People with breast implants have a small but increased risk for a rare form of deadly cancer.
The federal Food and Drug Administration states breast implant-associated anaplastic large cell lymphoma, a form of non-Hodgkin's lymphoma, has been linked to at least nine deaths. On Tuesday, the agency confirmed the disease can occur after breast implant surgery.
The decision comes on the heels of a similar determination made by the World Health Organization in 2016. WHO said the disease often presents itself as fluid build-up near the implant. The FDA said it's more often spotted in people undergoing 'implant revision operations" for seroma, or fluid build-up. ALCL cases, the agency said, tend to occur more often in textured implants than in people who receive smooth implants.
The FDA has been digging into a possible link between implants and the disease since 2011. It chose to update its understanding following the WHO findings and after medical organizations published diagnosis and treatment guidelines for ALCL.
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"The FDA continues to believe that the available information suggests women with breast implants have a very low, but increased risk of ALCL compared to women who do not have breast implants," the agency said Wednesday.
The Lymphoma Research Foundation states ALCL accounts for about 1% of non-Hodgkin's lymphoma cases. Most of the breast implant-related cases, the FDA said, are treated by removing the implant. However, chemotherapy and radiation also have been used.
The number of ALCL cases related to breast implants is difficult to determine, the FDA said, because of a lack of reporting data. However, the FDA did examine 359 medical reports, which found nine deaths. The Australian Therapeutic Goods Administration analyzed 46 cases in Australia, where it found three confirmed deaths.
The FDA recommends patients educate themselves on the different options associated with breast implants, particularly as it relates to texture.
"Before getting breast implants," the agency said in a statement, "make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants."