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Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants


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"One of the most important roles we have as a public health agency is educating patients and health care providers about both the benefits and risks of medical products, including breast implants.

I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture. We want to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products. We also want to be transparent in sharing the information we regularly gather and analyze in a way that provides important context to help inform these discussions.

Today, we are providing an update regarding the number of cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma and a known risk from breast implants. In 2011, the FDA was the first public health agency in the world to communicate about the risks of BIA-ALCL, warning women that the available information at the time indicated that there is a risk for women with breast implants for developing this disease. Since then, we have regularly updated the information available on our website regarding known BIA-ALCL cases, including deaths and known risks."

CONTINUE READING ON www.fda.gov

                   

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