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)."
Product Code |
Description |
Lot Numbers
Recalled |
Date Recalled |
| 0010206 | Bard® Composix® Kugel® Extra Large Oval, 8.7" x 10.7" | All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010207 | Bard® Composix® Kugel® Extra Large Oval, 10.8" x 13.7" | All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010208 | Bard® Composix® Kugel® Extra Large Oval, 7.7" x 9.7" | All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010209 | Bard® Composix® Kugel® Oval, 6.3" x 12.3" | All Lot Numbers manufactured before March 2006 | March, 24, 2006 |
| 0010202 | Bard® Composix® Kugel® Large Oval, 5.4" x 7.0" | Lot Numbers manufactured before October 2005 (see below) | January 10, 2007 |
| 0010204 | Bard® Composix® Kugel® Large Circle, 4.5" | Lot Numbers manufactured before October 2005 (see below) | January 10, 2007 |
Class
1 Recall is the highest health alert enacted
by the FDA. The definition of a Class 1 Recall is that
there is "reasonable probability that the use
of or exposure to a product will cause serious injury
or death." Since the recall, there have been
at least 24 reports of broken rings. Patients who have
had the device implanted during hernia
surgery are
advised to seek medical attention immediately if symptoms
include severe abdominal pain, fever, tenderness where
the patch was implanted or other unexplained pain.
As the FDA noted, Kugel Patch patients should seek
immediate attention if they experience any of the many
symptoms associated with ring breakage. These symptoms
include:
• Unexplained or persistent abdominal pain
• Fever
• Tenderness at the implant site
• Other unusual symptoms
If you or someone you care about was injured by the Bard
Composix Kugel Mesh Patch due to hernia surgery, please
fill out our Case Review Contact Form to the right on
this page to find out what your case is worth.
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