ABSTRACT

Injectable bovine collagen, Zyderm1 collagen implant, has been in use in the United States since 1977 (1). Originally developed by the Collagen Corporation (Palo Alto, California, U.S.) in 1979, the product became widely available to interested physicians in the United States under a phase III protocol. Ultimately, in July of 1981, the Zyderm collagen implant received the approval of the Food and Drug Administration (FDA), representing the first time an FDA-approved injectable device was available for soft tissue augmentation. This approval sparked interest in the entire field of filling substances and, to date, more than 1,300,000 individuals have received injectable collagen treatments. Following the approval of the first injectable form, Zyderm I1 collagen implant, the FDA cleared two additional formulations, Zyderm II1 collagen implant and Zyplast1 implant. Subsequently, a special packaging of Zyderm I collagen, which contains a 32-gauge needle, was made available. The barrel of the syringe for this product-Zyderm I with Fine-Gauge Needle-is specifically suited for use with the supplied metal-hub needle.