patients may have received transplants from disease-contaminated body parts. A small number of British patients may have received bone transplants from disease-contaminated body parts, according to a U.K. medical agency.
The Medicines and Healthcare Products Regulatory Agency, which oversees the safety of medicines and medical devices, on Wednesday released a list of 25 hospitals in the U.K. where patients may have received tainted bone material.
“Affected tissue has been recalled, but up to 82 units of affected bone graft material may have been implanted into a small number of patients,” said the agency in a statement.
Bone material is typically used as filler in orthopedic surgery, such as hip replacement operations or jaw surgery. Before being used in medical procedures, bones are subjected to chemical processing and sterilization procedures. The risk to patients is thought to be minimal, according to the agency.
Hospitals were alerted of the possible breach of procedure
Hospitals were alerted of the possible breach of procedure last October, but the information was only released publicly on Wednesday in response to a Freedom of Information request filed by the British Broadcasting Corp.
It is the latest development in a case that dates back to 2004, when the body of veteran BBC broadcaster Alistair Cooke was one of more than a thousand allegedly stolen by a ring of dealers in the U.S., who falsified the origins before selling body parts for transplantation.
Last year, Biomedical Tissue Services, a U.S.-based tissue procurement company at the center of the scandal, was accused of failing to adequately document its human tissue donors. It was said to have used bodies obtained illegally, without consent, and with falsified documents.
Royal National Orthopedic Hospital, one of the hospitals receiving questionable bone material
The Royal National Orthopedic Hospital, one of the hospitals receiving questionable bone material, issued a statement saying that “it would not be appropriate to contact patients,” because risk was negligible. “Any adverse reactions would in any case be picked up as part of the routine follow-up of patients,” the statement said.
Some ethicists, however, said that as a matter of standard practice, patients have the right to be informed when they have been potentially exposed to risk. Certain organisms, including the prion that causes Creutzfeldt-Jakob Disease or Mad Cow Disease are extremely resistant to sterilization procedures and could be transmitted by tissue transplants.
There are no laws governing the import and export of human body parts into the U.K. Though such laws exist to prohibit the transport of organs between countries, there is no comparable regulation for body parts.