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Project Title: Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma (ALCL) etiology and Epidemiology (PROFILE)

Principal Investigators: Colleen McCarthy, MD; 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 has a suspected or confirmed case of Breast Implant-Associated ALCL (BIA-ALCL)

Project Description: Reports in the scientific community have suggested a possible association between ALCL and breast implants. ALCL is a rare type of non-Hodgkin lymphoma (NHL), a cancer involving the cells of the immune system.

ASPS/PSF and FDA are collaborating to conduct research and develop a Breast Implant-Associated ALCL Registry, the PROFILE Registry, 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 is 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 collaboration is to better understand the role of the breast implants in the etiology of primary ALCL in women with breast implants. The research also will 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

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