Agency requires post-approval safety studies to assess rare events

The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.

The FDA’s approval is based on six years of data from 955 women demonstrating that there is 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. These complications include tightening of the area around the implant (capsular contracture), 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.