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Seminars in Immunopathology

, Volume 33, Issue 3, pp 287–294 | Cite as

Silicone breast implants and connective tissue disease: no association

  • Loren Lipworth
  • Lisbet R. Holmich
  • Joseph K. McLaughlin
Review

Abstract

The association of silicone breast implants with connective tissue diseases (CTDs), including systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and fibromyalgia, as well as a hypothesized new “atypical” disease, which does not meet established diagnostic criteria for any known CTD, has been extensively studied. We have reviewed the epidemiologic literature regarding an association between cosmetic breast implants and CTDs, with particular emphasis on results drawn from the most recent investigations, many of which are large cohort studies with long-term follow-up, as well as on those studies that address some of the misinformation and historically widespread claims regarding an association between breast implants and CTDs. These claims have been unequivocally refuted by the remarkably consistent evidence from published studies, as well as numerous independent meta-analyses and critical reviews, which have demonstrated that cosmetic breast implants are not associated with a subsequent increased occurrence of individual CTDs or all CTDs combined, including fibromyalgia. Moreover, there is no credible evidence for the conjectured excess of “atypical” CTD among women with cosmetic breast implants, or of a rheumatic symptom profile unique to these women. No increased risk of CTDs is evident in women with extracapsular ruptures in two studies, which evaluated risk by implant rupture status, and no consistent association has been observed between silicone breast implants and a variety of serologic markers or autoantibodies. Thus, any claims that remain regarding an association between cosmetic breast implants and CTDs are not supported by the scientific literature but rather are a residual byproduct of the unprecedented large-scale product liability litigation in the USA.

Keywords

Cosmetic breast implants Connective tissue disease Fibromyalgia Rheumatologic symptoms Autoantibodies Implant rupture 

Notes

Acknowledgments

Dr. McLaughlin has served as a consultant to the Inamed Corporation. The International Epidemiology Institute has received research funding for projects from Dow Corning Corporation, 3M Company and the Plastic Surgery Educational Fund of the American Society of Plastic Surgeons. None of the authors was compensated for this review.

References

  1. 1.
    Kumagai Y, Shiokawa Y, Medsger TA, Rodnan G (1984) Clinical spectrum of connective tissue disease after cosmetic surgery. Observations on eighteen patients and a review of the Japanese literature. Arthritis Rheum 27:1–12PubMedCrossRefGoogle Scholar
  2. 2.
    Spiera H (1988) Scleroderma after silicone augmentation mammoplasty. JAMA 260:236–238PubMedCrossRefGoogle Scholar
  3. 3.
    Van Nunen SA, Gatenby PA, Basten A (1982) Post-mammoplasty connective tissue disease. Arthritis Rheum 25:694–697PubMedCrossRefGoogle Scholar
  4. 4.
    Bridges AJ, Vasey FB (1993) Silicone breast implants. History, safety, and potential complications. Arch Intern Med 153:2638–2644PubMedCrossRefGoogle Scholar
  5. 5.
    Elberg JJ, Kjoller KH, Krag C (1993) Silicone mammary implants and connective tissue disease. Scand J Plast Reconstr Surg Hand Surg 27:243–248PubMedGoogle Scholar
  6. 6.
    Sergott TJ, Limoli JP, Baldwin CM Jr, Laub DR (1986) Human adjuvant disease, possible autoimmune disease after silicone implantation: a review of the literature, case studies, and speculation for the future. Plast Reconstr Surg 78:104–114PubMedCrossRefGoogle Scholar
  7. 7.
    Shons AR, Schubert W (1992) Silicone breast implants and immune disease. Ann Plast Surg 28:491–499PubMedCrossRefGoogle Scholar
  8. 8.
    Fryzek JP, Holmich L, McLaughlin JK et al (2007) A nationwide study of connective tissue disease and other rheumatic conditions among Danish women with long term cosmetic breast implantation. Ann Epidemiol 17:374–379PubMedCrossRefGoogle Scholar
  9. 9.
    Breiting VB, Holmich LR, Brandt B et al (2004) Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg 114:217–226PubMedCrossRefGoogle Scholar
  10. 10.
    Brinton LA, Buckley LM, Dvorkina O et al (2004) Risk of connective tissue disorders among breast implant patients. Am J Epidemiol 160:619–627PubMedCrossRefGoogle Scholar
  11. 11.
    Englert H, Joyner E, McGill N et al (2001) Women's health after plastic surgery. Intern Med J 31:77–89PubMedGoogle Scholar
  12. 12.
    Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS (2001) Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol 28:996–1003PubMedGoogle Scholar
  13. 13.
    Edworthy SM, Martin L, Barr SG, Birdsell DC, Brant RF, Fritzler MJ (1998) A clinical study of the relationship between silicone breast implants and connective tissue disease. J Rheumatol 25:254–260PubMedGoogle Scholar
  14. 14.
    Friis S, Mellemkjaer L, McLaughlin JK et al (1997) Connective tissue disease and other rheumatic conditions following breast implants in Denmark. Ann Plast Surg 39:1–8PubMedCrossRefGoogle Scholar
  15. 15.
    Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton LJ III (1994) Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 330:1697–1702PubMedCrossRefGoogle Scholar
  16. 16.
    Giltay EJ, Bernelot Moens HJ, Riley AH, Tan RG (1994) Silicone breast prostheses and rheumatic symptoms: a retrospective follow up study. Ann Rheum Dis 53:194–196PubMedCrossRefGoogle Scholar
  17. 17.
    Hennekens CH, Lee I, Cook NR et al (1996) Self-reported breast implants and connective tissue diseases in female health professionals. A retrospective cohort study. JAMA 275:616–621PubMedCrossRefGoogle Scholar
  18. 18.
    Holmich LR, Kjoller K, Fryzek JP et al (2003) Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants. Plast Reconstr Surg 111:723–732PubMedCrossRefGoogle Scholar
  19. 19.
    Kjoller K, Friis S, Mellemkjaer L et al (2001) Connective tissue disease and other rheumatic conditions following cosmetic breast implantation in Denmark. Arch Intern Med 161:973–979PubMedCrossRefGoogle Scholar
  20. 20.
    Nyren O, Josefsson S, McLaughlin JK et al (1998) Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden. Br Med J 316:417–422Google Scholar
  21. 21.
    Park AJ, Black RJ, Sarhadi NS, Chetty U, Watson AC (1998) Silicone gel-filled breast implants and connective tissue diseases. Plast Reconstr Surg 101:261–268PubMedCrossRefGoogle Scholar
  22. 22.
    Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH (1995) Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med 332:1666–1670PubMedCrossRefGoogle Scholar
  23. 23.
    Schusterman MA, Kroll SS, Reece GP et al (1993) Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report. Ann Plast Surg 31:1–6PubMedGoogle Scholar
  24. 24.
