Harmful Tissue Scandal In Transplant Procedures. Potentially harmful tissue used in transplant procedures for 30 UI Hospitals and Clinics patients will not alter screening practices at the hospital, a spokesman said Thursday.
UIHC surgeons had used tendon, bone, and skin grafts harvested by New Jersey-based Biomedical Tissue Services in various transplant procedures before the firm was accused of bribing funeral directors to provide it with parts from embalmed cadavers without the consent of the families.
The allegations led the Food and Drug Administration to recall all the company’s transplant material in October 2005.
The company also failed to follow proper procedures in sanitizing the tissue, causing concern that such diseases as syphilis, hepatitis B or C, or HIV 1 or 2 could have been transferred to patients receiving transplants.
Testing on 29 of the 30 UIHC transplant recipients yielded no diseases as a result of the illegally obtained material. The remaining patient has been contacted but has thus far chosen not to be tested, said UIHC media-relations coordinator Tom Moore.
30 Patients Who Received Tissue In Question
The 30 patients who received the tissue in question were offered testing for diseases in their home communities. Moore said the UIHC was advised, and obliged, to offer the tests free of charge. Testing for all the potential diseases will cost around $200 per patient, or $6,000 total.
Despite the concerns, Moore said the screening process the tissue went through sanitizes the material, reducing the chance that a patient would acquire a disease from tissue implants.
The UIHC’s tissue is processed by one of five procurement companies who sanitize the grafts before they are sent to hospitals.
Because the tissue procurers followed protocols and were unaware of the provider’s practices, their business relationships with the UIHC have not been affected, Moore said.
“The criminal activity of [Biomedical Tissue Services] was the problem,” he said. “The five companies and the hospitals are blameless in this episode.”
Vincent Traynelis, a UIHC neurosurgeon who used Biomedical Tissue Services bone grafts for spinal fusion procedures in “about 12” of the 30 patients, said tissue-transplant material arrives ready for surgery from the procurement companies. While Traynelis stressed that the incident had a criminal element and was not a regulation problem, he said further scrutiny of harvesting and procuring practices would be beneficial.
Several patients nationwide, claiming to have contracted syphilis from the company’s tissue transplants, have sued the company, with some naming participating hospitals and procurement companies as co-defendants.
Cedar Rapids medical-malpractice attorney John Riccolo said it would be difficult for a judge to hold hospitals accountable, even if patients indeed contracted a disease from the transplants.
“From my understanding, when the specimens get to the hospital, they already went through the process,” he said. “Because the certifications have all been signed, a suit would more likely be brought against the originator of the specimen – or someone on the chain.”