29445 United States Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Sunday, September 25, 2016: 1:40 PM
Erin L. Doren, MD , Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX
Roberto N Miranda, MD , Hematopathology, MD Anderson Cancer Center, Houston, TX
Jesse C Selber, MD, MPH , Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX
Patrick Bryan Garvey, MD, FACS , Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX
Jun Liu, MD, PhD , Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX
L. Jeffrey Medeiros, MD , Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX
Charles E Butler, MD , Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX
Mark W. Clemens, MD , Plastic Surgery, MD Anderson Cancer Center, The University of Texas, Houston, TX

Introduction:

There are an estimated 10 million women worldwide with breast implants and approximately 400,000 implants placed per year in the United States. Although rare, all cases of breast implant associated anaplastic large cell lymphoma (BI-ALCL) with adequate surgical history for confirmation have involved a textured breast prosthesis. A Dutch study reported the incidence of BI-ALCL to vary between 0.1 to 0.3 per 100,000 women based on 5 cases.1 The purpose of this study is to determine the U.S. incidence and lifetime prevalence of BI-ALCL in women with textured breast implants.

Methods:

This is a retrospective review of the U.S. literature and documented cases of BI-ALCL from 1996 to 2015. Incidence and prevalence of BI-ALCL was determined based on textured breast prostheses sales figures estimated from U.S. annualized data of published manufacturing sales reports. A non-linear regression model was used to estimate annual textured implants sold. 

Results:

100 pathologically confirmed BI-ALCL cases were identified in the U.S. from 1996-2015. Average age was 53.2±12.3 years. Interval from implant placement to diagnosis was 10.7±4.6 years. 49 patients had breast implants placed for cosmetic reasons, 44 for mastectomy. Patients were diagnosed with BIA-ALCL before 2000 (7%), between 2000-2013 (70%), or after 2013 (23%). Assuming BI-ALCL occurs only in textured breast implants it has an incidence rate of 0.14 per 10,000 person-years (range 0.1-0.15) and lifetime prevalence of 0.84 per 10,000 persons with textured breast implants. 1.4 cases will be observed when 10,000 patients with textured breast implants are followed for 10 years. 

Conclusion:

This study represents the first United States population based report demonstrating that the absolute risk of developing ALCL around a textured breast implant is much higher than the risk of developing ALCL in the general population. Patients with a textured breast prosthesis have a low risk of BI-ALCL, however the current incidence is ten times greater than previously reported in Europe. Further studies are required to determine if geographic, genetic, or surgical technique variability affects comparative susceptibility and disease risk. Improved global BI-ALCL registry mechanisms and centralized tissue banking are warranted to elucidate predisposing factors and genetic susceptibility.