FDA Updates Analysis of Medical Device Reports of Breast Implant Illness, Breast Implant-Associated Lymphoma
August 24, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants.
FDA also announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction. (FDA)
