Sunday, November 20, 2005

Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments

Ghoul case transplant recipients may face risk of HIV, syphilis, other ailments

Daily News dug up scandal Oct. 8. Biomedical president Michael Mastromarino. A body-snatching ring that illicitly harvested bone and tissue from corpses has placed thousands of transplant patients at risk for contracting infectious diseases.In a product recall notice, Tutogen Medical Inc. warned that human cadaveric tissue obtained from Biomedical Tissue Services Ltd. could be tainted.
The diseases could include HIV, syphilis, hepatitis and viral infections, according to regulatory authorities.
"There is a lack of assurance that appropriate [corpse] donor identification, donor screening and medical history data collection was performed and therefore, a risk of infectious disease exists," states the warning issued to doctors and hospitals throughout North America.
Tutogen, among others, distributed bone and tissue products it bought from Biomedical until earlier this month when the Daily News disclosed that the operation was under investigation by the Brooklyn district attorney's office.
The recall notice cited The News' disclosures on the ring, which is headed by Biomedical president Michael Mastromarino, a former dentist based in Fort Lee, N.J.
Along with others, Mastromarino personally carved up corpses and sold body parts to tissue processing companies that then distributed the products to doctors, dentists and medical centers for final transplant into human beings.
The Food and Drug Administration last week said that corpses harvested by the body-snatching ring "may not have been properly screened for certain infectious diseases."
"Some recipients of the tissues may be at increased risk of infections that could potentially be transmitted," the FDA said.
The agency also said that the risks of infection are low and that no adverse reactions have been reported so far, adding, "however, the actual infectious risk is unknown."
HIV, hepatitis, syphilis and viral infections are among the possible diseases cited by U.S. and Canadian health authorities.
Transplants possibly affected include bone for dental implants and a variety of orthopedic reconstructive procedures, skin for burn victims, fatty thigh tissue for cosmetic procedures and tendons and ligaments for those who have torn them.
FDA officials and the Centers for Disease Control and Prevention recommended blood tests for patients who got the questionable products.
The latest developments sent shock waves through the tissue transplant industry and doctors who use the products.
Dr. David Behrman, chief of the division of oral surgery at New York Weill Cornell Medical Center, said, "Many surgeons have been notified by their suppliers of bone-graft material that likely came from some of these questionable donors."
"We are awaiting guidance from the FDA as to what should be done and whether we should begin testing our patients for infectious disease among other recommendations," he said.
In Canada, Calgary public health officials immediately moved to quarantine product derived from Biomedical and said they will test one at-risk patient for HIV, hepatitis B and C, human T-cell lymphotrophic virus and syphilis.
"We confiscated the product, and traced it back, found one patient, contacted the patient, and we will begin the blood tests," said Leanne Niblock, spokeswoman for the Calgary Health Region.
Although the incidence of transplant recipients contracting disease from corpse body parts has been rare, several scandals have shaken the industry.
Three years ago, a 23-year-old Minnesota man died of an infection that came with transplanted ligaments inserted during knee surgery. The tissue was supplied by CryoLife, an Atlanta tissue bank, and the infection was identified as the rare bacterium Clostridium soredelli.
More recently, dozens of patients in Oregon were infected with hepatitis C contracted from tissue supplied from a single corpse.
Mastromarino's body parts were carved from hundreds of corpses obtained at funeral homes throughout the city and other states beginning in 2002 in an enterprise that continued until this month.
Mastromarino is under investigation by Brooklyn prosecutors for allegedly creating forged relatives' consent forms and phony medical records for the deceased in the harvesting scam.
The alleged medical record forgeries were designed to conceal conditions that would normally render the products unacceptable for sale. Those conditions include cancer, habitual intravenous drug use and many contagious diseases.
Joseph Nicelli of Staten Island an embalmer who was once Mastromarino's partner in the tissue recovery business, is also under investigation along with numerous funeral home directors who provided bodies.
After harvesting, the bone, tissue and other body parts were frozen by BTS and then shipped out overnight to Tutogen and other companies for processing before final transplant.
The other four processing companies are Lifecell Corp. of Branchburg, N.J., Lost Mountain Tissue Bank of Kennesaw, Ga., Blood and Tissue Center of Central Texas in Austin and Regeneration Technologies Inc. of Alachua, Fla.
All but Lost Mountain Tissue Bank told The News they were unaware of Mastromarino's allegedly illegal activities and that they follow extensive tissue testing and sterilization procedures of their own before they ship any product out.
James Wade, director of Lost Mountain, said, "I have no comment at all; we're following the FDA guidelines. I can't say more than that."
Originally published on October 30, 2005