First introduced into the U.S. market in 2000 by Davol, inc., the Composix Kugel Mesh Hernia Patch is designed to repair ventral hernias that cannot be repaired through traditional surgery. The patch is inserted into the abdomen through a small incision, where it unfolds and deploys via a ‘memory recoil ring’ that is embedded in the mesh.
Soon after being introduced, however, the Food & Drug Administration (FDA) began to receive a high number of reports about problems with the patch’s recoil ring, which had been found to break easily. Recoil ring breakage can lead to bowel perforations and other extremely serious injuries. These findings led the FDA in December 2005 to issue a recall of the Bard Composix Kugel Mesh X-Large Patch. Doctors were instructed to stop using the patch, and patients were told to seek immediate medical attention if they experienced any telltale side effects of a defective patch. By 2007, the recall had been expanded by the FDA to include several other sizes of the device.