Sacred Heart warning patients

Five patients who received human tissue transplants at Sacred Heart Medical Center in Spokane face the possibility of disease because the material came from a New Jersey supplier charged with stealing parts from funeral home corpses.

Patients were advised to seek medical testing for HIV/AIDS, hepatitis B and C and syphilis after tissues provided by a Sacred Heart supplier were recalled, a hospital official said this week. The unidentified patients received transplants of human bone, skin or tendons between early 2004 and September 2005; they are among thousands affected by a widening body-snatching scandal involving hospitals nationwide.

Sacred Heart officials sent warning letters to the patients and their surgeons in February, said Cheryl Thomas, the hospital’s director of risk management. That’s when the federal Food and Drug Administration shut down Biomedical Tissue Services Ltd., a Fort Lee, N.J., tissue supplier that provided suspect parts to one of the hospital’s distributors, Regeneration Technologies Inc. of Alachua, Fla.

“I got one call from a patient who thanked us for letting them know,” said Thomas.

Despite the recommendation for testing, FDA officials emphasized in a statement that the risk of infection is minimal.

Sacred Heart was the only Inland Northwest hospital urged to notify patients about questionable tissue. Representatives from Deaconess Medical Center and Holy Family Hospital in Spokane and Kootenai Medical Center in Coeur d’Alene said none of their patients received improperly collected material.

The FDA said Regeneration Technologies was one of five distributors nationwide to receive human tissues – known as “allografts” – from Biomedical Tissue Services. The owner of that firm, Michael Mastromarino, and three of his associates were indicted in Brooklyn in February for stealing body parts, forging consent and inspection documents and selling the unscreened material to distributors who sent it to surgeons for use in patients across the U.S.

Investigators alleged that Mastromarino and Brooklyn embalmer Joseph Nicelli removed bones, tendons, heart valves and other tissues from recently deceased people acquired through Nicelli’s businesses, which included a funeral home and a body transport business.

“What happened here – stealing tissue from the dead and selling it for transplant without consent of a family member and without taking any medical precautions to ensure that the transplants were free from disease or defect – is like something out of a cheap horror movie,” Kings County District Attorney Charles J. Hynes said in a February statement. “But, for the thousand of relatives of the deceased whose body parts were used for profit, and the recipients of the suspect parts, this was no bad movie. It was the real thing.”

Mastromarino and the others have pleaded not guilty to the charges.

Tissues used in local patients had been sterilized according to strict protocols used by Regeneration Technologies, minimizing the risk of infection, said Maureen Goins, Sacred Heart’s public relations director.

Goins said the hospital will continue to use tissues from the company, which is one of at least seven distributors that provide bones, tendons, heart valves, skin patches and other products used in thousands of local surgeries each year.

Although patients were advised to be tested, federal privacy rules prevent hospital officials from disclosing whether they actually were, or what the results of any tests might be, Goins said.

Nationwide, dozens of patients implanted with the illegally harvested body parts have filed individual and class-action lawsuits against Biomedical Tissue Services and the distributors that used them.

No similar lawsuits have been filed in Spokane County courts, records showed.

The ghoulish incident highlights the pressing demand for tissue in the lucrative allograft industry, which was estimated at more than $900 million annually by the financial firm Piper Jaffray. By law, human tissue cannot be bought or sold in the U.S., but providers can charge “processing fees” to handle donated material, said Margery Moogk, director of the Northwest Tissue Center in Seattle.

That nonprofit tissue center cooperates with hospitals in Washington, North Idaho and parts of Montana to procure and provide a range of tissues, with a particular emphasis on bone grafts, Moogk said. But most hospitals contract with a variety of providers, including private firms such as Regeneration Technologies, which hold claims on proprietary types of tissue favored by some surgeons.

“That’s how they happened to get tissue from BTS donors processed by RTI,” said Moogk. “I would not be surprised if those are proprietary grafts.”

The body-snatching scandal has cast a pall over the entire industry, said Moogk, whose agency had no contact with the New Jersey provider.

“It’s personally devastating to all of us,” she said. “That’s a betrayal of trust that we all depend on. They’ve broken every rule. And it’s appalling.”

Reach reporter JoNel Aleccia at (208) 765-7124 or by e-mail at jonela@spokesman.com