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Open Hernia Repair Surgery and Kugel® Patch

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Close to 750,000 hernia repair surgeries are performed in the United States annually. Traditionally, these surgeries are performed as an open hernia repair surgery, meaning that the abdomen is opened to allow the surgeon access to the site of the hernia. Open hernia repair surgeries are normally done to eliminate the pain of a hernia, prevent the symptoms of a hernia from interfering with daily activities, to prevent the hernia form becoming a greater health risk, and when the hernia restricts blood flow or causes a blocked intestine. An adult having open hernia repair surgery will usually require up to 4 weeks of recovery time before resuming any strenuous activities.

The procedure for open hernia repair surgery is simply explained. Before surgery, the patient receives a sedative to relax them. Local or general anesthesia is administered, so the procedure is completely painless. The surgeon then makes a single, long incision in the groin area. The tissue protruding into the hernia is placed back in its original location and the muscle wall is repaired using a small mesh patch. Placing the patch on the inside of the abdomen utilizes the natural outward pressure of the abdomen to secure the patch in place, making the repair stronger.

Open hernia repair surgery is considered safe. The recurrence of hernias after open hernia repair surgery is low, between 1-7% for an indirect hernia and between 4-10% for a direct hernia. The main risk from the surgery is a reaction to the anesthesia. Other risks include nerve damage, testicular atrophy, damage to femoral artery or vein, and numbness of the skin.

One of the most popular devices for open hernia repair surgery is the Kugel Mesh Hernia Patch manufactured by Davol, Inc., a division of C.R. Bard. The devices have a “memory recoil ring” that allows the patch to fold for insertion into the abdomen, then it springs open to finish the repair. In December of 2005, a connection was found between the biggest versions of the devices and severe injuries, leading to a recall of the patches by the manufacturer. The recall was issued due to the “memory recoil ring” breaking under the stress of placement in the abdomen, causing bowel perforations, bowel obstructions, and chronic intestinal fistulae, which are abnormal passageways between the intestines and other organs.

The US Food and Drug Administration (FDA) has received around 100 reports of severe injuries and deaths associated with the surgical implantation of the large and extra large versions of the Kugel Mesh Hernia Patch. The recall is considered a Class I Recall by the FDA, which is a class limited to “dangerous or defective products that predictably could cause serious health problems or death.” The FDA has also issued a warning advising patients who have had the larger styles of the Kugel Mesh Hernia Patch inserted during surgery to seek medical attention immediately at the first sign of symptoms associated with breakage of the “memory recoil ring”. The symptoms include tenderness at the site of the implant, unexplained or persistent abdominal pain, fever, or any other unusual symptoms.

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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