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Drugs & Devices > Kugel Mesh Patch

Urgent Class I  Hernia Patch Recall Notice

The FDA has urged any patients who received a Bard Composix Kugel Mesh Patch to seek immediate medical attention because the Bard Composix Kugel Mesh Patch malfunction has been associated with;

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

Patients are urged to consult with their doctor whether the patch should be removed or replaced.  This was a Class I recall placing it in the category of most serious recalls.

Click Here to see a list of the January 2007 list of Bard Composix Kugel Mesh Patch product that have been recalled. 

How Doctors Determine if the Kugel Mesh Patch has failed.

There are a different diagnostic test to determine if your Kugel Mesh has failed such as;

  • A lower plate X-Ray
  • Barium fluid swallowed or as an enema
  • Reverse Imaging CT scan

What is a Hernia Patch

The Bard Composix Kugel Mesh Patch was used to repair ventral hernias. The Kugel Mesh Patch was to be placed behind the hernia during surgery, then held open by a "memory recoil ring". It was that "memory recoil ring" that caused the Bard Composix Kugel Mesh Patch recall notifications.  The recoil ring has a tendency to break, which can lead to bowel perforations or chronic intestinal fistulae. For these reasons the FDA and the Davol the manufacturer of the patch have told  surgeons and hospitals to stop using the Bard Composix Kugel Mesh Patch.

History

January 24, 2007—The FDA expanded a recall of hernia patches manufactured by Davol, Inc., a subsidiary of C.R. Bard. The following Bard Composix Kugel Mesh Patch devices have been recalled due to risk of bowel perforations and other significant health problems:

Product Code

Description

Lot Numbers

0010206

Bard Composix Kugel Extra Large Oval, 8.7" x 10.7"

All lot numbers manufactured before January 2006

0010207

Bard Composix Kugel Extra Large Oval, 10.8" x 13.7"

All lot numbers manufactured before January 2006

0010208

Bard Composix Kugel Extra Large Oval, 7.7" x 9.7"

All lot numbers manufactured before January 2006

0010209

Bard Composix Kugel Oval, 6.3" x 12.3"

All lot numbers manufactured before March 2006

0010202

Bard Composix Kugel Large Oval, 5.4" x 7.0"

Lot numbers manufactured before October 2005

0010204

Bard Composix Kugel Large Circle, 4.5"

Lot numbers manufactured before October 2005

 

Class I Recall

Recall classified as Class I because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death.

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Kugel Mesh Patch
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