CosmoDermTM & CosmoPlastTM - Safety Information

Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis (PM), and dermatomyositis (DM) after bovine collagen injections in people with no previous history of these disorders. Conflicting studies have been published in scientific journals regarding the association between PM/DM and injectable bovine collagen. A connection between bovine collagen injections and the onset of PM/DM, or the other connective tissue diseases listed, has not been established. The frequency and degree of such reactions after human collagen injections have not been determined.

An increased frequency of the potential to develop an allergic response to various collagens has been found in people with systemic connective tissue diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). A person with any one of these diseases may thus have an increased risk of experiencing an allergic response to the collagen injection. Additionally, one might notice that the effect of the collagen treatment might not last as long. The frequency and severity of such reactions with human collagen injections has not been determined.

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