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Patients fear body tissue was tainted

Implant recipients get tests, file suits

May 5, 2006 | The Courier-Journal Kim Lanham remembers the exact moment she learned that donor tissue implanted in her neck might carry infectious diseases.

"It was very unsettling, it was scary, it was sickening," Lanham, 46, said of the letter she received on Jan. 10, informing her that bone tissue implanted as part of an August 2004 disk replacement might not have met U.S. Food and Drug Administration screening requirements.

The New Jersey company that provided the tissue, BioMedical Tissue Services, has been accused of illegally harvesting bone and other body tissue.

The FDA has ordered the company to cease all operations. And in February, the Brooklyn District Attorney indicted its executive director, Michael Mastromarino, and three others on 122 charges, including forgery, corruption, body stealing and opening graves.

In a case the New York media has branded as "body snatching," the indictment alleges the company doctored death certificates and forged consent forms to obtain body parts from people who had not consented or were too old or too ill to donate.

The company allegedly then sold the tissue to processors that shipped it to hospitals and doctor offices around the nation for use in such routine procedures as fracture repairs and back and neck surgeries.

Lanham is one of at least 200 people in Kentucky and Indiana who have been notified that their tissue implants, between early 2004 and September 2005, were obtained through BioMedical and they should be tested for such diseases as HIV, hepatitis and syphilis.

While there have been no reports of anyone locally testing positive for disease, some of the recipients have filed suit in Kentucky and Indiana. The FDA is investigating reports of possible infectious diseases in patients elsewhere, but would not provide details because of its ongoing investigation.

David Denkhoff who had back surgery at the Neurosurgical Institute of Kentucky in July 2004 and June 2005, is a plaintiff in a class-action lawsuit that a Louisville attorney filed in Jefferson Circuit Court against several defendants, including BioMedical.

"I thought it was safe," Denkhoff said of his tissue transplant. The accounting student at Jefferson Community College said that, while he's tested negative for infectious disease, he joined the suit in hopes that it will result in better regulation of the industry.

The attorney said he has about 10 plaintiffs. Court documents show that at least 172 people in Kentucky had tissue implanted that was provided by BioMedical. And at least two Indiana attorneys have filed suits.
Risk generally low

Annie Cheney, author of "Body Brokers: Inside America's Underground Trade in Human Remains," said tissue donation is "a much more involved process" than organ donation "and there is a lot more room for these types of problems."

But Bob Rigney, chief executive officer of the American Association of Tissue Banks, an industry group, disputes that, noting that the clinical criteria used for tissue and bone transplant are more extensive than those used for organs.

"The requirements for organ donation fill a few pages," he said, while requirements for tissue donation "fill a two-inch binder," in part because tissue and bone transplants generally are elective they are life-enhancing but not life-saving, as with organs.

The FDA has said it believes the risk to tissue recipients generally is low, although it's looking into whether changes need to be made to avoid situations like the one with BioMedical.

Rigney's group, which accredits member firms that handle and distribute tissue, said the chance of tissue spreading a disease is small because the companies that process and distribute it test and treat it to reduce the possibility of infection.

He also noted that out of 8 million to 10 million transplants in the past decade, there have been only a handful in which a patient contracted an infectious disease because of it.

Nearly all of the tissue distributed in the U.S. comes from banks accredited by Rigney's association. BioMedical is not one of them, but the tissue processors it distributed to are, he said.

"In 30 years, we have never had anything like this," Rigney said.
Testing urged

Once the alleged improper harvesting by BioMedical was discovered, the FDA and tissue processors recalled all unused materials and notified hospitals and doctors who received the products, recommending that patients be tested for possible infectious diseases.

After receiving her letter, Lanham informed Todd Leatherman, director of consumer protection for the Kentucky Attorney General. He began his own effort to ensure all affected Kentuckians knew to be tested.

He asked the five processors that received tissue from BioMedical to provide a list of all the places they distributed it in Kentucky and surrounding states. He then notified those facilities and urged them to encourage their patients to be tested.

Apparently not everyone has.

At the Spine Institute in Louisville, practice administrator Brenda Stewart said fewer than 30 of its patients were affected, and of those, fewer than half have checked with the office about testing.

At the Neurosurgical Institute of Kentucky in Louisville, 37 patients received donor bone tissue during the time period subject to recall, according to practice administrator Lenore Slawsky.

Slawsky said in an e-mail that about 20 percent of those have not returned for testing.

The fact that none of those tested have been found positive for infectious diseases due to the tissue does not ease the mind of Yvonne Lucas.

Lucas, of Chandler, Ind., said that learning about the potential problem from her neck surgery, done by Neurosurgical Institute in December 2004, has made her fearful about additional surgeries that her doctors say she should have.

"Since they've already gave me those tainted bones once," she said, "you don't know what you're going to have the next time."

Oba Ray, 67, of Owensboro, Ky., agreed the uncertainty is troubling.

Ray had back surgery at Neurosurgical Institute in June 2005, has been tested for diseases and all results have been negative. Still, he worries.

"There's that probability that maybe something will crop up down the road somewhere."

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