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Tissue Implants in Canada May Have Come From Bodies Taken From Funeral Homes

Posted on: Thursday, 27 October 2005, 21:01 CDT

By SHERYL UBELACKER

TORONTO (CP) - Some Canadians who received transplants of bone, skin or tendons need to be tested for infectious diseases like HIV and hepatitis after it was discovered the U.S. supplier of the products may have illegally procured them from corpses at funeral homes.

About 300 human tissue products from Biomedical Tissue Services Ltd. were exported to several Canadian companies, which supply tissue to hospitals and health professionals across the country for grafting during dental and orthopedic procedures.

This week, a Health Canada advisory said distributors that purchased human tissue from Biomedical have recalled the products.

The Fort Lee, N.J., company is under investigation for allegedly obtaining bones and other tissues from bodies trafficked from New York-area funeral homes.

U.S. law prohibits the sale of body parts for profit, but the probe by the Brooklyn district attorney's office alleges that relatives' consent forms were forged and cause of death records altered to make the donations to tissue-processing companies acceptable.

Health Canada has asked importers to advise hospitals, physicians and dentists to contact patients who received the products and arrange for them to be tested for HIV, hepatitis B and C, human T-cell lymphotrophic virus (HTLV 1 and II) and syphilis.

"One of the things that even (Health Canada) has pointed out was they feel there is a low risk of any chance of disease, but the risk is still there," Bert Kelly, a spokesman for Medtronic Inc., said from Memphis, Tenn.

Kelly said Medtronic buys and distributes tissue products from Regeneration Technology Inc. (RTI) of Florida. His division sells bone products to Canadian hospitals and health professionals through Medtronic's branch in Mississauga, Ont. The products are used for such procedures as fracture repair and spinal fusion surgery.

Even though RTI goes through a rigorous screening and sterilization process of donor tissue, the company "felt the best thing to do would be to recall any tissue that came from this BTS company to alleviate the concerns of patients and everybody involved," Kelly said.

"The documentation could not be confirmed as to how patients died . . . and certainly if a patient had died of a disease like HIV or hepatitis, they would have been disqualified from donating," he said.

"So not knowing what the real cause of death was, that's absolutely of major concern for RTI and for us."

Medtronic first began purchasing the questionable tissues from Biomedical Tissue Services (BTS) in May 2002 and began recalling them in the United States and Canada earlier this month.

But the first recall came Sept. 30 after LifeCell Inc., a Branchburg, N.J., company that produces skin graft products, found discrepancies in donor documents from BTS. It notified the U.S. Federal Drug Administration, which issued a recall warning to all companies dealing with the products.

"While no adverse events have been reported, we took this prudent and precautionary measure because LifeCell is committed to patient safety and quality," CEO Paul Thomas said of the recall in a release.

"If the allegations . . . are proven true, we are sickened and outraged by BTS's activities," said Thomas.

Sharon Mullin, an assistant manager of compliance with the Health Products and Food Branch, Inspectorate, said Health Canada hasn't yet determined how many of the 300 tissue products actually ended up in Canadians' bodies.

"It's too early to say how many were transplanted and how many were on the shelf," Mullin said Thursday from Ottawa.

No cases of disease or death related to these tissue products have been reported in Canada or the United States, Mullin said. "The risk continues to be low."

Source: Canadian Press

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