Human Body Tissues Scandal Disturbs the Medical Community
In February 2006, the United States Food and Drug Administration (FDA) asked Biomedical Tissue Services, Ltd., a human body tissue distribution and recovery company to immediately stop manufacturing human body tissues. This report was the conclusion of year’s long investigation into the health and ethical violations in the recovery of human body tissues for using them in skin grafts, transplants and other medical procedures. The FDA announced to recall existing products of Biomedical Tissue Services and prevented the company from manufacturing the tissue products due to the repeated violations associated with human body tissues.
Human Body Tissue Industry
Harvested human body tissues are used in a wide range of medical procedures including organ transplants, bone and skin grafts and dental implants. The tissue banks acquire these human body tissues from funeral homes, morgues, universities and hospitals. The federal and state laws regulate the tissue banks these laws require them to these acquisitions to the survivors of the deceased and conduct tests to establish whether the tissues are free of infections and diseases and fit for donation. The FDA has submitted detailed rules regulating every aspect of the human tissue industry’s distribution process in an effort to avoid hazardous infected tissues from getting into the market.
Yet, the human body tissue industry is highly unregulated. There more than hundreds of tissue banks across the United States but less than seventy-nine of these tissue banks belong to the American Association of Tissue Banks, an organization that inspects and accredits tissue banks. Additionally, only few states perform licensing and monitoring on these tissue banks. Moreover, the tissue donation system critics inadequate training and oversight tissue bank facilities.
The result of this negligence in the human tissue bank industry is severe: often, donated human tissues are infected with diseases that can pass to the transplant recipient. Tissue transplant infections occur due to some pre – existing disease, contamination due to insanities condition or cross contamination when the donated human tissue is exposed to other contaminated tissue. The unlawful sale of human body tissues puts patient at the risk for the contraction of severe health diseases including hepatitis, HIV and other infectious diseases.
The FDA exposed the severe faults associated with the unregulated human body tissue industry in the United States. The human body tissue scandal uncovered after several lawsuits were filed against Biomedical Tissue Services, a human body tissue manufacturing company. The investigation conducted by the FDA revealed various breaches in health and ethical codes at the firm’s facilities. This firm failed to follow standard practices and insufficiently screened the donors for donation suitability and infectious diseases. Additionally the company has been caught up with the unlawful acquisition of human body tissues from the body of the deceased. The investigation further revealed that the Biomedical Tissue Services kept insufficient record of tissue sales and origin and was found in falsifying death certificates. The FDA named Executive Director of Operations and Michael Mastromarino, D.D.S., CEO for Biomedical Tissue Services, in its order.
If you or any of your family members has been affected with the side effects of infected tissue transplants then immediately contact an experienced medical malpractice attorney. You may recover compensation and financial damages for your lost wages, suffering and pain and medical bills. A medical attorney will assist you in evaluating and properly filing your human body tissues claim.
Human Body Tissues Scandal Disturbs the Medical Community