Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel

Objective. To assist in evaluating expert testimony and scientific evidence presented in law suits brought against silicone breast implant manufacture rs, a US District Court Order established a National Science Panel to asses s whether existing studies provide scientific evidence of an association be tween silicone breast implants and systemic classic/accepted connective dis ease, atypical connective disease, and certain signs and symptoms identifie d by plaintiffs in the law suits. Local disorders potentially associated wi th these implants were not addressed in this review. Therefore, we performe d a systematic review of published studies on the association between silic one breast implants and systemic connective tissue disorders. Methods. Data from relevant studies (human cohort, case-control, or cross-s ectional studies with; greater than or equal to 10 participants and appropr iate controls) were identified through literature searches of Medline, Curr ent Contents, HealthStar, Biological Abstracts, EMBase, Toxline, and Disser tation Abstracts. Two independent reviewers, using standard collection form s, extracted data from the included studies. Adjusted relative risks (RRs) in cohort studies and odds ratios (ORs) in case-control and cross-sectional studies were reported if provided; otherwise, unadjusted RRs and ORs were calculated. Results. Twenty-four studies meeting inclusion criteria were identified. No association was evident between breast implants and any established or aty pical connective tissue disorder. There was discordance among studies in re ports of arthralgias, lymphadenopathy, myalgias, sicca symptoms, skin chang es, and stiffness. Conclusion. The panel found no evidence to support expert testimony suggest ing an association between silicone breast implants and connective diseases . Discordance for symptoms may reflect differences in symptoms included in various categories, the small number of cases, and the effect of having sin gle subjects with >1 symptom represented in analyses of each symptom report ed. The process presented here is an early example of the use of independen t scientific panels to help courts clarify scientific evidence in legal pro ceedings.