This issue of Arthritis and Rheumatism contains 2 articles related to the continuing controversy over the possible relationship between silicone breast implants and connective tissue diseases. The first, a scholarly article by Donald Marcus, is a critical analysis of the current state of knowledge of the immunologic effects of exposure to silicones (1). The second item is a review of the recent book by Marcia Angell, entitled Science on Trial (2). This book narrates the treatment that scientific evidence about the role of silicones in causing rheumatic diseases has received in the courtroom. Both articles stress the conclusion that there is presently no credible evidence that silicone breast implants cause any systemic disease.
Establishing a cause-and-effect relationship between an agent and a disease, an age-old problem in medicine, requires a minimum of 2 bodies of evidence: a valid statistical association between the putative agent and the disease, and a feasible biologic mechanism to account for the association. At present, neither body of evidence supports a causal role of implants in systemic disease. As the book by Angell relates, the epidemiologic association began as a series of case histories in which silicone breast implants were associated with a connective tissue disease, or more broadly, a vaguely defined autoimmune disease, in individual patients. This increasing chorus of case reports gave rise to 3 inter-Dr. Rose has served as an expert witness for defendants in litigation involving silicone breast implants.