Silicone breast implant-related illness or breast implant-related “ASIA” syndrome: expert consensus
Keywords:
breast implants, adjuvants, silicone, ASIA syndromeAbstract
Breast augmentation surgeries are very common, but in recent years there has been a growing interest in their possible relationship with the appearance of nonspecific symptoms and signs, as well as the development of autoimmune disorders. The lack of a unified consensus about the syndrome poses a controversial issue for the scientific community and generates uncertainty among women with breast implants in Colombia.
Objective: to provide guidance on the evaluation, approach and followup of the disease associated with silicone breast implants or ASIA syndrome, based on evidence and the opinion of clinical experts.
References
1. International Society of Aesthetic Plastic Surgery - ISAPS. ISAPS International Survey on Aesthetic/Cosmetic procedures performed in 2023 [Internet]. 2024. www.isaps.org/media/rxnfqibn/isaps-glo- bal-survey_2023.pdf
2. Cohen Tervaert J, Mohazab N, Redmond D, Van Eeden C, Osman
M. Breast implant illness: scientific evidence of its existence. Expert Review of Clinical Immunology. 2022 Jan 2;18(1):15-29.
3. Cohen Tervaert JW. Autoinflammatory/autoimmunity syndrome induced by adjuvants (ASIA; Shoenfeld’s syndrome): A new flame. Autoimmunity Reviews. 2018 Dec;17(12):1259-64.
4. Ospina-Gómez JE, Ayala-Gutierrez MC, Amaya Muñoz MC, Cáceres Ramírez C, Monsalve-Suárez EF, Saaibi-Solano DL, et al. Adjuvant- Induced Autoimmune Syndrome: A Bibliometric Analysis. Cureus. 16(7):e65184.
5. Cohen Tervaert JW, Colaris MJ, van der Hulst RR. Silicone breast implants and autoimmune rheumatic diseases: myth or reality. Current opinion in rheumatology. 2017;29(4):348-54.
6. Goren I, Segal G, Shoenfeld Y. Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants. Who is at risk? Clin Rheumatol. 2015 Oct;34(10):1661-6.
7. Watad A, Rosenberg V, Tiosano S, Cohen Tervaert JW, Yavne Y, Shoenfeld Y, et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. International Journal of Epidemiology. 2018 Dec 1;47(6):1846-54.
8. Cohen Tervaert JW, Martinez-Lavin M, Jara LJ, Halpert G, Watad A, Amital H, et al. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in 2023. Autoimmunity Reviews. 2023 May; 22(5):103287.
9. Spit KA, Scharff M, Blok CJ de, Niessen FB, Bachour Y, Nanayakkara PW. Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study. BMJ Open. 2022 Jun 1;12(6):e057159.
10. Magno-Padron DA, Luo J, Jessop TC, Garlick JW, Manum JS, Carter GC, et al. A population-based study of breast implant illness. Arch Plast Surg. 2021 Jul;48(4):353-60.
11. Sociedad Colombiana de Cirugía Plástica Estética y Reconstructiva (SCCP), Asociación Colombiana de Reumatología (Asoreuma). Síndro- me autoinmune/autoinflamatorio inducido por adyuvantes (Asia) [Internet]. [cited 2024 Aug 15]. https://cirugiaplastica.org.co/sindrome- autoinmune-autoinflamatorio-inducido-por-adyuvantes-asia/
12. INVIMA. Resultados del programa de tecnovigilancia sobre implantes mamarios [Internet]. 2023 [cited 2024 Aug 15] p. 1-4. blob:chrome- extension://mhnlakgilnojmhinhkckjpncpbhabphi/e2117881-6252- 4c92-ad62-4f80d64dddb7
13. AGREE Next Steps Consortium. The AGREE II Instrument [Electronic version] [Internet]. 2013. https://www.agreetrust.org/ wp-content/uploads/2013/10/AGREE-II-Users-Manual-and-23- item-Instrument_2009_UPDATE_2013.pdf
14. Joanna Briggs Institute (JBI). JBI Critical Appraisal Tools | JBI [Internet]. [cited 2024 Sep 24]. [https://jbi.global/critical-appraisal-tools](https://jbi.global/critical-appraisal-tools)
15. Holey EA, Feeley JL, Dixon J, Whittaker VJ. An exploration of the use of simple statistics to measure consensus and stability in Delphi studies. BMC medical research methodology. 2007;7(1):52.
