On March 31, 2006, the FDA announced a second recall of Davol, Inc.’s Bard Composix Kugel Mesh Patch.
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 springs open and lays 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. The FDA notice contains all of the product codes and lot numbers affected by the recall.
Reported injuries sustained from the recalled patch include broken rings migrating into or through the abdominal wall causing infection, ring migration into the vagina, bowel perforation, bowel obstruction, death from septic shock, consumptive coagulopathy, and heart attack following surgery to repair small and large bowel fistulas caused by perforation from the broken rings. If you have had hernia repair surgery within the past 2-3 years and are experiencing unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms, please contact 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. If you believe that your health may have been affected by the recalled patch, please fill out the form on the right to caontact a hernia patch attorney. If you are unsure as to the particular type, size, and product id or lot number, please contact your surgeon, get your medical records, and we will help you determine what type of patch you received.