Injectable collagen: A six-year clinical investigation

Abstract

An injectable form of bovine dermal collagen has been developed for use in correcting cutaneous contour deficiencies. This material is a sterile device composed predominantly of highly purified type I collagen dispersed in phosphate-buffered physiological saline containing 0.3% lidocaine. The safety and efficacy of injectable collagen, which is now in widespread clinical use in the United States, Canada, England, Germany, France, Switzerland, Brazil, and 11 other countries, were evaluated in a 6 1/2-year investigation in which 5,109 patients were evaluated by 728 dermatologists and plastic surgeons. The incidence of adverse treatment reactions was 1.3%, most of which manifested with localized swelling and erythema. Current data covering an estimated 100,000 patients indicate that the incidence of treatment reactions has not increased during the 3 1/2 years since the material was cleared for marketing by the United States Food and Drug Administration. Subjective assessment of efficacy indicated that the material may be employed successfully to elevate dermal contour defects associated with various etiological factors.