The Composix Kugel mesh patch has been the subject of three recalls by its maker, Davol, and the Food and Drug Administration since December 2005.

Davol has conducted studies indicating that the “memory-recoil ring” which surrounds the mesh patch in larger models has a tendency to break. When this happens, a number of serious medical conditions result, including bowel obstruction, bowel perforation and chronic enteric fistulas.

Bowel obstructions

A bowel obstruction is a partial or complete blockage in the intestines. This does not allow the intestinal contents to pass through normally. Blockages of this kind can be caused by several conditions, including hernias, medication, scar tissue, tumors, twisted intestines, gallstones or foreign objects such as the Kugel mesh hernia patch.

Patients suffering bowel obstruction may have abdominal pain, constipation, bloating, vomiting or diarrhea. If it is not treated, a bowel obstruction can lead to infection, gangrene or bowel perforation.

Bowel perforations

When an opening forms in the intestinal wall, its contents may flow into the abdominal cavity. This condition is known as a bowel perforation. Injury, illness and bowel obstruction have been known to cause bowel perforations.

Some of the early symptoms of bowel perforations include high fever, abdominal pain, nausea and vomiting. If left untreated, a bowel perforation can lead to sepsis, an potentially fatal blood infection.

So far, at least seven Kugel mesh hernia patch patients have suffered a bowel perforation. Eleven Kugel mesh hernia patch patients have experienced breakage of the memory-recoil ring, which then migrated through the abdominal wall.

Chronic enteric fistulas

A chronic enteric fistula is an abnormal connection that forms between two parts of the intestine. Some patients with enteric fistulas may have few serious symptoms, but in others this condition can cause major abdominal pain.

Sometimes, one fistula opening closes while the other remains open. This results in an accumulation of bowel contents in this cavity. An abscess or infection may develop which, in some cases, can spread to the bloodstream.

Several Kugel mesh patch patients have suffered chronic enteric fistulas after receiving the patch. One of them died of septic shock and heart attack after an operation to repair the intestinal fistulas.

Call toll-free: (866) 275-4454