Future of Human Tissue

The safety of human tissue use will continue to be an issue following the CryoLife recall. Despite the large use of soft tissues, the tissue industry is not restricted by any strict guidelines by the government. Florida and New York are the only states that require licensing and inspection of tissue banks, and there is little involvement at the federal level until the recent CryoLife recall in August 2002. A 2001 report found the FDA had no idea how many tissue banks were even in operation and the agency had never inspected 20% of the 154 facilities identified.

The FDA still says panicking over the risk of infection with soft tissues is unnecessary still, but reports continue to be made of patients enduring horrifying cases of infection. Patients and doctors are beginning to reevaluate the need to use human soft tissue and look at alternate options. When undergoing reconstructive knee surgery patients can opt to use a piece of their hamstring to replace a damaged tendon. Heart valves are a little trickier than knee surgery because while mechanical heart valves are available, they can be too large to use for babies. In addition, tissue is often a better and more effective option.

Stronger processing regulations are in the future, according to the FDA. Right now there are federal laws requiring only that donors test negative for HIV and hepatitis. Researchers will continue to work on biologically engineered tissues to be shaped into missing parts. There are nearly 900,000 tissue implants collected from donor cadavers and shipped to hospitals every year. Authorities are unable to report how many patients have developed infections after receiving heart valve transplants and soft tissue, but so far the CDC has identified 54 cases of infection following surgery, with almost half of these linked to CryoLife.

Until science can provide a safer, alternate way to conduct surgical procedures without the use of human donor tissue, there are going to have to be a much stricter way of reducing the risk of infection from occurring.

If you have undergone a surgical procedure using soft tissue implant or heart valve implant, please contact us to learn more about your legal rights from a tissue implant attorney.