Advertisement
Clinical Studies| Volume 106, ISSUE 1, P11-19, January 1999

Download started.

Ok

Association of silicone breast implants with immunologic abnormalities: a prospective study 1

  • Elizabeth W Karlson
    Correspondence
    Requests for reprints should be addressed to Elizabeth W. Karlson, MD, 75 Francis Street, Boston, Massachusetts 02115
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Susan E Hankinson
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Matthew H Liang
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Jorge Sanchez-Guerrero
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Graham A Colditz
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Barbara J Rosenau
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Frank E Speizer
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author
  • Peter H Schur
    Affiliations
    Department of Medicine, Division of Rheumatology, Immunology, and Allergy, Multipurpose Arthritis and Musculoskeletal Diseases Center, Channing Laboratory, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
    Search for articles by this author

      Abstract

      Purpose: To study the possible association of silicone-breast-implant exposure and immunologic abnormalities within the Nurses’ Health Study, an ongoing prospective cohort study of women.
      Subjects and Methods: From this cohort, we randomly selected 200 women who had been exposed to silicone breast implants and who had never reported connective tissue diseases during 14 years of follow-up, and 500 age-matched, nonexposed women, including 100 with definite connective tissue diseases validated by medical record review, 100 with at least one symptom of a connective tissue disease, 100 with diabetes, and 200 healthy controls. Assays for antinuclear antibodies (ANA), including anti-dsDNA, anti-ssDNA, anti-Sm/RNP/Ro/La, and anti-Scl-70, rheumatoid factor, immunoglobulins, serum complement, and C-reactive protein level, and anticardiolipin, antithyroglobulin, antithyroid microsomal, and antisilicone antibodies were performed by standard techniques in blood samples collected in 1989 or 1990 before collection of silicone-breast-implant exposure data in 1992.
      Results: ANA was positive (≥1:40) in 14% of women with silicone breast implants compared with 20% of healthy women (P = 0.11). Rheumatoid factor was positive (≥1:40) in 5% of women with silicone breast implants and 2% of healthy women (P = 0.16). Women with silicone breast implants had a significantly higher frequency of anti-ssDNA antibodies than healthy women (41% and 29%, P = 0.012). Duration of implant was associated with a higher frequency of anti-ssDNA antibodies (P = 0.03) but not with ANA or rheumatoid factor. No other significant differences in the frequencies of autoantibodies were observed in silicone breast implant–exposed women. Antisilicone antibodies were not found in any sample.
      Conclusion: We found no increased frequency of any immunologic abnormalities in women exposed to silicone breast implants, except for anti-ssDNA, which has unknown clinical relevance.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to The American Journal of Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Cook R.R
        • Delongchamp R.R
        • Woodbury M
        • Perkins L.L
        • Harrison M.C
        The prevalence of women with breast implants in the United States—1989.
        J Clin Epidemiol. 1995; 48: 519-525
        • Terry M.B
        • Skovron M.L
        • Garbers S
        • Sonnenschein E
        • Toniolo P
        The estimated frequency of cosmetic breast augmentation among US women, 1963 through 1988.
        Am J Public Health. 1995; 85: 1122-1124
        • Sanchez-Guerrero J
        • Schur P.H
        • Sergent J.S
        • Liang M.H
        Silicone breast implants and rheumatic disease. Clinical, immunologic, and epidemiologic studies.
        Arthr Rheum. 1994; 37: 158-168
        • Bridges A.J
        • Vasey F.B
        Silicone breast implants. History, safety, and potential complications.
        Arch Intern Med. 1993; 153: 2638-2644
        • Gabriel S.E
        • Woods J.E
        • O’Fallon W.M
        • Beard C.M
        • Kurland L.T
        • Melton III, L.J
        Complications leading to surgery after breast implantation.
        NEJM. 1997; 336: 677-682
        • Weisman M.H
        • Vecchione T.R
