Bard Kugel Hernia Mesh
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The Bard Composix Kugel Mesh hernia repair patch, manufactured by Davol Inc. (a subsidiary of C.R. Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries.
The device gained FDA approval in 1996, but when the company began introducing larger versions of the patch in 2002, reports of problems with the mesh material and memory recoil ring began to pour in. These problems have led to a number of FDA warnings, alerts, and recall notices as well as hundreds of lawsuits over patient injuries and fatalities. Complications associated with the hernia mesh include bowel perforation and obstruction, severe abdominal pain, infection, and even death.
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History of Kugel Mesh FDA Recalls
Thousands of actions were filed under a multidistrict litigation (MDL) against Bard and Davol for the defective medical device. In 2011, the manufacturers came to a settlement agreement with many plaintiffs for $184 million. Only six cases remain pending as of March 2017.
2005 – The FDA issues a Class 1 recall of the Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE).
2006 – The FDA recall is expanded to include Oval, Large Oval, and Large Circle Kugel mesh hernia patches.
2007 – The hernia patch recall is further updated to include additional product codes and lot numbers recalled by Davol/Bard since the first recall was issued.