Fertility and sterility
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Fertility and sterility · Jun 1992
Review Randomized Controlled Trial Clinical TrialWas the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings.
To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. ⋯ This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.