Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated report 2012-2020 Journal Article


Authors: McCarthy, C. M.; Roberts, J.; Mullen, E.; Loyo-Berrios, N.; Clemens, M. W.; Yoon, S. W.; Levinson, H.; Sommers, K.; Hume, K.; Carr, L.
Article Title: Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated report 2012-2020
Abstract: Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. Method: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-Associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. Results: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). Conclusions: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL. © 2023 Lippincott Williams and Wilkins. All rights reserved.
Keywords: breast neoplasms; device removal; register; registries; breast tumor; breast endoprosthesis; breast implants; breast augmentation; breast implantation; lymphoma, large-cell, anaplastic; anaplastic large cell lymphoma; humans; human; female
Journal Title: Plastic and Reconstructive Surgery
Volume: 152
Issue: 4
ISSN: 0032-1052
Publisher: Lippincott Williams & Wilkins  
Date Published: 2023-10-01
Start Page: 16S
End Page: 24S
Language: English
DOI: 10.1097/prs.0000000000010475
PUBMED: 36995215
PROVIDER: scopus
DOI/URL:
Notes: Article -- MSK corresponding author is Colleen McCarthy -- Source: Scopus
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  1. Colleen Marie McCarthy
    144 McCarthy