Background: The reported incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is highly variable, demonstrating a need for more accurate estimates. This study estimates the incidence and incidence rate of BIA-ALCL in a single institution performing a high volume of implant-based breast reconstruction to enable accurate long-term follow-up and implant tracking.
Methods: All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively reviewed to analyze implant utilization and the development of BIA-ALCL. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table.
Results: During the 26-year study period, 9,373 patients underwent reconstruction with 16,065 implants, of which 9,589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1,000 patients (1 in 559) with textured implants and 1.15 per 1,000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range: 6.4–15.5 years). Time-to-event analysis demonstrated that up to 6 years the cumulative incidence of BIA-ALCL was zero, increasing to 4.4 per 1,000 patients at 10–12 years and to 9.4 per 1,000 at 14–16 years, though a sensitivity analysis showed loss to follow-up may affect these estimates.
Conclusions: BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing with time, particularly in patients exposed to textured implants for greater than 10 years.