The Kugel mesh patch was recalled because there is a tendency for the memory-recoil ring to break, causing bowel perforations and chronic intestinal fistulas—abnormal connections between the intestines and other organs. The company has suggested that improper surgical placement techniques may put too much stress on the ring, causing it to fracture.

The recall pertains to the following varieties of the Kugel mesh patch, manufactured prior to January 2004:

     • Composix Kugel Extra Large Oval (7.7" × 9.7")
     • Composix Kugel Extra Large Oval (8.7" × 10.7")
     • Composix Kugel Extra Large Oval (10.8" × 13.7")
     • Composix Kugel Oval (6.3" × 12.3")
     • Composix Kugel Large Oval (5.4" × 7")
     • Composix Kugel Large Circle (4.5")

Initially, the recall involved just the Extra Large patches but it was expanded in March 2006 to include the Kugel Oval, Large Oval and Large Circle mesh patches. Davol sent a letter to hospitals and surgeons, offering instruction on proper insertion techniques of the Kugel mesh patch.

The Kugel mesh patch is used to repair ventral hernias that result from post-surgical stretching or thinning of scar tissue. The folded patch is inserted through a small incision, placed behind the hernia and held open by a memory recoil ring. It permits the patch to be folded for insertion by the surgeon’s finger. After it is put in place, the Kugel mesh patch then springs open and lays flat.

Prior to the latest recall, Davol had received reports of 31 broken rings, 20 of which led to injuries. In 11 cases, the ring migrated into or through the patients’ abdominal wall, causing an infection in some cases. Seven patients suffered from bowel perforation, one had a bowel obstruction, and one died from septic shock and a heart attack following surgery to repair fistulas caused by a malfunctioning Kugel mesh hernia patch.