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Problems with a Bard Composix Kugel hernia patch caused a Texas man to suffer devastating complications about ten years after it was implanted, resulting in emergency surgery that discovered the hernia mesh failed.
The complaint (PDF) filed by Michael Loughridge in the U.S. District Court for the Eastern District of Texas on July 24, alleging that that the manufacturers knew about problems with a memory recoil ring used the design of the hernia mesh for years before it was implanted in his body.
Loughridge indicates that a Bard Composix Kugel Hernia Patch was used during a ventral hernia repair in October 2007. However, he had to undergo revision surgery to have the mesh removed in July 2016, during which his surgeon discovered that the patch had failed due to contracting, buckling and breaking at the PET ring.
The lawsuit indicates the manufacturers covered up known problems with the Composix Kugel mesh for years, intentionally concealing information from consumers and the medical community.
“No later than September 2004, Defendants uncovered serious problems with the weld process involving the memory recoil ring. Despite attempts to correct the problem at the plant, Defendants found the corrective measures to be ineffective and the process still not in control,” Loughridge’s lawsuit states. “Defendants were aware these weld issues had existed from the time the CK Patches were originally placed on the market and all current lots suffered from this dangerous defect.”
Loughridge presents claims of negligence, gross negligence, failure to warn, defective design, defective manufacturing and breach of implied warranty, seeking compensatory and punitive damages.
In recent years, Bard and Davol have faced thousands of Composix Kugel hernia mesh lawsuits over problems with Composix Kugel products, most involving allegations that the memory recoil ring around the perimeter of the mesh broke, resulting in serious internal injuries.
In 2011, C.R. Bard agreed to Kugel mesh settlements that resulted about 2,600 cases, paying about $70,000 to each plaintiff. However, the agreement left hundreds of claims unsettled, and individuals with the recalled hernia mesh implanted in their body continue to experience problems when the hernia mesh fails.