Manufacturer Expands Recall of Composix Kugel Mesh Patches
Posted by
John GhezziJanuary 18, 2007 3:20 PMDavol/Bard and the FDA notified healthcare professionals of an expanded recall and withdrawal of Bard Composix Kugel Large Oval and Large Circle mesh patches. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.
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).
Davol/Bard expanded the recall action to certain manufacturing lots of the Kugel mesh patches based on having received additional complaint reports of PET recoil ring breakage. With respect to Product Code 0010202, a total of 6 ring breakages were reported and Davol/Bard confirmed four of those reports. One (1) incident occurred during the mesh placement surgery and the product was not implanted. One (1) incident of a broken ring was noted at the time of surgery and the ring was removed but the mesh was left implanted. One (1) incident was reported where a broken ring had migrated into the abdominal wall and was removed, leaving the mesh implanted. One (1) incident was reported where the mesh was explanted as a response to reported abdominal pain and a broken ring was noted. Two (2) inconclusive incidents were reported where bowel perforation and broken rings were noted at the time of explant. No ring breakages were reported with respect to Product Code 0010204, but Davol/Bard recalled this product code as a precautionary measure due to the similarity of the ring joint welding process and the PET ring diameter of product code 0010202.
Davol/Bard also decided to voluntarily recall all remaining Bard Composix Kugel Large Oval and Large Circle mesh patches that have the same component design as the manufacturing lots included in the expanded recall.
If you had hernia repair surgery recently 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.