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February 28, 1996, Vol 275, No. 8 >
ARTICLE | February 28, 1996

Self-reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals: Title and subTitle BreakA Retrospective Cohort Study FREE

Charles H. Hennekens, MD, DrPH; I-Min Lee, MBBS, ScD; Nancy R. Cook, ScD; Patricia R. Hebert, PhD; Elizabeth W. Karlson, MD; Fran LaMotte; JoAnn E. Manson, MD, DrPH; Julie E. Buring, ScD
[+] Author Affiliations

Reprint requests to the Division of Preventive Medicine, Brigham and Women's Hospital, 900 Commonwealth Ave E, Boston, MA 02215-1204 (Dr Hennekens).


JAMA. 1996;275(8):616-621. doi:10.1001/jama.1996.03530320040032
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References

Objective.  —To evaluate the association of breast implants with connectivetissue diseases.

Design and Participants.  —Retrospective cohort study of 395 543 female health professionals who completed mailed questionnaires for potential participation in the Women's Health Study. A total of 10830 women reported breast implants and 11 805 reported connective-tissue diseases between 1962 and 1991. Cox proportional hazards regression models were used in analyses.

Main Outcome Measure.  —Self-reported connective-tissue diseases.

Results.  —Compared with women who did not report breast implants, the relative risk (RR) of the combined end point of any connective-tissue disease among those who reported breast implants was 1.24(95% confidence interval, 1.08 to 1.41, P=.0015). With respect to the individual diseases, the finding for other connectivetissue diseases (including mixed) was statistically significant (P=.017), the findings for rheumatoid arthritis, Sjögren's syndrome, dermatomyositis or polymyositis, or scleroderma were of borderline statistical significance (.05<P<.10), and the finding for systemic lupus erythematosus was not statistically significant (P=.44). There were no clear trends in RR with increasing duration of breast implants.

Conclusion.  —These self-reported data from female health professionals are compatible with prior reports from other cohort studies that exclude a large hazard, but do suggest small increased risks of connective-tissue diseases among women with breast implants. The very large sample size makes chance an unlikely explanation for the results, but bias due to differential overreporting of connective-tissue diseases or selective participation by affected women with breast implants remains a plausible alternative explanation. The major contribution of this and other observational analytic studies has been to exclude large risks of connective-tissue diseases following breast implants.(JAMA. 1996;275:616-621)

