Kugel hernia patch recall could have occurred earlier
An article in today’s New York Times suggests that the recent Kugel hernia patch recall could have occurred sooner. If the maker of the hernia repair mesh had taken quicker actions to notify physicians of problems with the patch and remove it from the market, it is possible serious injuries could have been avoided for many who had the mesh implanted. Saiontz, Kirk & Miles, P.A. is reviewing potential hernia patch recall lawsuits nationwide.
>>INFORMATION: Kugel Hernia Mesh Problems
In 2002 Davol, Inc., a subsidiary of C.R. Bard, Inc., introduced larger versions of their Composix Kugel hernia repair mesh which are designed so that they can be folded during placement and then spring open once in place to lay flat under the hernia. It was not long after they were introduced that the makers began to receive reports of an unusually high number of reports that the plastic memory recoil ring in the larger hernia patches was breaking, which could cause injury to internal organs and tissue.
As a result of the manufacturers failure to properly assess the hernia patch problems, they continued to manufacture the mesh and distributed it for placement inside of patients. In December 2005, the largest of these devices, known as the Kugel Extra-Large Oval, were recalled. However, they did not recall other potentially defective large patches.
The New York Times reports that after the initial hernia patch recall, the FDA inspected Davol and found there were inconsistencies and discrepancies in how Davol monitored hernia mesh problems and reported injuries. According to inspection reports, Davol did not accurately report the number of problems as well as the extent of the problems with the hernia mesh. This has led to two subsequent recalls of the Composix Kugel Large Oval and Large Circle.
>>INFORMATION: List of Recalled Composix Kugel Hernia Patch Products
The defective hernia repair patches are used to repair ventrical hernias which may develop at the site of prior surgical incisions in the abdomen. The patch problems could result in failure of the memory recoil ring, leading to possible bowel perforation, intestinal fistula or death.
KUGEL HERNIA PATCH RECALL LAWSUITS
The Kugel hernia patch problems are so severe that the FDA classified the recall as Class I in January 2007, since the defect has a reasonable probability of causing serious adverse health consequences, including death. Individuals who have had a hernia repair surgery and suffer severe abdominal pain, high fever, tenderness at the site of the hernia repair or other unusual and unexplained symptoms, should consult with their doctors immediately.
The Kugal hernia patch recall lawyers at Saiontz, Kirk & Miles, P.A. provide free consultations to help determine if you may be eligible for compensation. Request a free claim evaluation.
