An association of silicone-gel breast implant rupture and fibromyalgia

Abstract

Silicone-gel breast implant rupture is common. Silicone-gel from ruptured implants may escape the scar capsule that forms around breast implants and become “extracapsular silicone.” Our previously published study found that women with extracapsular silicone gel were at higher risk of reporting that they were diagnosed with fibromyalgia. There has been a limited number of studies addressing this association in the literature. Some studies addressing the issue of silicone breast implants and connective tissue disease specifically exclude patients with fibromyalgia from the sample or do not include the syndrome in the analysis. Case series describing fibromyalgia in patients with implants have been published, but many of these papers lack information on extracapsular silicone and are not representative because the patients are typically from referral populations. In addition, most studies do not have control groups of women without implants for comparison or do not distinguish between saline and silicone implants. Additional observational studies of women from nonreferral populations are necessary to validate an association. These studies should provide information on how the rupture is diagnosed, state whether the rupture extended beyond the capsule, and provide an appropriate control group for comparison. The findings from such studies may be important to physicians as they describe potential risks associated with implants to their patients. These findings should also be important for regulatory decision making on silicone-gel breast implants.

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References and Recommended Reading

  1. 1.

    Silverman BG, Brown SL, Bright RA, et al.: Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 1996, 124:744–756.

    PubMed  CAS  Google Scholar 

  2. 2.

    Kessler DA: The basis of the FDA’s decision on breast implants. N Engl J Med 1992, 326:1713–1715.

    PubMed  CAS  Article  Google Scholar 

  3. 3.

    Safety of Silicone Breast Implants. Edited by Bondurant S, Ernster V, Herdman R. Washington, DC: National Academy of Sciences Press; 1999.

  4. 4.

    Wolfe F: "Silicone related symptoms" are common in patients with fibromyalgia: no evidence for a new disease. J Rheumatol 1999, 26:1172–1175. The symptom content and rate of symptoms in patients with fibromyalgia are compared with those with silicone implant-associated syndrome.

    PubMed  CAS  Google Scholar 

  5. 5.

    Fenske TK, Davis P, Aaron SL: Human adjuvant disease revisited: a review of eleven post-augmentation mammoplasty patients. Clin Exp Rheumatol 1994, 12:477–481.

    PubMed  CAS  Google Scholar 

  6. 6.

    Gabriel SE, O’Fallon WM, Kurland LT, et al.: Risk of connectivetissue diseases and other disorders after breast implantation. N Engl J Med 1994, 330:1697–1702.

    PubMed  Article  CAS  Google Scholar 

  7. 7.

    Hennekens CH, Lee I-M, Cook NR, et al.: Self-reported breast implants and connective-tissue diseases in female health professionals: a retrospective cohort study. JAMA 1996, 275:616–621.

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Sanchez-Guerrero J, Colditz GA, Karlson EW, et al.: Silicone breast implants and the risk of connective-tissue disease and symptoms. N Engl J Med 1995, 332:1666–1670.

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Brown SL, Pennello G, Berg WA, et al.: Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol 2001, 28:996–1003. Describes an association between extracapsular silicone-gel, detected by magnetic resonance imaging, and fibromyalgia in a population of women with breast implants.

    PubMed  CAS  Google Scholar 

  10. 10.

    Cronin TD, Gerow FJ: Augmentation mammaplasty: a new "natural feel" prosthesis. Excerpta Medica 1964:41-49.

  11. 11.

    The Merck Manual of Diagnosis and Therapy. Edited by Beers MH, Berkow R. Whitehouse Station, NJ: Merck; 1999.

  12. 12.

    Wolfe F, Smythe HA, Yunus MB, et al.: The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990, 33:160–172.

    PubMed  Article  CAS  Google Scholar 

  13. 13.

    Wolfe F, Ross K, Anderson J, et al.: The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 1995, 38:19–28.

    PubMed  Article  CAS  Google Scholar 

  14. 14.

    Brown SL, Middleton MS, Berg WA, et al.: Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. AJR Am J Roentgenol 2000, 175:1057–1064. A study of a nonreferred population of women with breast implants who underwent magnetic resonance examination of their breasts to detect implant rupture.

    PubMed  CAS  Google Scholar 

  15. 15.

    Hölmich LR, Kjøller K, Vejborg I, et al.: Prevalence of silicone breast implant rupture among Danish women. Plast Reconstr Surg 2001, 108:848–858.

    PubMed  Article  Google Scholar 

  16. 16.

    Marotta JS, Widenhouse CW, Habal MB, Goldberg EP: Silicone gel breast implant failure and frequency of additional surgeries: analysis of 35 studies reporting examination of more than 8000 explants. J Biomed Mater Res 1999, 48:354–364.

    PubMed  Article  CAS  Google Scholar 

  17. 17.

    Feng L-J, Amini SB: Analysis of risk factors associated with rupture of silicone gel breast implants. Plast Reconstr Surg 1999, 104:955–963.

    PubMed  Article  CAS  Google Scholar 

  18. 18.

    Brown SL, Silverman BG, Berg WA: Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis. Lancet 1997, 350:1531–1537.

    PubMed  Article  CAS  Google Scholar 

  19. 19.

    Destouet JM, Monsees BS, Oser RF, et al.: Screening mammography in 350 women with breast implants: prevalence and findings of implant complications. AJR Am J Roentgenol 1992, 159:973–978.

    PubMed  CAS  Google Scholar 

  20. 20.

    Shermis RB, Adler DD, Smith DJJr, Hall JD: Intraductal silicone secondary to breast implant rupture. Breast Dis 1990, 3:17–20.

    Google Scholar 

  21. 21.

    Savrin DA, Martin EW, Ruberg RL: Mass lesion of the breast after augmentation mammoplasty. Arch Surg 1979, 114:1423–1424.

