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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.