Clinical Immunotherapeutics

, Volume 1, Issue 6, pp 406–412 | Cite as

Immunological Reactions to Silicone Implants

Risk and Management
  • Robert F. Spiera
  • Allan Gibofsky
  • Harry Spiera
Leading Article


Implantable silicones have been widely used in medicine and surgery during the past 4 decades. Recently, concerns have arisen regarding the safety and efficacy of some of these devices. In particular, questions have emerged regarding a possible association between implantation of silicone gel-filled breast prostheses used in augmentation mammoplasty and reconstructive surgery with the development of autoimmune disease.

Silicones are not entirely biologically inert. Local host tissue reactions range from a bland scarring response to evidence of chronic inflammation and fibroproliferation. Silicones are capable of migration in vivo and can elicit inflammation at sites distant from implantation. There is experimental evidence supporting the potential immunogenicity and adjuvanticity of these substances.

A variety of systemic connective tissue diseases have been reported in women with silicone gel-filled breast implants. Scleroderma-like illnesses are markedly over-represented in women with silicone implants and identifiable connective tissue disease. This mimics the earlier reported Japanese experience with injectable silicones. Although the association between silicone exposure and development of scleroderma is supported by clinical experience and seems biologically plausible, there are to date no adequate epidemiological data that definitively demonstrate a causal relationship.

