BETHESDA, Md.—Nine women have died and another 350 have developed a rare form of cancer because of their breast implants, the Food and Drug Administration said.
The FDA first identified a possible association between breast implants and development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin's lymphoma, in 2011, according to the fact sheet on the FDA website.
"At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk," the agency said.
As of Feb. 1, 2017, however, the FDA knew of enough cases—359 in all—to concur with the World Health Organization's designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop in women following breast implants, it said.
"At this time, most data suggest that that BIA-ALCL occurs more frequently following implementation of breast implants with textured surfaces rather than those with smooth surfaces," the FDA said.
At this time, according to the FDA website, both silicone-gel-filled and saline-filled breast implants are approved for sale in the U.S. They all have silicone outer shells, but vary in shape, size, shell thickness and shell surface texture, it said.
Because of health concerns, the FDA placed a partial ban on silicone-gel breast implants in April 1992, approving their use for reconstructive surgery only. In November 2006, however, it approved Premarket Approval Applications (PMAs) for augmentation surgery from Mentor Corp. and Allergan Corp.
In its fact sheet on BIA-ALCL, the FDA made a list of recommendations for doctors and patients to follow when considering breast implant surgery.