The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. ALCL is not cancer of the breast tissue. The FDA believes that women with breast implants may have a very low but increased risk of developing ALCL adjacent to the breast implant. A literature review identified 34 unique cases of ALCL in women with breast implants worldwide. In total, the agency is aware of approximately 60 cases of ALCL in women with breast implants that were identified through the FDA’s contact with other international regulatory agencies, scientific experts and breast implant manufacturers. This is a very small fraction of the 5-10 million women who have received breast implants worldwide.
Additional data is needed to fully understand the possible relationship between ALCL and breast implants. The FDA is asking health care providers to report all confirmed cases of ALCL in women with breast implants through FDA’s MedWatch Program.
The documents below include the FDA’s analyses of the data and steps we plan to take to better understand and characterize the possible association.