The history of the Bard Davol Composix Kugel Mesh Hernia Patch begins in 2000. Its purpose is to repair ventral hernias in cases when the stomach muscles cannot withstand the necessary stitching which is needed for the surgery. What happens is that the mesh is inserted and placed between the intestines and the stomach lining in order to retain the intestines in their original position. Unfortunately, by 2005, there were a great number of reports to the FDA concerning the breaking of the recoil ring, which is the key mesh's component. The procedure is that the patch is inserted into the abdomen through a small incision and because of the small incision the mesh is folded in half. Once inside, the mesh redeploys as a result of a 'memory recoil ring' contained with the mesh. Unfortunately, the memory recoil ring breaks under the stress of the surgery and can form a sharp edge, which cuts into and through the surrounding organs. When the ring breaks, patients experience bowel perforations and other intestinal and migration-related injuries. As a result, the first recall was issued by the FDA in December 2005 for the large oval patch.
The basic problem with the Kugel Mesh Hernia Patch is that it has tended to cause intestinal perforations, and consequently possible ischemic bowel, and serious injury and death from septic shock.
The Kugel Hernia Patch, manufactured by Davol Inc., a subsidiary of. C.R. Bard, was first recalled by the FDA on December 22, 2005 (Class I recall on certain models).
The Kugel Hernia 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 patented “memory coil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The reason for the recall is that the memory coil ring can break, possibly releasing the mesh. This can lead to abdominal pain, abdominal wall infection, bowel obstruction, bowel perforations and/or chronic enteric fistulas (abnormal connections or passageways between the intestines and other organs).
But there is a help. Nadrich and Cohen are currently representing Kugel Mesh Hernia Patch victims from coast to coast. Our national Kugel Mesh Hernia Patch litigation team has the experience, resources, success and expertise to successfully represent all hernia mesh patch side effect recall victims.
Please contact a Kugel Patch lawyer at the Nadrich and Cohen team as soon as possible. For your convenience, you can complete the internet inquiry here.