A macabre scandal in which corpses were plundered for body parts could be even bigger than previously disclosed, with one company alone saying it has distributed thousands of pieces of human tissue that authorities fear could be tainted with disease.
In addition, three other companies have reported quarantining or destroying more than $5 million in tissue from Biomedical Tissue Services — the now-defunct New Jersey supply house at the center of the scandal.
While the exact number of pieces distributed and used in operations has not been revealed, hospitals in recent weeks have spoken of contacting hundreds of patients who may have received tainted tissue.
BTS has been accused of collecting body parts without donor consent and selling them for use in transplants performed at hospitals and other medical facilities across the country. The owner of BTS and three others were charged in a scheme that earned them millions of dollars. All four have pleaded not guilty.
BTS supplied bone, skin and tendons to various processors, who in turn provided them to distributors. Those companies are not accused of any wrongdoing.
Minneapolis-based distributor Medtronic Inc. reported that at least 8,000 pieces that came from BTS were implanted, and others are being recalled, according to documents filed January in a federal lawsuit in Ohio.
The number was revealed in a question-and-answer form the company sent to surgeons around the country in November 2005 shortly after it was notified that the tissue had dubious origins.
“We’ve been as transparent as possible,” Medtronic spokesman Bert Kelly said. “We felt like we had to be as open as possible. This is about patient safety for us.”
The Food and Drug Administration is concerned those parts could be infected with the AIDS virus, syphilis and hepatitis, but has said the risk of infection is small.
The FDA will not say whether any patients have ailments that might be linked with suspect tissue. The FDA has also refused to reveal how many people received BTS tissue.
“At this time the agency is not releasing any specifics of that investigation in order to preserve the integrity of that investigation,” FDA spokesman Stephen King wrote in an e-mail.
Medtronic said it acquired more than 13,000 pieces of BTS tissue from one tissue processor, Regeneration Technologies Inc.; of that number, 8,000 were implanted.
In Securities and Exchange Commission filings, Regeneration and two other companies that process parts — LifeCell Corp. and Tutogen Medical Inc. — reported quarantining or destroying more than $5 million in BTS tissue.
David Wade, chief executive of another tissue processor, Lost Mountain Tissue Bank, said it processed several thousand pieces obtained via BTS, but only a few hundred were distributed, and only 20 pieces or so were transplanted into people.