    Wells KE, Cruse CW, Baker JL Jr et al (1994) The health status of women following cosmetic surgery. Plast Reconstr Surg 93:907–912PubMedCrossRefGoogle Scholar
  25. 25.
    Lee IM, Cook NR, Shadick NA, Pereira E, Buring JE (2010) Prospective cohort study of breast implants and the risk of connective tissue diseases. Int J Epidemiol (in press)Google Scholar
  26. 26.
    Burns CJ, Laing TJ, Gillespie BW et al (1996) The epidemiology of scleroderma among women: assessment of risk from exposure to silicone and silica. J Rheumatol 23:1904–1911PubMedGoogle Scholar
  27. 27.
    Dugowson CE, Daling J, Koepsell TD, Voigt L, Nelson JL. Silicone breast implants and risk for rheumatoid arthritis. 56th Annual Meeting. American College Rheumatology. Arthr Rheum 1992;35:Suppl:S66Google Scholar
  28. 28.
    Englert H, Morris D, March L (1996) Scleroderma and silicone gel breast prostheses–the Sydney study revisited. Aust N Z J Med 26(3):349–355PubMedGoogle Scholar
  29. 29.
    Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH (1995) Breast implants, rheumatoid arthritis, and connective tissue diseases in clinical practice. J Clin Epidemiol 48:571–582PubMedCrossRefGoogle Scholar
  30. 30.
    Hochberg MC, Perlmutter DL, Medsger TA Jr et al (1996) Lack of an association between augmentation mammoplasty and systemic sclerosis (scleroderma). Arthritis Rheum 7:1125–1131CrossRefGoogle Scholar
  31. 31.
    Lai S, Goldman JA, Child AH, Engel A, Lamm SH (2000) Fibromyalgia, hypermobility, and breast implants. Rheumatol 27:2237–2241Google Scholar
  32. 32.
    Laing TJ, Gillepsie BW, Lacey JV et al (1996) The association between silicone exposure and undifferentiated connective tissue disease among women in Michigan and Ohio. Arthritis Rheum 39:S150Google Scholar
  33. 33.
    Laing TJ, Schottenfeld D, Lacey JV Jr et al (2001) Potential risk factors for undifferentiated connective tissue disease among women: implanted medical devices. Am J Epidemiol 154:610–617PubMedCrossRefGoogle Scholar
  34. 34.
    Strom BL, Reidenberg MM, Freundlich B, Schinnar R (1994) Breast silicone implants and risk of systemic lupus erythematosus. J Clin Epidemiol 47:1211–1214PubMedCrossRefGoogle Scholar
  35. 35.
    Williams HJ, Weismann MH, Berry CC (1997) Breast implants in patients with differentiated and undifferentiated connective tissue disease. Arthritis Rheum 40:437–440PubMedCrossRefGoogle Scholar
  36. 36.
    Wolfe F, Anderson J (1999) Silicone filled breast implants and the risk of fibromyalgia and rheumatoid arthritis. J Rheumatol 26:2025–2028PubMedGoogle Scholar
  37. 37.
    Bondurant S, Ernster V, Herdman R (1999) Safety of silicone breast implants, Report of the Committee on the Safety of Silicone Breast Implants (IOM). National Academy Press, Washington, D.CGoogle Scholar
  38. 38.
    Lipworth L, Tarone RE, McLaughlin JK (2004) Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence. Ann Plast Surg 52:598–601PubMedCrossRefGoogle Scholar
  39. 39.
    Blackburn WD Jr, Everson MP (1997) Silicone-associated rheumatic disease: an unsupported myth. Plast Reconstr Surg 99:1362–1367PubMedCrossRefGoogle Scholar
  40. 40.
    Hochberg MC, Perlmutter DL (1996) The association of augmentation mammoplasty with connective tissue disease, including systematic sclerosis (scleroderma): a meta-analysis. Curr Top Microbiol Immunol 210:411–417PubMedGoogle Scholar
  41. 41.
    Independent Review Group, Rogers J et al (1998) Silicone gel breast implants: the report of the independent review group. Crown, CambridgeGoogle Scholar
  42. 42.
    Janowsky EC, Kupper LL, Hulka BS (2000) Meta-analyses of the relation between silicone breast implants and the risk of connective tissue disease. N Engl J Med 342:781–790PubMedCrossRefGoogle Scholar
  43. 43.
    Lamm SH (1998) Silicone breast implants, breast cancer and specific connective tissue diseases: a systematic review of the data in the epidemiological literature. Int J Toxicol 17:497–527CrossRefGoogle Scholar
  44. 44.
    Lewin SL, Miller TA (1997) A review of epidemiologic studies analyzing the relationship between breast implants and connective tissue diseases. Plast Reconstr Surg 100:1309–1313PubMedCrossRefGoogle Scholar
  45. 45.
    Silman AJ, Hochberg MC (2001) Epidemiology of rheumatic diseases, 2nd edn. Oxford University Press, New YorkGoogle Scholar
  46. 46.
