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Biomedical Tissue Services, a New Jersey tissue bank, tampered with tissue
transplants.
In March 2006, the Food and Drug Administration (FDA) notified healthcare
professionals that the company, Biomedical Tissue Services (BTS) of Ft. Lee, New
Jersey, may not have properly screened donors for infectious diseases for bone,
skin, and tendon tissues which were transplanted in patients requiring implants.
When reality TV becomes too real: Instead of receiving life-saving tissue
transplants, patients received contaminated tissues acquired illegally from
corpses where the deceased victim's families had no idea about the cadaver
theft. What could be more evil?
Where is the dignity for preserving healthy tissue
transplants by not using stolen body parts?
Based on an ongoing investigation, the FDA has been advised of additional
information regarding the reliability of donor blood samples which are an
important consideration for healthcare providers. The FDA strongly recommends
that healthcare providers inform patients who received tissue implants from
Biomedical Tissue Services that they may have an increased risk of communicable
disease transmission and should be tested for infectious diseases by the
hospitals. The FDA believes the risks from these tissues implants are low
because the tissues were routinely processed using methods to help reduce the
risk of infectious disease, however, the actual infectious risk is unknown.
The number of patients who were implanted with Biomedical Tissue Services is
unknown. Biomedical Tissue Services' tissue was distributed by Regeneration
Technologies, LifeCell Corporation, and Tutogen Medical Inc. Medtronic also used
Biomedical Tissue Services tissue.
On January 31, 2006, the FDA issued an Order to Cease Manufacturing and to
Retain Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) to
Biomedical Tissue Services. The order was issued after the FDA uncovered serious
violations of the frequently unregulated regulations governing donor screening
and record keeping practices.
Despite records maintaining otherwise, Biomedical Tissue Services had
inadequately screened donors for risk factors for communicable diseases.
Additionally, the FDA found many instances where death certificates maintained
by Biomedical Tissue Services and through research conducted by the FDA varied.
Besides being grisly and distasteful, some of the stolen body parts came from
elderly people and possibly even victims of infectious or terminal diseases. The
paperwork was doctored to say that the donors were younger and in good health.
Important information such as cause, place of death, time of death, and the
identity of the next of kin conflicted. Therefore, the donor screening performed
cannot be relied on to exclude donors with risk factors for or clinical evidence
of infectious diseases.
FDA regulations require that, before tissues are released for distribution,
blood samples from each donor be provided to the testing laboratory for donor
testing. Each sample must be clearly linked to an individual donor, and each
tissue clearly linked to that donor. In some instances, blood samples did not
come from the same donor as the linked tissues. Therefore, the results of
communicable disease tests obtained from the blood sample may not correctly
reflect the status of the donor.
Have you or a loved one received a bone, tendon, skin,
or tissue transplant? Contact us for a free NO-OBLIGATION
confidential consultation. Are you eligible for a tissue transplant lawsuit?
