Public Health & Policy
The FDA has approved a new silicone breast implant for augmentation in women ages 22 and up, and for reconstruction in women of all ages, the agency said.
It's the third silicone implant approved in the U.S., and Santa Barbara, Calif.-based manufacturer Sientra will have to conduct postmarketing studies to assess long-term safety and risk of rare diseases.
The caution spurs from an FDA review released last year that found a possible link between breast implants and a rare form of non-Hodgkin's lymphoma. It uncovered about three dozen cases of anaplastic large-cell lymphoma in women with breast implants; most of the cases involved silicone-filled devices.
The agency followed up with a report six months later showing silicone implants didn't increase the risk of breast cancer, reproductive abnormalities, or other problems, but the lymphoma link was still under investigation and implants were tied to local complications and often needed to be replaced within 10 years.
Silicone implants in Europe and Latin America made headlines earlier this year when those from French manufacturer Poly Implant Prostheses were found to have been made of industrial grade silicone, rather than medical grade. Those implants also had an unusually high rupture rate. They were never sold in the U.S.
After its review last year, the FDA said women with implants should have regular checkups and pay attention to any changes in their breasts.
In a statement announcing the new approval, William Maisel, MD, MPH, deputy director for science in the FDA's Center for Devices and Radiological Health, echoed that earlier warning.
"It's important to remember that breast implants are not lifetime devices," Maisel said in the statement. "Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential."
He noted, however, that data on silicone implants "continue to demonstrate a reasonable assurance of safety and effectiveness."
Still, Sientra will have to follow an original cohort of 1,788 patients -- the data on which final approval was based -- for an additional seven years, and will also have to conduct a 10-year study of 4,782 women receiving the implants to assess long-term local complications and other disease outcomes including rheumatoid arthritis and breast and lung cancer.
The agency is also requiring an additional five case-control studies looking at associations with rare diseases, including rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.
The FDA said the initial 1,788-patient trial had an expected number of complications and outcomes similar to those seen with other implants, including a tightening of the area around the implant, reoperation, implant removal, uneven appearance, and infection.