An incisional hernia, also called a ventral hernia, is caused by the thinning of scar tissue at the site of a surgical incision. This causes a weakened area in the abdominal wall through which parts of the intestines or organs can protrude. This type of hernia appears as a bulge near or at the prior incision point. Incisional hernias occur in around 10% of patients that have had abdominal surgery and are the hardest to treat.
There are several risk factors linked to the development of incisional hernias, including obesity, wound infection, or stress on the area of the incision due to vomiting, coughing, or heavy lifting. The most common symptom of an incisional hernia is a small bulge on the abdomen near the site of the original incision. Incisional hernias have been known to increase their size over time and the only cure is surgery. Other common symptoms of an incisional hernia include abdominal pain, nausea, vomiting, and the inability to have a bowel movement. A dangerous situation can occur if the intestines or a portion of an organ becomes ensnared in the hernia. When a portion of the intestine or organ becomes trapped, the supply of blood to the area can be greatly reduced, causing the tissue to die. These types of situations require emergency surgery to repair the damaged organs or intestines.
More than 750,000 hernia repair surgeries are done each year in the United States. Most are performed to prevent the hernia from turning into a greater health risk as well as eliminating the discomfort of a hernia. The procedure normally includes the application of a mesh patch at the site of the hernia and is done as either an outpatient procedure or with a short hospital stay required. After insertion in the abdomen, the patch is arranged behind the hernia defect. A thin ring allows the patch to be folded for insertion, and then springs open to hold the device flat in place.
A popular hernia repair surgery device is the Kugel Mesh Hernia Patch, which is manufactured by Davol, Inc., a division of C. R. Bard. An association between the large and extra-large types of the Kugel Mesh Hernia Patch and severe side effects was found, leading to the recall of the patches by the manufacturer in December of 2005. These patches were recalled because the “memory recoil ring” that deploys the device can break during placement in the abdomen, causing severe, life-threatening injuries. The breakages have caused bowel perforations, bowel obstructions, and chronic intestinal fistulae, which are abnormal connections between the intestines and other organs.
The US Food and Drug Administration (FDA) released a warning advising individuals who have the large and extra-large versions of the Kugel Mesh Hernia Patch implanted to seek medical attention immediately at the appearance of the first sign associated with the breakage of the “memory recoil ring”. These signs include fever, unexplained or persistent abdominal pain, tenderness at the site of the implant, or any other unusual symptoms. Nearly 100 reports of serious events associated with use of the Kugel Mesh Hernia Patch have been received by the FDA to date, including severe injuries and deaths. The large and extra-large versions of the patch were recalled by the manufacturer, Davol, Inc. and a revised recall list naming additional recalled models was issued January 10, 2007. The recall is considered 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."