The Kugel Mesh Patch is a surgical device used to repair hernias caused by thinning scar tissue that is formed after surgery. The patch is inserted behind the hernia and expands/collapses as needed to protect the wound from re-opening. In 2006, the FDA issued a Class 1 recall on the Kugel Mesh Patch due to reports of bowel perforation after the recoil ring within the product broke, causing abdominal pain, internal bleeding and chronic intestinal fistulae.
The FDA issued a Class 1 recall on the Kugel Mesh Patch due to reports of bowel perforation.
While a useful concept in design, the product was rushed to market and under tested. Patients who have experience problems or symptoms around the patch site are advised to seek medical attention immediately. A Class 1 Recall is the highest health alert the FDA can enact. It means that there is a “reasonable probability that the use of or exposure to a product will cause serious injury or death.”
As Medical Device Defect attorneys we can help
At the Didier Law Firm we have extensive experience in litigating product defect cases involving medical and surgical devices, and stand ready to bring our knowledge and expertise to bear for you. If we can be of assistance to you in evaluating or pursuing a product defect claim relating to use of a Kugel Mesh Patch to repair a hernia please immediately.