FDA Approves New Silicone Gel-filled Breast Implant
The FDA recently approved the MemoryShape Breast Implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.
The FDA’s approval is based on 6 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 included capsular contracture, reoperation, implant removal, breast asymmetry, and wrinkling. Fissures or cracks were observed in the gel of some MemoryShape Breast Implants.
“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,” said Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health.
Post-approval Safety Studies
The FDA requires that Mentor conduct a series of postapproval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.
There were a number of conditions of approval for the MemoryShape Breast Implants, including that Mentor must continue to follow 955 women who received the MemoryShape Breast Implants as part of the premarket core study that provided safety and effectiveness data for the device approval. ■