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Davol, Incorporated, a subsidiary of C.R. Bard, Inc., issued their first recall for their Composix Kugel® Mesh Patch on December 22, 2005. This recall and the subsequent recalls followed alarming reports that the hernia patch’s “memory recoil ring” can break under stress.
The Kugel® Mesh Patch is used to repair ventral hernias. It is usually placed, through a small incision, behind the hernia defect. The “memory recall ring” is used to open the Kugel® Mesh Patch after it has been inserted. The ring allows the patch to be folded for insertion and later, once the patch is in place, to spring open and lay flat.
A Defective Kugel® Mesh Patch Can Lead to Serious Injury and Even Death!
According to the U.S. Food and Drug Administration, the rupture of the recoil spring can lead to “bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs.)”
Patients who have been implanted with the recalled Kugel® Mesh Patch are urged to seek immediate medical attention. The symptoms associated with ring breakage are: Unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
The FDA has received reported incidents of broken memory recall rings, one of which states that the “broken ring had migrated into the abdominal wall.”
The following table lists all recalled Kugel® Mesh Patch product codes and lot numbers.