The immunogenicity of injectable collagen. I. A 1-year prospective study.

With the growing use of collagen-based biomaterials, questions have been raised regarding the immunogenicity of this protein in humans. Currently a bovine collagen implant is in widespread use for the correction of dermal contour deficiencies ( Zyderm Collagen Implant (hereafter referred to as "the implant"); Collagen Corporation, Palo Alto, CA). To investigate potential immunologic consequences of this material, sixty-one subjects were evaluated in a 1-year prospective study. Two of the sixty-one subjects (3%) experienced localized, self-limiting inflammatory responses to the implant material; only in these two subjects could elevated levels of anti-implant collagen antibodies be measured by radioimmunoassay. These antibodies did not cross-react with human dermal collagen nor did they result in elevated levels of circulating immune complexes. Routine blood and urine testing failed to reveal any results of clinical significance. Thus, this protein displayed only weak antigenic activity in this study population.