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A lawsuit has been filed in Rhode Island against the makers of the Composix Kugel Mesh Patch claiming the patch failed after it was implanted, causing severe pain to a hernia patient. The patient required bowel dissection surgery to remove the patch.
The plaintiff had the Kugel Mesh Patch implanted in 2004. His patch was not included in the initial patch recall of December 22, 2005, but was later included in the updated recall announced March 31, 2006.
Lawyers argue that the plaintiff suffered from abdominal tenderness and developed a second hernia after his Kugel Mesh Patch was inserted. It was during the surgery to repair the second hernia that doctors discovered the patch was stuck to the patient's bowel. This required a bowel dissection to remove the patch from his bowel, resulting in chronically inflamed bowels.
Mesh Patch lawyers for the plaintiff argue that Davol, Inc. (maker of the Mesh Patch), knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.
The patch is inserted through a small incision and is placed behind the hernia. A memory recoil ring is used to keep the mesh patch closed until after it has been inserted in the body. The purpose of the mesh patch is to prevent the hernia from pushing through weakened tissue walls, specifically when stomach muscles are too weak for surgery to repair the hernia.
The hernia surgery failure problem is that the memory recoil ring can break under the stress of placement in the body, resulting in bowel perforations and chronic intestinal fistulae.