PROFILE
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 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
- PROFILE Registry Frequently Asked Questions
- How to Add a Case to PROFILE
- A Patient Death Attributable to Implant-Related Primary Anaplastic Large Cell Lymphoma of the Breast
- Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma
- Commentary on: Lymphomas Associated with Breast Implants: A Review of the Literature
- Breast Implant-Associated Anaplastic Large Cell Lymphoma: Two Distinct Clinicopathological Variants with Different Outcomes
- Breast Implant-Associated Anaplastic Large Cell Lymphoma: Sensitivity, Specificity, and Findings of Imaging Studies in 44 Patients
- Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases
- Implant-Associated Primary Anaplastic Large-Cell Lymphoma with Simultaneous Involvement of Bilateral Breast Capsules
- Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma
- Chronic Biofilm Infection in Breast Implants is Associated with an Increased T-Cell Lymphocytic Infiltrate: Implications for Breast Implant-Associated Lymphoma
- Complete Surgical Excision is Essential for the Management of Patients with Breast Implant-Associated Anaplastic Large-Cell Lymphoma
- Coming of Age Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation
- Anaplastic Large-Cell Lymphoma in Women with Breast Implants
- Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients
- Managing Late Periprosthetic Fluid Collections (Seroma) in Patients with Breast Implants: A Consensus Panel Recommendation and Review of the Literature
- Breast Implant-Associated ALCL: A Unique Entity in the Spectrum of CD30 Lymphoproliferative Disorders
- The 2016 Revision of the World Health Organization Classification of Lymphoid Neoplasms
- Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Systematic Review of the Literature and Mini-Meta Analysis
- MBN 2016 Aesthetic Breast Meeting BIA-ALCL Consensus Conference Report
- 22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health
- Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk
- Discussion: Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand High-Surface-Area Textured Implants Are Associated with Increased Risk
- Discussion: Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand High-Surface-Area Textured Implants Are Associated with Increased Risk
Myckatyn, Terence M.; Parikh, Rajiv P.
Plastic and Reconstructive Surgery. 140(4):655-658, October 2017. - Reply: Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants
- U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma
- Global Adverse Event Reports of Breast Implant–Associated ALCL: An International Review of 40 Government Authority Databases
- Bacterial Biofilm Infection Detected in Breast Implant–Associated Anaplastic Large-Cell Lymphoma
- Breast Implant–Associated Anaplastic Large Cell Lymphoma: A Systematic Review
- The Case against Biofilm as the Primary Initiator of Breast Implant–Associated Anaplastic Large Cell Lymphoma
Brody, Garry S. - Anaplastic Large T-Cell Lymphoma and Breast Implants: A Review of the Literature
- Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review
- How to diagnose and treat breast implant associated anaplastic large cell lymphoma
- Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast
- BIA-ALCL in a transgender woman
- Whole exome sequencing reveals activating JAK1 and STAT3 mutations in breast implant-associated anaplastic large cell lymphoma anaplastic large cell lymphoma.
- Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma.
- The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
- Clinicopathologic Features and Prognostic Impact of Lymph Node Involvement in Patients With Breast Implant-associated Anaplastic Large Cell Lymphoma.
- Implant–Associated Anaplastic Large Cell Lymphoma A Systematic Review.
For more ALCL Resources, please visit www.plasticsurgery.org/alcl or contact alcl@plasticsurgery.org.