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Silicone implants represent small risk

BMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7031.595a (Published 09 March 1996) Cite this as: BMJ 1996;312:595
  1. John Roberts

    Silicone breast implants are unlikely to represent a serious danger to health, according to the largest US study to date. The study, published in this week's JAMA (the journal of the American Medical Association), was a retrospective cohort study of nearly 400000 women health professionals. It found that the relative risk of developing any kind of connective tissue disease was 1.24 (95% confidence interval 1.08 to 1.41) among women who had received breast implants compared with those who had not.

    The issue has been extremely controversial in the US, and the results of this trial have been long awaited. Silicone implants were introduced in the US in 1962. In 1992 the Food and Drug Administration banned their use except in clinical trials because of case reports of associated illnesses.

    At least four case control and seven cohort studies have been done on the issue, and the two largest have found no risk. In this study researchers from Harvard University sent 1.7 million questionnaires to women health professionals and had responses from 426774. After excluding women with implants or disease before 1962, they looked for an association between disease status and whether women had had breast implants.

    Although they found a small risk overall, the breakdown by specific disease showed only a strong relation to mixed connective tissue disease.” When you look at all the evidence from all the sources, it provides reassuring evidence that there's no large risk of connective tissue disease,” said Dr Charles Hennekens, who headed the study.

    His team also noted that the study's finding of excess risk may not be real because it depended entirely on the women's recall of diseases they got between 1962 and 1991.

    Dow Corning provided $1.3m (pounds sterling866000) of the $18.3m (pounds sterling12.2m) cost of the study but, according to Hennekens, “had absolutely nothing to do with the design, conduct, interpretation, or outcome.”—JOHN ROBERTS, North American editor, BMJ

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