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.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): Consultant: 2021 Bella Seno 4.000,00€
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo. 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
