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Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining An Accurate Risk
Jonas A. Nelson, MD1, Stefan Dabic, MPH1, Babak J. Mehrara, MD1, Peter G. Cordeiro, MD1, Joseph J. Disa, MD1, Andrea L. Pusic, MD, MHS2, Evan Matros, MD, MMSc1, Joseph H. Dayan, MD1, Robert J. Allen, MD1, Michelle Coriddi, MD1, Thais O. Polanco, MD1, Meghana G. Shamsunder, MPH1, Itay Wiser, MD, PhD1, Monica Morrow, MD1, Ahmet Dogan, MD1, Michele R. Cavalli, BA1, Elizabeth Encarnacion, BA1, Meghan E. Lee, BS1, Collen M. McCarthy, MD1.
1Memorial Sloan Kettering Cancer Center, New York, NY, USA, 2Brigham and Women's Hospital, Boston, MA, USA.

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: 6.415.5 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 1012 years and to 9.4 per 1,000 at 1416 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.


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