        • Albert D
        • Moore L.T
        • Mueller M.R
        Connective-tissue disease following breast augmentation.
        Plast Reconstr Surg. 1988; 82: 626-630
        • Dugowson C.E
        • Daling J
        • Koepsell T.D
        • Voyt L
        • Nellson S.L
        Silicone breast implants and the risk of rheumatoid arthritis.
        Arthr Rheum. 1992; 35: S66
        • Schusterman M.A
        • Kroll S.S
        • Reece G.P
        • et al.
        Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue.
        Ann Plast Surg. 1993; 31: 1-6
        • Englert H.J
        • Brooks P
        Scleroderma and augmentation mammoplasty—a causal relationship?.
        Aust N Z J Med. 1994; 24: 74-80
        • Gabriel S.E
        • O’Fallon W.M
        • Kurland L.T
        • Beard C.M
        • Woods J.E
        • Melton III, L.J
        Risk of connective-tissue diseases and other disorders after breast implantation.
        NEJM. 1994; 330: 1697-1702
        • Giltay E.J
        • Bernelot Moens H.J
        • Riley A.H
        • Tan R.G
        Silicone breast prostheses and rheumatic symptoms.
        Ann Rheum Dis. 1994; 53: 194-196
        • Strom B.L
        • Reidenberg M.M
        • Freundlich B
        • Schinnar R
        Breast silicone implants and risk of systemic lupus erythematosus.
        J Clin Epidemiol. 1994; 47: 1211-1214
        • Wells K.E
        • Cruse C.W
        • Baker Jr, J.L
        • et al.
        The health status of women following cosmetic surgery.
        Plast Reconstr Surg. 1994; 93: 907-912
        • Sanchez-Guerrero J
        • Colditz G.A
        • Karlson E.W
        • Hunter D.J
        • Speizer F.E
        • Liang M.H
        Silicone breast implants and the risk of connective-tissue diseases and symptoms.
        NEJM. 1995; 332: 1666-1670
        • Goldman J.A
        • Greenblatt J
        • Joines R
        • White L
        • Aylward B
        • Lamm S.H
        Breast implants, rheumatoid arthritis, and connective tissue diseases in a clinical practice.
        J Clin Epidemiol. 1995; 48: 571-582
        • Hochberg M.C
        • Perlmutter D.L
        • Medsger Jr, T.A
        • et al.
        Lack of association between augmentation mammoplasty and systemic sclerosis (scleroderma).
        Arthr Rheum. 1996; 39: 1125-1131
        • Burns C.J
        • Laing T.J
        • Gillespie B.W
        • et al.
        The epidemiology of scleroderma among women.
        J Rheumatol. 1996; 23: 1904-1911
        • Hennekens C.H
        • Lee I.M
        • Cook N.R
        • et al.
        Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study.
        JAMA. 1996; 275: 616-621
        • Silverman S
        • Bornstein D
        • Solomon G
        • Espinoza L
        • Colin M
        Preliminary operational criteria for systemic silicone related disease (SSRD).
        Arthr Rheum. 1996; 39: S51
        • Williams H.J
        • Weisman M.H
        • Berry C.C
        Breast implants in patients with differentiated and undifferentiated connective tissue disease.
        Arthr Rheum. 1997; 40: 437-440
        • Marcus D.M
        An analytical review of silicone immunology.
        Arthr Rheum. 1996; 39: 1619-1626
        • Bridges A.J
        • Conley C
        • Wang G
        • Burns D.E
        • Vasey F.B
        A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease.
        Ann Intern Med. 1993; 118: 929-936
        • Cuellar M.L
        • Scopelitis E
        • Tenenbaum S.A
        • et al.
        Serum antinuclear antibodies in women with silicone breast implants.
        J Rheumatol. 1995; 22: 236-240
        • Press R.I
        • Peebles C.L
        • Kumagai Y
        • Ochs R.L
        • Tan E.M
        Antinuclear autoantibodies in women with silicone breast implants.
        Lancet. 1992; 340: 1304-1307
        • Claman H.N
        • Robertson A.D
        Antinuclear antibodies and breast implants.
        West J Med. 1994; 160: 225-228
        • Fisher J.C
        The silicone controversy—when will science prevail?.
        NEJM. 1992; 326: 1696-1698
        • Karlson E.W
        • Sanchez-Guerrero J
        • Wright E.A
        • et al.
        A connective tissue disease screening questionnaire for population studies.
        Ann Epidemiol. 1995; 5: 297-302
        • Sanchez-Guerrero J
        • Lew R.A
        • Fossel A.H
        • Schur P.H
