Kugel Mesh Hernia Patch Under probe for infections. An Arkansas man is suing the makers of the Kugel Mesh Hernia Patch, alleging that a hernia patch made by Davol and its parent company Bard caused a massive infection that forced him to undergo surgery to have the patch replaced. Though the complaint does not say if the hernia patch responsible for his injuries was one of the recalled Davol patches, Marion Teague’s story is consistent with others who have been harmed by the faulty Kugel Mesh Hernia Patch.
The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. Apparently, the recoil that opened the patch could break.
When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the Food & Drug Administration (FDA) issued a Class I recall, its most serious type of recall, of the Bard Composix Kugel Mesh X-Large Patch.
Doctors where warned to stop using that version of the Kugel Mesh Hernia Patch, and patients who received the patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.
FDA issued Davol a warning letter that cited serious problems
Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter that cited serious problems at Davol’s Cranston headquarters. The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions.
What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.
Marion Teague’s lawsuit, which was filed in the Texarkana Division of the Eastern District of Texas, claims that after having several surgeries to repair hernias, he began to experience abdominal pain and inflammation. Teague claims the Davol-made mesh patch used to repair the hernias had become infected, requiring additional surgery to remove the patch.
Teague alleges his injuries are caused by the defective design, manufacture and marketing of the Davol hernia patches. The claims the makers of the patch were negligent for designing an unreasonably dangerous product, failing to reduce patch malfunction in the product design, failing to provide adequate warnings or instructions and failing to monitor its manufacturing process to prevent the defective patch from reaching consumers.
Teague is seeking more than $75,000 in damages for past and future physical pain
Teague is seeking more than $75,000 in damages for past and future physical pain, mental anguish, disfigurement, physical impairment, medical expenses, lost wages, lost earning capacity, and loss of household services.