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. 2024 Sep 1;154(3):473-483.
doi: 10.1097/PRS.0000000000011370. Epub 2024 Feb 22.

American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma

Mark W Clemens  1 , Terence M Myckatyn  2 , Arianna Di Napoli  3 , Andrew L Feldman  4 , Elaine S Jaffe  5 , Cara L Haymaker  1 , Steven M Horwitz  6 , Kelly K Hunt  1 , Marshall E Kadin  7 , Colleen M McCarthy  6 , Roberto N Miranda  1 , H Miles Prince  8 , Fabio Santanelli di Pompeo  3 , Sari D Holmes  9 , Linda G Phillips  10
Affiliations

American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma

Mark W Clemens et al. Plast Reconstr Surg. .

Abstract

Background: In the absence of high-quality evidence, there is a need for guidelines and multidisciplinary consensus recommendations on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis and management of BIA-ALCL caused by textured implants. This article aims to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL.

Methods: A comprehensive search was conducted in the MEDLINE, Cochrane Library, and Embase databases, and supplemented by manual searches of relevant English-language articles and "related articles" sections. Studies focusing on breast surgery and lymphoma associated with breast implants were included for analysis. Meta-analyses were performed and reviewed by experts selected by the American Association of Plastic Surgeons using a Delphi consensus method.

Results: A total of 840 articles published between January of 2011 and January of 2023 were initially identified and screened. The full text of 188 articles was assessed. An additional 43 articles were excluded for focus, and 145 articles were included in the synthesis of results, with 105 of them being case reports or case series. The analysis encompassed a comprehensive examination of the selected articles to determine the incidence, risk factors, clinical presentation, diagnostic approaches, and treatment modalities related to BIA-ALCL.

Conclusions: Plastic surgeons should be aware of the elevated risks by implant surface type, implement appropriate patient surveillance, and follow the recommendations outlined in this statement to ensure patient safety and optimize outcomes. Ongoing research on the pathogenesis, genetic drivers, and preventative and prophylactic measures for BIA-ALCL is crucial for improving patient care.

Clinical question/level of evidence: Risk, V.

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Conflict of interest statement

Dr. Clemens is on the faculty of MD Anderson Cancer Center, which participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation. Dr. Myckatyn receives unrestricted research funds and product development royalties from RTI and has received a research gift from Sientra. Dr. Feldman received research funding from Seattle Genetics, is an inventor of technology for which Mayo Clinic holds unlicensed patents, and is an inventor of intellectual property licensed to Zeno Pharmaceuticals. Dr. Haymaker is on the faculty of MD Anderson Cancer Center, which participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation; receives speaker’s fees from the Society for Immunotherapy of Cancer (Milwaukee, WI); serves as an advisory board member for Briacell (West Vancouver, CA) and the Mesothelioma Applied Research Foundation (Washington, DC); has received personal fees from Nanobiotix (Paris, France); and receives funding to the MD Anderson Cancer Center from Iovance (San Carlos, CA) Sanofi (Paris, France), Dragonfly Therapeutics (Waltham, MA), and BTG (São Paulo, Brazil) outside the submitted work. Dr. Horwitz has consulted for, received honorarium from, or participated in advisory boards for Acrotech Biopharma, C4 Therapeutics, Janssen, Kura Oncology, Kyowa Hakko Kirin, Myeloid Therapeutics, ONO Pharmaceuticals, Seagen Inc., Takeda, Trillium Therapeutics, and Vividion Therapeutics, and has received research support for clinical trials from ADC Therapeutics, Affimed, Aileron, Celgene, Daiichi Sankyo, Forty Seven Inc., Kyowa Hakko Kirin, Millennium/Takeda, Portola Pharmaceuticals, Seagen Inc., Trillium Therapeutics, and Verastem.

Dr. Hunt is on the faculty of MD Anderson Cancer Center, which participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation. Dr. Kadin has received honoraria from Allergan, Inc., for serving on an advisory board for BIA-ALCL, and receives financial support for research on BIA-ALCL from the Aesthetic Surgery Education and Research Foundation. Dr. Miranda is on the faculty of MD Anderson Cancer Center, which participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation. Dr. Prince is a consultant for and has held advisory board roles for BMS, Janssen, Amgen, and Sanofi, and receives funding from BMS. Dr. Santanelli di Pompeo is affiliated with the Neurosciences, Mental Health and Sense Organs Department, which received research funds from Motiva (Houston, TX), Establishment Labs (Alajuela, Costa Rica; in 2017), and GC Aesthetics (Dublin, Ireland; in 2018 and 2020). The department also received mini-implants from Establishment Labs, GC Aesthetics, and Sebbin (Boissy l’Aillerie, France) for research purposes. Dr. Santanelli di Pompeo is also a paid consultant for BellaSeno GmbH (Leipzig, Germany); received reimbursements for travel and lodging expenses from ICEAG (Bilthoven, Utrecht, the Netherlands; in 2015) and SCHEER-WG (Luxembourg City, Luxembourg; in 2019, 2020, and 2021); and is a member of Notified Body 0373, which is part of the Superior Institute of Health and which carried out CE Mark certification activities for the Italian Ministry of Health for the year 2021; he has no ownerships or investments to declare. The remaining authors (Drs. Di Napoli, Elaine S. Jaffe, Colleen M. McCarthy, Sari D. Holmes, and Linda G. Phillips) have no financial interests to declare.

Figures

Fig. 1.
Fig. 1.
Predetermined aims of the multidisciplinary BIA-ALCL expert panel.
Fig. 2.
Fig. 2.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram.
See this image and copyright information in PMC

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