So are thousands of others. Each year close to 900,000 implants collected from donor cadavers are shipped to hospitals for use in a variety of procedures, including repairing cartilage, fusing bone and replacing heart valves. The products improve outcomes and save lives–and the vast majority are successfully implanted. But after Brian Lykins, 23, died last November, days after knee surgery involving CryoLife tissue, federal health agencies began taking a closer look at implant safety. The Centers for Disease Control and Prevention has turned up 54 cases of infections after surgery, almost half linked to CryoLife, one of the country’s largest tissue suppliers. The FDA clamped down after finding CryoLife’s response to a warning letter “inadequate” and concluding that the company could not ensure its products’ safety. NEWSWEEK has learned that last month the FDA also issued a warning letter to another tissue bank, AlloSource, citing it for a series of problems in its processing procedures. The company says it welcomes the scrutiny and is fine-tuning safety measures.
Prior to Lykins’s death, the risk of deadly infections seemed largely theoretical. Even now the FDA says there’s no reason to panic. But across the country, patients and their surgeons are thinking twice about the options. In reconstructive knee surgery–the most common joint procedure–doctors can use a piece of the patient’s own hamstring to replace a damaged tendon. Mechanical heart valves can replace real ones. But sometimes donor tissue is the best or only way to go. Connolly had already used his own tendon in a prior surgery. Artificial heart valves are too big for infants. And in vascular surgery, the choice could end up being a donated vein or amputation.
The critical issue is safety. As the number of tissue banks has increased–more than 200 are now registered with the FDA–so has concern. Federal law requires that donors test negative for HIV and hepatitis. But there are no standardized decontamination procedures. Irradiation can burn off contaminants, but it can also damage soft tissue, like tendons and ligaments. CryoLife’s David Fronk says that’s why the company’s soft-tissue products, like those of other tissue banks, are not sterile. But, he says, they are aseptically cleaned, which includes soaking them in an antimicrobial cocktail. CryoLife says it has implemented certain stricter standards and has requested a hearing with the FDA to appeal.
The demand for oversight will only intensify. The FDA says stronger processing regulations, long under review, are now a priority. Seventy-four of the country’s tissue banks, including AlloSource, are already voluntarily accredited by the American Association of Tissue Banks, which publishes detailed safety standards. But the association cannot guarantee the purity of its members’ products. Jay James is well aware of the risks. He sued CryoLife three years ago, claiming the tissue he received in his knee was contaminated. (The suit was settled.) After multiple corrective surgeries, he says, “I want my knee back.”
In the future patients may have more high-tech options. Scientists are working on biologically engineered tissues that can be shaped into missing parts. And they’re studying agents that one day might induce the body to grow its own tissue. Until then, however, donor tissue remains a critical option–and vigilance a critical necessity.
