The Kugel Mesh Hernia Patch: A Disturbing HistoryJul 30, 2007 | Parker Waichman LLP Since 2005, Kugel Mesh Hernia Patches have been recalled three separate times by the Food and Drug Administration (FDA) due to a malfunction with the memory recoil ring that often caused patients to suffer serious injury.
Before the Kugel Mesh Hernia Patch was introduced to us, hernias were fixed through a process known as “tension repair.” The tension repair process caused problems in patients when the muscle tissue would tear open again after the procedure was finished. Dr. Robert D. Kugel created the Kugel Mesh Patch to help out with the recovery process after surgeries and cut back on reappearing hernias. Today, more than 700,000 surgeries are performed each year in the U.S. to repair hernias, which can develop in the groin, near the navel or anywhere a surgical incision is at.
The Kugel Mesh Patch was supposed to let surgeons make a tension-free repair by placing a folded patch behind the hernia with a small incision. The memory recoil ring would act like a spring and open the patch to its full size where the patch would lay flat behind the incision. Unfortunately, the memory recoil ring could break inside a patient causing bowel perforation, bowel obstruction, serious infections or intestinal fistulae (which are abnormal connections or passageways between the intestines and other organs.) Symptoms of a broken memory recoil ring include fever, persistent or unexplained abdominal pain, or tenderness at the site where the implant is located.
The FDA recalled the Bard Composix Kugel Extra Large Oval Patches for the first time in December 2005. Shortly after, in March 2006, the Bard Composix Kugel Oval Patches were recalled and a warning letter was also sent out to hospital administrators to let them know about the defect of the device. Most recently, in January 2007 the Bard Composix Kugel Large Oval and Large Circle patches were recalled.
The maker of the Kugel Mesh Patch, Davol Inc., received a letter from the FDA in 2006 regarding problems with the manufacturing process of the patches. The letter informed Davol that those problems had to be investigated and fixed or regulatory actions could be taken. The FDA has received nearly 100 reports of problems related to the Kugel Mesh Patch. Several of those reports have included fatalities.