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).
