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Development of a Novel Nonantigenic Dermal Implant Composed of Human Placental Collagen

Injectable bovine collagen has proven to be safe and effective for the treatment of contour defects for more than 20 years. After intradermal exposure to bovine collagen, the most commonly reported side effect is hypersensitivity (incidence of approximately 3 percent to test and approximately 1 to 2 percent to subsequent treatment). The main purpose of this study was to evaluate tissue response and antibody production in bovine collagen-sensitive patients who were treated with human collagen (predominantly type I) implant. Twenty-seven patients with confirmed hypersensitivity to bovine collagen received a depot of human collagen implant and then were treated for facial contour defects on two to five separate occasions over a 9- to 12-month period and followed through 36 months. Measurement of antibody titers indicated that none of the subjects receiving human collagen implant developed antibodies against human collagen, even in the presence of positive antibody titers against bovine collagen. Histologic examination of the depot sites in these patients showed only mild inflammation. These findings indicate that treatment with human collagen did not elicit an allergic response in these subjects who had confirmed hypersensitivity to bovine collagen.