TY - JOUR
T1 - 2022 Practice Recommendation Updates From the World Consensus Conference on BIA-ALCL
AU - di Pompeo, Fabio Santanelli
AU - Clemens, Mark W.
AU - Atlan, Michael
AU - Botti, Giovanni
AU - Cordeiro, Peter G.
AU - de Jong, Daphne
AU - di Napoli, Arianna
AU - Hammond, Dennis
AU - Haymaker, Cara L.
AU - Horwitz, Steven M.
AU - Hunt, Kelly
AU - Lennox, Peter
AU - Mallucci, Patrick
AU - Miranda, Roberto N.
AU - Munhoz, Alexandre M.
AU - Swanson, Eric
AU - Turner, Suzanne D.
AU - Firmani, Guido
AU - Sorotos, Michail
N1 - Funding Information: Prof Santanelli di Pompeo is affiliated with the NESMOS Department, which received research funds from Motiva (Houston, TX), Establishment Labs (Alajuela, Costa Rica) in 2017, and from GC Aesthetics (Dublin, Ireland) in 2018 and 2020. The NESMOS 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/lodgment 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 declared no ownerships or investments. Dr Hammond has a consulting agreement with the Mentor Corporation (Irvine, CA) and Establishment Labs, is a member of the medical advisory board for Establishment Labs, is a stockholder, owns unexcersized stock options with Establishment Labs, and holds a royalty agreement related to a medical device with Establishment Labs. Dr Turner receives research funding from Allergan (Irvine, CA). MD Anderson Cancer Center participates in clinical trials for Mentor Corporation and Establishment Labs. Drs Clemens, Haymaker, Hunt, and Miranda are faculty of MD Anderson Cancer Center. Dr. Haymaker receives speaker’s fees from the Society for Immunotherapy of Cancer (Milwaukee, WI), serves as an advisory board member for Briacell (W 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. Atlan is a speaker/consultant for GC Aesthetics (FixNip) and Renuvion (Apyx Medical Corporation, Clearwater, FL). Dr Swanson receives royalties from Springer Nature (Cham, Switzerland). Dr Horwitz discloses research Support from Affimed (Heidelberg, Germany), Millennium/Takeda (Cambridge, MA), Seattle Genetics (Bothell, WA) and consultancy relationships with Seattle Genetics, Takeda, and Tubulis (München, Germany). Dr. Hunt is on the Medical Advisory Board of Armada Health (Hunt Valley, MD) and AstraZeneca (Cambridge, UK) and discloses research funding from her Institution – Cairn Surgical (Lebanon, NH), Eli Lilly and Company (Indianapolis, IN) and Lumicell (Newton, MA). Dr. Mallucci is a temporary consultant for POLYTECH (Dieburg, Germany), Laboratoires SeBBin and BD (Franklin Lakes, NJ) and is an investor in B-Lite (Amsterdam, the Netherlands). Dr. Munhoz is a shareholder and member of the advisory board for Establishment Labs. Drs De Jong, Di Napoli, Lennox, Cordeiro, Sorotos, Firmani, and Botti declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Publisher Copyright: © The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - Background: Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3rd World Consensus Conference on BIA-ALCL. Objectives: The authors sought to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects, and international authority guidance. Methods: A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted with the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted employing the Delphi process, gathering 18 experts panelists and utilizing email-based questionnaires to record the level of agreement with each statement by applying a 5-point Likert Scale. Median response, interquartile range, and comments were employed to accept, reject, or revise each statement. Results: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 round, panelists agreed on all criteria. Conclusions: BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.
AB - Background: Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3rd World Consensus Conference on BIA-ALCL. Objectives: The authors sought to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects, and international authority guidance. Methods: A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted with the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted employing the Delphi process, gathering 18 experts panelists and utilizing email-based questionnaires to record the level of agreement with each statement by applying a 5-point Likert Scale. Median response, interquartile range, and comments were employed to accept, reject, or revise each statement. Results: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 round, panelists agreed on all criteria. Conclusions: BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.
UR - http://www.scopus.com/inward/record.url?scp=85139427035&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/asj/sjac133
DO - https://doi.org/10.1093/asj/sjac133
M3 - Article
C2 - 35639805
SN - 1090-820X
VL - 42
SP - 1262
EP - 1278
JO - Aesthetic Surgery Journal
JF - Aesthetic Surgery Journal
IS - 11
ER -