Absence of Longitudinal Changes in Rheumatologic Parameters after Silicone Breast Implantation: A Prospective 13-Year Study

Abstract

There have been numerous questions regarding the association of polysiloxane with connective tissue disease and alteration of host immune response. C-reactive protein, rheumatoid factor, and anti-streptolysin-O titers were measured in 218 patients. These studies are routinely used in the diagnosis of autoimmune disease and mixed connective tissue disease. This prospective study has been in progress since 1985. The first patients were seen in July of 1985, and those individuals willing to participate were followed from 1985 to 1998. The implants included saline-filled elastomer shells and polysiloxane gel-filled elastomer shells. These groups were examined separately and in combination for changes between preoperative and postoperative states. In each instance, there was no statistical increase or decrease. Each patient underwent a physical examination and completed a questionnaire focusing on signs and symptoms of autoimmune and connective tissue diseases. The laboratory data and subjective clinical results demonstrated no significant differences between a nonimplanted group versus the saline group alone, the gel group alone, or the combined groups. The data failed to suggest any causal relationship between implants and autoimmune or connective tissue diseases over the study period of 13 years (since 1985).

Permanent Injectables for Soft Tissue Augmentation

“…The most convincing of these investigations involved approximately 6 [17][18][19][20][21][22] large retrospective cohort studies that followed up patients with breast implants for up to 10 years or longer and detected no increased associated risk of connective tissue disease, such as rheumatoid arthritis, scleroderma, systemic lupus erythematosus, polymyositis/dermatomyositis, Sjögren syndrome, and mixed connective tissue disease. At least 3 of these studies, from the Mayo Clinic (Rochester, Minn), Sweden, and Denmark, aspired to being population based; in the United States, several large studies based on querying female health professionals enrolled up to several hundred thousand subjects each, thus greatly minimizing the risk that even small adverse effects would fail to be detected owing to inadequate sample size.…”

Evidence-Based Medicine for Dermatologic Surgeons: Concepts in Critical Appraisal of Information

“…Based on some early case reports about possibly toxic rheumatologic effects of silicone breast implants, large‐scale litigation ensued which cost the manufacturer billions of dollars, created immense worry in patients who had these implants, and generated huge amounts of money for attorneys. Subsequent cohort and case‐control studies have shown no evidence for a link between breast implants and rheumatologic disease 28–32 …”