The use of silicone breast implants for cosmetic purposes has been prohibited by the Food and Drug Administration since April, 1992. Reports from the Japanese in the 1970’s and 80’s suggested that silicone exposure could lead to both classic and non-classic connective tissue disease (Kumagai et al. 1979, 1984). Questions about the safety of these devices has led tens of thousands of women to seek medical attention. We began to see these women in early 1992 before the ban was imposed.

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.

A period of in vitro culture prior to transplantation has been shown to prolong the survival of many types of MHC-incompatible endocrine grafts. The effectiveness of this strategy has been attributed to a selective depletion of intragraft antigen-presenting cells. We report that in vitro culture at 24 degrees C results in a significantly better survival of rat isolated islet allografts than does culture at 37 degrees C. Using in vitro assays of APC activity, we were unable to detect differences in the quantity of residual intraislet APCs between 24 degrees C and 37 degrees C culture preparations. In contrast, islet endocrine cells cultured at 24 degrees C evidenced a reduced level of cell surface class I MHC antigen expression and were significantly less vulnerable to lysis in vitro by CTL. These findings suggest that culture at 24 degrees C produces islet alterations other than APC depletion, and that its beneficial effect on graft survival correlates with a reduction in endocrine cell class I MHC antigen expression.