Our clinical approach to managing patients with silicone implants and systemic disease is individualised, but may involve removal of the prosthesis, particularly when the disease is of adequate severity to otherwise warrant toxic or immunosuppressive pharmacotherapy.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Wilkerson P. General silicone chemistry. Distributed communication to FDA Advisory Panel, February 1992Google Scholar
  2. 2.
    Speirs AL, Blocksman R. New implantable silicone rubbers: an experimental evaluation of tissue response. Plast Reconstr Surg 1963; 31: 166–75PubMedCrossRefGoogle Scholar
  3. 3.
    McGrath MH, Burkhardt BR. The safety and efficacy of breast implants for augmentation mammoplasty. Plast Reconstr Surg 1984; 74: 550–60PubMedCrossRefGoogle Scholar
  4. 4.
    Heggers JP, Kossovsky N, Parsons RW, et al. Biocompatibility of silicone implants. Ann Plast Surg 1983; 11: 38–41PubMedCrossRefGoogle Scholar
  5. 5.
    Kumagai Y, Shiokawa Y, Medsger TA Jr, et al. Clinical spectrum of connective tissue disease after cosmetic surgery: observations on 18 patients and a review of the Japanese literature. Arthritis Rheum 1984; 27: 1–12PubMedCrossRefGoogle Scholar
  6. 6.
    Sergott TJ, Limoli JP, Baldwin CM Jr, et al. Human adjuvant disease, possible autoimmune disease after silicone implantation: a review of the literature, case studies, and speculation for the future. Plast Reconstr Surg 1986; 78: 104–14PubMedCrossRefGoogle Scholar
  7. 7.
    Baldwin CM Jr, Kaplan EN. Silicone-induced human adjuvant disease? Ann Plast Surg 1983; 10: 270–3PubMedCrossRefGoogle Scholar
  8. 8.
    Endo LP, Edwards NL, Longley S, et al. Silicone and rheumatic diseases. Semin Arthritis Rheum 1987; 17: 112–18PubMedCrossRefGoogle Scholar
  9. 9.
    Sahn EE, Garen PD, Silver RM, et al. Scleroderma following augmentation mammoplasty. Arch Dermatol 1990; 126: 1198–202PubMedCrossRefGoogle Scholar
  10. 10.
    Nosanchuk J. Injected dimethylpolyfluid: a study of antibody and histologic response. Plast Reconstr Surg 1968; 42: 562–6PubMedCrossRefGoogle Scholar
  11. 11.
    Kossovsky N, Heggers JP. Experimental demonstration of the immunogenicity of silicone-protein complexes. J Biomed Mater Res 1987; 21: 1125–33PubMedCrossRefGoogle Scholar
  12. 12.
    Goldblum RM, Pelley RP, O’Donell AA, et al. Antibodies to silicone elastomers and reactions to ventriculo-peritoneal shunts. Lancet 1992; 340: 510–13PubMedCrossRefGoogle Scholar
  13. 13.
    Smith DJ, Sazy JA, Crissman JD, et al. Immunogenic potential of carpal implants. J Surg Res 1990; 48: 13–20PubMedCrossRefGoogle Scholar
  14. 14.
    Naim JO, Lanzafame RJ, van Oss CJ. The adjuvant effect of silicone gel on antibody formation in rats. Immunol Invest 1993; 22: 151–61PubMedCrossRefGoogle Scholar
  15. 15.
    Pemis B, Paronetto F. Adjuvant effect of silica (tridymite) on antibody production. Proc Soc Exp Biol Med 1962; 110: 390–2Google Scholar
  16. 16.
    Allison AC, Harington JS, Birbeck M. An examination of the cytotoxic effects of silica on macrophages. J Exp Med 1966; 124: 141–54PubMedCrossRefGoogle Scholar
  17. 17.
    Rodnan GP, Benedek TG, Medsger TA Jr, et al. The association of progressive systemic sclerosis (scleroderma) with coal miners’ pneumoconiosis and other forms of silicosis. Ann Intern Med 1967; 66: 323–34PubMedGoogle Scholar
  18. 18.
    Cowie RL. Silica dust-exposed mine workers with scleroderma. Chest 1987; 92: 260–2PubMedCrossRefGoogle Scholar
  19. 19.
    Lugano EM, Dauber JH, Elias JA, et al. The regulation of lung fibroblast proliferation by alveolar macrophages in experimental silicosis. Ann Rev Respir Dis 1984; 129: 767–71Google Scholar
  20. 20.
    Dauber JH, Rossman MD, Pietra GG, et al. Experimental silicosis: morphologic and biochemical abnormalities produced by instillation of quartz into guinea pig lungs. Am J Pathol 1980; 101: 595–612PubMedGoogle Scholar
  21. 21.
    Vargas A. Shedding of silicone particles from inflated breast implants. Plast Reconstr Surg 1979; 64: 252–3PubMedCrossRefGoogle Scholar
  22. 22.
    Pearl RM, Laub DR, Kaplan EN. Complications following silicone injection for augmentation of the contours of the face. Plast Reconstr Surg 1978; 61: 888–91PubMedGoogle Scholar
  23. 23.
    Wilkie TF. Late development of granuloma after liquid silicone injections. Plast Reconstr Surg 1977; 60: 179–88PubMedCrossRefGoogle Scholar
  24. 24.
    Gurdin M, Carlin G. Complications of breast implantations. Plast Reconstr Surg 1967; 40: 530–3PubMedCrossRefGoogle Scholar
  25. 25.
    Thomsen JL, Christensen L, Nielsen M, et al. Histologic changes and silicone concentrations in human breast tissue surrounding silicone breast prostheses. Plast Reconstr Surg 1990; 85: 38–41PubMedCrossRefGoogle Scholar
  26. 26.
    Christie AJ. Silicone lymphadenopathy and synovitis complication of silicone elastomer finger joint prosthesis. JAMA 1977; 237: 1463PubMedCrossRefGoogle Scholar
  27. 27.
    Bogoch ER. Silicone synovitis. J Rheumatol 1987; 14: 1086–7PubMedGoogle Scholar
  28. 28.
    Peimer CA, Medige J, Eckert BS. Reactive synovitis after silicone arthroplasty. J Hand Surg 1986; 11A: 624–638Google Scholar
  29. 29.
    Paplanus SH, Payne CM. Axillary lymphadenopathy 17 years after digital silicone implants: study with x-ray microanalysis. J Hand Surg 1988; 13A: 411–12Google Scholar
