FDA approves a new silicone gel-filled breast implant
The Food and Drug Administration (FDA) has approved a new silicone gel breast implant for use in women at least 22 years old to increase breast size (augmentation) and to rebuild breast tissue (reconstruction) in women of any age.
The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC, which will monitor women who receive them and research long-term effects.
On Friday, the FDA gave its nod of approval to the Mentor MemoryShape Breast Implant based on six years of data from 955 women demonstrating “a reasonable assurance” of safety and effectiveness for this implant. This is the fifth time the FDA has given its approval to silicone gel-filled breast implants available in the U.S. from Mentor and two other companies, Allergan and Sientra.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “We will be looking at the results from post-approval studies that will focus on the implants’ long-term safety and effectiveness.”
The device showed similar rates of complications and outcomes as those found in previously approved implants, including tightening of the area around the breast, re-operation or implant removal, an uneven appearance and wrinkling. Cracks were observed in the gel of some MemoryShape implants, according to the FDA.
“It’s important to remember that breast implants are not lifetime devices,” said Shuren. “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 will continue following the 955 women in the core study for 10 years, as well as another 350 women implanted with a certain kind of MemoryShape device for five years.
Additionally, Mentor has to conduct a study of 2,500 women with MemoryShape implants to collect information about any long-term local complications for 10 years and conduct five case control studies of some 10,750 women to evaluate the potential association between any silicone breast implants and the following five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.
The FDA said that Mentor, which is based Santa Barbara, California, must also evaluate the women’s perceptions of package labeling, and also analyze any returned MemoryShape devices.
Silicone gel-filled breast implants are implanted under the breast tissue or chest muscle for breast reconstruction or augmentation. They come in different sizes and styles and have either a smooth or textured silicone outer shell that is filled with silicone gel.
Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
SOURCE: U.S. Food and Drug Administration, FDA News Release, “FDA approves a new silicone gel-filled breast implant” (June 14, 2013).