16. Suh LJ, Khan I, Kelley-Patteson C, Mohan G, Hassanein AH, Sinha M. Breast Implant-Associated Immunological Disorders. J Immunol Res. 2022 May 4;2022:8536149.
17. Giacomazzo C, Sakai C, Araujo R, Ono M, Duarte-da-Silva A, Freitas R. Adjuvant-induced autoimmune syndrome triggered by silicone breast implants: systematic review. Revista Brasileira de Cirurgia Plástica. 2022;37(4):485-93.
18. Pelc Z, Skórzewska M, Kurylcio A, Olko P, Dryka J, Machowiec P, et al. Current Challenges in Breast Implantation. Medicina (Kaunas). 2021 Nov 7;57(11):1214.
19. Jara LJ, García-Collinot G, Medina G, Cruz-Dominguez MDP, Vera-Lastra O, Carranza-Muleiro RA, et al. Severe manifestations of autoimmune syndrome induced by adjuvants (Shoenfeld’s syndrome). Immunol Res. 2017 Feb;65(1):8-16.
20. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000 Mar 16;342(11):781-90.
21. Lieffering AS, Hommes JE, Ramerman L, Rakhorst HA, Mureau MAM, Verheij RA, et al. Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants. JAMA Netw Open. 2022 Oct 7;5(10):e2236519.
22. Miseré RML, Colaris MJL, Tervaert JWC, van der Hulst RRWJ. The Prevalence of Self-Reported Health Complaints and Health-Related Quality of Life in Women With Breast Implants. Aesthet Surg J. 2020 Jul 17;41(6):661-8.
23. Greenbaum A, Halpert G, Dotan A, Shivatzki S, Heidecke H, Kaplan Neeman R, et al. The Prevalence of Hearing Impairments in Women with Silicone Breast Implants. Diseases. 2023 Feb 9;11(1):31.
24. Bird GR, Niessen FB. The effect of explantation on systemic disease symptoms and quality of life in patients with breast implant illness: a prospective cohort study. Sci Rep. 2022 Dec 6;12:21073.
25. Valente D, Itikawa W, Catherino F, Votto R, Groth A. Breast silicone explant: a multicenter longitudinal study. Revista Brasileira de Cirurgia Plástica. 2022;37(2):154-62.
26. Miranda R. En bloc explant of silicone breast prostheses and quality of life and evolution of ASIA syndrome symptoms. Revista Brasileira de Cirurgia Plástica. 2001;35(4):427-31.
27. André D, Gouveia F, Nascimento R, Luís H, Caldeira M, Ferreira C, et al. ASIA syndrome: Adverse reaction or autoimmunity? JRSM open. 2022;13(4):20542704221086166.
28. Carrera Muñoz C, González Rodríguez J, Abó Rivera A, Estarán E, Roig Cárcel J, Segarra Medrano A. Systemic sclerosis and microscopic polyangiitis after systemic exposure to silicone. Clinical Kidney Journal. 2021;14(7):1848-50.
29. Wroński J, Bonek K, Stanisławska-Biernat E. Scleroderma-like syndrome in a woman with silicone breast implants-case report and critical review of the literature. Reumatologia/Rheumatology. 2019;57(1):55-8.
30. Wehr A, Grieb G, Trautwein C, Streetz K. Unusual onset of adult still’s disease due to a systemic reaction to artificial breast implants. Zeitschrift für Rheumatologie. 2017;76(6).
