Breast Implant Anaplastic Large Cell Lymphoma (BIA- ALCL): A Systematic Review and Case Report Regarding Incidence and Pathology Workup Systematic review and case report regarding incidence and pathological workup
Main Article Content
Abstract
Background: Breast implant–associated anaplastic large cell lymphoma (BIA ALCL) is a rare indolent yet lethal disease. Recently the WHO accepted it as an individual new entity. Since then national and international registries have attempted to collect epidemiological data, but incidence rates vary strongly. The aim of this article is to provide an update on the status of the national BIA-ALCL registries and identify pitfalls alongside the current collection and diagnostic algorhythm.
Methods: A systematic review of the literature was performed and epidemiological data from national registries were compared. Furthermore a case report of a false positive diagnosis was added and the pitfalls alongside the diagnostic algorhythm was worked out.
Results: The comparison of national registries revealed significant differences in the collected data. Mean start of the registries was 2014, median 2015. Reporting of BIA-ALCL cases is mandatory except in two countries. Capture rates vary between 0-100%. Incidence rates range from 0.0 up to 8.9 per million implant years. The number of deaths does not correlate with the number of implants or the total population. The very same strains of CD30 can be interpreted differently.
Conclusion: Comparing epidemiologic data revealed significant differences among national registries. In particular, non-published sales data of breast implants and non-mandatory recording of the disease lead to an overall underreporting of cases. Therefore, the incidence rates still cannot be compared uniformly. Furthermore the definition of CD30 straining intensity should be standardized and adjusted in the guidelines.
Article Details
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
2. McCarthy CM, Loyo-Berríos N, Qureshi AA, et al. Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):65S-73S. doi:10.1097/PRS.0000000000005571
3. Clemens MW, Brody GS, Mahabir RC, Miranda RN. How to Diagnose and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2018;141(4):586e-599e. doi:10.1097/PRS.0000000000004262
4. U. S. Food and Drug Administration. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Published January 9, 2021. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
5. American Society of Plastic Surgeons. BIA-ALCL Physician Resources. Published March 3, 2021. Accessed March 3, 2021. https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources
6. Keech JA, Creech BJ. Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg. 1997;100(2):554-555. doi:10.1097/00006534-199708000-00065
7. Largent J, Oefelein M, Kaplan HM, Okerson T, Boyle P. Risk of lymphoma in women with breast implants: analysis of clinical studies. Eur J Cancer Prev. 2012;21(3):274-280. doi:10.1097/CEJ.0b013e328350b0ae
8. U.S. Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses. Accessed January 10, 2021. http://wayback.archive-it.org/7993/20171115053750/https:/www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm#executivesummary
9. Lekander J. Årsrapport 2014 Bröstimplantatregistret - BRIMP. Accessed April 25, 2022. https://registercentrum.blob.core.windows.net/brimp/r/BRIMP_arsrapport_2014-HkemJ8JvXH.pdf
10. Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375-2390. doi:10.1182/blood-2016-01-643569
11. Carty MJ, Pribaz JJ, Antin JH, et al. A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg. 2011;128(3):112e-118e. doi:10.1097/PRS.0b013e318221db96
12. St Cyr TL, Pockaj BA, Northfelt DW, Craig FE, Clemens MW, Mahabir RC. Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Current Understanding and Recommendations for Management. Plast Surg (Oakv). 2020;28(2):117-126. doi:10.1177/2292550320925906
13. Kuehlmann B, Prantl L. Die Zeit ist reif für ein deutschlandweit verpflichtendes Brustimplantateregister - Pilotprojekt Brustimplantate Erhebungsbogen: (Need for a German Breast Implant Registry - Pilot Project Breast Implant Template). Handchir Mikrochir plast Chir. 2016;48(4):199-204. doi:10.1055/s-0042-111003
14. Miranda RN, Aladily TN, Prince HM, et al. Breast implant-associated anaplastic large-cell lymphoma: long-term follow-up of 60 patients. J Clin Oncol. 2014;32(2):114-120. doi:10.1200/JCO.2013.52.7911
15. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
16. Bargon CA, Becherer BE, Young-Afat DA, et al. Moving breast implant registries forward: Are they FAIR and Functional? J Plast Reconstr Aesthet Surg. 2021;74(1):4-12. doi:10.1016/j.bjps.2020.10.001
17. Australian Breast Device Registry. 2020-ABDR-Annual-Report-FINALweb. Accessed April 24, 2022. https://www.abdr.org.au/wp-content/uploads/2021/12/2020-ABDR-Annual-Report-FINALweb.pdf
18. Therapeutic Goods Administration. BIA-ALCL: Information for health professionals. Published April 24, 2022. Accessed April 24, 2022. https://www.tga.gov.au/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
