KUGEL MESH PATCH

Kugel Mesh

The Composix Kugel Mesh Patch is a plastic coil ring that is used to repair ventral (also known as incisional) hernias that are caused by thinning or stretching of scar tissue that forms after surgery.

(A hernia is a protrusion of an organ or tissue through an abnormal opening in the body. Most hernias happen when a piece of intestine breaks through a weakness in the abdominal wall, usually after a surgical incision, creating a bulge that you can usually see and feel.)

After the patch is placed behind the hernia through a small incision, it is held open by a “memory coil ring” so that the patch can be folded for insertion and, once in place, spring open and lay flat.

On December 22, 2005 the Composix Kugel Mesh Patch, manufactured by Davol, Inc., a division of C.R. Bard, was recalled from the U.S. market because the “memory coil ring” can break in the intra-abdominal space when increased stress is placed on the large-size Kugel Mesh Patch.  A break can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs.

The recall notice was updated on March 31, 2006 to include the following product codes:

The FDA announced that surgeons and hospitals should stop using the recalled product and return unused units to the company.  Davol Inc. notified U.S. customer of the recall on December 27, 2005 by letter, via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to additional recalled products. The letters included updated Instructions for Use clarifying the proper insertion technique and Supplemental Patient Management Information.

Through March 10, 2006, the manufacturer reported a total of 31 ring breaks, one of which resulted in a death: the patient allegedly developed septic shock, consumptive coagulopathy and acute myocardial infarction after surgery to repair small and large bowel fistulas reportedly caused by perforation by the broken ring.

Twenty of the breaks required surgery, including the following:

• 11 cases where the broken ring migrated into or through the patient’s abdominal wall, with associated infection in 2 cases;
• 1 case where the ring reportedly migrated into the vagina;
• 7 cases of bowel perforation reported in association with a broken ring;
• 1 case of bowel obstruction, which was repaired without removal of the mesh (causality to the broken ring has not been clearly established in this case);

If a patient who has been implanted with a Kugel Mesh patch experiences symptoms that could be associated with ring breakage, such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptom, they should seek medical attention immediately.

On October 18, 2006 Bard reported its third quarter 2006 net sales were $498.9 million, an increase of 13 percent over the prior-year period. For the third quarter 2006, net income was $87.6 million and diluted earnings per share were 82 cents.