The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part I
The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the frontiers of the interface of law and medicine, and the complex method of evaluating causal relationships in medicine. Should the law wait for an answer? This paper provides a system for evaluating the results of studies in the area of breast implant litigation, in terms of the extent to which those results support or refute a causal relationship. The concept and characteristics of causation and the reliability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommendations for the care and treatment of patients with breast implants are being made without careful thought. The consequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.