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

Doren, Erin L. M.D.; Miranda, Roberto N. M.D.; Selber, Jesse C. M.D., M.P.H.; Garvey, Patrick B. M.D.; Liu, Jun M.D.; Medeiros, L. Jeffrey M.D.; Butler, Charles E. M.D.; Clemens, Mark W. M.D.

Plastic and Reconstructive Surgery: May 2017 - Volume 139 - Issue 5 - p 1042–1050
doi: 10.1097/PRS.0000000000003282
Breast: Original Articles
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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.

Milwaukee, Wis.; and Houston, Texas

From the Department of Plastic Surgery, Medical College of Wisconsin, Tosa Center; and the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center.

Received for publication August 16, 2016; accepted November 4, 2016.

Disclosure: The authors have no financial interest to declare in relation to the content of this article.

A “Hot Topic Video” by Editor-in-Chief Rod J. Rohrich, M.D., accompanies this article. Go to and click on “Plastic Surgery Hot Topics” in the “Digital Media” tab to watch. On the iPad, tap on the Hot Topics icon.

Mark W. Clemens, M.D., Department of Plastic Surgery, The University of Texas M. D. Anderson Cancer Center, P.O. Box 301402, 1400 Pressler, Unit 1488, Houston, Texas 77230-1402,

©2017American Society of Plastic Surgeons