The Kugel Hernia Mesh Patch has been on the market for over eight years, but it’s been the subject of a great deal of controversy since that time – including recalls, injuries and lawsuits. Here are the facts about the product in a nutshell:

What is it?

The Bard Composix Kugel Mesh Patch, more often simply referred to as the Kugel Mesh or Kugel Hernia patch, is manufactured by Davol, Inc., which is a subsidiary of C.R. Bard. It is used to strengthen the abdominal wall and repair incisional hernias caused by the stretching or thinning of scar tissue that form after surgery. It was approved by the U.S. Food & Drug Administration (FDA) for market use in 2001, but complaints starting rolling in as far back as 2002.

Why is it dangerous?

The patch is surrounded by a "collapsible” plastic coil ring that is sandwiched between two pieces of mesh fabric so that it can be inserted into a small incision and then "un-coil” once inside the body – the design is similar to a collapsible sun shade used at the beach. It’s that coil ring which is causing all of the problems. In some circumstances, that ring has broken creating a sharp surface that has caused havoc with patients’ internal organs and intestines.

Three recalls

The FDA announced a Class 1 recall of the patch in December 2005 (the most serious form of recall) because the product’s memory coil ring could break, causing the user’s bowels to perforate or create abnormal connections or passageways between the intestines and other organs. The FDA announced a second recall of the product in March 2006 and a third recall in January 2007 due to reports of bowel perforations and other injuries.

The FDA says that patients implanted with one of the recalled devices* should, "seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.”