Allograft Implants
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The United States Food and Drug Administration (FDA) has recently discovered that there are companies dealing with human tissue transplants that have been violating the safety regulations of the regulatory board. It was discovered that, with desire for more profitable gains, these companies deviated from the proper and accepted ways of screening, handling, and acquiring bone, soft tissue, and skin allograft materials. These possibly contaminated materials were disseminated for transplants, presenting serious risks for patients whom had acquired serious medical conditions. As a result of this negligence, the FDA and the Center for Disease Control (CDC) focused their attention on two companies, Cyrolife and Biomedical Tissue Services, both found to have distributed contaminated products and devices in patients.
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 resulted from implants conducted by the human tissue transplant company. After being cited with multiple violations, 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.
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 taken from cadavers not issued as 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 people 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 them. These allografts could cause fungal infections, syphilis, bacterial infections, hepatitis, and even HIV. These 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 degree of 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 are 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 expressed your concerns with a doctor. An experienced lawyer can 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 may help you get financial compensation from the parties responsible for your pain. The compensation will not only cover your suffering, but also the medical expenses incurred for diagnostic testing, medications, and other hospital fees. The necessary treatments, should an illness be found, may also be reimbursed. More importantly, you can seek justice for medial malpractice and negligence. The distress you suffered, whether or not you were inflicted with an illness, should be reconciled. If you are a family member of an individual who had not consented to be a donor, you can also file legal claims and seek justice. It is trying enough to have to lose a loved one, but you should never have to worry about whether or not foul play has occurred. A qualified attorney can speak on your behalf.
Tags: product malfunction, product liability, product liability lawyer, product liability attorney, device malfunction, device malfunction lawyer, device malfunction attorney, allograft skin implant, skin implant laws
