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The main priority of the FDA Human Tissue Task Force (HTTF) will be to assess effectiveness of the new human tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery businesses are not following federal requirements for tissue recovery. (Medical News)
A dozen people treated in Wales have body parts stolen from a New York funeral parlor. Two facilities have identified a dozen patients who were treated with bone grafts bought from the U.S. company, Biomedical Tissue Services, which is at the center of a body part stealing scandal. Patients received their stolen body parts from University Hospital in Cardiff and Llandough Hospital in the Vale of Glamorgan. Three more patients from the private Bupa Hospital in Cardiff received bone grafts from Biomedical Tissue Services. Hospital managers took the appropriate steps to reassure patients that the risk of infection was minimal. (IC Network)
Stolen Body Parts Reach the UK
A number of British patients may have received bone grafts from contaminated body parts stolen in the US according to the Medicines and Healthcare Products Regulatory Agency. MHPRA identified 77 pieces of bone that were imported into the UK last year from the New Jersey-based Biomedical Tissue Services.
in 2005, the US Food and Drug Administration ordered a recall of the potentially tainted products and said many patients could have been exposed to HIV and other diseases.
After finding out that the Raleigh company, Donor Referral Services, harvested bone and tissue corpses without properly reporting critera, patients who had spinal surgery implants are upset that they may have received diseased tissue. According to the FDA, the company listed some donors as younger than they were, listed more than one donor who died of cancer as cancer-free, and failed to identify a donor as an intravenous drug user.
Donor bone fragments are frequently used in orthopedic and neurosurgery procedures to stimulate new bone around a repaired joint or vertebrae. Soft tissues taken from cadavers have a wealth of uses. Donor tendons are used to repair torn ligaments, skin grafts are used to repair burns and pressure sores, and cadaver corneas are used for transplants.
This is the second time in the past year that concerns have been raised about the safety of bone and tissue products used in many corrective surgeries.
In the most recent case involving Donor Referral Services, a distributor in July began to recall tissue it had received from the Raleigh company. On Aug. 18, the FDA shut down Donor Referral Services, citing serious deficiencies in its processing, donor screening, and record-keeping. Local hospitals were alerted to the problem. The FDA needs to revisit and tighten their procedures in monitoring bone and tissue collection and processing. (News Observer)
According to Philly.com, the Food and Drug Administration formed a task force to study its regulation of the body part industry.
The FDA task force will look at the effectiveness of rules implemented just last year, prior to the two most recent scandals. In Philadelphia, a funeral home was under investigation for its ties to New Jersey-based Biomedical Tissue Services and a ring of more than 30 funeral homes that allegedly harvested body parts - many were diseased - without the consent of the donors or their families.
In August 2006, the FDA shut down another company -- Donor Referral Services of Raleigh, N.C., saying the company had serious deficiencies in processing, screening, and record-keeping. The FDA said the records for at least five donors did not match their death certificates which leads one to believe that the tissue is not as safe as represented.
If you received a tissue transplant, you should do some research. If you are having problems with that implant, the result could be that you were given bad tissue. Many patients are not aware that they received cadaver tissue and have not been told by the hospital or doctor. Cadaver tissue is used for everything from back surgery to dental implants. Some doctors don't even tell their patients they'll be getting donated human tissue. When asked, some doctors don't know where the tissue came from.
Read morea about Advice to Patients with TIssue Transplants.