What is the problem with tissue transplants and tissue banks?
Real life imitates science fiction when unethical funeral homes and crematoriums
were highly paid to turn a blind eye to the confiscation of skin and bones as
unscrupulous tissue brokers sold snatched body parts for profit to tissue banks & hospitals
throughout the United States and Canada.
Worse investigations are underway for the illegal looting of hundreds of dead
bodies where skin and bones were harvested from elderly people and victims of
infectious diseases that were later sold to hospitals and surgically implanted
into unsuspecting patients.
Ghoulish as it may seem, hundreds of families recently learned about beloved
dead family members who were secretly carved up for a tissue bank and robbed of their skin and
bones before being buried or cremated.
Lawsuits have been filed for a woman who received a bone implant for a back
injury and then contracted syphilis.
Tissue banks have sent out letters to
implant patients requesting that they might be at risk for HIV, hepatitis B,
hepatitis C, and syphilis and should be tested regularly.
Under the current tissue transplant system, there are many links in the chain
from donor to recipient. First, a donor is identified. The cause of death must
not be one, like cancer, that would make the tissues less strong or healthy.
Donors can be identified at hospitals, morgues, crematoriums, and funeral homes.
Then the tissue is purchased by a tissue bank, which is responsible for
retrieving, processing, storing, and distributing the tissue. Tissue banks may
distribute their goods to other companies before they finally reach a hospital,
which is not required to do any further testing, but trusts the tissue bank to
have been a proper gatekeeper.
Federally-designated organ procurement organizations, such as the New York Organ
Donor Network, receive a phone call every time there is a death in a nearby
hospital. They apply several strict screening processes, including talking to
the family of the donor, to ensure that the tissue is safe. They recover the
tissue in a sterile operating room before selling it to a tissue bank, for a
price determined by a federally-overseen formula that determines how much money
it cost them to recover the tissue. This keeps costs low and appropriate, but
once the tissue is sold to a tissue bank, the strict regulations end.
Biomedical Tissue Services was registered with the FDA and had been cited for
several violations in 2003, not by the FDA but by the New York State Department
of Health. Was the FDA aware of these citations? Did the FDA follow up with
its own inspection? Did the FDA see the warning signs that Biomedical Tissue
Services would act improperly?
The FDA ordered the recall of all of Biomedical Tissue's products in October
2005, saying concerns had been raised that the social-medical histories of some
donors were inaccurate.
The number of potential plaintiffs is virtually limitless. The hospitals
involved trusted their suppliers. Tissues were provided through standard
channels and presumed to be clear and free of any contaminants or infections.
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