Soft Tissues Implants

Despite the large number of soft tissue implants being performed each year, 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.

After a November 7, 2001 death of a 23-year old patient that had received a soft tissue implant for a reconstructive knee surgery that was derived from CryoLife, the FDA continued receiving reports of other infections in soft tissue implant patients and along with the CDC realized the majority of them were due to CryoLife. The two agencies determined that CryoLife failed to take necessary measures to prevent or address the possibility of fungal and bacterial infections due to their processing and testing methods. An FDA commissioner felt that the agency "tried to work with CryoLife and get them in compliance, but it just didn't work" (Time, 8/26/02).

The CDC had found that the donor for the 23-year olds death had used soft tissue implant from a donor that had committed suicide in October, with the body not reaching refrigeration for 19 hours after being picked up by a tissue bank. This time frame is significantly beyond the time allowed by industry standards. As a result, the patient met his death just four days after his knee surgery from a rare bacterium, Clostridium sordelli. Though no other patients died from the soft tissue used off of the same cadaver, there were ten other patients that received grafts from the same donor that CryoLife had taken.

As the investigation continued, agency officials found that of the 26 infected tissues implanted into patients, fifty percent of them came from CryoLife. The number of infected tissues found to have been implanted into patients later increased to 54 infections, but still fifty percent of them had been derived from CryoLife. While most processors test each piece of soft tissue for microbes when received and discard the tissue if signs of contamination are present, CryoLife suspended the testing a few years ago. When CryoLife was criticized the company finally renewed the testing in May 2002.

The FDA did not issue a CryoLife heart valve recall, leaving many to question how the heart valves can remain when CryoLife uses the same processing procedures as the soft tissues that were recalled. Due to the large percentage of human heart valves supplied by CryoLife, seventy percent, the government is still investigating CryoLife heart valve infections that have been reported due to the impact a recall can have on patients in need of the implant. Unlike human soft tissue, heart valves are often necessary to save lives, especially in babies when artificial heart valves are too big for them and with vascular surgery with the choices being a donated vein or amputation.

More tissue banks have opened up while the lack of standardized decontamination procedures still remain. There are technical guidelines for handling tissues that the American Association of Tissue Banks has come up with in addition to regular inspections of the members' operations, but CryoLife does not belong to the American Association of Tissue Banks and has its own procedures. There are seventy-four tissue banks in the U.S. that have been voluntarily accredited.

As CryoLife was receiving reports from doctors, laboratories, and the CDC of infections occurring because of their soft tissue implants, CryoLife continued to tell the investors that there was no contamination. Although CryoLife has backed off of that statement since then, they had continued to claim there were no problems for months. Records show that CryoLife key corporate officers and directors stopped buying and started to sell millions of dollars worth of stock when health investigators were sending the company letters. The SEC is now investigating this matter and shareholder are suing CryoLife, in addition to the families of the infection victims and the infected.

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.