Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review

Textured implants represent less than 10% in the United States, despite reporting the highest number of Breast Implant Associated Anaplastic Large Cell Lymphomas (BIA-ALCL).A systematic literature review on US-based epidemiology was performed to update knowledge on BIA-ALCL in the United States.Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on Medline (via PubMed [National Institutes of Health; Bethesda, MD]), Embase (Elsevier; Amsterdam, the Netherlands), Web of Science (Clarivate; London, UK) and SCOPUS (Elsevier; Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA-MAUDE database, and the PSF-PROFILE registry, while the denominator was estimated with chest x-ray method, including female transgenders. Prevalence and Risk were assessed accordingly, while incidence rate (IR) could not due to lack of available data.Ten from 987 identified manuscripts were included. US BIA-ALCL prevalence in literature ranged from 1:300 to 1:500,000 and IR from 4.5 per 10,000 to 31.1 per 100 million persons/year. A mean value of 453,5 BIA-ALCL cases were identified. From a denominator of 4,264,618 individuals with any breast implants surface we calculated 414,521 with textured implants, with a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913.BIA-ALCL IR, prevalence and risk, aided by the high case tracking efficiency of US healthcare system, has increased over previous publications when calculated exclusively on patients with textured devices. While US macrotextured implants were recalled by the FDA, these findings may impact the surveillance of existing patients and the use of macrotextured implants in other parts of the world which remains widespread.