The Big Business of Body Parts (page 4 of 4)

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Infected Tissues

At press time, the criminal investigation was reaching far and wide. Prosecutors believe Mastromarino expanded his services to Philadelphia, Newark, and Rochester, New York. And in Denver, Colorado, Dr. Michael Bauer reviewed up to 30 medical and consent donor documents that were signed and sent by Mastromarino to tissue processing company LifeCell Corporation. "When I finished," Dr. Bauer says, "they were all wrong; there was not one legitimate phone number in the charts I had."

The breadth and scope of BioMedical's dispersal led the FDA to issue recalls in October 2005. Tissue banks quickly complied and pulled unused BioMedical inventory off the shelves. The agency shut down BioMedical's operations in January.

But what about the BioMedical tissue that had already been implanted in needy patients? The FDA and Centers for Disease Control and Prevention acknowledge that while the tissue is processed to reduce the likelihood of disease, "the actual infectious risk is unknown." The agencies urged doctors to test their patients for HIV, hepatitis and syphilis.

Notices went out, and worried patients called their doctors -- as well as lawyers. "We've been contacted by more than 350 people from across the country," says attorney Andrew D'Arcy of Galloway Township, New Jersey. He explains that so far a handful of callers have tested positive for hepatitis B and C and syphilis, but he believes it's too early to determine definitively a causal connection between the diseases and the implant. Yet worry and uncertainty have already set in.

Heather Augustin called D'Arcy after a meeting with her doctor. The 42-year-old FAA administrative assistant from Mays Landing, New Jersey, learned that the bone implants used in her neck surgery last March were part of the recall. So far, her blood tests proved negative, but she must repeat the tests later this year. The anxiety has her wondering, How do I know that in ten years, something's not going to show up? What do I do to protect myself and my family?

Sen. Charles E. Schumer (D-NY) has responded with legislation that would require the FDA to ban the retrieval of tissue from funeral homes and morgues unless they are types in short supply. And officials would have to conduct annual tissue bank inspections and periodic audits of documentation, and define the terms for "reasonable processing fees."

Yet Michael Meyer, a medical ethicist and professor at Santa Clara University in California, thinks more can be done. "National standards are the first step toward transparency. There can't be a patchwork quilt."

Vito Bruno favors more protection for transplant recipients. "An unbelievably horrible crime has taken place against families and other victims who are sitting there not knowing if they have ticking time bombs inside of them."

Alistair Cooke's daughter hopes that public awareness will be raised by the investigation and media coverage. Meanwhile, she prays that what happened to her father never happens to anyone else.