The Bard ® Composix ® Kugel Mesh Patch is used to repair hernias resulting from the formation of scar tissue after surgery.  The patch was designed to facilitate easy hernia surgeries and was approved by the FDA in 1996. The patch itself is comprised of two mesh layers enclosed by a plastic ring called a memory recoil ring. This ring facilitates insertion of the patch into the site of the hernia through a small incision made in the skin. Once inserted, the ring settles into place, encouraging the hernia to heal.

Davol Inc., the manufacturer of the patch, is a specialized medical technology company, delivering products for hernia repair, soft tissue reconstruction and orthopedic and laparoscopic use.

Injuries Related to Kugel Hernia Mesh Patch Use

By 2002, reports of the memory recoil rings breaking off after implantation, exposing the intestines and other organs to a variety of side effects including perforation and obstructions of the bowels and internal fistulae, began to emerge.  Initially, the company ignored such reports claiming the injuries were the result of doctors' failure to follow proper insertion and placement procedures.  But soon, it was revealed that the breakage of the ring always occurred at the same spot.

When connections between the insertion of the mesh patches and these internal injuries became apparent, Davol Inc. issued a recall of its Extra Large patches in 2006.  The following year, the recall notice was expanded to include the Oval, Large Oval and Large Circle Patches.   The reason given for the recall, according to the U.S. Food and Drug Administration, was that the memory recoil rings that aided the placement of these patches were prone to breakage under stress of placement in the intra-abdominal region.  Doctors, as well as hospitals, were advised to stop using the patches immediately, and patients who had been implanted with the patches were asked to look for signs of breakage that included abdominal tenderness, pain and fever.  

Since the recall expansion in March of 2006, the company has received more reports of breakage of the memory recoil ring.  After more deaths and at least 80 injuries were linked to the defective patches, another recall was issued in January 2007.  Since then, it has become evident that Davol Inc. played down reports of the seriousness of injuries associated with the use of its mesh patch, continuing to minimize the importance of these illnesses even after one death had occurred.