Bard Composix Kugel Large Oval Patch

Davol Kugel Patch, Kugel Patch, Bard Hernia Repair Patch, Davol Hernia Repair Patch

Composix Kugel Mesh Patches are placed behind hernia defects via a small abdominal incision during hernia repair surgery. The patch is held open by a ring, known as a “memory recoil ring” that is designed to allow the patch to be folded for insertion through the small incision. Once in place, the “memory recoil ring” is supposed to spring open and lay flat.

Hernia Repair Patches Recalled

In December 2005 and January 2006, Davol, a subsidiary of C.R. Bard, issued a recall of six sizes of the Bard Composix Kugel Mesh Patch, used to repair ventral hernias after six breakage reports to the FDA. The hernia repair patches, tiny devices places behind hernia defects to hold them closed, are held open by a recoil ring which, after being inserted through a small abdominal incision, is supposed to spring the patches open to lay flat.

Among the six reports of breakage were two incidents of bowel perforation, a serious internal injury which can allow bacterial contamination to seep into the abdominal cavity and lead serious or even fatal personal injury, including:

• Bacteremia;
• Sepsis;
• Multiorgan Failure; and
• Shock.

In March 2006, Davol expanded the recall to include even more sizes of the hernia patch. The FDA announced a recall of all sizes of the Bard Composix Kugel Mesh Patch on January 10, 2007.

Sources: FDA Safety Alert, January 10, 2007; FDA Class I Recall, Bard Composix Kugel Mesh Patch - Updated, December 22, 2005, accessed January 24, 2007; “C.R. Bard surgical patch recall is serious: FDA,” Reuters, February 1, 2007.

Hernia Patch Defects May Lead to Serious Injuries

On January 10, 2007, the FDA reported six incidents of breakage among over 25,000 units of the Bard Composix Kugel Mesh Patch manufactured between January 1, 2004 and September 30, 2005, Among the six incidents were two reports of bowel perforation. The FDA warned that “memory recoil ring” welds may break under the stress placed on the product during surgical placement. Improper placement, or breakage of the product, could result in serious personal injury to a patient implanted with the device, including:

• Chronic enteric fistulas;
• Bowel perforation;
• Bowel obstruction;
• Abdominal pain; and
• Abdominal infection.

Sources: FDA Safety Alert, January 10, 2007; FDA Class I Recall, Bard Composix Kugel Mesh Patch - Updated, December 22, 2005, accessed January 24, 2007.

Hire a Hernia Patch Lawyer Today – Free Call, No Obligation

If you or someone you love suffered abdominal pain and complications from bowel perforation, bowel obstruction, enteric fistula or other issues after hernia repair surgery, it may be in your best interest to contact a product liability lawyer.

Contact our personal injury law firm today. If you are suffering from injuries related to the implantation of a Bard Composix Kugel Mesh Patch, you may be entitled to compensation for the injuries you may have suffered as a result. Our legal team is investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Hernia Repair Patch lawsuit.

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