REFERENCES

1 +
Barton FE.  Augmentation mammaplasty. Sel Readings Plast Surg . 1983;;2:1-14.
2 +
Cook RR, Harrison MC, LeVier RR.  The breast implant controversy. Arthritis Rheum . 1994;;2:153-157.
3 +
Kessler DA.  The basis of the FDA's decision on breast implants. N Engl J Med . 1992;;326:1713-1715.
4 +
Angell M.  Breast implants: protection or paternalism? N Engl J Med . 1992;;326:1695-1696.
5 +
Fisher JC.  The silicone controversy: when will science prevail? N Engl J Med . 1992;;326:1696-1699.
6 +
Foreman J.  Safety of solid silicone at issue. Boston Globe . (January 25) , 1992;;section I:1.
7 +
Kolata G.  Legal system and science come to differing conclusions on silicone. New York Times . (May 16) , 1995;;section D:6.
8 +
Busch H.  Silicone toxicology. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):11-17.
9 +
Kossovsky N, Stassi J.  A pathophysiologic examination of the biophysics and bioreactivity of silicone breast implants. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):18-21.
10 +
Hennekens CH, Buring JE. Epidemiology in Medicine . Boston, Mass: Little Brown & Co, 1987;: 101-131.
11 +
Dugowson CE, Daling J, Koepsell TD, Voight L, Nelson JL.  Silicone breast implants and risk for rheumatoid arthritis. Arthritis Rheum . 1992;;35 ( (suppl 192) ):S566.
12 +
Englert HJ, Brooks P.  Scleroderma and augmentation mammoplasty—a causal relationship? Aust N Z J Med . 1994;;24:74-80.
13 +
Strom BL, Reidenberg MM, Freundlich B, Schinnar R.  Breast silicone implants and risk of systemic lupus erythematosus. J Clin Epidemiol . 1994;;47:1211-1214.
14 +
Hochberg MC, Perlmutter DL, White B, et al.  The association of augmentation mammoplasty with systemic sclerosis: results from a multi-center case-control study. Arthritis Rheum . 1994;;37( (suppl 1249) ): S369.
15 +
Schusterman MA, Kroll SS, Reece GP, et al.  Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report. Ann Plast Surg . 1993;;31:1-6.
16 +
Giltay EJ, Moens HJB, Riley AH, Tan RG.  Silicone breast protheses and rheumatic symptoms: a retrospective follow up study. Ann Rheum Dis . 1994;;53:194-196.
17 +
McLaughlin JK, Fraumeni JF Jr, Olsen J, Mellemkjaer L.  Re: breast implants, cancer and systemic sclerosis. J Natl Cancer Inst . 1994;;86:1424.
18 +
Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton H III.  Risk of connectivetissue disease and other disorders after breast implantation. N Engl J Med . 1994;;330:1697-1702.
19 +
Wells KE, Cruse CW, Baker JL, et al.  The health status of women following cosmetic surgery. Plast Reconstr Surg . 1994;;93:907-912.
20 +
Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH.  Breast implants, rheumatoid arthritis and connective tissue disease in a clinical practice. J Clin Epidemiol . 1995;;48:571-582.
21 +
Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH.  Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med . 1995;;332:1666-1670.
22 +
Dugowson CE, Koepsell TD, Voight LF, Bley L, Nelson JL, Daling JR.  Rheumatoid arthritis in women: incidence rates in a group health cooperative, Seattle, Washington, 1987-1989. Arthritis Rheum . 1991;;34:1502-1507.
23 +
Michet CJ Jr, McKenna CH, Elveback LR, Kaslow RA, Kurland LT.  Epidemiology of systemic lupus erythematosus and other connective tissue diseases in Rochester, Minnesota, 1950 through 1979. Mayo Clin Proc . 1985;;60:105-113.
24 +
Oddis CV, Conte CG, Steen VD, Medsger TA.  Incidence of polymyositis-dermatomyositis: a 20year study of hospital diagnosed cases in Allegheny County, PA 1963-1982. JRheumatol . 1990;;17:1329-1334.
25 +
Silman M, Jannini S, Symmons D, Bacon P.  An epidemiological study of scleroderma in the West Midlands. Br J Rheumatol . 1988;;27:286-290.
26 +
Bridges AJ.  Silicone implant controversy continues. Lancet . 1994;;344:1451-1452.
27 +
Swan SH, Teuber SS, Gershwin ME.  Silicone implant controversy. Lancet . 1995;;345:319.
28 +
Cook RR, Delongchamp RR, Woodbury M, Perkins LL, Harrison MC.  The prevalence of women with breast implants in the United States—1989. J Clin Epidemiol . 1995;;48:519-525.
29 +
Buring JE, Hennekens CH.  The Women's Health Study: summary of the study design. J Myocardial Ischemia . 1992;;4:27-29.
30 +
Cox DR.  Regression models and life tables. JR Stat Soc (B) . 1972;;34:187-220.
31 +
Kumagai Y, Shiokawa Y, Medsger TA, Rodnan GP.  Clinical spectrum of connective tissue disease after cosmetic surgery. Arthritis Rheum . 1984;;27: 1-12.
32 +
Little RJA, Rubin DB. Statistical Analysis With Missing Data . New York, NY: John Wiley & Sons; 1987;.
33 +
Star VL, Scott J, Sherwin R, Hochberg MC.  Validity of self-reported physician-diagnosed rheumatoid arthritis for use in epidemiologic studies. Arthritis Rheum . 1993;;36:5100. Abstract.
34 +
Hochberg MC, Perlmutter DL, Medsger TA, et al.  The prevalence of self-reported physician-diagnosed systemic lupus erythematosus in the United States. Lupus . 1995;;4:454-456.
35 +
Sanchez-Guerrero J, Liang MH, Karlson EW, Hunter DJ, Colditz GA.  Postmenopausal estrogen therapy and risk of developing systemic lupus erythematosus. Ann Intern Med . 1995;;122:430-433.
36 +
Vassey FB, Havice DL, Bocanegra TS, et al.  Clinical findings in symptomatic women with silicone breast implants. Semin Arthritis Rheum . 1994;; 24( (suppl 1) ):22-28.
37 +
Borenstein D.  Siliconosis: a spectrum of disease. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):1-7.
38 +
Bridges M, Conley C, Wang G, Burns DE.  A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med . 1993;;118:929-936.
39 +
Chow HY, Calabrese LH, Wilke WS, Cash JM.  Is silicone associated illness really chronic fatigue syndrome? Arthritis Rheum . 1995;;38:264. Abstract.