    PubMed  CAS  Google Scholar 

  22. 22.

    Truong LD, Cartwright J, Goodman MD, Wozincki D: Silicone lymphadenopathy associated with augmentation mammaplasty: morphologic features of nine cases. Am J Surg Pathol 1988, 12:484–491.

    PubMed  CAS  Article  Google Scholar 

  23. 23.

    Vaamonde R, Cabrera JM, Vaamonde-Martín, et al.: Silicone granulomatous lymphadenopathy and siliconomas of the breast. Histol Histopathol 1997, 12:1003–1011.

    PubMed  CAS  Google Scholar 

  24. 24.

    Kulber DA, Mackenzie DA, Steiner JH, et al.: Monitoring the axilla in patients with silicone gel implants. Ann Plast Surg 1995, 35:580–584.

    PubMed  Article  CAS  Google Scholar 

  25. 25.

    Mason J, Apisarnthanarax P: Migratory silicone granuloma. Arch Dermatol 1981, 117:366–367.

    PubMed  Article  CAS  Google Scholar 

  26. 26.

    Foster WC, Springfield DS, Brown KLB: Pseudotumor of the arm associated with rupture of silicone-gel breast prostheses. J Bone Joint Surg Am 1983, 65:548–551.

    PubMed  CAS  Google Scholar 

  27. 27.

    Capozzi A, DuBou R, Pennisi VR: Distant migration of silicone gel from a ruptured breast implant. Plast Reconstr Surg 1978, 62:302–303.

    PubMed  Article  CAS  Google Scholar 

  28. 28.

    Teuber SS, Reilly DA, Howell L, et al.: Severe migratory granulomatous reactions to silicone gel in 3 patients. J Rheumatol 1999, 26:699–704.

    PubMed  CAS  Google Scholar 

  29. 29.

    Borenstein D: Siliconosis: a spectrum of illness. Semin Arthritis Rheum 1994, 24:1–7.

    PubMed  Article  CAS  Google Scholar 

  30. 30.

    Cuellar ML, Gluck O, Molina JF, et al.: Silicone breast implantassociated musculoskeletal manifestations. Clin Rheumatol 1995, 14:667–672.

    PubMed  Article  CAS  Google Scholar 

  31. 31.

    Freundlich B, Altman C, Snadorfi N, et al.: A profile of symptomatic patients with silicone breast implants: a Sjögrenslike syndrome. Semin Arthritis Rheum 1994, 24:44–53.

    PubMed  Article  CAS  Google Scholar 

  32. 32.

    Solomon G: A clinical and laboratory profile of symptomatic women with silicone breast implants. Semin Arthritis Rheum 1994, 24:29–37.

    PubMed  Article  CAS  Google Scholar 

  33. 33.

    Vasey FB, Havice DL, Bocanegra TS, et al.: Clinical findings in symptomatic women with silicone breast implants. Semin Arthritis Rheum 1994, 24:22–28.

    PubMed  Article  CAS  Google Scholar 

  34. 34.

    Blackburn WDJr, Grotting J, Everson MP: Lack of evidence of systemic inflammatory rheumatic disorders in symptomatic women with breast implants. Plast Reconstr Surg 1997, 99:1054–1060.

    PubMed  Article  Google Scholar 

  35. 35.

    Peters W, Smith D, Fornasier V, et al.: An outcome analysis of 100 women after explantation of silicone gel breast implants. Ann Plast Surg 1997, 39:9–19.

    PubMed  Article  CAS  Google Scholar 

  36. 36.

    Weisman MH, Vecchione TR, Albert D, et al.: Connective-tissue disease following breast augmentation: a preliminary test of the human adjuvant disease hypothesis. Plast Reconstr Surg 1988, 82:626–630.

    PubMed  Article  CAS  Google Scholar 

  37. 37.

    Thomas WO III, Harper LL, Wong SW, et al.: Explantation of silicone breast implants. Am J Surg 1997, 5:421–429.

    Google Scholar 

  38. 38.

    Lai E, Goldman JA, Child AH, et al.: Fibromyalgia, hypermobility, and breast implants. J Rheumatol 2000, 27:2237–2241.

    PubMed  CAS  Google Scholar 

  39. 39.

    Fryzek JP, Signorello LB, Hakelius L, et al.: Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery. Plast Reconstr Surg 2001, 107:206–213.

    PubMed  Article  CAS  Google Scholar 

  40. 40.

    Fryzek JP, Signorello LB, Hakelius L, et al.: Local complications and subsequent symptom reporting among women with cosmetic breast implants. Plast Reconstr Surg 2001, 107:214–221.

    PubMed  Article  CAS  Google Scholar 

  41. 41.

    Croft P, Schollum J, Silman A: Population study of tender point counts and pain as evidence of fibromyalgia. BMJ 1994, 309:696–699.

    PubMed  CAS  Google Scholar 

  42. 42.

    Barsky AJ, Borus JF: Functional somatic syndromes. Ann Intern Med 1999, 130:910–921.

    PubMed  CAS  Google Scholar 

  43. 43.

    Nielson WR, Merskey H: Psychosocial aspects of fibromyalgia. Curr Pain Headache Rep 2001, 5:330–337.

    PubMed  CAS  Google Scholar 

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Brown, S.L., Duggirala, H.J. & Pennello, G. An association of silicone-gel breast implant rupture and fibromyalgia. Curr Rheumatol Rep 4, 293–298 (2002). https://doi.org/10.1007/s11926-002-0037-6

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Keywords

  • Fibromyalgia
  • Chronic Fatigue Syndrome
  • Breast Implant
  • Symptomatic Woman
  • Functional Somatic Syndrome