Inguinal Hernia and Kugel® Patch

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An inguinal hernia occurs when tissue protrudes through a weak area in the lower abdominal wall. The resulting bulge can be painful, especially when bending over, lifting a heavy object, or coughing. In many cases, the weakness in the abdominal wall is present at birth, resulting when the abdominal lining doesn’t close properly within the first few weeks of life. In other cases, the inguinal hernia develops as a result of weakened muscles due to age, chronic coughing, or strenuous physical activity.

Even though inguinal hernias are not considered dangerous themselves, they have been known to lead to life-threatening complications. It is highly likely that surgical repair of the hernia will be recommended to reduce the pain associated with the hernia and to prevent the hernia from becoming larger. Men are more than 10 times more likely to develop an inguinal hernia than women, but no one is immune. Inguinal hernias have also been found in pregnant women, infants, and the elderly.

Aside from being male, there are many risk factors associated with the development of an inguinal hernia. One common risk factor is the presence of a chronic cough, such as associated with smoking, emphysema, or chronic lung diseases. Another is chronic constipation, as it causes stress on the abdomen by straining during bowel movements. Being moderately to severely overweigh can put a large amount of pressure on the abdomen, as well as having a job requiring long hours standing or lifting heavy items. The symptoms of an inguinal hernia include a bulge created by the protruding intestines, pain or discomfort in the groin area, pain and swelling in the scrotum around the testicles, or a heavy, dragging sensation in the groin area. Some inguinal hernias are asymptomatic and remain undetected until a routine medical examination discovers it.

Close to 750,000 hernia repair surgeries are performed every year in the United States. The procedure routinely includes the insertion of a mesh patch in the area experiencing the hernia and can be completed as either an outpatient procedure or with a short stay in the hospital required. The patch is inserted in the abdomen and place behind the site of the hernia defect. A thin ring, called a “memory recoil ring”, allows the patch to be folded for insertion and then releases to open and hold the device flat in place.

A popular device for hernia repair surgery is the Kugel Mesh Hernia Patch, manufactured by Davol, Inc., a division of C. R. Bard. A link between serious side effects and the larger types of the Kugel Mesh Hernia Patch was discovered, leading to the devices being recalled by the manufacturer in December of 2005. The patches were recalled because the “memory recoil ring” that positions the device can rupture during placement in the abdomen, causing life-threatening injuries. The ring breakage has caused bowel obstructions, bowel perforations, and chronic intestinal fistulae, which are abnormal passageways between the intestines and other organs.

The US Food and Drug Administration (FDA) has released an alert advising individuals implanted with the large and extra-large versions of the Kugel Mesh Hernia Patch to request emergency medical attention immediately after the appearance of a single sign associated with the rupture of the “memory recoil ring”. These signs include tenderness at the site of the implant, fever, unexplained or persistent abdominal pain, or any other unusual symptoms. Around 100 reports of serious injuries and deaths associated with use of the Kugel Mesh Hernia Patch have been received by the FDA to date. Large and extra-large patches have been recalled by the manufacturer, Davol, Inc. and a revised recall listing naming additional versions was issued on January 10, 2007. The recall of the Kugel Mesh Hernia Patch is considered a Class I Recall by the FDA, meaning 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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