Incidence of breast implant-associated anaplastic large cell lymphoma in the US

In 2020, the FDA mandated a black box warning on all breast implants, warning of an association with anaplastic large cell lymphoma (ALCL). The WHO recently introduced breast implant associated (BIA)-ALCL as a new provisional entity. Following the inaugural use of the new diagnostic code within the SEER program, BIA-ALCL cases diagnosed in adult women were identified. The age-adjusted incidence rate of BIA-ALCL in 2021 and 2022 was 17.2 (95% CI 7.6-33.8) and 26.9 (14.8-45.5) per 100 million person-years, respectively; increased compared to the prior estimate for 2012-2018 (14.5 to 19.6 cases per 100 million person-years) and substantially exceeding the FDA’s earlier estimate foor 2001-2007 (3 cases per 100 million person-years. The authors conclude that BIA-ALCL incidence rate is increasing rapidly in the US.