19. Therapeutic Goods Administration. Breast implants and anaplastic large cell lymphoma. Published April 24, 2022. Accessed April 24, 2022. https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
20. e International Society of Aesthetic Plastic Surgery. ISAPS Global Survey Results 2018. Accessed April 24, 2022. https://www.isaps.org/wp-content/uploads/2019/12/ISAPS-Global-Survey-Results-2018-new.pdf
21. Australian Bureau of Statistics. Population Clock. Accessed April 25, 2022. https://www.abs.gov.au/ausstats/[email protected]/94713ad445ff1425ca25682000192af2/1647509ef7e25faaca2568a900154b63?OpenDocument
22. Scientific Committee on Health, Environmental and Emerging Risks. FINAL Opinion on the safety of breast implants in relation to anaplastic large cell lymphoma. Accessed April 25, 2022. https://ec.europa.eu/health/system/files/2021-04/scheer_o_018_0.pdf
23. Statistics Denmark. Population at the first day of the quater 2021 Q2. Published April 25, 2022. Accessed April 25, 2022. https://www.dst.dk/en/Statistik/emner/borgere/befolkning
24. International Society of Aesthetic Plastic Surgery. Global Surve_2019_Stand_2020.indd. Accessed April 25, 2022. https://www.isaps.org/wp-content/uploads/2020/12/Global-Survey-2019.pdf
25. Institut national de la statistique et des études économiques. Demography - Population at the beginning of the month - France (including Mayotte since 2014) | Insee. Published April 25, 2022. Accessed April 25, 2022. https://www.insee.fr/en/statistiques/serie/001641607
26. Bundesinstitut für Arzneimittel und Medizinprodukte. Möglicher Zusammenhang zwischen Brustimplantaten und der Entstehung eines anaplastischen großzelligen Lymphoms (ALCL). Published April 25, 2022. Accessed April 25, 2022. https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/Brustimplantate_ALCL_FDA.html
27. International Society of Aesthetic Plastic Surgery. ISAPS-Global-Survey_2020. Accessed April 24, 2022. https://www.isaps.org/wp-content/uploads/2022/01/ISAPS-Global-Survey_2020.pdf
28. Statistisches Bundesamt. Bevölkerung nach Nationalität und Geschlecht (Quartalszahlen). Published July 7, 2021. Accessed April 25, 2022. https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoelkerung/Bevoelkerungsstand/Tabellen/liste-zensus-geschlecht-staatsangehoerigkeit.html
29. Prantl L, Gerken M, Zeman F, et al. Incidence of Anaplastic Large Cell Lymphoma and Breast-Implant-Associated Lymphoma-An Analysis of a Certified Tumor Registry over 17 Years. J Clin Med. 2020;9(5). doi:10.3390/jcm9051247
30. Ministero della Salute. Protesi mammarie e Linfoma anaplastico a grandi cellule (ALCL). Published April 25, 2022. Accessed April 25, 2022. https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=4419&area=dispositivi-medici&menu=vigilanza
31. Istituto Nazionale di Statistica. Resident population by age, sex and marital status on 1st January 2022. Published April 25, 2022. Accessed April 25, 2022. https://demo.istat.it/popres/index.php?anno=2022&lingua=eng
32. Campanale A, Spagnoli A, Lispi L, Boldrini R, Marletta M. The Crucial Role of Surgical Treatment in BIA-ALCL Prognosis in Early- and Advanced-Stage Patients. Plast Reconstr Surg. 2020;146(5):530e-538e. doi:10.1097/PRS.0000000000007240
33. Centraal Bureau voor de Statistiek. Bevolkingsteller. Published April 25, 2022. Accessed April 25, 2022. https://www.cbs.nl/nl-nl/visualisaties/dashboard-bevolking/bevolkingsteller
34. Boer M de, van Leeuwen FE, Hauptmann M, et al. Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast. JAMA Oncol. 2018;4(3):335-341. doi:10.1001/jamaoncol.2017.4510
35. INE. INEbase / Demografía y población /Padrón. Población por municipios /Estadística del Padrón continuo / Últimos datos. Published April 24, 2022. Accessed April 25, 2022. https://www.ine.es/dyngs/INEbase/es/operacion.htm?c=Estadistica_C&cid=1254736177012&menu=ultiDatos&idp=1254734710990
36. Swedish National Quality Register for Breast Implants. BRIMP-Annual-Report-2020. Accessed April 25, 2022. https://registercentrum.blob.core.windows.net/brimp/r/BRIMP-Annual-Report-2020--SkgiRSNRXF.pdf
37. Statistiska centralbyrån. Befolkningsstatistik. https://www.scb.se/hitta-statistik/statistik-efter-amne/befolkning/befolkningens-sammansattning/befolkningsstatistik/pong/tabell-och-diagram/helarsstatistik--kommun-lan-och-riket/folkmangd-i-riket-lan-och-kommuner-31-december-2020-och-befolkningsforandringar-2020/
38. Ionescu P, Vibert F, Amé S, Mathelin C. New Data on the Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Eur J Breast Health. 2021;17(4):302-307. doi:10.4274/ejbh.galenos.2021.2021-5-6
39. Office for National Statistics. Population estimates. Published April 25, 2022. Accessed April 25, 2022. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/
40. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. FDA. Published . Accessed April 24, 2022. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma.
