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Ventral Hernia and Kugel® Patch

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A ventral hernia, also called an incisional hernia, is caused by the stretching or thinning of scar tissue formed after surgery. This causes an area of weakness in the abdominal wall through which portions of the intestines or organs can protrude. These hernias appear as a bulge at or near the area of the prior incision. Ventral hernias can be the most difficult to treat and occur in roughly 10% of patients that undergo abdominal surgery.

Risk factors associated with the development of ventral hernias include wound infection, obesity, or stress on the incision due to coughing, vomiting, or heavy lifting. The most telling symptom of a ventral hernia is a bulge in the abdominal area at or near the site of a surgical incision. Ventral hernias can increase in size over time and the only cure for a ventral hernia is surgery. Other symptoms of a ventral hernia include nausea, vomiting, abdominal pain, and the inability to have a bowel movement. A serious situation occurs if the intestines or part of an organ becomes trapped in the hernia. When a portion of the intestine or organ becomes trapped, the blood supply to that portion can be cut off, causing the trapped tissue to die. This may require emergency surgery to repair.

Over 750,000 hernia repair surgeries are done in the US every year. They are mainly done to prevent the hernia from progressing into a serious health risk and to eliminate the pain of a hernia. The surgical procedure includes the insertion of a mesh patch and can be done as an outpatient surgery or may require a short hospital stay. After being inserted through a small incision in the abdomen, the patch is positioned behind the site of the hernia defect. The thin ring that allows the patch to be folded for insertion springs open, holding the patch flat in place.

The most popular hernia repair surgery patch was the Kugel Mesh Hernia Patch manufactured by Davol, Inc., a division of C. R. Bard. The large and extra-large versions of these patches were linked to serious side effects and were recalled by the manufacturer in December of 2005. These versions were recalled because the ring that opens the patch can break during placement in the abdominal area, causing serious, life-threatening injuries. The breakage can cause bowel obstruction, bowel perforation, or chronic intestinal fistulae, which are abnormal pathways and connections between the intestines and other organs.

The US Food and Drug Administration (FDA) issued a warning to the public advising patients who have had the large and extra-large styles of the Kugel Mesh Hernia Patch inserted during surgery to seek emergency medical attention at the first sign of symptoms associated with ring breakage. The symptoms include unexplained or persistent abdominal pain, tenderness at the site of the implant, fever, or any other unusual symptoms. Close to 100 reports of serious adverse events associated with use of the patch has been received by the FDA, including severe injuries and even deaths. The Kugel Mesh Hernia Patch was recalled by the manufacturer and an updated recall list naming more recalled models was issued on January 10, 2007. This recall is classified as a Class I Recall by the FDA, meaning that the recall is for “dangerous or defective products that predictably could cause serious health problems or death.”

Kugel Hernia Patch Lawsuit Update: On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.”

As early as August 2001, Davol began receiving reports of complications and failures of its hernia mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. The reports also contain descriptions of problems other then memory recoil ring breakage including, “buckled mesh,” “patch shriveling” and “edges curled up,” as well as descriptions of the mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated” and “folded.”

 

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