BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1,501 Patients.

Abstract

Epidemiologic studies on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations. Aims of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications. In a prospective cohort observational study, 1,501 patients who received a cosmetic breast augmentation, between 2006 and 2016, were monitored recording any implant-related complication, including BIA-ALCL. Cross-checking clinical, pathology and external records data was used to identify cases. Prevalence, Implant-Specific Prevalence (I-SP), Incidence Rate (IR), Event Free Time (EFT) and Kaplan Meier survival estimate were calculated. All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated, prevalence was 1:300 patients, I-SP was 6.9 cases/1000 individuals/BIOCELL and 1.3 cases/1000 individuals/Siltex devices, IR was 1.07 cases/1,000 women/year. Mean (SD) EFT was of 9.2 years. When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IR between reconstructive and cosmetic cohorts, their even distribution can be consequent to underreporting due to poorer follow up and lower awareness in the latter group. The genetic predisposition in oncologic cohort reasonably affects the early onset more than the IR. Importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient's counseling in the decision for prophylactic explantation.