In February 2006, the Food and Drug Administration (FDA)
ordered human body tissue recovery and distribution company
Biomedical Tissue Services, Ltd. to cease manufacturing
human body tissue. The report was the culmination of a
years-long investigation into ethical and health violations
in the recovery of human body tissue to be used in
transplants, skin grafts and other medical procedures. With
the order, the FDA both recalled Biomedical Tissue
Services' existing tissue products and prevented the firm
from any further manufacture of tissue products, citing
repeated violations of body tissue regulations.
The Human Body Tissue Industry - An Overview
Human body tissue is harvested and used in a variety of
medical procedures, including, but not limited to bone and
skin grafts, dental implants and organ transplants. These
tissues are acquired by so-called "tissue banks" from
universities, morgues, hospitals, and funeral homes. The
tissue banks are regulated by federal and state laws, which
require them to report these acquisitions to the family
members of the deceased and perform industry-standard tests
to determine whether the tissues are free of disease and
fit for donation. The FDA has submitted detailed rules that
regulate every aspect of the human tissue industry's
acquisition and distribution process in an effort to
prevent dangerous infected tissues from getting onto the
market.
However, the human body tissue industry is largely
unregulated. There are hundreds of tissue banks throughout
the United States, but less than eighty of these belong to
the American Association of Tissue Banks, a peer
organization that accredits and inspects tissue banks. In
addition, only a few states perform monitoring and
licensing on these tissue banks. In addition, critics of
the tissue donation system cite often-inadequate training
and oversight at tissue bank facilities.
The consequence of this negligence in the human tissue bank
industry is often severe: donated human tissue is often
infected with diseases that then are passed on to
transplant recipients. Tissue transplant infections can be
due to pre-existing disease (not caught through proper
screening), contamination because of unsterile conditions,
or cross-contamination when the tissue is exposed to other
infected tissue. The illegal sale of human body tissue puts
patients at risk for the contraction of serious health
conditions, including but not limited to HIV, hepatitis,
and other infectious diseases.
Biomedical Tissue Services Under Fire
The FDA order regarding Biomedical Tissue Services exposes
the severe flaws of the unregulated human body tissue
industry in this country. The FDA's investigation revealed
significant breaches in ethical and health codes at the
company's facilities, where industry-standard practices
were not followed and donors were inadequately screened for
infectious diseases and donation suitability. In addition,
the company has been implicated in the illegal acquisition
of human body tissue from cadavers whose families did not
give consent.
Biomedical Tissue Services also kept inadequate records of
tissue origins and sales and was implicated in falsifying
death certificates. The FDA specifically named Michael
Mastromarino, D.D.S., CEO and Executive Director of
Operations for Biomedical Tissue Services, in its order.
If You've Been Affected
If you or a family member has been affected with ill-health
side effects from contaminated tissue transplants, contact
a medical malpractice attorney immediately. It may be
possible to recover financial damages and compensation for
medical bills, lost wages, pain and suffering, and other
causes of action.
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