Kugel Hernia Mesh

The Bard Composix Kugel Mesh Patch is a medical product used to help repair incisional hernias, which are a type of hernia that can occur after surgery. Either scar tissue or an incompletely healed surgical wound can leave an organ's tissue weak, allowing the inside of the organ to protrude into the abdominal cavity.

For hernias not caused by surgery, fixing them is as simple as re-adjusting the organ and stitching the tissue back together. But because incisional hernias involve tissue that is sensitive from the recent surgery, that tissue cannot be used, and repair is more difficult.

The Bard Composix Kugel Mesh Patch allowed doctors to repair a hernia without stretching the surrounding tissue. The patch, inserted through a small incision, is placed behind the hernia and then opens to lay flat against the hole, keeping the organs from spilling through.

However, according to the FDA, the Composix Kugel Mesh Patch "has a reasonable probability to cause serious adverse health consequences, including death." The defect is that the patch is prone to breaking, which can cause the inner organ to once again protrude, which can cause bowel perforations and chronic intestinal fistula, and other complications which, noted by the FDA, can lead to death.

The FDA recalled thousands of Composix Kugel Mesh Patches in December of 2005, and issued a second recall for additional lots in March of 2006. All told, over 75,000 patches were recalled. Doctors and hospitals were ordered to cease using the patches immediately, and patients having already received them have been put on alert for abdominal pain, fever, tenderness at the site of implant, and other seemingly unusual symptoms.

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