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KUGEL MESH PATCH

  

The FDA approved the Bard Composix Kugel Mesh Patch (or, the Bard Hernia Patch, as it is also called) is manufactured by (Davol, Inc., a subsidiary of C.R. Bard) to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery.

One of the components of the patch, the “memory recoil ring”, allows the patch to lay flat once it has been inserted behind the hernia. In the larger size patches, the ring tends to break, which can lead to bowel perforations and/or chronic intestinal fistulae, which are abnormal connections or passageways between the intestines and other organs.

In January 2007,the FDA expanded a recall of hernia patches. The following Bard Composix Kugel Mesh Patch devices have been recalled due to risk of bowel perforations and other significant health problems:

  • Bard Composix Kugel Extra Large Oval, 8.7" x 10.7", 10.8" x 13.7", 7.7" x 9.7" All lot numbers manufactured before January 2006

  • Bard Composix Kugel Oval, 6.3" x 12.3" All lot numbers manufactured before March 2006

  • Bard Composix Kugel Large Oval, 5.4" x 7.0" Lot numbers manufactured before October 2005

  • Bard Composix Kugel Large Circle, 4.5" Lot numbers manufactured before October 2005

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