Objectives: To learn the risk stratification on patients at risk of BIA-ALCL, so to properly conusel them on prophilactic explantation of textured devices.
Introduction: BIA-ALCL epidemiology is unclear due to lack of breast implant sales data and implant registries. This makes difficult to understand patients at risk for BIA-ALCL and deserving prophylactic explantation. To overcome this limitation and extract risk factor for patients stratification, we decided to identify published BIA-ALCL cases, calculate BIA-ALCL Incidence Rate (IR) and Event Free Time (EFT) and the patients’ characteristics influencing them.
Materials / method: A systematic literature review and Meta-Analyses statement (PRISMA) was done on PubMed, Scopus, and Web of Science, to identify unique case reports and case series of BIA-ALCL from anytime to April 2022. After excluding all irrelevant and duplicated papers, a total of 114 pertinent articles were selected, featuring 248 BIA-ALCL cases. Collected data were analyzed with descriptive statistics, IR, Kaplan-Meier survival curves, and Pearson correlation coefficient. Significant risk factors were extracted from Event Free Time and Survive analyses and used for patients risk stratification.
Results: 48% reconstructive and 52% aesthetic indication; 73.8% were macrotextured, 0% to smooth. Age at first implantation was inversely associated to EFT (r=-0.27, p-value <0.001). Overall IR was 0.80 new cases/100women/month, 0.90 if no BI replacement, 0.75 if 1 and 0.40 if 2 (p<0.0001). Mean EFT was 129 months, 75% of the cases developing by 168 months. Hazard without BI replacement peaked at 187 months since implantation, with 1 replacement at 211, and with >1 replacement peaked exponentially after 297 (p<0.0001). BRCA1 and TP53 pts showed a significant shorter EFT (p=0.09).
Conclusion: One point score was assigned to each significant risk factor to stratify patients in three risk categories: low, medium and high.
For the first-time implant replacement has been identified as a protective factor since BIA-ALCL IR is lower and EFT longer in patients with implant replacements. Prophylactic explantation of asymptomatic patients can find indication after stratification of BIA-ALCL risks. Since BRCA1 and TP53 patients are associated to significant shorter EFT, the use of textured implants should be reconsidered in this population.
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请注明名称（个人，公司，学会等等）: Consultant: 2021 Bella Seno 4.000,00€
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这项工作没有任何直接或间接的资金支持。由作者自己承担责任。 Research found: 2017 Motiva, Establishment Lab 30.000,00€. 2017 Mini-implants, Establishment Labs, GC Aesthetics and Sebbin. 2018 GCAesthetic 15.000,00€. 2020 GCAesthetic 15.000,00€. 2019-20-21 SCHEER-WG Reimbursement. 2021 Notify Body 0373 CE Mark, Minis
