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.
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
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.”