31. Van Assche S, Parmentier H, Varkas G, Peene I, Herdewyn S. Progressive sensory ataxia and breast implant rupture, an uncommon presentation of a debated concept: a case report. BMC neurology. 2022;22(1):368.
32. Simeonova D, Georgiev T, Shivacheva T. Takayasu arteritis associated with autoimmune/inflammatory syndrome induced by adjuvants: a case-based review. Rheumatology International. 2023;43(5):975-81.
33. Schierbeck J, Davidsen JR, Nielsen SG, Bille C. Silicone implant incompatibility syndrome (SIIS) in a 57-year-old woman with unilateral silicone breast implant. Case Reports. 2017;2017:bcr-2016.
34. Posso-Osorio I, Méndez-Rayo T, Jimenez C, Escobar D, Sepúlveda M, Navarro E, et al. Hepatic infiltration by silicone in a patient With ASIA syndrome. Hepatology. 2017;67(1):444-5.
35. e Silva DN, Gründler C, de Melo Teixeira M das G, Horimoto AMC, Machado MA, Frazão IC, et al. Autoimmune syndrome induced by adjuvants (ASIA) after silicone breast augmentation surgery. Plastic and Reconstructive Surgery Global Open. 2017;5(9).
36. Ignacio Moreno-Urbina S, Paola Gameros-Palma C, Gaspar Ramos-Estrada J, Hiracheta-Torres A. Síndrome autoinmunitario inflamatorio inducido por adyuvantes. Reporte de caso. Revista Medica del IMSS. 2023;61(2).
37. Moling O, Piccin A, Tauber M, Marinello P, Canova M, Casini M, et al. Intravascular large B-cell lymphoma associated with silicone breast implant, HLA-DRB1* 11: 01, and HLA-DQB1* 03: 01 manifesting as macrophage activation syndrome and with severe neurological symptoms: a case report. Journal of Medical Case Reports. 2016;10(1):1-13.
38. Maldonado G, Guerrero R, Intriago M, Rios C. Autoinflammatory/Autoimmunity Syndrome Induced By Adjuvants (ASIA) Due to Silicone Incompatibility Syndrome. Case Reports in Rheumatology. 2021;2021.
39. Loftis CE, Nunez AC, De La Garza M, Dulgheru E. Two cases of autoimmune syndrome induced by adjuvants (ASIA): a multifaceted condition calling for a multidisciplinary approach. Cureus. 2022;14(10).
40. Roberta Fenoglio M, Cecchi I, Roccatello D. ASIA Syndrome Following Breast Implant Placement. Isr Med Assoc J 2018 Nov; 20(11):714-716.
41. De Stefano L, Volpi N, De Stefano P, Ginanneschi F, Frati E, Rossi A. Sporadic late-onset nemaline myopathy in a patient with silicone breast implants. Clinical neurology and neurosurgery. 2020; 196:105999.
42. de Carvalho JF, de Oliveira CBA, Boas RV, Matias MFV, Bastos LMC. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) with postural orthostatic tachycardia syndrome after silicone breast implantation: Case report. Eur J Rheumatol 2023 Jan; 10(1):23-25. Doi: 10.5152/eurjrheum.2022.21108.
43. Dagan A, Kogan M, Shoenfeld Y, Segal G. When uncommon and common coalesce: adult onset Still’s disease associated with breast augmentation as part of autoimmune syndrome induced by adjuvants (ASIA). Clinical rheumatology. 2016;35:1643-8.
44. Shoenfeld Y, Agmon-Levin N. ‘ASIA’-autoimmune/inflammatory syndrome induced by adjuvants. Journal of autoimmunity. 2011; 36(1):4-8.
45. Alijotas-Reig J. Human adjuvant-related syndrome or autoimmune/ inflammatory syndrome induced by adjuvants. Where have we come from? Where are we going? A proposal for new diagnostic criteria. Lupus. 2015 Sep;24(10):1012-8.
