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Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) epidemiologic studies focus on incidence and risk estimates., Objectives: The aim of this study was to perform a thorough literature review, and to provide an accurate estimate of BIA-ALCL prevalence in Europe., Methods: We searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications reporting BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant-bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from national plastic surgery societies, health authorities, and disease-specific registries to calculate the numerator. The denominator was estimated by combining European demographic data with scientific reports., Results: Our research identified 507 articles: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 articles, we selected 35 that discussed epidemiology and 12 reviews. The CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the 28 member states of the European Union (EU-28). Countries where specific measures have been implemented to tackle BIA-ALCL account for 61% of the EU-28 population and actively reported 382 cases with an overall prevalence of 1:9121., Conclusion: Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared with the European mean, suggesting that these countries have improved the detection of the condition and reduced underreporting, which affects the numerator value. Other nations should adopt projections based on these measures to avoid underestimating how widespread BIA-ALCL is., (© 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

During the last two decades the number of breast implants used in aesthetic, oncologic and risk reducing surgery has increased substantially mainly due to the improvement and confirmed safety of these devices. Since identification of the first case of anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) 20 years ago, there has been an increase in the number of reports of this very rare disease, demonstrating a clear association with breast implants. Whilst the majority of cases are localised and cured by implant removal and full capsulectomy, a small percentage require chemotherapy and the mortality rate is very low. The evidence linking BIA-ALCL to implant surface texturing, as the majority of cases were diagnosed in patients with textured implants, has raised concerns about the long term safety of these devices resulting in patient and regulatory authority concerns globally. We hereby present the current published knowledge about the link between BIA-ALCL and implant surface texture and a review of current regulatory and professional body advice across Europe, which may enable a better understanding of this rare disease, how to manage and ultimately prevent it. We conclude by giving EUSOMA recommendation, towards the unnecessary change in attitudes towards implant based surgery, according to the most recent available published evidence as long as patients are properly informed about the risk of BIA-ALCL., (Copyright © 2019 Elsevier Ltd. All rights reserved.)