        Utility of anti-Sm, anti-RNP, anti-Ro/SS-A, and anti-La/SS-B (extractable nuclear antigens) detected by enzyme-linked immunosorbent assay for the diagnosis of systemic lupus erythematosus.
        Arthr Rheum. 1996; 39: 1055-1061
        • Eaton R.B
        • Schnneider G
        • Schur P.H
        Enzyme immunoassay for antibodies to native DNA. Specificity and quality of antibodies.
        Arthr Rheum. 1983; 26: 52-62
        • Rosenau B
        • Schneebaun A.B
        • Schur P.H
        The development of an ELISA method for the detection of “antibodies” to silicone.
        Curr Top Microbiol Immunol. 1996; 210: 69-74
        • Ginsburg K.S
        • Liang M.H
        • Newcomer L
        • et al.
        Anticardiolipin antibodies and the risk for ischemic stroke and venous thrombosis.
        Ann Intern Med. 1992; 117: 997-1002
        • Falanga V
        • Medsger Jr, T.A
        • Reichlin M
        • Rodnan G.P
        Linear scleroderma. Clinical spectrum, prognosis, and laboratory abnormalities.
        Ann Intern Med. 1986; 104: 849-857
        • Falanga V
        • Medsger Jr, T.A
        • Reichlin M
        Antinuclear and anti-single-stranded DNA antibodies in morphea and generalized morphea.
        Arch Dermatol. 1987; 123: 350-353
        • Kulick K.B
        • Provost T.T
        • Reichlin M
        Antibodies to single-stranded DNA in patients with discoid lupus erythematosus.
        Arthr Rheum. 1982; 25: 639-646
        • Maddison P.J
        • Provost T.T
        • Reichlin M
        Serological findings in patients with “ANA-negative” systemic lupus erythematosus.
        Medicine (Baltimore). 1981; 60: 87-94
        • Schur P.H
        • Sandson J
        Immunologic factors and clinical activity in systemic lupus erythematosus.
        NEJM. 1968; 278: 533-538
        • Koffler D
        • Carr R
        • Agnello V
        • Thoburn R
        • Kunkel H.G
        Antibodies to polynucleotides in human sera.
        J Exp Med. 1971; 134: 294-312
        • Carr R.I
        • Hoffman A.A
        • Harbeck R.J
        Comparison of DNA binding in normal population, general hospital laboratory personnel, and personnel from laboratories studying SLE.
        J Rheumatol. 1975; 2: 178-185
        • Sanchez-Guerrero J
        Autoantibody testing in patients with silicone implants.
        N Am Clin Lab Med. 1997; 17: 341-353
        • Bar-Meir E
        • Teuber S.S
        • Lin H.C
        • et al.
        Multiple autoantibodies in patients with silicone breast implants.
        J Autoimmun. 1995; 8: 267-277
        • Keystone E
        • Peters W
        • Snow K
        • Rubin L
        • Smith D
        Frequency of autoantibody detection in patients with silicone-gel implants.
        Arthr Rheum. 1993; 36: S71
        • Edworthy S.M
        • Martin L
        • Barr S
        • et al.
        A clinical study of the relationship between silicone breast implants and connective tissue disease.
        Arthr Rheum. 1998; 25: 254-260
        • Cuellar M.L
        • Stem Jr, T.W
        • Espinoza L.R
        Prevalence of antinuclear antibodies (ANAs) in women with silicone breast implants (SBI).
        Arthr Rheum. 1994; 37: S270
        • Zandman-Goddard G
        • Blank M
        • Ehrenfeld M
        • et al.
        Arthr Rheum. 1996; 39: S51
        • Goldblum R.M
        • Pelley R.P
        • O’Donell A.A
        • Pyron D
        • Heggers J.P
        Antibodies to silicone elastomers and reactions to ventriculoperitoneal shunts [published erratum appears in Lancet 1992;340:800].
        Lancet. 1992; 340: 510-513
        • Wolf L.E
        • Lappe M
        • Peterson R.D
        • Ezrailson E.G
        Human immune response to polydimethylsiloxane (silicone).
        FASEB J. 1993; 7: 1265-1268
        • van Oss C.J
        • Naim J.O
        Aspecific immunoglobulin binding to hydrophobic surfaces.
        Curr Top Microbiol Immunol. 1996; 210: 85-91
        • Butler J.E
        • Lu E.P
        • Navarro P
        • Christiansen B
        The adsorption of proteins on a polydimethylsiloxane elastomer (PEP) and their antigenic behavior.
        Curr Top Microbiol Immunol. 1996; 210: 75-84
        • Tenenbaum S.A
        • Rice J.C
        • Espinoza L.R
        • et al.
        Use of antipolymer antibody assay in recipients of silicone breast implants.
        Lancet. 1997; 349: 449-454