05.22.07

Following Last Week's Body Tissue Indictments In Rochester, Schumer Announces Legislation To Plug Gaping Holes In Tissue Transplant Industry

Last Week an Unsealed Indictment Charged 7 in Rochester with Stealing 36 Bodies to Sell Tissue to Biomedical Companies The Body Tissue Black Market Damages the Health of Patients Seeking Life-Saving Tissue Transplants and the Family Members of those Affected Schumer Announces Legislation to Strengthen Regulations on the Tissue Transplant Industry: Surprise Inspections, Str

Following last Thursday's unsealed indictment charging seven individuals in Rochester, NY for illegally harvesting 36 bodies for body tissue to sell biomedical companies, today, U.S. Senator Charles E. Schumer announced he will reintroduce his legislation to strengthen regulations on the tissue transplant industry. Schumer noted that yesterday's indictment highlighted the insufficient regulatory oversight for tissue transplants which allow for potentially contaminated tissue to be transplanted into otherwise healthy patients.

"Yesterday's indictment underscores a new problem that is not only profoundly troubling, but also threatens the health of the very individuals who believe they are receiving lifesaving treatments," said Senator Schumer. "My legislation will take the necessary steps to tighten up regulations in the tissue transplant industry so patients can have restored confidence in the system."

Thursday's unsealed indictment highlighted the current lack of restrictions regulating the exchange and sale of transplanted tissues. The indictment charged three funeral home directors and four former employees of a Rochester branch of the Biomedical Tissue Services, a biomedical supply company, with secretly removing skin, bone and other body parts without consent from 36 corpses in 2005.

Despite tissue transplantation being similar to organ transplantation, the industry is regulated much more loosely in comparison. While organ donors are only identified by doctors in hospitals, tissue donations can come out of funeral homes or morgues. Although the companies that test and sterilize tissue must be registered with the FDA, they are only inspected when the FDA decides there has been a risk associated with the bank. Exacerbating the issue is that tissue transplantation is used by certain companies as a profitmaking machine, utilizing materials desperately needed by patients for personal monetary gain.

Under the current system, the transfer of tissue between the donor and the recipient features several stages, opening up the process to improper and illegal behavior. In many instances, after a donor is identified either at a hospital, morgue, crematorium, or funeral home, it must be determined that the cause of death is not detrimental to the health and quality of the tissue. The tissue is then purchased by a tissue bank, which is responsible for retrieving, processing, storing, and distributing the tissue. Finally, the tissue banks are allowed to distribute the materials to additional companies before they finally reach a hospital. Even though the tissue has been exchanged numerous times by numerous sources before its final destination at the hospital, the hospital is not required to do any final testing on the tissue.

To combat this growing problem, today Senator Schumer pushed to reintroduce his legislation to regulate the tissue transplant industry. His legislation would specifically:

"Require the FDA to conduct surprise inspections of tissue banks at least once every two years;
"Require the FDA to develop or approve an accreditation system for tissue banks;
"Require tissue banks to meet strict minimum standards for providing adequate information to donor families and obtaining truly informed consent;
"Create new civil and criminal penalties for bad actors, up to a $250,000 fine and/or 10 years in prison;
"Require FDA to define the term "reasonable processing fee." It is currently illegal to buy and sell tissue, but it is legal to charge "reasonable processing fees." This term has never been defined, and can currently be used by forprofit tissue banks to make money off of body parts.

"This legislation will work to safeguard patients against being implanted with possibly contaminated tissue that was acquired illegally from corpses, and will protect the family members having to be affected by these tragic incidents," add Senator Schumer.

The owner of Biomedical Tissue Services, Michael Mastromarino, was charged along with three other men last year for removing bone and tissue without the permission of families from 1,077 bodies at more than a dozen funeral homes in New Jersey, Philadelphia, New York City and Rochester. In Rochester, the affected bodies included 23 bodies at Thomas E. Burger Funeral Home in the suburb of Hilton, 11 bodies at Profetta Funeral Chapel in the suburb of Webster and two bodies at Serenity Hills Funeral Chapel in Rochester.



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