AlloDerm is used in the United States across a broad spectrum of reconstructive and cosmetic surgical procedures. Processes involving AlloDerm require the use of soft-tissue grafts and can include breast augmentations, skin reconstruction and dental enhancements. The product has received negative scrutiny by patients complaining of infections, abscess and second or third procedures to fix the problems. Several lawsuits have commenced against the manufacturer of AlloDerm, LifeCell, however the corporation continues to report increasing profits and success with the AlloDerm product.
AlloDerm is used in nearly every part of the human anatomy from dental work to penile implants. AlloDerm is also used to treat hernias and severe burns. AlloDerm can be used in complex surgical procedures requiring the use of extra skin and tissue to close the incision. The AlloDerm product is procured through the harvesting of living skin cells from donated cadavers. Of particular concern is the AlloDerm hernia patch which was recalled in 2005 after patients experienced several forms of adverse side effects.
Side effects associated with AlloDerm products include severe systemic infections, abscesses and repeat surgical procedures to correct issues arising from AlloDerm. The AlloDerm hernia patch, known as the bio-active mesh, is used to treat those suffering from hernia conditions and many have reported that the hernia reappeared after the procedure. Complaints also surfaced of itching, bruising and severe discomfort.
The FDA issued a voluntary recall of the bio-active mesh in 2005 under which the manufacturer quickly recalled three of its products: AlloDerm, Repliform, and GraftJacket. The recall was based upon questionable operating procedures involving the propriety of the procurement of cadaver bodies. Since 2005, the FDA has not issued any further recalls or warnings with respect to any of AlloDerm’s products, however dozens of patients have reported problems with the device.
Ensure you receive adequate information if you are about to undergo a procedure involving any AlloDerm skin grafting. The problems are not widespread at this point but many patients have been forced to undergo painful second and third procedures to correct damage caused by AlloDerm.
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