      Kugel Mesh Patch FAQsWhat is the Kugel® Mesh Patch?The Bard Composix Kugel hernia patch is a self-expanding patch used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is made of a double layer of monofilament polypropylene on one side, and expanded polytetra-fluoroethylene (ePTFE) on the other. The patch also contains a “memory recoil ring”, which was designed to cause the patch to spring open and maintain its shape during placement. How does the Kugel® Mesh Patch work?The patch is placed behind the hernia defect through a small incision. The patch is then held open by the “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. The Monofilament polypropylene was designed to stimulate tissue ingrowth and help reduce the risk of recurrence. The ePTFE barrier was designed to minimize tissue attachment to the prosthesis, while helping to protect against erosion of the mesh into vital organs. Why was the Kugel® Mesh Patch recalled?The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list on March 31, 2006 and again on January 24, 2007. The Kugel Mesh Patch was recalled because the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break in the intra-abdominal space, which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur. The FDA has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company. What tests can be used to determine if the Kugel® Mesh Patch has failed?There are three procedures that can be used to determine if your Kugel Mesh has failed.
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