The Bard Composix Kugel Mesh Recall was prompted by the FDA and according to the United States Food and Drug Administration the patch has a reasonable probability to cause serious adverse health consequences, including death.

The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Patch on December 22, 2005 and updated the list again on January 10, 2007.

The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). This problem has prompted the Kugel Mesh Recall.

The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.

The FDA has instructed surgeons and hospitals to immediately stop using the Kugel Mesh Hernia Patch and has recalled products and return the unused patches to the company.

We are now evaluating claims for all patients who have used this patch in compliance with the Kugel Mesh Recall.