Kugel Mesh Patch Facts:

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The Composix Kugel Mesh Patch, used for ventral or incisional hernias is manufactured by Davol, Inc., a division of C.R. Bard, was removed from the U.S. market on December 22, 2005 because of the reasonable probability to cause serious adverse health consequences, including death. Hernia repair surgeries, or 'hernioplasties', number over 750,000 each year.

According to the Food and Drug Administration, the memory recoil ring that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement. The plastic coil ring is designed to aid in its deployment of the device but can break when increased stress is placed on it from certain surgical placement techniques.

If the device breaks, it can cause a number of serious and potentially life-threatening complications, such as bowel perforation, chronic intestinal fistulae, or abnormal tissue growth between intestines and other gastrointestinal organs. This causes damage to the intestines and other organs and possibly death.

Signs of ring breakage include; severe abdominal pain, fever, and tenderness at the site the Kugel Mesh Hernia Patch was implanted.

Usage:

Ventral hernias are caused by post-surgical thinning or stretching of scar tissue. The patch is generally inserted behind the hernia through a small incision; its "memory recoil ring" allows the device to be implanted while in a folded state, it then springs open once it has been properly placed.

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Litigation:

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In late 2005, Bard recalled certain versions of the mesh because a plastic component could break and cut through a patient's internal organs and tissue. On Janary 10, 2007, Davol/Bard expanded an earlier recall and market withdrawal of the Kugel Large Oval and Kugel Large Circle patches due to reports of recoil ring breakage.

Recalls of the Kugel hernia patch have included all lot numbers of the Bard ® Composix ® Kugel Extra Large Oval, 8.7" x 10.7", Bard ® Composix ® Kugel Extra Large Oval, 10.8" x 13.7", Bard ® Composix ® Kugel Extra Large Oval, 7.7" x 9.7", Bard ® Composix ® Kugel Oval, 6.3" x 12.3", and certain lot numbers of the Bard ® Composix ® Kugel Large Oval, 5.4" x 7" and Bard ® Composix ® Kugel Large Circle, 4.5". Please contact your doctor immediately to see if the hernia patch recall affects you and if you need the device removed or replaced.

If you have suffered from side effects or symptoms due to your implantable mesh patch, you may be eligible for monetary compensation for your medical bills, lost wages and other expenses associated with the defective hernia patches. Please fill out our brief contact form and a DrugSettlement.com attorney or representative will call you to explain your legal rights in this matter.

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