  30. 30.
    Chastre J, Basset F, Vino F, et al. Acute pneumonitis after subcutaneous injections of silicones in trans-sexual men. N Engl J Med 1983; 308: 764–7PubMedCrossRefGoogle Scholar
  31. 31.
    Ellenbogen R, Rubin L. Injectable fluid silicone therapy — human morbidity and mortality. JAMA 1975; 234: 308PubMedCrossRefGoogle Scholar
  32. 32.
    Miyoshi K, Miyamia T, Kobayashi Y, et al. Hypergammaglobulinemia by prolonged adjuvanticity in man: disorders developed after augmentation mammoplasty. Jpn Med J 1964; 2122: 9–14Google Scholar
  33. 33.
    Miyoshi K, Shiragami H, Yoshida K. Adjuvant disease of man. Clin Immunol (Tokyo) 1973; 5: 785–94Google Scholar
  34. 34.
    Van Nunen SA, Gatenby PA, Basten A. Post-mammoplasty connective tissue disease. Arthritis Rheum 1982; 25: 694–7PubMedCrossRefGoogle Scholar
  35. 35.
    Spiera H. Scleroderma after silicone augmentation mammoplasty. JAMA 1988; 260: 236–8PubMedCrossRefGoogle Scholar
  36. 36.
    Brozena SJ, Fenske NA, Cruse CW, et al. Human adjuvant disease following augmentation mammoplasty. Arch Dermatol 1988; 124: 1383–6PubMedCrossRefGoogle Scholar
  37. 37.
    Varga J, Schumacher R, Jimenez SA. Systemic sclerosis after augmentation mammoplasty with silicone implants. Ann Intern Med 1989; 111: 377–82PubMedGoogle Scholar
  38. 38.
    Gutierrez FJ, Espinoza LR. Progressive systemic sclerosis complicated by severe hypertension: reversal after silicone implant removal. Am J Med 1990; 89: 390–2PubMedCrossRefGoogle Scholar
  39. 39.
    Marik PE, Kaik AL, Zambakides A. Scleroderma after silicone augmentation manmmoplasty: a report of 2 cases. S Afr Med J 1990; 77: 212–3PubMedGoogle Scholar
  40. 40.
    Lazar AP, Lazar P. Localized morphen after silicone gel breast implantation: more evidence for a cause and effect relationship. Arch Dermatol 1991; 127: 263PubMedCrossRefGoogle Scholar
  41. 41.
    Press RI, Peebles CL, Kumagai Y, et al. Antinuclear autoantibodies in women with silicone breast implants. Lancet 1992; 340: 1304–7PubMedCrossRefGoogle Scholar
  42. 42.
    Osbom TG, Lawrence JM, Madson KL, et al. Silicone gel breast implants: spectrum of rheumatic complaints. Arthritis Rheum 1992; 35: S162Google Scholar
  43. 43.
    Silveira LH, Cuellas ML, Scopelitis E, et al. Evaluation of rheumatic complaints in women with silicone breast implants. Arthritis Rheum 1992; 35: S347Google Scholar
  44. 44.
    Silver RM, Sahn EE, Allen JA, et al. Demonstration of silicon in sites of connective tissue disease in patients with siliconegel breast implants. Arch Dermatol 1993; 129: 63–8PubMedCrossRefGoogle Scholar
  45. 45.
    Spiera H, Kerr LD. Scleroderma following silicone implantation: a cumulative experience of 12 cases. J Rheumatol 1993; 20: 958–61PubMedGoogle Scholar
  46. 46.
    Bridges AJ, Conley C, Wang G, et al. A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med 1993; 118: 929–36PubMedGoogle Scholar
  47. 47.
    Muhanna A, Rubin L, Keystone E, et al. Silicone breast implants and rheumatic disease — clinical and immunological investigations. Arthritis Rheum 1992; 35: S65Google Scholar
  48. 48.
    Spiera H. Rheumatic disease in patients with silicone implants. Arthritis Rheum 1992; 35: S349Google Scholar
  49. 49.
    Freundlich B, Tomaszewski J, Callegari P. A Sjogren’s-like syndrome in women with silicone-gel breast implants. Arthritis Rheum 1992; 35: S67CrossRefGoogle Scholar
  50. 50.
    Walsh FW, Solomon DA, Espinoza LR, et al. Human adjuvant disease: a new cause of chylous effusions. Arch Intern Med 1989; 149: 1194–6PubMedCrossRefGoogle Scholar
  51. 51.
    Kaiser W, Biesenbach G, Stuby U, et al. Human adjuvant disease: remission of silicone-induced autoimmune disease after explantation of breast augmentation. Ann Rheum Dis 1990; 49: 937–8PubMedCrossRefGoogle Scholar
  52. 52.
    Weiner SR, Paulus HE. Chronic arthropathy occurring after augmentation mammoplasty. Plast Reconstr Surg 1986; 77: 185–7PubMedCrossRefGoogle Scholar
  53. 53.
    Love LA, Weiner SR, Vasey FB, et al. Clinical and immunogenetic features of women who develop myositis after silicone implants. Arthritis Rheum 1992; 35: S46Google Scholar
  54. 54.
    Spiera RF, Gibofsky A, Spiera H. Silicone gel-filled breast implants and connective tissue disease: an overview. J Rheumatol 1994; 21: 239–45PubMedGoogle Scholar
  55. 55.
    Byron MA, Venning VA, Mowat AG. Post-mammoplasty human adjuvant disease. Br J Rheumatol 1984; 23: 227–9PubMedCrossRefGoogle Scholar
  56. 56.
    Jacobs JC, Imundo LF. Silicone implants and autoimmune disease. Lancet 1994; 343: 354–5PubMedCrossRefGoogle Scholar
  57. 57.
    Phelan DL, Mohanakumar T, McWilliams J, et al. Breast implants and autoimmunity: association with HLA. Hum Immunol 1992; 34: S34CrossRefGoogle Scholar
  58. 58.
    Levine JJ, Ilowite NT. Scleroderma-like esophageal disease in children breast-fed by mothers with silicone breast implants. JAMA 1994; 271: 213–6PubMedCrossRefGoogle Scholar

Copyright information

© Adis International Limited 1994

Authors and Affiliations

  • Robert F. Spiera
    • 1
  • Allan Gibofsky
    • 1
  • Harry Spiera
    • 2
  1. 1.The Hospital for Special SurgeryCornell University Medical CollegeNew YorkUSA
  2. 2.Mount Sinai School of MedicineMount Sinai HospitalNew YorkUSA

Personalised recommendations