U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

[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.