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Medical Devices / Regulatory Affairs

FDA Issues Update on Lymphoma Associated With Breast Implants

Feb. 8, 2019

CDER released an update on the number of cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma.

The center reported that as of September 2018, it received 660 total MDRs regarding large cell lymphoma cases linked to breast-implants since 2010. Further analysis found 457 unique cases of the disease and linked the implants to nine fatalities.

“Unfortunately, not every report provides thorough information about each case, including what type of breast implant (e.g., surface texture) the patient received, which makes it more difficult to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer,” said Binita Ashar, director of CDER’s surgical device division.

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