Exposure of breast tissue to silicone has been associated with autoimmune diseases in the medical literature since the 1960's. Japanese women injected with raw silicone had features of a collagen vascular disease but did not meet criteria for a specific diagnosis. Subsequently, we have seen women with silicone breast implants that have similar problems. We performed a prospective noncontrolled study on women with silicone breast implants. Results from the first 50 consecutive women revealed the most prominent complaints in this group were fatigue (89%), generalized stiffness (75%), poor sleep (71%), and arthralgias (78%). Other problems included Raynaud's phenomenon, alopecia, adenopathy, night sweats, and frequent sore throats. Unexpectedly, half of these women complained of dry eyes and dry mouths. Positive antinuclear antibodies and or rheumatoid factors were discovered in 38% of patients although the anti-SSA antibody was found in only one patient and anti-SSB in none. Labial salivary gland biopsies in 5 cases showed mononuclear cell infiltrates compatible with Sjögren's syndrome in 4. The infiltrating cells were predominantly CD68 positive monocyte/macrophages, which is different from what is found in Sjögren's syndrome. These findings may indicate the presence of a unique syndrome associated with silicone implants that is characterized by musculoskeletal pain and autoimmune features.