United States Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

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Abstract

BACKGROUND

Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases of BI-ALCL with adequate history have involved a textured breast implant. The objective of this study is to determine the United States incidence and lifetime prevalence of BI-ALCL in women with textured breast implants.

METHODS

This is a retrospective review of documented cases of BI-ALCL in the United States from 1996 to 2015. The incidence and prevalence of BI-ALCL was determined based on a literature and institutional database review of BI-ALCL cases and textured breast implant sales figures from implant manufacturers' annualized data.

RESULTS

One hundred pathologically confirmed BI-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 7 for unknown reasons. Assuming BI-ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1,000,000 person-years (203 per 100 million), which is 67.6 times higher than that of breast ALCL (3 per 100 million; p<0.001). Lifetime prevalence was 33 per million persons with textured breast implants.

CONCLUSIONS

This study suggests a statistically significant association between textured breast implants and BI-ALCL. Although women with a textured breast implant have a low risk of developing BI-ALCL, the current United States incidence is significantly higher than that of breast ALCL in the general population.

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