FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

Today, the U.S. Food and Drug Administration 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. The FDA is also qualifying the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in the assessment of certain medical devices such as breast implants. Qualification of the BREAST-Q Reconstruction Module MDDT included the Physical Well-being (Chest), Psychosocial Well-being, Sexual Well-being and Satisf...