41. U.S. Census Bureau. QuickFacts: United States. Accessed April 25, 2022. https://www.census.gov/quickfacts/fact/table/US/PST045219
42. Doren EL, Miranda RN, Selber JC, et al. U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2017;139(5):1042-1050. doi:10.1097/PRS.0000000000003282.
43. Wang SS, Deapen D, Voutsinas J, et al. Breast implants and anaplastic large cell lymphomas among females in the California Teachers Study cohort. Br J Haematol. 2016;174(3):480-483. doi:10.1111/bjh.13779
44. GIN. Home Page - GIN. Published February 1, 2022. Accessed April 21, 2022. https://g-i-n.net/
45. Guidelines and Measures | Agency for Healthcare Research and Quality. Published April 21, 2022. Accessed April 21, 2022. https://www.ahrq.gov/gam/index.html
46. Hutton B, Salanti G, Caldwell DM, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med. 2015;162(11):777-784. doi:10.7326/M14-2385
47. Lamaris GA, Butler CE, Deva AK, et al. Breast Reconstruction Following Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):51S-58S. doi:10.1097/PRS.0000000000005569
48. Tevis SE, Hunt KK, Clemens MW. Stepwise En Bloc Resection of Breast Implant-Associated Anaplastic Large Cell Lymphoma with Oncologic Considerations. Aesthet Surg J Open Forum. 2019;1(1):ojz005. doi:10.1093/asjof/ojz005
49. van Dongen JJM, Langerak AW, Brüggemann M, et al. Design and standardization of PCR primers and protocols for detection of clonal immunoglobulin and T-cell receptor gene recombinations in suspect lymphoproliferations: report of the BIOMED-2 Concerted Action BMH4-CT98-3936. Leukemia. 2003;17(12):2257-2317. doi:10.1038/sj.leu.2403202
50. Montgomery-Goecker C, Fuda F, Krueger JE, Chen W. Immunophenotypic characteristics of breast implant-associated anaplastic large-cell lymphoma by flow cytometry. Cytometry B Clin Cytom. 2015;88(5):291-293. doi:10.1002/cyto.b.21222
51. NHS Digital. Breast and Cosmetic Implant Registry - January 2020 to December 2020, Management Information - NHS Digital. Published April 25, 2022. Accessed April 25, 2022. https://digital.nhs.uk/data-and-information/publications/statistical/mi-breast-and-cosmetic-implant-registry/2021
52. U.S. Food and Drug Administration. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). FDA. Published . Accessed April 25, 2022. https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl.
53. Prantl L, Fritschen U von, Liebau J, et al. Konzept für ein nationales Implantatregister zur Verbesserung der Patientensicherheit. Handchir Mikrochir plast Chir. 2016;48(6):320-329. doi:10.1055/s-0042-118863
54. Deva AK, Turner SD, Kadin ME, et al. Etiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Current Directions in Research. Cancers (Basel). 2020;12(12). doi:10.3390/cancers12123861
55. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(Suppl_1):S3-S13. doi:10.1093/asj/sjy331
56. Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK. Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):30S-40S. doi:10.1097/PRS.0000000000005567
57. Quesada AE, Medeiros LJ, Clemens MW, Ferrufino-Schmidt MC, Pina-Oviedo S, Miranda RN. Breast implant-associated anaplastic large cell lymphoma: a review. Mod Pathol. 2019;32(2):166-188. doi:10.1038/s41379-018-0134-3
58. Jones JL, Hanby AM, Wells C, et al. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): an overview of presentation and pathogenesis and guidelines for pathological diagnosis and management. Histopathology. 2019;75(6):787-796. doi:10.1111/his.13932
59. Di Napoli A, Pepe G, Giarnieri E, et al. Cytological diagnostic features of late breast implant seromas: From reactive to anaplastic large cell lymphoma. PLoS One. 2017;12(7):e0181097. doi:10.1371/journal.pone.0181097
60. Das DK, Chowdhury V, Kishore B, Chachra K, Bhatt NC, Kakar AK. CD-30(Ki-1)-positive anaplastic large cell lymphoma in a pleural effusion. A case report with diagnosis by cytomorphologic and immunocytochemical studies. Acta Cytol. 1999;43(3):498-502. doi:10.1159/000331109