Transplant Tissue: Cryolife Human Soft Tissue Implants Recalled

Abstract

In a rare step, the U.S. Food and Drug Administration (FDA) in August ordered Cryolife Corporation to recall all human soft tissue it had processed since October of last year, stating that the safety of Cryolife products could not be assured. Although a subsequent agreement between the FDA and Cryolife led to a limited relaxation on the recall order for “medically urgent uses when alternative therapies are exhausted or unavailable,” the sale of Cryolife soft tissue remains severely restricted. Cryolife insists that its procedures are safe and that its overall rates of infection are extremely low, and is appealing the FDA recall?Cryolife is the nation’s largest processor of donated human tissue, and supplies 15 to 20 percent of the market for soft tissue implants. Such implants are widely used in elective orthopedic surgery: about 650,000 Americans have surgery involving soft tissue implants each year. Cryolife also processes 70 percent of the country’s heart valves.