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Hernia Mesh Complications Lead to Lawsuits
Modern surgical techniques for hernia repair involve the use of mesh, which is a sterile, woven material constructed from synthetic fibers or processed human donor tissue. Hernia mesh products have been the subject of numerous recalls and class action lawsuits. Reports began to surface in 2002 regarding problems with the memory recoil ring surrounding the mesh. Ring breakage has been linked to severe injuries, including bowel perforations, bowel obstructions and systemic infections. On December 22, 2005, the United States Food and Drug Administration, known as the FDA, issued a Class 1 recall of the Bard Composix Kugel Mesh patch, reporting that product defects had a probability of causing serious health conditions, including death. The recall was subsequently updated on January 10, 2007.
Davol, Inc., the manufacturer of the Composix Kugel Mesh patch issued a voluntary recall of its mesh patch in December 2005 after serious injuries were reported following ring breakage. A second recall was issued by the company in March 2006, followed by a third recall in January 2007. According to the FDA, Davol began receiving numerous reports of patient injuries and deaths from use of its mesh patches after they were released in 2002, although the first recall was not issued until December 2005, three years later. FDA inspectors discovered inconsistencies in the company's complaint tracking system, resulting in its failure to disclose the severity of reported complications.
AlloDerm Regenerative Tissue Matrix has come under scrutiny due to reports of severe complications resulting from use during hernia repair surgery. AlloDerm, manufactured by LifeCell, is a biological mesh created from harvested donor tissue. The surgically removed donor tissue is chemically processed to remove all cells that could potentially cause rejection of the graft material. Lawsuits against LifeCell have alleged severe injuries to organs, tissue and blood vessels. Intestines have been damaged by problems with the adhesive used during placement of the mesh. Lawsuits allege chronic abdominal pain, disfigurement, hernia recurrence, tissue rejection, infection and death. AlloDerm is alleged to cause internal organ failure due to ring breakage, as in other hernia mesh products. AlloDerm is linked to disease transmission from the graft site due to improper processing of cadaver tissue.
According to recent statistics, approximately 2,000 product liability lawsuits are currently pending against Davol, Inc., the manufacturer of the Kugel patch. Litigation involves allegations that the company, a subsidiary of C.R. Bard, Inc., continued to manufacture and sell defective hernia patches despite recall efforts and information regarding complications. It was announced in July 2011 that C.R. Bard, Inc. has extended settlement offers totaling approximately $184 million as a result of approximately 2,600 lawsuits alleging life-threatening complications from use of its hernia mesh products.
It is important for anyone who has suffered complications following a hernia repair procedure using mesh patches to seek legal counsel immediately. Financial compensation may be available to assist with medical and household expenses, lost wages and loss of future earnings. A competent attorney with expertise in hernia mesh failure will diligently advocate for a rightful and deserved settlement, while also sending an important message to powerful medical companies that sub-standard products will not be tolerated.
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