LUVMyBirman
Well-known member
Tissue implants benefits outweigh risks-industry
By Susan Nadeau
CHICAGO (Reuters) - A massive recall of frozen human ligaments, tendons and other tissue used in transplant operations has put the safety of the procedures under the spotlight, but industry experts say the benefits far outweigh the risks.
Earlier in the week, the U.S. Food and Drug Administration ordered Kennesaw, Georgia-based CryoLife Inc. to recall and quarantine most of the human tissue it collected and processed since October 3, 2001. The decision was linked to the death last year of a Minnesota man who had knee surgery.
The company, which is the biggest U.S. provider of frozen human soft tissue for implant, has been the target of a handful of lawsuits that allege its tissue caused infections in transplant patients.
But since the recall, medical and industry experts have expressed little concern about the safety of the procedure. Other processors, such as Regeneration Technologies Inc. and Osteotech Inc., are eager to increase tissue preparation in order to cover for CryoLife.
"The riskiest part of the an allograft (human tissue transplant) is driving to the hospital," said Dr. Gary Friedlaender, professor and chairman of the Department of Orthopedics and Rehabilitation at Yale University School of Medicine and Yale-New Haven Hospital.
The FDA said inspections of CryoLife uncovered a number of violations of tissue processing regulations. Also, regulators said the company improperly distributed tissue from a donor after the firm confirmed the presence of harmful microorganisms in tissue samples from the same donor.
"I don't think this is an indictment of the tissue banking services in the country," Friedlaender added. "This is an example of the system working well."
CryoLife has maintained the ligaments, tendons, cartilage and other tissue it processes are safe, and it is appealing the FDA order. On its Web site, CryoLife said the infection rate in orthopedic surgeries, for example, with Cyrolife-processed tissue is about 0.2 percent - compared with infection rates of general U.S. orthopedic surgeries between 0.6 and 2.2 percent.
SOME 600,000 TO 800,000 TRANSPLANTS ANNUALLY
Tissue for transplants is taken from cadavers by tissue banks, tested, processed and frozen in a number of ways. There are more than 400 tissue banks nationwide.
The tissue CryoLife receives from the banks and processes is used in various types of surgeries. CryoLife provides some 75 percent of all human-tissue heart valves implanted in the United States, and many of them are in children who would die without the transplants.
CryoLife also provides some 90 percent of human vessels used to prepare kidney-failure patients for life-saving dialysis and to improve circulation to avoid amputation, as well as tissue for orthopedic knee surgeries. Although the orthopedic conditions are usually not life-threatening, surgery can make a huge impact on a patient's ability to get around and can dramatically reduce pain.
Use of human tissue picked up in the 1950s, and large tissue banks evolved in the 1980s. Now, an estimated 600,000 to 800,000 Americans receive soft-tissue transplants each year.
Still, bacteria and fungus can be present in the donor tissue or can develop if the donor body is not frozen quickly enough. The process is high-tech and industry analysts say it is difficult to sterilize tissue without rendering it useless.
"Clearly this issue...has put a spotlight on the company," said Archie Smith, senior health care industry analyst for U.S. Bancorp Piper Jaffray. "The infection rate we're talking about is about the rate if you walk down the halls of Mass Gen (Massachusetts General Hospital) with your socks off."
CryoLife says it remains confident in the safety of its tissue. It has asked the FDA to allow limited distribution of its tissue for life-saving and limb-saving surgeries, a request the FDA said it is considering. The company's human heart valves were not included in the initial FDA order, though they are also under review.
By Susan Nadeau
CHICAGO (Reuters) - A massive recall of frozen human ligaments, tendons and other tissue used in transplant operations has put the safety of the procedures under the spotlight, but industry experts say the benefits far outweigh the risks.
Earlier in the week, the U.S. Food and Drug Administration ordered Kennesaw, Georgia-based CryoLife Inc. to recall and quarantine most of the human tissue it collected and processed since October 3, 2001. The decision was linked to the death last year of a Minnesota man who had knee surgery.
The company, which is the biggest U.S. provider of frozen human soft tissue for implant, has been the target of a handful of lawsuits that allege its tissue caused infections in transplant patients.
But since the recall, medical and industry experts have expressed little concern about the safety of the procedure. Other processors, such as Regeneration Technologies Inc. and Osteotech Inc., are eager to increase tissue preparation in order to cover for CryoLife.
"The riskiest part of the an allograft (human tissue transplant) is driving to the hospital," said Dr. Gary Friedlaender, professor and chairman of the Department of Orthopedics and Rehabilitation at Yale University School of Medicine and Yale-New Haven Hospital.
The FDA said inspections of CryoLife uncovered a number of violations of tissue processing regulations. Also, regulators said the company improperly distributed tissue from a donor after the firm confirmed the presence of harmful microorganisms in tissue samples from the same donor.
"I don't think this is an indictment of the tissue banking services in the country," Friedlaender added. "This is an example of the system working well."
CryoLife has maintained the ligaments, tendons, cartilage and other tissue it processes are safe, and it is appealing the FDA order. On its Web site, CryoLife said the infection rate in orthopedic surgeries, for example, with Cyrolife-processed tissue is about 0.2 percent - compared with infection rates of general U.S. orthopedic surgeries between 0.6 and 2.2 percent.
SOME 600,000 TO 800,000 TRANSPLANTS ANNUALLY
Tissue for transplants is taken from cadavers by tissue banks, tested, processed and frozen in a number of ways. There are more than 400 tissue banks nationwide.
The tissue CryoLife receives from the banks and processes is used in various types of surgeries. CryoLife provides some 75 percent of all human-tissue heart valves implanted in the United States, and many of them are in children who would die without the transplants.
CryoLife also provides some 90 percent of human vessels used to prepare kidney-failure patients for life-saving dialysis and to improve circulation to avoid amputation, as well as tissue for orthopedic knee surgeries. Although the orthopedic conditions are usually not life-threatening, surgery can make a huge impact on a patient's ability to get around and can dramatically reduce pain.
Use of human tissue picked up in the 1950s, and large tissue banks evolved in the 1980s. Now, an estimated 600,000 to 800,000 Americans receive soft-tissue transplants each year.
Still, bacteria and fungus can be present in the donor tissue or can develop if the donor body is not frozen quickly enough. The process is high-tech and industry analysts say it is difficult to sterilize tissue without rendering it useless.
"Clearly this issue...has put a spotlight on the company," said Archie Smith, senior health care industry analyst for U.S. Bancorp Piper Jaffray. "The infection rate we're talking about is about the rate if you walk down the halls of Mass Gen (Massachusetts General Hospital) with your socks off."
CryoLife says it remains confident in the safety of its tissue. It has asked the FDA to allow limited distribution of its tissue for life-saving and limb-saving surgeries, a request the FDA said it is considering. The company's human heart valves were not included in the initial FDA order, though they are also under review.
