http://www.yourlawyer.com/topics/overview/texas_blood_tissue_center_scandal Sat, 21 Nov 2009 19:40:14 -0800 pixel-app en http://www.yourlawyer.com/articles/read/11777 Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11777
While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

• LifeCell Corporation of Branchburg, NJ
• Lost Mountain Tissue Bank of Kennesaw, GA
• Blood and Tissue Center of Central Texas in Austin, TX
• Tutogen Medical, Inc., of Alachua, FL
• Regeneration Technologies, Inc., of Alachua, FL

These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.]]> http://www.yourlawyer.com/topics/overview/texas_blood_tissue_center_scandal Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/texas_blood_tissue_center_scandal The Blood and Tissue Center of Central Texas Scandal Health officials in numerous states as well as the Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) are tremendously worried about the gruesome tale of stolen body parts, missing persons, contaminated human tissue grafts, and the possibility that thousands of innocent patients are currently in danger of developing everything from HIV/AIDS and syphilis to hepatitis B and C.

On October 11, 2005 The Blood and Tissue Center of Central Texas issued a voluntary recall of all materials that were manufactured from BioMedical Tissue Services (BTS) donor tissue. Blood and tissue centers are accountable for the collection and distribution of blood, bone, tendons, skin, and heart valves for the purpose of improving the quality of life for transplant recipients by preventing amputation, restoring mobility, relieving pain and saving lives.

The untested body parts and tissue scandal centers around Biomedical Tissue Services (BTS), which allegedly acquired body parts without donor permission and sold them for use in transplants performed at hospitals and other medical facilities throughout the United States. The owner and three other employees of Biomedical Tissue Services (BTS) have been indicted in Brooklyn, New York for taking body parts without legal consent and without proper screening. It is believed that funeral home operators accepted money from Biomedical Tissue Services (BTS) in exchange for ignoring obviously forged death certificates and consent forms. The body parts and tissue in question have been distributed throughout the country and used in thousands of operations.

Biomedical Tissue Services (BTS) sold these illegal body parts to several large companies including Lifecell Corp., Regeneration Technologies, Inc., Tutogen Medical, Inc., and Lost Mountain Tissue Bank. The FDA and most of the companies involved have not disclosed the number of patients that received the untested parts and tissue.

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