconstruction procedures.
The MemoryShape implant is cleared for breast augmentation in patients age 22 and older and for breast reconstruction in patients of any age, according to a news release. Regulators reviewed six years’ worth of data on 955 patients who received the implants. The product demonstrated complication rates and outcomes that were similar to those of previously approved breast implants, the FDA noted.
Complications from Memory Shape implants included capsular contracture, asymmetry, wrinkling, implant removal and reoperation. Gel fracture — cracks or fissures — were seen in the gel of some MemoryShape implants.
Conditions of the FDA’s approval of MemorsyShape implants require Mentor to continue to follow the 955 patients who received the products as part of the premarket core study. These patients will be followed until they complete 10-year evaluations. The company also must follow approximately 350 subjects who received MemoryShape Medium Height Moderate Profile Breast Implants as part of a continued access study, which was not related to the premarket core study.
The FDA is also requiring Mentor to collect data on long-term complications by conducting a new study of about 2,500 patients who receive MemoryShape Breast Implants.
Other silicone gel-filled breast implants approved by the FDA are manufactured by Allergan, Mentor and Sientra.
In a news release, Mentor says its MemoryShape product gives a “more natural shape and youthful feel” from breast augmentation or reconstruction procedures.
