The Food and Drug Administration has approved a new silicone gel breast implant, but with strict requirements that Mentor Worldwide LLC monitor the women who use it and research long-term effects.
The agency on Friday gave the nod to the Mentor MemoryShape Breast Implant to boost breast size in women older than 22 and to rebuild breast tissue in women of any age.
The approval brings to five the number of FDA-approved silicone gel-filled breast implants available in the U.S. from Mentor and two other companies: Allergan and Sientra.
The new approval is based on six years of data from 955 women that demonstrated “a reasonable assurance” of safety and effectiveness, FDA officials said in a statement. The device showed similar rates and types of complications as those found in previously approved implants, including tightening of the area around the breast, need for re-operation or implant removal, uneven appearance and wrinkling. Cracks were seen in the gel of some MemoryShape implants, the FDA said.
“It’s important to remember that breast implants are not lifetime devices,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “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 FDA approved the new implant on the condition that the company continue to follow the 955 women in the core study for 10 years and that they follow 350 additional subjects implanted with a certain kind of MemoryShape device for five years. In addition, the firm must conduct a study of 2,500 women who get MemoryShape devices to track risk of long-term local complications for 10 years and conduct five case control studies of some 10,750 women to evaluate the potential association of any silicone breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.
The Santa Barbara, Calif., company must also evaluate the women’s perceptions of package labeling and analyze returned MemoryShape products, the FDA said.
