Davol/Bard Kugel Hernia Mesh Patch

On December 22, 2005 the FDA issued an immediate recall of Bard Composix Kugel Mesh Hernia Repair Patches and updated the list on March 31, 2006 and again on January 24, 2007. The Kugel Mesh Patch, used to repair ventral (incisional) hernias, was recalled because the "memory recoil ring" that opens the Mesh Patch can break in the intra-abdominal (inside the belly area) space, which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). This can also lead to serious infection due to migration of a broken memory coil ring, which can require additional surgeries to repair a perforation caused by a broken ring, or even death.

The Davol Bard Composix Kugel Mesh patch can cause serious complications in hernia patients. Specifically the device is used to repair hernias which have developed due to thinned or weakened scar tissue following surgery. The patch is folded and inserted behind the hernia defect through a small incision, After placement its patented memory recoil ring allows the patch to automatically spring open, much like an automatic umbrella, and to lay flat against the implicated tissue. Unfortunately, experience has shown that the patch, once properly inserted in the intra-abdominal space can break, subjecting the patient to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

For patients who have who have been implanted with a Kugel Mesh Patch during hernia surgery, the FDA recommends seeking medical attention immediately if they "experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms."

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