    Silverman BG, Brown SL, Bright RA et al (1996) Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 124:744–756PubMedGoogle Scholar
  47. 47.
    Tugwell P, Wells G, Peterson J et al (2001) Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum 44:2477–2484PubMedCrossRefGoogle Scholar
  48. 48.
    Wong O (1996) A critical assessment of the relationship between silicone breast implants and connective tissue diseases. Regul Toxicol Pharmacol 23(1 Pt 1):74–85PubMedCrossRefGoogle Scholar
  49. 49.
    McLaughlin JK, Lipworth L, Murphy DK, Walker PS (2007) The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Ann Plast Surg 59:569–580PubMedCrossRefGoogle Scholar
  50. 50.
    Karlson EW, Lee IM, Cook NR et al (1999) Comparison of self-reported diagnosis of connective tissue disease with medical records in female health professionals: the Women's Health Cohort Study. Am J Epidemiol 150:652–660PubMedGoogle Scholar
  51. 51.
    Kallenberg CG (1994) Overlapping syndromes, undifferentiated connective tissue disease and other fibrosing conditions. Curr Opin Rheumatol 6:650–654PubMedCrossRefGoogle Scholar
  52. 52.
    Wolfe F (1999) “Silicone related symptoms” are common in patients with fibromyalgia: no evidence for a new disease. J Rheumatol 26:1172–1175PubMedGoogle Scholar
  53. 53.
    Jensen B, Bliddal H, Kjoller K et al (2001) Rheumatic manifestations in Danish women with silicone breast implants. Clin Rheumatol 20:345–352PubMedCrossRefGoogle Scholar
  54. 54.
    Jensen B, Kjoller K, McLaughlin JK et al (2001) Muscular rheumatism following breast surgery in Denmark. Clin Exp Rheumatol 19:229PubMedGoogle Scholar
  55. 55.
    Fryzek JP, Signorello LB, Hakelius L et al (2001) Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery. Plast Reconstr Surg 107:206–213PubMedCrossRefGoogle Scholar
  56. 56.
    Press RI, Peebles CL, Kumagai Y, Ochs RL, Tan EM (1992) Antinuclear autoantibodies in women with silicone breast implants. Lancet 340:1304–1307PubMedCrossRefGoogle Scholar
  57. 57.
    Melmed EP (1998) A review of explantation in 240 symptomatic women: a description of explantation and capsulectomy with reconstruction using a periareolar technique. Plast Reconstr Surg 101:1364–1373PubMedCrossRefGoogle Scholar
  58. 58.
    Solomon G (1994) A clinical and laboratory profile of symptomatic women with silicone breast implants. Semin Arthritis Rheum 24:29–37PubMedCrossRefGoogle Scholar
  59. 59.
    Holmich LR, Lipworth L, McLaughlin JK, Friis S (2007) Breast implant rupture and connective tissue disease: a review of the literature. Plast Reconstr Surg 120:62S–69SPubMedCrossRefGoogle Scholar
  60. 60.
    Lipworth L, Tarone RE, McLaughlin JK (2004) Breast implants and fibromyalgia: a review of the epidemiologic evidence. Ann Plast Surg 52:284–287PubMedCrossRefGoogle Scholar
  61. 61.
    Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L (1995) The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 38:19–28PubMedCrossRefGoogle Scholar
  62. 62.
    Lai S, Goldman JA, Child AH, Engel A, Lamm SH (2000) Fibromyalgia, hypermobility, and breast implants. J Rheumatol 27:2237–2241PubMedGoogle Scholar
  63. 63.
    Jensen B, Wiik A, Wittrup IH et al (2003) Silicate antibodies in Danish women with silicone breast implants. Rheumatol 42:1032–1035CrossRefGoogle Scholar
  64. 64.
    Jensen B, Wittrup IH, Wiik A et al (2004) Antipolymer antibodies in Danish women with silicone breast implants. J Long Term Eff Med Implants 14:73–80PubMedCrossRefGoogle Scholar
  65. 65.
    Karlson EW, Lee IM, Cook NR, Buring JE, Hennekens CH, Bloch KJ (2001) Serologic evaluation of women exposed to breast implants. J Rheumatol 28:1523–1530PubMedGoogle Scholar
  66. 66.
    De jong WH, Goldhoorn CA, Kallewaard M et al (2002) Study to determine the presence of antipolymer antibodies in a group of Dutch women with a silicone breast implant. Clin Exper Rheumatol 20:151–160Google Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Loren Lipworth
    • 1
    • 2
  • Lisbet R. Holmich
    • 3
  • Joseph K. McLaughlin
    • 1
    • 2
  1. 1.International Epidemiology InstituteRockvilleUSA
  2. 2.Departments of Preventive Medicine (LL) and Medicine (JKM)Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer CenterNashvilleUSA
  3. 3.Department of Plastic SurgeryHerlev HospitalHerlevDenmark

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