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Composix Kugel Mesh patches, manufactured by C.R. Bard subsidiary Davol Inc., were designed with a “memory recoil ring” that allowed the patch to be folded, inserted through a small abdominal incision and, once in place, spring open and lie flat over the affected area. Unfortunately, that ring may buckle or break under the stress of placement, causing a number of painful, life-threatening and potentially fatal complications.
Warning signs of hernia mesh failure include fever, abdominal tenderness, nausea, diarrhea, abnormal bowel movements, and abdominal distention.
As of January 2007, the number of recalled Composix Kugel Mesh products exceeded 100,000 units. Of these, the FDA received 34 reports of ring breakage, 21 of which caused serious patient injury and one resulting in death.
Specific lots of the Composix Kugel Mesh patch were initially recalled in December 2005 by manufacturer Davol, Inc. after it was discovered that the memory recoil ring can buckle or break under the stress of placement. The recall notice was expanded multiple times between December 2005 and January 2007, with all recalls classified by the FDA as Class I, the highest level of recall for medical products considered to be dangerous or defective and predictably could cause serious health problems or death.