Failure of Certain Composix Kugel Mesh Patches
Posted by
John GhezziDecember 20, 2006 12:32 PMIf you had hernia repair surgery within the last 2-3 years, you may be at risk for serious physical injury and possibly death. In December 2005 and March 2006, Davol, Inc., one of the primary manufacturers of mesh prosthetics for hernia repair, recalled certain Composix Kugel Mesh Patches used during hernia repair surgery.
The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. The FDA issued a Class 1 Recall of certain lot numbers of the Composix Kugel Mesh Patch because the "memory recoil ring" that opens the Composix® Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). The FDA notice contains all of the product codes and lot numbers affected by the recall.
Davol informed doctors and the public that it had received reports of the following injuries associated with the recalled Kugel Mesh patches: broken ring migrated into or through abdominal wall with associated infection; ring migration into vagina; bowel perforation; bowel obstruction; death from septic shock, consumptive coagulopathy and acute myocardial infarction following surgery to repair small and large bowel fistulas reportedly caused by perforation by the broken ring.
If you had hernia repair surgery within the last 2-3 years and one of the recalled mesh repair patches was implanted in your body, you should have received a recall notice. If you experience unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms, consult your doctor immediately. Our law firm Reich & Binstock is investigating potential legal claims for those persons who may have suffered injury as a result of the recalled Composix Kugel Mesh Patches.