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Tissue implant scandal heightens FDAs concern

by Gayatri on September 4, 2006 at 4:20 PM
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Tissue implant scandal heightens FDAs concern

Due to the tissue suppliers' scandals, the patients who received tendons, cartilage and other parts from donated cadavers, are being advised to undergo tests for hepatitis and HIV. This is happening for the second time in a year.

Since the federal officials won't tell the number of people, across the country, who had got tissue before the recalls were announced, it is difficult to tell about the risk recipients face.

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Patients may be unaware that they had got cadaver tissue implanted. All the doctors may not tell the patients about the donated tissue. Usually, the doctors themselves don't know the source of the tissue.

According to experts, patients can get an idea about their potential risk by ensuring 2 steps: - Urging the doctors to tell about the tissue supplying company and its involvement in recalls. - Getting done the recommended tests for infectious diseases like HIV, hepatitis B and C, and syphilis.
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"If they're six months out [from the transplant] and they test negative, they don't have to worry," said Dr. L. Clifford McDonald, an infectious disease specialist at the federal Centers for Disease Control and Prevention. "Chances are good that an infection would have taken hold by then, or at least shown up in blood tests," he said.

Annually, cadaver tissue is being used in more than 1.3 million procedures, from knee repairs to spine surgeries. Reputed companies supply most of the tissue. However, a 3-month Associated Press investigation earlier this year, revealed that this industry is not regulated properly.

Philip Guyett Jr. and Donor Referral Services of Raleigh, N.C. were shut down by the U.S. FDA on August 18, due to "serious deficiencies" in manufacturing practices. A mismatch of the records with the official death certificates and lack of information on the donor's history of cancer or drug use, making the tissue ineligible for transplantation, were some of the flaws reported in the FDA's order.

The doctors were advised, to get in touch with the patients who got transplants from that company, by the FDA on Wednesday, as more information from the ongoing investigation had raised the FDA's concern.

Tissues supplied by Donor Referral Services have been recalled voluntarily by the following companies: Alamo Tissue Services of San Antonio; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando; and US Tissue and Cell of Cincinnati. (AlloSource of Centennial, Colo., which acquired some of US Tissue's assets in March, is handling US Tissue's recall.)

Patients in any part of the country could be affected as tissues are usually, distributed nationwide.

Source: Medindia
GYT
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