The Food and Drug Administration announced this week that it would not ban textured breast implants, despite reports that link them to a rare form of cancer, anaplastic large cell lymphoma, that has affected hundreds of women.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” the agency said in a statement on Thursday.
Textured breast implants are characterised by a rough surface meant to stick to the breast tissue. In most cases of anaplastic large cell lymphoma — a cancer of the immune system — linked to women with these implants, the implant was made by Allergan. The company’s textured implants have been pulled from sale in dozens of other countries in recent months.
The FDA began reviewing the claims just months ago (though the FDA acknowledged roughly a decade ago that breast implants could be linked to the form of cancer). An FDA hearing with medical professionals and the makers of breast implants in which women shared their experiences with health complications was held in March.
While granting this week that most of the women who developed the form of lymphoma had textured implants, the agency said it “believes regulatory action must be based on scientific data” and that more information is needed. It also said it could not positively link breast implants with symptoms such as fatigue and pain.
“While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness,” the agency said. “We believe women considering a breast implant should be aware of these risks.”
Instead of moving to bar the sale of these textured implants—as have Canada and France, among others — the FDA said it will instead “take steps to improve the information available to women and health care professionals about the risks of breast implants,” including the risk for developing the form of lymphoma as well as other symptoms. It said its efforts included exploring ways to display product information more prominently and overhaul labelling.
According to NBC News, nearly 460 women have been diagnosed with breast implant-associated anaplastic large cell lymphoma in the U.S. alone, with more than 17 worldwide deaths reported. The FDA acknowledged in its statement this week the regulatory actions take by other countries, but said that those respective markets include textured implants not sold in the U.S. and that their use in those countries is much higher.
A spokesperson for Allergan did not immediately respond to a request for comment about the decision. However, amid reports of halted sales in international markets, the company said in a statement last year that it “stands behind the benefit/risk profile of our breast implant products.”