Hernia Patch Side Effects
Since December 2005, the FDA and Davol, Inc. have issued three hernia patch recalls for the Composix Kugel mesh patch.
Studies by Davol have indicated that the “memory-recoil ring” which surrounds the mesh patch can break in larger models. These broken patches can lead to a number of serious medical conditions, including bowel perforation, bowel obstruction and chronic enteric fistulas.
Bowel perforations
A perforated bowel occurs when an opening forms in the wall of the intestine, allowing its contents to spill into the abdominal cavity. Bowel perforations can be caused by injury, illness or bowel obstruction.
Early symptoms of a perforated bowel include high fever, nausea, abdominal pain and vomiting. If left untreated, a bowel perforation can lead to sepsis, a blood infection that is almost always fatal.
So far, at least seven patients have suffered a bowel perforation after receiving the Kugel mesh hernia patch.
Chronic enteric fistulas (intestinal fistulas)
Chronic enteric fistulas are abnormal connections that form between two portions of the intestine. This condition can cause severe abdominal pain.
When one opening of a fistula closes while the other remains open, bowel contents can accumulate in this cavity, allowing an abscess or infection to develop which, in some cases, can spread to the bloodstream.
Several patients have experienced chronic enteric fistulas after receiving the Kugel mesh patch, including one patient who died of septic shock and heart attack after surgery to repair intestinal fistulas.
Bowel obstructions
Bowel obstructions are partial or complete blockages in the intestines which prevent the intestinal contents from passing through normally. These blockages can be caused by several conditions, including hernias, scar tissue, medication, tumors, twists in the intestines, gallstones or foreign objects such as the Kugel mesh hernia patch.
Patients with a bowel obstruction may experience abdominal pain, constipation, vomiting, diarrhea or bloating. If a bowel obstruction is not treated, it can lead to infection, gangrene or bowel perforation.