Several patients who were injured after using the Composix Kugel mesh patch have filed hernia patch lawsuits against the manufacturer, Davol Inc., and its parent company, C.R. Bard Inc.

These lawsuits allege that the two companies were aware of manufacturing and design problems that existed in the Kugel hernia patch, but failed to inform patients, doctors or health officials of the health risks posed by the Kugel mesh patch.

Since December 2005, Davol has issued three hernia patch recalls after problems were detected in certain models of the Kugel mesh patch.

The company found that the “memory-recoil ring” which surrounds the patch and holds it in place has a tendency to break after it is implanted.

This can lead to severe hernia patch side effects, including bowel obstruction, bowel perforation and chronic enteric fistulas (abnormal connections between the intestines).

An inspection by the Food and Drug Administration revealed that Davol failed to accurately report a number of complaints it received about injuries or deaths related to the Kugel mesh patch.

Soon after the hernia patch was released in 2002, Davol began receiving a disproportionately high number of reports of broken patches from doctors.

However, the company continued selling the hernia patch without informing the FDA of the increase in complaints. It was only after the first hernia patch recall in December 2005 that the design and manufacturing problems associated with the hernia patch became widely known.

In addition to allegations that Davol and Bard were aware of the problems with the Kugel mesh patch, the hernia patch lawsuits which have been filed against the two companies accuse them of negligence, deceptive trade practices, fraud and wrongful death.

Many of these patients believe that if Davol had acted faster to issue the hernia patch recall, they might have been saved from serious hernia patch side effects.

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