The Bard Composix Kugel Mesh Patch was recalled by the Food and Drug Administration (FDA) in December 2005 because it poses potential serious health risks to patients.

The FDA issued a Class 1 recall for the Composix Kugel Mesh Patch. This is the strongest recall available to the FDA and is reserved for dangerous or defective products that could cause serious health problems or death.

The Composix Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision made by a physician. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The problem with the Composix Kugel Mesh Patch is that the plastic “memory recoil ring” can break causing bowel perforations and chronic intestinal fistulae (abnormal connections or passageways between intestines and other organs).

According to the patch's manufacturer, C.R. Bard, Inc., as of earlier this year, the company had received 24 reports of broken rings. Here is a list of the product codes and lot numbers recalled by the manufacturer:

Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience any of the following symptoms that could be associated with ring breakage:

• unexplained or persistent abdominal pain
• fever
• tenderness at the implant site, or
• other unusual symptoms