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1 +
Barton FE.  Augmentation mammaplasty. Sel Readings Plast Surg . 1983;;2:1-14.
2 +
Cook RR, Harrison MC, LeVier RR.  The breast implant controversy. Arthritis Rheum . 1994;;2:153-157.
3 +
Kessler DA.  The basis of the FDA's decision on breast implants. N Engl J Med . 1992;;326:1713-1715.
4 +
Angell M.  Breast implants: protection or paternalism? N Engl J Med . 1992;;326:1695-1696.
5 +
Fisher JC.  The silicone controversy: when will science prevail? N Engl J Med . 1992;;326:1696-1699.
6 +
Foreman J.  Safety of solid silicone at issue. Boston Globe . (January 25) , 1992;;section I:1.
7 +
Kolata G.  Legal system and science come to differing conclusions on silicone. New York Times . (May 16) , 1995;;section D:6.
8 +
Busch H.  Silicone toxicology. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):11-17.
9 +
Kossovsky N, Stassi J.  A pathophysiologic examination of the biophysics and bioreactivity of silicone breast implants. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):18-21.
10 +
Hennekens CH, Buring JE. Epidemiology in Medicine . Boston, Mass: Little Brown & Co, 1987;: 101-131.
11 +
Dugowson CE, Daling J, Koepsell TD, Voight L, Nelson JL.  Silicone breast implants and risk for rheumatoid arthritis. Arthritis Rheum . 1992;;35 ( (suppl 192) ):S566.
12 +
Englert HJ, Brooks P.  Scleroderma and augmentation mammoplasty—a causal relationship? Aust N Z J Med . 1994;;24:74-80.
13 +
Strom BL, Reidenberg MM, Freundlich B, Schinnar R.  Breast silicone implants and risk of systemic lupus erythematosus. J Clin Epidemiol . 1994;;47:1211-1214.
14 +
Hochberg MC, Perlmutter DL, White B, et al.  The association of augmentation mammoplasty with systemic sclerosis: results from a multi-center case-control study. Arthritis Rheum . 1994;;37( (suppl 1249) ): S369.
15 +
Schusterman MA, Kroll SS, Reece GP, et al.  Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report. Ann Plast Surg . 1993;;31:1-6.
16 +
Giltay EJ, Moens HJB, Riley AH, Tan RG.  Silicone breast protheses and rheumatic symptoms: a retrospective follow up study. Ann Rheum Dis . 1994;;53:194-196.
17 +
McLaughlin JK, Fraumeni JF Jr, Olsen J, Mellemkjaer L.  Re: breast implants, cancer and systemic sclerosis. J Natl Cancer Inst . 1994;;86:1424.
18 +
Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton H III.  Risk of connectivetissue disease and other disorders after breast implantation. N Engl J Med . 1994;;330:1697-1702.
19 +
Wells KE, Cruse CW, Baker JL, et al.  The health status of women following cosmetic surgery. Plast Reconstr Surg . 1994;;93:907-912.
20 +
Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH.  Breast implants, rheumatoid arthritis and connective tissue disease in a clinical practice. J Clin Epidemiol . 1995;;48:571-582.
21 +
Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH.  Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med . 1995;;332:1666-1670.
22 +
Dugowson CE, Koepsell TD, Voight LF, Bley L, Nelson JL, Daling JR.  Rheumatoid arthritis in women: incidence rates in a group health cooperative, Seattle, Washington, 1987-1989. Arthritis Rheum . 1991;;34:1502-1507.
23 +
Michet CJ Jr, McKenna CH, Elveback LR, Kaslow RA, Kurland LT.  Epidemiology of systemic lupus erythematosus and other connective tissue diseases in Rochester, Minnesota, 1950 through 1979. Mayo Clin Proc . 1985;;60:105-113.
24 +
Oddis CV, Conte CG, Steen VD, Medsger TA.  Incidence of polymyositis-dermatomyositis: a 20year study of hospital diagnosed cases in Allegheny County, PA 1963-1982. JRheumatol . 1990;;17:1329-1334.
25 +
Silman M, Jannini S, Symmons D, Bacon P.  An epidemiological study of scleroderma in the West Midlands. Br J Rheumatol . 1988;;27:286-290.
26 +
Bridges AJ.  Silicone implant controversy continues. Lancet . 1994;;344:1451-1452.
27 +
Swan SH, Teuber SS, Gershwin ME.  Silicone implant controversy. Lancet . 1995;;345:319.
28 +
Cook RR, Delongchamp RR, Woodbury M, Perkins LL, Harrison MC.  The prevalence of women with breast implants in the United States—1989. J Clin Epidemiol . 1995;;48:519-525.
29 +
Buring JE, Hennekens CH.  The Women's Health Study: summary of the study design. J Myocardial Ischemia . 1992;;4:27-29.
30 +
Cox DR.  Regression models and life tables. JR Stat Soc (B) . 1972;;34:187-220.
31 +
Kumagai Y, Shiokawa Y, Medsger TA, Rodnan GP.  Clinical spectrum of connective tissue disease after cosmetic surgery. Arthritis Rheum . 1984;;27: 1-12.
32 +
Little RJA, Rubin DB. Statistical Analysis With Missing Data . New York, NY: John Wiley & Sons; 1987;.
33 +
Star VL, Scott J, Sherwin R, Hochberg MC.  Validity of self-reported physician-diagnosed rheumatoid arthritis for use in epidemiologic studies. Arthritis Rheum . 1993;;36:5100. Abstract.
34 +
Hochberg MC, Perlmutter DL, Medsger TA, et al.  The prevalence of self-reported physician-diagnosed systemic lupus erythematosus in the United States. Lupus . 1995;;4:454-456.
35 +
Sanchez-Guerrero J, Liang MH, Karlson EW, Hunter DJ, Colditz GA.  Postmenopausal estrogen therapy and risk of developing systemic lupus erythematosus. Ann Intern Med . 1995;;122:430-433.
36 +
Vassey FB, Havice DL, Bocanegra TS, et al.  Clinical findings in symptomatic women with silicone breast implants. Semin Arthritis Rheum . 1994;; 24( (suppl 1) ):22-28.
37 +
Borenstein D.  Siliconosis: a spectrum of disease. Semin Arthritis Rheum . 1994;;24( (suppl 1) ):1-7.
38 +
Bridges M, Conley C, Wang G, Burns DE.  A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med . 1993;;118:929-936.
39 +
Chow HY, Calabrese LH, Wilke WS, Cash JM.  Is silicone associated illness really chronic fatigue syndrome? Arthritis Rheum . 1995;;38:264. Abstract.

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