Human tissue transplants, also known as allografts, are commonly used during surgery to repair damaged skin, bone, and muscle tissues. While these transplanted tissues are collected from cadaver donors, both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have strict regulations in place for selecting, collecting, and storing tissue donations. In the U.S., the tissue banking industry generates more than 1 billion dollars every year.
Medical Tissue FDA Warning
Despite FDA regulations, some tissue banks illegally collected and distributed unsafe tissues for transplantation. In February 2005, the FDA announced that it was mandating that Biomedical Tissue Services, Ltd. – one such negligent tissue bank “ stop its operations. About eight months later in October 2005, the FDA issued a statement that it was going to investigate how seriously Biomedical Tissue Services (BTS) was in violation of the proper screening and processing of donated transplant tissue. This investigation revealed that contaminated tissue transplants were used in medical facilities across the U.S. since as early as 2004.
Additionally, the FDA investigation found that Biomedical Tissue Services forged donor-consent forms and altered death certificates to make donors appear to be younger or healthier than they were to fit the eligibility requirements.
Biomedical Tissue Services was not the only medical manufacturer violating the FDA’s policies and distributing contaminated transplant tissue. Other companies that have come under scrutiny for possible negligence include, Regeneration Technologies, Inc., the Blood and Tissue Center of Central Texas, Lost Mountain Tissue Bank, and LifeCell Corporation.
Contaminated Tissue Transplant Litigation
Patients who have received contaminated tissue transplants have a high risk of being diagnosed with serious diseases, such as HIV, hepatitis, and syphillis. Some injured patients will require followup surgeries to remove the contaminated tissue, while others will suffer with incurable, deadly diseases that will require lifelong treatment. Those who have been injured by diseased tissue will have a strong cases against the company that supplied the diseased transplant tissue and are encouraged to secure the compensation they deserve by initiating contaminated tissue transplant litigation.
If you or a loved one received bone or tissue from BTS and contracted HIV, AIDS, hepatitis, or syphilis you should contact our contaminated tissue transplant attorneys immediately for a free and confidential case review. You may be entitled to compensation and we can help.