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Tenn. patients file Kugel mesh lawsuit
Monday, 07 April 2008
Two Tennessee men have filed a hernia patch lawsuit against Davol Inc., the manufacturer of the Composix Kugel mesh hernia patch. The lawsuit by Hugh French and Michael Earles alleges that their health has become much worse after being implanted with the Kugel mesh patch, and that they may face additional health problems in the future because of the device.

The Kugel hernia patch is a mesh patch surrounded by a plastic ring that is designed to be implanted inside the abdominal wall to repair hernias. Davol was forced to issue several hernia patch recalls after reports emerged that this “memory-recoil ring” could break, leading to serious and potentially fatal health problems. Kugel patients who experience a broken ring may experience bowel obstruction, bowel perforation or abnormal connections between parts of the bowel, known as chronic enteric fistulas.

In their Kugel mesh lawsuit, the two men allege that the problems with the hernia patch were the result of errors manufacturing errors made by Davol, and that, despite learning of problems with the device, it failed to properly notify patients. According to the hernia patch lawsuit, Davol received reports of broken patches soon after the Kugel mesh patch went on the market, but did not inform the Food and Drug Administration of these cases until 20 months later.

Thousands of patients who used the Kugel hernia patch have experienced problems, the lawsuit adds. So far, more than 2100 patients have filed Kugel mesh lawsuits against Davol.