What is a Kugel hernia patch?

The Bard Composix Kugel Mesh Patch (aka the Bard Hernia Patch) is manufactured by (Davol, Inc., a subsidiary of C.R. Bard) is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The hernia patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.The FDA approved the Kugel hernia patch on February 9, 2001.

What are the dangers associated with Kugel hernia patch?

On December 22, 2005 – The FDA issued a recall on the Bard Composix Kugel Mesh Patch. The “memory recoil ring” that opens the Kugel hernia mesh patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). 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.

January 24, 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

What can I do?

If you or a loved one has suffered from chronic intestinal fistulae or bowel perforations or any other serious injury as the result of receiving an Kugel hernia patch, you may be entitled to compensation. For a free legal consultation, contact us today!



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