Kugel Mesh Hernia Patch Still Has Potential to Injure Many PatientsJul 18, 2007 | Parker Waichman LLP
The Kugel Mesh Hernia Patch, which has been the subject of several Food & Drug Administration (FDA) recalls, has not been removed from all the patients who received it. Patients with the device who have not experienced symptoms of patch failure still need to be aware of the problems that can occur with the Kugel Mesh patch. If a Kugel Mesh patient experiences any of those symptoms, they must seek medical attention immediately.
Hernias are an extremely painful condition where one part of the body bulges between the muscles surrounding it (for instance, the stomach could bulge through a fissure in the abdominal muscles). The extreme pain and discomfort caused from a hernia can greatly reduce a patient’s quality of life. Surgery is the only way to permanently repair a hernia. A patch, like the Kugel Mesh Patch is supposed to close the fissure and prevent the bulge.
The FDA first began receiving reports of failures with the Bard Composix Kugel Mesh X-Large Patch in 2005. Once the device was implanted, the wire recoil ring that opened the patch was prone to breaking. When this happened, patients often experienced serious problems like bowel perforations. At that time, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. In April 2006, the Class I recall was expanded to the “mid-line” size of the patch. The recall was expanded for a third time in February of 2007 to include the large size patch.
Not long after expanding the recall of the Bard Composix Kugel Mesh Patch, the FDA issued a warning letter to Davol Inc., the patch’s manufacturer, citing serious regulatory problems with quality assurance systems used in the manufacture of the Kugel patches. The letter, which was dated April 24, 2007, came after the FDA conducted an inspection of the company’s Cranston, Rhode Island headquarters.
Many patients had to have their Kugel patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Understandably, patients who have not had problems were told to take a “wait and see” approach towards their patches. Some patients may not even be aware that their hernia surgery involved the use of a Kugel Patch. Patients in this situation should contact their doctors to find out if they have one of the recalled patches. All Kugel Patch patients should know that the ring can break at any time, and should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences.