WASHINGTON — Allergan and Johnson & Johnson silicone breast implants have been deemed safe by federal regulators after a review of clinical studies and side effects reported during five years of marketing.
The Food and Drug Administration’s analysis didn’t find a link between the implants and connective tissue disease, reproductive issues, breast cancer or other new side effects, the agency said Wednesday. Women with breast implants should follow up with their doctor for routine MRI scans because the chances of complications increase with time, the FDA said.
The safety of silicone-gel implants has been debated since the products were reintroduced for aesthetic rather than medical use. An estimated 389,000 women got implants last year for reconstruction after surgery or to increase their breast size, according the American Society of Plastic Surgeons. About half of patients chose silicone over saline implants.
“Our review of this information continues to support the safety and effectiveness of silicone breast implants when used as intended,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on a conference call with reporters. “The risks and complications, though frequent, are well understood.”
Twenty percent of women who get breast implants for aesthetic reasons and 50 percent who have breast reconstruction will need the devices removed within 10 years because of complications, according to the FDA. The most common safety risks are hardening around the capsule and additional surgeries. Pain, scarring, wrinkling and implant rupturing are also common.
The FDA reiterated its warning from January that as many as 60 of the 5 million to 10 million with breast implants globally have developed a rare type of cancer called anaplastic large cell lymphoma. This risk is “profoundly small,” Shuren said.
The FDA approved the use of silicone implants for cosmetic surgery in November 2006, after 14 years of allowing them only for breast reconstruction because of concerns that women had been injured by leakage. The products had been on the market since before the FDA began regulating devices in 1976.
Allergan makes Natrelle silicone breast implants as well as saline implants. The Irvine, Calif.-based company reported $319 million in sales of breast aesthetic devices last year, or 6.6 percent of revenue. The Mentor division of New Brunswick, N.J.-based J&J makes MemoryGel silicone implants. J&J didn’t disclose sales of the products in its annual report.
The FDA required Allergan and Mentor to each conduct six post-approval studies of the implants’ safety and performance as a condition for marketing. The agency said Wednesday that it plans to hold an advisory panel meeting in the next few months to discuss how to make these types of studies more effective.
The FDA is working with the companies in the meantime to encourage study compliance. Allergan said about 60 percent of its study participants have completed a questionnaire for their first year after surgery. They get $20 for each annual questionnaire and $100 for each of three follow-up visits with their surgeon during a 10-year period.
“Our study compliance rate continues to increase each quarter,” said Caroline Van Hove, a spokeswoman for Allergan, in an email. “With all of the past and current studies on silicone breast implants, which involve hundreds of thousands of patients, I think it is safe to state that breast implants are now the most extensively studied devices of any medical product today.”