Allograft Implants
The United States Food and Drug Administration has recently discovered that there are some companies dealing in human tissue transplants that have been violating the safety regulations of the regulatory board. It was discovered that because of wanting more profit gains, these companies deviated from the proper way of the screening, handling and acquiring of bone, soft tissue and skin allograft material. These possibly contaminated materials were disseminated for transplants and presented serious risks among patients acquiring medical conditions that could become severe. This negligence resulted in the FDA and the Center for Disease Control focusing their attention on two companies, Cyrolife and Biomedical Tissue Services, which were found to have provided allograft implants that may have been contaminated.
An investigation was conducted by the FDA on Cyrolife after reports from CDC affirmed that an estimated half of the allograft infection cases in the United States were from implants done by the human tissue transplant company. After being cited with multiple violations against federal regulations, the FDA ordered the retention, recall, and destruction of all Cyrolife allografts on August 13, 2002. This FDA order caused the recall of 7,913 allograft implant products that were possibly contaminated.
The Biomedical Tissue Services, on the other hand, was investigated by federal regulators for its participation in distributing stolen tissue and bone allograft materials that were sourced out from cadavers that were not donors. The company, which worked with funeral parlors, was alleged to have doctored death records and taken tissues from bodies without prior consent from the family or the deceased. These allografts, which were never screened for any diseases, were sold to distributors and allograft makers all over the country, which in turn voluntarily recalled all of the tissues and bones that they got from BTS that were resold as allograft materials. This happened after the FDA issued a recall of all tissues sold by the company in the fall of 2005.
The recipients of these contaminated allograft implants are not the only ones at risk for acquiring infections. The handlers of these tissues, as well as the health care workers, could also get diseases after having been in contact with the polluted allografts. These allografts could cause fungal infections, syphilis, bacterial infections, hepatitis and even HIV. These allograft implants are often used in reconstructive surgeries, which call for the use of extra cartilage, skin, bone, connective tissues and tendons for their completion.
The reach of the contamination of these allograft products, though, could not be determined fully by the FDA, causing great concern among recipients and their families. If you or a loved one is among those who are worried about the allograft material that was implanted in your body, then it is best to contact a lawyer after having told your doctor about your concerns. An experienced lawyer will be able to help determine whether or not your allograft implant was among those suspected to have been contaminated by the FDA and the CDC. If you are suffering from an infection that you got after having been a recipient of an allograft implant, then contacting a lawyer is also best because he will help you in getting financial compensation against the parties responsible for your pain. The compensation will not only cover your suffering but also the medical expenses incurred for the diagnostic tests that you underwent to detect any illnesses that may have been caused by the contaminated allograft. The resulting treatment, should an illness be found, will also be reimbursed by the compensation.
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