The U.S. Food and Drug Administration on Thursday announced that it will not ban textured breast implants that can cause a rare cancer, but the agency is considering steps to ensure that women and doctors are informed of the risks of the device.
During a two-day public meeting on implant safety last month, scores of women implored an FDA advisory panel to end marketing of rough-surfaced implants, which have been linked to breast implant-associated anaplastic large-cell lymphoma, a type of cancer that typically begins with swelling in the breast.
Several countries, including Canada, France, and the Netherlands, have halted or restricted textured implant sales, but the FDA advisers rejected the idea.
On Thursday, FDA officials said existing scientific evidence does not legally justify a ban. They pointed out that textured implants make up only 10 percent of the U.S. market, and that the lymphoma has developed in a small number of cases in which the implant surface was smooth or unknown.
While refusing to restrict sales, the FDA for the first time conceded that implants may cause systemic symptoms such as chronic fatigue, cognitive problems, and pain. Many women testified last month about what is now called “breast implant illness,” but the link has been debated since silicone gel implants were introduced in the 1960s.
“While the FDA doesn’t have definitive evidence ... the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed," the statement said. "We believe women considering a breast implant should be aware of these risks,” the FDA statement said.
The FDA said it is considering requiring a “black box warning," its strongest safety warning, on breast implant labeling. It may also require something women have pushed for: a check-list of risks that doctors and implant patients would have to review and sign.
The agency also said it has required companies to submit individual reports of complications or harms attributed to implants, rather than “summary reports,” which lump the problems together and omit details.
Diana Zuckerman, president of the National Center for Health Research and a presenter at last month’s hearings, called the FDA’s rejection of a sales ban “unfortunate,” but said the steps to improve reporting of problems and informed consent are “important.”
On the issue of breast implant illness, she asked whether the FDA will “require the research needed to provide the definitive proof the FDA says is lacking.”
Jamee Cook, 41, of Dallas, who suffered severe symptoms until she had her implants removed in 2015, co-founded a Facebook group devoted to breast implant lymphoma and gave an impassioned presentation at the March hearings.
She said she was disappointed that the FDA didn’t take more stringent action against textured implants, but still saw “progress” to address safety concerns.
"These other steps are good steps forward,” Cook said.
U.S. breast implant sales remain strong, with about 300,000 women a year undergoing breast enlargement, and 80,000 having breast reconstruction after cancer surgery.