"Updated Epidemiology Of Breast Implant-associated Anaplastic Large Cell Lymphoma
(BIA-ALCL) In The United States"

Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is a hematological malignancy identified in 1997, recognized by the FDA in 2011, and classified by the World Health Organization in 2016. A cornerstone in BIA-ALCL epidemiology is to determine an accurate incidence rate, prevalence, and risk, but also to implement a reliable methodology for estimating a denominator in the absence of readily available manufacturer data or mandatory/opt-out breast implant registries. Epidemiological studies on BIA-ALCL suffer from discrepancies and a lack of homogeneity in reporting or estimation of the denominator (ie, the number of individuals with breast implants), which is inferred by population estimates or calculated from implant sales data. The United States provides a unique perspective: despite the market there being dominated by smooth implants, it still reports the highest number of BIA-ALCL cases worldwide, with 505 from the total of 1130 unique reported cases as of April 1, 2022. Current US-based reports provide very wide risk estimates, ranging from 1:355 to 1:51,000 individuals, which may explain the wide author/geographic variations in epidemiological assessment from implant markets with different smooth/textured ratios or industry shares.