Do silicone breast implants cause rheumatologic disorders?: A systematic review for a Court-Appointed National Science Panel

Abstract

Objective To assist in evaluating expert testimony and scientific evidence presented in law suits brought against silicone breast implant manufacturers, a US District Court Order established a National Science Panel to assess whether existing studies provide scientific evidence of an association between silicone breast implants and systemic classic/accepted connective disease, atypical connective disease, and certain signs and symptoms identified by plaintiffs in the law suits. Local disorders potentially associated with these implants were not addressed in this review. Therefore, we performed a systematic review of published studies on the association between silicone breast implants and systemic connective tissue disorders. Methods Data from relevant studies (human cohort, case–control, or cross‐sectional studies with ≥10 participants and appropriate controls) were identified through literature searches of Medline, Current Contents, HealthStar, Biological Abstracts, EMBase, Toxline, and Dissertation Abstracts. Two independent reviewers, using standard collection forms, 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 atypical connective tissue disorder. There was discordance among studies in reports of arthralgias, lymphadenopathy, myalgias, sicca symptoms, skin changes, and stiffness. Conclusion The panel found no evidence to support expert testimony suggesting 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 single subjects with >1 symptom represented in analyses of each symptom reported. The process presented here is an early example of the use of independent scientific panels to help courts clarify scientific evidence in legal proceedings.

Altered systemic serologic parameters in patients with silicone mammary implants

“…In addition, we analysed antibodies against polymerized acrylamide, which was originally developed for the diagnosis of fibromyalgia and reactions to foreign materials [22]. Although previous studies analysing several systemic immunologic parameters failed to provide unequivocal proof of an association between rheumatologic diseases and silicone contact, those studies did not analyse sICAM-1, APA, Pro III or CIC [12,[23][24][25], which we found to be altered in various groups of SMI patients.…”

Flow Cytometric Analysis of Peripheral Blood Lymphocyte Subsets in Patients with Silicone Breast Implants

“…[2][3][4] In addition to these local phenomena, several case reports of systemic autoimmune disease (scleroderma, rheumatoid arthritis, or lupuslike symptoms) and musculoskeletal disorders have been published. [13][14][15][16][17][18][19][20][21][22][23] Despite the widespread use of silicone implants, there have been few systematic studies on the immunologic effects of silicone in humans. 6,20,24 -27 The purpose of our study was to investigate the distribution of immune cells in peripheral blood samples of patients with silicone breast implants and to understand whether silicone induces only the formation of foreign body granulomas as a local reaction or gives rise to subsequent systemic immune reactions as well.…”

Causes of Death Among Finnish Women with Cosmetic Breast Implants, 1971–2001

“…[1][2][3][4] Although mortality from breast cancer among women with breast implants has been assessed in some studies, only two studies to date have evaluated the overall mortality pattern of breast implant recipients. 5,6 The overall risk of death for women with breast implants was decreased (standardized mortality ratio [SMR], 0.7; 95% confidence intervals [CI], 0.6 -0.8) in one study 5 and elevated in the other (SMR, 1.5; 95% CI, 1.2-1.8); 6 both studies reported an increased risk of death from suicide.…”