Incidence of breast implant-associated anaplastic large cell lymphoma.

In 2020, the Food and Drug Administration mandated a black box warning on all breast implants, warning of an association with anaplastic large cell lymphoma (ALCL). The World Health Organization recently introduced breast implant-associated ALCL (BIA-ALCL) as a new provisional entity. We identified BIA-ALCL cases diagnosed in adult women, 1/1/2021-12/31/2022, following the inaugural use of the new diagnostic code within the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. Age-adjusted incidence was calculated to the 2000 U.S. standard population. The age-adjusted incidence rate of BIA-ALCL in 2021 and 2022 was 17.2 (95% CI, 7.6-33.8) and 26.9 (95% CI, 14.8-45.5) per 100 million person-years, respectively; increased compared to our prior estimate for 2012-2018 (14.5 to 19.6 cases/100 million person-years) and substantially exceeding the FDA's earlier estimate for 2001-2007 (3 cases/100 million persons-years). This study presents the first population-based incidence rate estimations of BIA-ALCL, which is increasing rapidly in the U.S.