Long Island, Manhattan Accident Attorney Blog

Kugel Mesh Hernia Patch Recall

The popular Bard Composix Kugel Mesh Hernia Patch has been linked to serious, life-threatening side effects and has been voluntarily recalled by its manufacturer and in association with the U.S. Food & Drug Administration (FDA).

On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without "memory recoil rings."

As early as August 2001, Davol began receiving reports of complications and failures of its hernia mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix Kugel® Mesh Patches. The reports also contain descriptions of problems other then memory recoil ring breakage including, "buckled mesh," "patch shriveling" and "edges curled up," as well as descriptions of the mesh as being "crumpled," "wrinkled," "rolled up," "delaminated" and "folded."

What is the Kugel Patch?

The Kugel patch is used to repair Inguinal, Ventral and Laparoscopic hernias. In the more common Ventral or Incisional hernia, the 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.

Timeline - Why was the Kugel Patch Recalled?

In three (3) separate product recalls, Davol Inc. and its subsidiary C.R. Bard Inc. in association with the FDA initiated a voluntary recall of the Kugel patch. The dates for the specific recalls are as follows:

December 22, 2005

March 31, 2006

January 24, 2007

The recall of the hernia patch was initiated because the "memory recoil ring" that opens the Kugel patch can break under the stress of placement of the large sized products in the intra-abdominal space.

What are the Side Effects?

The memory recoil ring defect in the hernia patch can lead to serious, life-threatening side effects. The side effects of a defective patch are as follows:

bowel perforation;

bowel obstruction;

chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs);

serious infection; and/or

death.

Signs of a Problem