Breast Implant-associated Anaplastic Large Cell Lymphoma (bia-alcl) Prevalence In A Cohort Of 1,508 Patients From A Private Cosmetic Practice
Fabio Santanelli di Pompeo, MD, PhD1, Jerzy Kolasinski, MD2, Michail Sorotos, MD, PhD1.
1Sapienza University, Rome, Italy, 2Klinik Kolasinski, Poznań, Italy.
Background: The highest Incidence Rate (IR) reported for BIA-ALCL of 1:300, was prospectively assessed in large oncologic populations. Objectives: to estimate the cumulative IR in non-oncologic breast augmentation patients, and to calculate the implant-specific IR (ISIR).Material and Methods: We conducted a prospective observational study featuring 1,508 breast augmentation patients between 2006-2016. Patients were monitored yearly since implant placement and any implant-related complication, including BIA-ALCL, was recorded. All cases were identified by cross-checking clinical, pathology and external records data. Cumulative IR was evaluated with reverse Kaplan-Meier method. Patients were subdivided by implant manufacturer/characteristics, and IRs was calculated dividing the number of cases by the total follow-up years among them. Results: All patients received either macro or microtextured implants bilaterally. Mean follow-up was of 3.2 years (range: 1 months to 16.4 years). Overall, 216 patients (14,3%) received 257 revisional surgeries. BIA-ALCL occurred 6 times, after a median exposure of 10.7 years (range: 2.9 - 16.3). Cumulative IR was 4 cases/1000 individuals (1:250), the person-IR was 0.25 cases/1000 person-years. Implant-specific IR was 8.6 cases/1000 individuals with Allergan Biocell® devices and 1.3/1000 individuals with Mentor Siltex® devices. Conclusion: An IR similar to the highest was confirmed also in a non-oncologic population, whose reliability seems linked to having in common the accuracy and length of follow-up, independently of potential oncological predisposition. Allergan Biocell® surface confirmed the higher implant-specific IR
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