KUGEL HERNIA PATCH RECALL

January 10, 2007: The FDA and Davol/Bard notify healthcare professionals of an expanded recall and withdrawal of Bard Composix Kugel Mesh Patches that can have defective ring coils.

Background:

The Bard Composix Kugel Mesh Patch is used to repair hernias. A hernia is a condition where part of the internal organs bulge through a weak area in muscles, usually in the abdomen or groin. During the surgical procedure to correct the hernia, the Bard Composix Kugel Mesh Patch is placed behind the hernia flaw through a small incision. Once inserted in the patient, the hernia patch is opened by a “memory recoil ring” and then lays flat against the patient's internal cavity, preventing the hernia from pushing through the weakened tissue area. By inserting the memory recoil ring behind the hernia, it allows the Bard Composix Kugel Mesh Patch to be folded for insertion and then spring open once it is placed in the body.

On January 10, 2007, the FDA recalled the Bard Composix Kugel Mesh Patch because, when inserted the patch can break, leading to loose mesh going into the bowel - causing bowel perforations, abdominal pain, and requiring necessary bowel dissection surgery to remove the failed patch. The Bard Composix Kugel Mesh Patch is manufactured by Davol Inc., a division of C.R. Bard located in Cranston, Rhode Island. The FDA first issued a Class I Recall of the Bard Composix Kugel Mesh Patch on December 22, 2005. A Class I recall is the strongest recall available to the FDA, reserved for medical devices that are potentially life-threatening or could cause a serious risk to a patient's health. Shortly after the first recall, an updated recall was issued on March 31, 2006, that included additional Bard Composix Kugel Mesh Patch sizes and lot numbers.

Additional information about the recalls?

• 12.22.05: Class 1 Recall: Bard Composix Kugel Mesh X-Large Patch, fda.gov
• 3.31.06: Class 1 Recall: Bard Composix Kugel Mesh Patch - Updated, fda.gov
• 1.10.07: 2007 Safety Alert: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal, fda.gov
• 2.01.07: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawl

What can you do?

If you have experienced serious side effects associated with the Bard Composix Kugel Hernia Mesh Patch, you are urged to see your doctor. It may also be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced in this litigation, please call attorney Ron Goldser at 1.800.755.0098 for a free consultation or click here to fill out a confidential, free online case review. We welcome any questions you may have.