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Human Tissue Scandal Rocks Medical World

Apr 16, 2008
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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