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Allograft Implant Litigation in Knoxville, Tennessee

In recent years, the FDA has discovered that some of the nation’s most prominent human tissue transplant companies have been defying federal safety regulations for their own profit. The FDA has uncovered evidence of improper handling, screening and acquisition of harvested skin, bone and soft tissue allograft material, which is dispersed for transplantation in patients across the nation. These negligent and reprehensible actions within the billion dollar tissue transplant industry have put many allograft recipients in and around the Knoxville, Tennessee area and the United States at risk for developing serious medical conditions.

FDA Allograft Recall - Cryolife and Biomedical Tissue Services

Two key human tissue transplant companies, Cryolife and Biomedical Tissue Services have come under fire from the Food and Drug Administration (FDA) and the Center for Disease Control (CDC) for supplying potentially contaminated allograft implants to patients all over the country:

Cryolife was investigated by the FDA after CDC reports showed that approximately half of the nation’s allograft infection cases were linked to Cryolife implants. Upon investigation of the Cryolife processing facilities, the FDA cited multiple federal regulation violations, which could have caused allograft contamination. Cryolife never adequately completed the facility revisions required by the FDA and on August 13, 2002 the FDA demanded that Cryolife retain, recall and destroy all of their human tissue products. As a result, 7,913 potentially contaminated allograft implant products were recalled.

Biomedical Tissue Services (BTS) has been under federal investigation for its involvement in the theft and distribution of bone and tissue allograft products from non-donor cadavers. Working in conjunction with funeral parlors, Biomedical Tissue Services allegedly falsified death records and removed tissue from the cadavers with out the consent of the deceased or the deceased’s family. In addition, these illegally acquired allografts were never screened for disease. BTS sold its illegally harvested tissue to allograft makers and distributors nationwide, including Regeneration Technologies, Inc., and Medtronic. After an FDA recall of BTS tissue in the fall of 2005, Regeneration Technologies and Medtronic, along with other companies, voluntarily recalled all of the bone and tissue it received from BTS and resold in the form of allografts. However, none of the tissue processing or allograft distribution companies involved has offered any explanation as to how their internal testing and controls could have allowed such illegal bone and tissue to be sold for transplantation into patients. Finally, in February 2006 the FDA demanded that Biomedical Tissue Services cease production and retain all inventory.

The FDA has stated that there is no way to determine exactly how wide spread the allograft contamination problem has become. If you are concerned that an allograft you received may have been contaminated, contact Gilreath and Associates in Knoxville, Tennessee for an investigation of your allograft implant. Gilreath & Associates has represented plaintiffs against Cryolife allograft recipients and currently represents multiple clients in suits against Biomedical Tissue Services, Regeneration Technologies and Medtronic.

Allograft Related Health Dangers – Who is at Risk?

Not only are the recipients of a potentially contaminated allograft implant at risk for infection, but healthcare workers and tissue handlers who are in contact with the allograft are also faced with the threat of contracting disease. Contaminated allograft implants can carry the following:

HIV and AIDS
Hepatitis
Fungal Infection
Bacterial Infection
Syphilis
Harmful Microorganisms

Allograft implants are often utilized for a wide variety of reconstructive surgeries that require extra bone, skin, cartilage, tendons and connective tissue to complete, such as:

Knee surgery
Back/spine surgery
Burn reconstruction
Vein grafting
Periodontal (gum) surgery
Reconstructive plastic surgery procedures
Brain surgery

Due to the recent contamination concerns regarding bone and soft tissue, the FDA has additionally warned that cross contamination in processing facilities could have affected other human tissue products including replacement corneas and heart valves.

If you have contracted any type of infection or disease after receiving a human tissue allograft, contact Gilreath and Associates in Knoxville, Tennessee for a lawyer who will aggressively pursue financial compensation from those at fault for your pain and suffering.

Allograft Contamination Lawyers in Knoxville, Tennessee - Request a Review of Your Allograft Implant

If you have received a contaminated human tissue allograft during a surgical procedure, our allograft contamination lawyers in Knoxville, Tennessee at Gilreath and Associates can help you. The first step toward determining if you received contaminated human tissue is to undergo diagnostic testing with a physician to detect any medical abnormalities that may be the result of your allograft. If infection is discovered, or if your allograft is defective or unstable as a result of a diseased donor, our experience in handling these cases and network of resources in medical litigation will help you get the answers and, potentially, the financial recovery you deserve.

We invite you to read more about human allograft litigation and controversy in the news.

Disclaimer

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Contaminated human bone, skin, and soft tissue grafts have caused serious infection in allograft recipients nationwide. In Knoxville, Tennessee, the law firm of Gilreath and Associates is helping these victims obtain compensation for their injuries.

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Contaminated human bone, skin, and soft tissue grafts have caused serious infection in allograft recipients nationwide.

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