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Dr. Kim Mulvihill ReportingLate today the FDA ordered a company dealing in donated human tissue to immediately cease all operations. The agency says Biomedical Tissue Services of New Jersey committed significant violations that pose a danger to human health.
Matt McLean of Redwood City is a weekend warrior whose knee finally gave out.
Matt McLean: "The years of roller blading and basketball and all that stuff."
Surgeons fixed it, transplanting a tendon from a cadaver donor.
Matt McLean: "They said, 'you potentially could have the tissue you received that was unscreened.'"
Unscreened for certain infectious diseases transmitted thru tissue, such as HIV, hepatitis B and C and syphilis.
Matt McLean: "It was just like a kick in the stomach, especially because now I'm thinking, ok I just had a newborn and I've got a wife, so everyone was at risk"
Matt is not the only one. Doctors and hospitals around the country, even as far as Europe and China, are informing their patients, tissue they received in a transplant may not have been properly screened.
The FDA is investigating a company suspected of using falsified documents and looted cadavers, including the body of TV host Alistair Cooke.
Matt McLean: "So I'm essentially carrying stolen property"
Orthopedic surgeon Dr. Kevin Stone wants to reassure patients.
Dr. Kevin Stone, M.D., Orthopedic Surgeon: "Today with new tissue sterilization techniques and careful testing and harvesting, most of the problem can be caught, but not everyone. "
New FDA rules that took effect last year require tissue banks to test donated tissues for a list of diseases.
Jan Pierce, U.S. Tissue & Cell Bank: "We're looking for hepatitis, HIV, other retroviruses like HTLV. We're also looking for CID or mad cow disease."
Most reputable banks also review a patient's medical history and medical records.
Last year, two million tissue transplants were done, with few infections. Fear is with a case like this is fewer people will donate tissue.
