Kugel Mesh Patch: Recalled due to Serious Injuries

November 3, 2006, 12:00AM. By Heidi Turner

Murray Hill, NJThe US Food and Drug Administration in cooperation with Davol, Inc. have recalled Bard Composix Kugel Mesh Patches following reports of serious injuries related to the patches.

The Kugel Mesh Patch is used to repair ventral hernias that are caused by thinning or stretching of scar tissue that forms after surgery. The patch is inserted through a small incision, placed behind the hernia and held open by a memory recoil ring. The memory recoil ring allows the patch to be folded for insertion through a small incision and then spring open and lay flat when it has been put in place.

The Kugel Mesh Patch was recalled because in some instances the memory recoil ring breaks, leading to bowel perforations and chronic intestinal fistulae. This causes abnormal connections between the intestines and other organs. Certain surgical placement techniques may place stress on the ring which causes it to break.

The Bard Composix Kugel Mesh recall involves the following lot numbers, manufactured up to and including December, 2003:

PC#0010206	Bard Composix Kugel	Extra Large Oval	8.7" x 10.7"
PC#0010207	Bard Composix Kugel	Extra Large Oval	10.8" x 13.7"
PC#0010208	Bard Composix Kugel	Extra Large Oval	7.7" x 9.7"
PC#0010209	Bard Composix Kugel	Oval	6.3" x 12.3"
PC#0010202	Bard Composix Kugel Large	Oval	5.4" x 7"
PC#0010204	Bard Composix Kugel	Large Circle	4.5"

Initially, the recall involved only the X-large patch, however in March 2006, the recall was expanded to include Oval, Large Oval and Large Circle Kugel Mesh Patches.

At that time a letter was also issued to hospitals and health care professionals instructing them on proper insertion techniques and patient management for the Kugel Mesh Patch. Surgeons were also told to immediately stop using patches with the recalled product codes.

Up to the latest recall, Davol recorded 31 broken rings, 20 of which led to injury in the patient. In 11 cases the ring migrated into or through the patient's abdominal wall, causing an infection in at least two cases. Seven patients suffered from bowel perforation, one person developed a bowel obstruction, and one person died after developing septic shock, consumptive coagulopathy and acute myocardial infarction after undergoing surgery to repair fistulae caused by the broken ring.

Patients who still have the recalled Kugel Mesh Patches implanted should seek medical attention if they experience unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

Davol, Inc. is a subsidiary of CR Bard. US customers were notified of the recall by a letter sent December 27, 2005. Between 2002 and the time the letter was sent, approximately 32,000 units had been sold worldwide. The recall does not affect any of the company's other hernia products.