PROFILE: Investigating Breast Implant Associated ALCL

    ALCL Breast Implant Registry

    Project Title: Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE)

    Principal Investigators: Colleen McCarthy, MD; Benjamin Eloff, PhD; and Nilsa Loyo-Berrios, PhD

    Clinical Coordinating Center: The Plastic Surgery Foundation

    Participating Sites: Open to all physicians who have a patient with breast implants that is diagnosed with Anaplastic Large Cell Lymphoma

    Project Description: Reports in the scientific community have suggested a possible association between anaplastic large cell lymphoma (ALCL) and breast implants.  ALCL is a rare type of non-Hodgkin lymphoma (NHL), a cancer involving the cells of the immune system. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute, approximately 1 in 500,000 women is diagnosed with ALCL in the United States each year. ALCL in the breast is even rarer; approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast.

    ASPS/PSF and FDA are collaborating to conduct research and develop a Breast Implant-Anaplastic Large Cell Lymphoma registry, the PROFILE Study, to increase the scientific data on ALCL in women with breast implants. The collaboration involves the development of PROFILE and in the proposed research to characterize ALCL in women with breast implants. 

    Data will be collected retrospectively and prospectively on confirmed cases of primary ALCL (including localized or systemic disease, and of any anatomic site and ALCL cell phenotype) in women with breast implants. The primary goal of this research collaboration is to better understand the role of the breast implants in the etiology of primary ALCL in women with breast implants.  The research will also focus on identifying potential risk factors and criteria detection and management of this disease. In addition to providing health care practitioners and patients with information they need about breast implants and treatment of ALCL, the confirmed cases in the Registry of primary ALCL in women with breast implants will be available for analytical epidemiological studies.

    Status: Currently collecting cases

    Publications/Resources: For more information regarding ALCL in women with breast implants, please contact

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