The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part II

Abstract

The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the fron-tiers 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 re-liability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommen-dations for the care and treatment of patients with breast implants are being made without careful thought. The con-sequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.