Composix Kugel Hernia Patch
There
are over 750,000 hernia repair surgeries per year in
the United States. The Bard® Composix® Kugel
Mesh Patch is used in hernia repair surgery. Developed
by Dr.
Robert D. Kugel, the patch was designed to repair
ventral
hernias caused by thinning or stretching of
scar tissue that can occur around incisions after surgery,
reduce recovery time and decrease the rate of hernias
from recurring. The primary component of the patch
is a memory recoil ring that causes the patch to spring
open after the surgeon folds it flat to insert it into
the body.
Unfortunately, this recoil ring has been known to
break due to the stress of placing it in the body,
causing some serious problems in many patients that
have led to further surgeries to repair bowel perforations and the removal of the patch.
Complications that have arisen from the Bard Composix
Kugel Mesh Patch include the following:
• Migration of recoil ring
• Breakage of recoil ring
• Abdominal pain
• Bowel perforation
• Chronic enteric fistulas
• Unnatural connections / tissue growth between bowels, intestines and
other organs
In December of 2005, the FDA first recalled the Composix Kugel Mesh Patch. Since then, the FDA has had to issue
another five recalls for various types of Kugel patches
(see chart below).
According to the FDA, the reason for the recalls is:
"The 'memory recoil ring' that opens
the Bard® Composix® Kugel® Mesh Patch can
break under the stress of placement of the large sized
products in the intra-abdominal (inside the belly area)
space. This can lead to bowel perforations (rupture)
and/or chronic (recurring) intestinal fistulae (abnormal
connections or passageways between the intestines and
other organs)."
