PURPOSE: Textured implants represent less than 10% in the US, 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 US. METHODS: All publications on US BIA-ALCL epidemiology were searched 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 an updated denominator was estimated by chest x-ray, including female transgenders. Prevalence and Risk were assessed, while incidence rate (IR) could not due to lack of available data. RESULTS: 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. CONCLUSION: BIA-ALCL IR, prevalence and risk, due to the high case tracking efficiency of US healthcare system, increases if calculated exclusively on patients with textured devices. While macrotextured implants were recalled by the FDA, these findings may impact their use in other parts of the world which remains widespread and the surveillance of existing patients.
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Pompeo et al. (2024) studied this question.
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