FAQs: Kugel Mesh

Frequently Asked Questions About Bard® Compoxix® Kugel® Mesh Patch

• The Reason for the Recall of the Kugel® Mesh Patch
• The Recall
• Potential Dangers
• The Company that Manufactures the Kugel® Mesh

The Reason for the Recall of the Kugel® Mesh Patch

In order for the mesh to fit through the small incision made during the surgery, the mesh is folded in half.  This product was designed to re-deploy by using a hard memory recoil ring that surrounds the mesh.  The memory recoil ring was designed to open the mesh patch after it has been inserted into the intra-abdominal space.

However, the memory recoil ring can break and when it breaks, it can form a sharp, knife-like projectile, which can slice into and through internal organs.  This can lead to bowel perforations and/or chronic intestinal fistulae, which are abnormal connections or passageways between the intestines and other organs.

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The Recall

The Compoxix® Kugel® Mesh is subject to what is called a Class One Recall by the FDA.  The affected lot numbers were recalled between December 2005 and March 2006.  The recalls of December 2005 and March 24, 2006 were for the extra-large and oval designed.  On January 10, 2007, the recall was extended for a third time.  The January 10, 2007 recall includes large oval and large circle designs.

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Potential Dangers

If Compoxix® Kugel® Mesh fails as a result of the memory recall ring breaking inside of the abdominal cavity, the broken ring can perforate the intestines and cause fistulae, abscesses, bowel obstruction, and sepsis.  Symptoms from these complications can include fever, abdominal tenderness, nausea, diarrhea, abnormal bowel movements, and abdominal distension.  A patient with any of those symptoms following insertion of such a device should seek immediate medical attention.

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The Company that Manufactures the Kugel® Mesh

The Compoxix® Kugel® Mesh is manufactured by Davol Incorporated, which is a subsidiary of a company called C. R. Bard®, Inc.  Davol’s corporate headquarters is located in Cranston, Rhode Island. 

If you or a loved one believes you may have received a Compoxix® Kugel® Mesh Patch in a hernia repair, or if you have been injured by that product and you wish to speak to an attorney about your rights, call the lawyers at the firm of Blizzard, McCarthy & Nabers, L.L.P. at the toll free number of 877-844-3760

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Kegel Mesh Information