Injectable collagen: a six-year clinical investigation.

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.

Collagen implantation in patients treated previously with silicone.

This multicentric, open study evaluated the efficacy and safety of Zyderm Collagen Implant (ZCI) in 158 patients with contour deficiencies of the dermis and a history of silicone fluid therapy. Following test implantation with ZCI, thirty-seven patients dropped out, including four patients who exhibited untoward responses to the implant material. Hence, 121 patients completed the course of therapy and were available for efficacy and safety evaluation. At 2-week intervals. ZCI was implanted intradermally in 327 sites; 186 (57%) were the identical sites that had been injected previously with silicone fluid. In 89% of patients, five injections or less of ZCI produced favourable clinical results. Moreover, of 176 sites injected five times or less, a consistent pattern of progressive improvement was observed with each additional injection, regardless of the aetiology of dermal lesions. Furthermore, no undesirable textural or pigmentary changes were apparent at any of the 327 treatment sites. An adverse effect consisting of localized swelling, induration and erythema at implantation sites occurred in one patient, but resolved spontaneously.