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Composix Kugel Mesh Patch Frequently Asked Questions

What is a Composix™ Kugel Mesh and why is it used?

The Composix™ Kugel Mesh is used to repair ventral hernias, or hernias of the abdominal region. A hernia occurs when the stomach muscles are too weak to contain the intestines and as a result a rupture occurs in the muscle wall which allows the intestines to protrude. Normally a hernia can be repaired surgically by stitching the stomach muscles back together, but in some cases the stomach muscles are too weak or thin, often due to post-surgery scar tissue, and this method of repair is not a viable option. In these cases the mesh is inserted through a small incision and is placed between the intestines and the stomach muscles to provide support and keep the intestines in the abdominal cavity.

Why has the Composix™ Kugel Mesh been recalled?

The Composix™ Kugel Mesh is inserted into the abdomen through a small incision. In order to fit through the small incision the mesh is folded in half. Once inside the abdomen the mesh re-deploys as a result of a hard memory recoil ring that surrounds the mesh. The Composix® Kugel Mesh was recently recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc after it was discovered that the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. The memory recoil ring can form a sharp, hard knifelike projectile which can slice into and through internal organs.

The Composix™ Kugel Mesh is subject to a Class 1 recall by the FDA. Affected lots were recalled between December 2005 and March 2006. On January 10, 2007, the recall was extended for a third time. The initial recalls of December, 2005 and March 24, 2006 were for extra-large and oval design. The January 10, 2007, recall includes large oval and large circle designs.

What are the dangers associated with the Composix™ Kugel Mesh failure?

As of January 10, 2007, the total number of recalled Kugel Mesh products that were distributed amounted to more than 100,000 units. Of this amount, the FDA received 34 reports of ring breakage, 21 of which caused serious patient injury and one resulted in death. It is unclear just how many of these devices were implanted, but the implants will number in the thousands.

If the Kugel Composix™ Mesh fails as a result of the memory recoil ring breaking inside the abdomen it can cause perforation of the intestines, ring migration through the abdominal wall, fistulae (an abnormal connection or passageway between organs or vessels that normally do not connect), abscesses, bowel obstruction and sepsis. The symptoms one could expect to experience include fever, abdominal tenderness, nausea, diarrhea, abnormal bowel movements and abdominal distention. If a client has any of these sympsymptoms following insertion of the device they should seek immediate medical attention.

What tests can be carried out to determine if the Composix™ Kugel Mesh has failed?

The three main procedures that can be carried out to determine if ones Kugel Mesh has failed are:

1. Lower plate x-ray
2. Barium swallow or enema
3. Reverse Imaging CT scan

Any of these three procedures can be carried out by the surgeon who originally inserted the Composix™ Kugel Mesh. These tests should establish whether the mesh has failed. If the mesh has failed, or if a client suspects the mesh has failed, he or she should seek medical attention immediately.

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