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A Retrospective Cohort Study

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

JAMA. 1996;275(8):616-621.

Abstract
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)

Author Affiliations
From the Divisions of Preventive Medicine (Drs Hennekens, Lee, Cook, Hebert, Manson, and Buring, and Ms LaMotte) and Rheumatology/Immunology (Dr Karlson), Department of Medicine, Harvard Medical School and Brigham and Women's Hospital;the Department of Ambulatory Care and Prevention (Drs Hennekens, Cook, and Buring), Harvard Medical School; and the Department of Epidemiology (Drs Hennekens, Lee, and Buring), Harvard School of Public Health, Boston, Mass.

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

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