FDA orders Cryolife Corporation to remove its soft tissue products

The FDA ordered Cryolife Corporation on August 14, 2002, to immediately recall distributed human tissue processed from October 3, 2001 to the present. Cryolife was unable to adequately assure patients that its soft tissue products were free of deadly bacteria and fungi. As the biggest supplier of human tissue used in implants, Cryolife is responsible for supplying about half of the soft-tissue implants needed in the 650,000 annual surgical procedures in the U.S. alone.

The FDA recall includes all soft tissues, including tendons, ligaments and cartilage that has been widely used in elective orthopedic surgery to repair worn out knees as well as other joints. A Cryolife heart valve recall is also being considered by the FDA due to similar contamination risks found to occur with the soft tissues. Identical technology is used when Cryolife processes the soft tissues and heart valves. Processing 70% of the nation's heart valves and 90% of vascular tissue, Cryolife obtains the tissue from cadavers.

Associated with the November 7, 2001 death of a 23-year old patient who had received a soft issue implant during reconstructive knee surgery, the FDA continued to find numerous and significant violations of regulations that led up to the agency's recall of all soft tissues. The Centers for Disease Control and Prevention (CDC) learned shortly after the death of the young man that the donor providing the knee tissue had committed suicide in October and the body had not been refrigerated for 19 hours after being picked up by a tissue bank, significantly outside the time allowed by industry standards. The patient had died just four days after his knee surgery due to a rare bacterium, Clostridium sordelli. Ten other patients received grafts from Cryolife taken from the same donor.

These findings led to a larger investigation of bacterial contamination and uncovered that of 26 infected tissues implanted into patients, half of them came from Cryolife, later increased to 54 infections with half still from Cryolife. Cryolife was given recommendations from the CDC stating the tissues should be tested for microbes before soaking in antibacterial and antifungal solutions because the failure to do so could result in a creation of superbugs, a type of bacteria and fungi that acquires resistance to antibiotics and antifungal agents. The FDA was not satisfied with Cryolife's response to its June 17th issued warning letter, alerting the company they had "neither adequately investigated its validation of processing and testing methods, nor implemented recommendations from the Centers for Disease Control and Prevention, or any other procedures, to ensure that tissue processed by the firm is not contaminated."

The CDC has received complaints about Cryolife heart valves and the future of these tissues is still uncertain.

If you have received a tissue implant you are encouraged to review your rights by contacting us

Although most people who became ill after receiving soft-tissue implants usually developed symptoms within days or a few weeks of their surgery, it can take months for infections in heart valves to produce symptoms. There have been 27 serious infections as a result of tissue implants processed by Cryolife Corporation and one fatality.

The FDA recall includes all soft tissues, including tendons, ligaments, and cartilage that has been widely used in elective orthopedic surgery to repair worn out knees as well as other joints. A Cryolife heart valve recall is also being considered by the FDA due to similar contamination risks found to occur with the soft tissues. Identical technology is used when Cryolife processes the soft tissues and heart valves. Processing 70% of the nation's heart valves and 90% of vascular tissue, Cryolife obtains the tissue from cadavers.

Associated with the November 7, 2001 death of a 23-year old patient who had received a soft issue implant during reconstructive knee surgery, the FDA continued to find numerous and significant violations of regulations that led up to the agency's recall of all soft tissues. The Centers for Disease Control and Prevention (CDC) learned shortly after the death of the young man that the donor providing the knee tissue had committed suicide in October and the body had not been refrigerated for 19 hours after being picked up by a tissue bank, significantly outside the time allowed by industry standards. The patient had died just four days after his knee surgery due to a rare bacterium, Clostridium sordelli. Ten other patients received grafts from Cryolife taken from the same donor.

These findings led to a larger investigation of bacterial contamination and uncovered that of 26 infected tissues implanted into patients, half of them came from Cryolife, later increased to 54 infections with half still from Cryolife. Cryolife was given recommendations from the CDC stating the tissues should be tested for microbes before soaking in antibacterial and antifungal solutions because the failure to do so could result in a creation of superbugs, a type of bacteria and fungi that acquires resistance to antibiotics and antifungal agents. The FDA was not satisfied with Cryolife's response to its June 17th issued warning letter, alerting the company they had "neither adequately investigated its validation of processing and testing methods, nor implemented recommendations from the Centers for Disease Control and Prevention, or any other procedures, to ensure that tissue processed by the firm is not contaminated."

The CDC has received complaints about Cryolife heart valves and the future of these tissues is still uncertain. If you have received a tissue implant you are encouraged to review your rights by contacting us. Although most people who became ill after receiving soft-tissue implants usually developed symptoms within days or a few weeks of their surgery, it can take months for infections in heart valves to produce symptoms. There have been 27 serious infections as a result of tissue implants processed by Cryolife Corporation and one fatality.

August 28, 2002

CryoLife was ordered to recall all tissue used in orthopedic surgery, including ligaments, tendons, cartilage, and other soft tissue. At the time of the recall CryoLife's heart valves were also been reviewed for safety reasons. The leading supplier of donated human tissue, CryoLife has provided human heart valves for 41,000 patients since 1984 and the federal Centers for Disease Control and Prevention is now investigating several cases of bacterial or fungal infections in heart valves that were reported since March by physicians and patients. The FDA has sent notices to heart surgeons warning about the heart valves in which at least two of the valves were from CryoLife. CryoLife is the only company that is being investigated by the disease control center.

As of yet, the government has no strict guidelines for harvesting or processing human tissue, including for both heart valves and soft tissue. Authorities are unable to report how many people have developed infections after receiving a human heart valve transplant. When donor tissues are implanted, microbes can result in tremendous growth that releases deadly toxins. CryoLife discontinued testing each piece of tissue for microbes upon receiving them a few years ago because they said there was no evidence it made tissues safer but renewed the testing in May when the company was criticized.