Incidence of breast implant–associated anaplastic large cell lymphoma

Abstract 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 anaplastic large cell lymphoma as a new provisional entity. We identified breast implant–associated anaplastic large cell lymphoma cases diagnosed in adult women, from January 1, 2021, to December 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 US standard population. The age-adjusted incidence rate of breast implant–associated anaplastic large cell lymphoma in 2021 and 2022 was 17.2 (95% confidence interval [CI] = 7.6 to 33.8) and 26.9 (95% CI = 14.8 to 45.5) per 100 million person-years, respectively, which increased compared with our prior estimate for 2012-2018 (14.5 to 19.6 cases per 100 million person-years) and substantially exceeded the US Food and Drug Administration’s earlier estimate for 2001-2007 (3 cases per 100 million persons-years). This study presents the first population-based incidence rate estimations of breast implant–associated anaplastic large cell lymphoma, which is increasing rapidly in the United States.