46. Seida I, Alrais M, Seida R, Alwani A, Kiyak Z, Elsalti A, et al. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA): past, present, and future implications. Clinical and Experimental Immunology. 2023;uxad033.
47. Borba V, Malkova A, Basantsova N, Halpert G, Andreoli L, Tincani A, et al. Classical examples of the concept of the ASIA syndrome. Biomolecules. 2020;10(10):1436.
48. Watad A, Rosenberg V, Tiosano S, Cohen Tervaert JW, Yavne Y, Shoenfeld Y, et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. International Journal of Epidemiology. 2018 Dec 1;47(6):1846-54.
49. INVIMA. Boletín Informativo Edición Especial. Informe especial dedicado a pacientes implantadas con protesis mamaria en Colombia. [Internet]. [https://www.invima.gov.co/sites/default/files/dispositivos-medicos/2023-10/tecnoboletin-03_0.pdf](https://www.invima.gov.co/sites/default/files/dispositivos-medicos/2023-10/tecnoboletin-03_0.pdf)
50. Bresnick S, Lagman C, Morris S, Bresnick S, Robbins M. Correlation Between Medically Diagnosed Anxiety and Depression Disorder and Self-Reported Breast Implant Illness. Aesthet Surg J. 2024 Sep 16;44(10):1118-1126. Doi: 10.1093/asj/sjae089.
51. Sugiyama D, Nishimura K, Tamaki K, Tsuji G, Nakazawa T, Morinobu A, et al. Impact of smoking as a risk factor for developing rheumatoid arthritis: a meta-analysis of observational studies. Ann Rheum Dis. 2010 Jan;69(1):70-81.
52. Di Giuseppe D, Discacciati A, Orsini N, Wolk A. Cigarette smoking and risk of rheumatoid arthritis: a dose-response meta-analysis. Arthritis Res Ther. 2014 Mar 5;16(2):R61.
53. Parisis D, Bernier C, Chasset F, Arnaud L. Impact of tobacco smo- king upon disease risk, activity and therapeutic response in systemic lupus erythematosus: A systematic review and meta-analysis. Autoimmun Rev. 2019 Nov;18(11):102393.
54. Miseré RML, van der Hulst RRWJ. Self-Reported Health Complaints in Women Undergoing Explantation of Breast Implants. Aesthet Surg J. 2022 Jan 12;42(2):171-80.
55. Colaris MJL, van der Hulst RR, Tervaert JWC. Vitamin D deficiency as a risk factor for the development of autoantibodies in patients with ASIA and silicone breast implants: a cohort study and review of the literature. Clin Rheumatol. 2017;36(5):981-93.
56. Barroso Da Silva EA, Vásquez Ortiz L, Aragón Salleg C, Briceño Balcázar I, Tuta Quintero E, Urrea X, et al. Autoinmunidad en pacientes con implantes mamarios de silicona: una revisión exploratoria. Revista Colombiana de Reumatología. 2023 Feb;S0121812323000051.
57. Kabir R, Stanton E, Sorenson TJ, Hemal K, Boyd CJ, Karp NS, et al. Breast Implant Illness as a Clinical Entity: A Systematic Review of the Literature. Aesthet Surg J. 2024 Aug 20;44(9):NP629-NP636. Doi: 10.1093/asj/sjae095.
58. Hoa S, Milord K, Hudson M, Nicolaidis SC, Bourré-Tessier J. Risk of rheumatic disease in breast implant users: a qualitative systematic review. Gland Surg. 2021 Aug;10(8):2557-76.
59. Pisetsky DS. Pathogenesis of autoimmune disease. Nature Reviews Nephrology. 2023;19(8):509-24.
60. Hill AB. The Environment and Disease: Association or Causation? Proc R Soc Med. 1965 May;58(5):295-300.
