Abstract

Background: Breast implant–associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases with adequate history have involved a textured breast implant. The objective of this study was to determine the U.S. incidence and lifetime prevalence of breast implant–associated ALCL in women with textured breast implants. Methods: This is a retrospective review of documented cases of breast implant–associated ALCL in the United States from 1996 to 2015. The incidence and prevalence were determined based on a literature and institutional database review of breast implant–associated ALCL cases and textured breast implant sales figures from implant manufacturers’ annualized data. Results: One hundred pathologically confirmed breast implant–associated ALCL cases were identified in the United States. Mean age at diagnosis was 53.2 ± 12.3 years. Mean interval from implant placement to diagnosis was 10.7 ± 4.6 years. Forty-nine patients had breast implants placed for cosmetic reasons, 44 for mastectomy reconstruction, and seven for unknown reasons. Assuming that breast implant–associated ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1 million person-years (203 per 100 million person-years), which is 67.6 times higher than that of primary ALCL of the breast in the general population (three per 100 million per year; p < 0.001). Lifetime prevalence was 33 per 1 million persons with textured breast implants. Conclusions: This study demonstrates a statistically significant association between textured breast implants and breast implant–associated ALCL. Although women with a textured breast implant have a low risk of developing breast implant–associated ALCL, the current U.S. incidence is significantly higher than that of primary ALCL of the breast in the general population.