The Bard® Composix® Kugel"Mesh Patch is used to repair ventral (incisional) hernias. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery.

A hernia occurs when part of an internal organ pushes through an opening in the organ's wall and often presents itself as a painful lump in the abdomen or groin.

The FDA issued the following Kugel Hernia Patch safety alert on 2/1/07: "Recall classified as Class I because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death."

Incisional hernias occur specifically when a previous operation leaves an abdominal hole through which tissue and organs protrude. Hernias are usually repaired by a simple operation in which a surgeon stitches the stomach muscles back together, but this is not always possible because the stomach muscles are often too weak or thin for the surgery, in which case a Bard Composix Kugel Mesh Patch may be used.

The Bard Composix Kugel Mesh Patch is inserted into the body through a small incision made by the doctor and placed behind the hernia. The  memory recoil ring opens the patch after it has been inserted into the body. The patch then lays flat against the inner body cavity, preventing the hernia from pushing through the weakened tissue wall.

The Composix Kugel Mesh Patch can break, however, leading to bowel perforations and chronic intestinal fistulae. These are very serious conditions that pose a pronounced health risk to affected patients.

Symptoms may include severe pain, nausea, vomiting, or a large bulge at the site of the previous surgery.

The patch is manufactured by Davol, Inc., a division of C.R. Bard, and is under a Class I recall by the Food and Drug Administration (FDA).

FDA Class I Hernia Patch Recall
The FDA issued a Class I recall for the Composix Kugel Mesh Patchthe strongest recall available to the FDAreserved for dangerous or defective products that predictably could cause serious health problems or death. The Class I recall was issued on December 22, 2005, and then updated on March 31, 2006, to include additional lots of defective patches.

The FDA says surgeons and hospitals should immediately stop using the recalled products and return the unused patches to the company.

Patients who have been implanted with one of the recalled devices should seek immediate medical attention if they experience:

• Persistent or unexplained abdominal pain
• Fever
• Tenderness at implant site
• Any other unusual symptoms

Free Consultation
If you or someone you care about had a hernia surgery where a Bard Composix Kugel Mesh Patch was used and suffered from abdominal pain, fever, tenderness at the incision site, or painful lumps or bulges where surgery occurred, contact your doctor immediately. You may be entitled to compensation, even if you have an implanted device on the recall list but have not experienced any symptoms. Contact our law firm today for a free and confidential case evaluation. We have intake specialists standing by to take your call.

The list below includes all recalled product codes and lot numbers: