Hernia Patch Dangers

The Bard® Composix® Kugel™ Mesh Hernia Patch is used to repair ventral (incisional) hernias. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. A hernia occurs when part of an internal organ pushes through an opening in the organ’s wall and often presents itself as a painful lump in the abdomen or groin.

Update I:

Our attorneys are looking at all possible hernia patch cases. After uncovering evidence of ring breakage in non-recalled Kugel Mesh Hernia Patches, our law firm has decided to look into ALL cases in which a Kugel Mesh Hernia Patch was implanted and caused harm. Regardless of whether or not your hernia patch was part of the Food and Drug Administration (FDA) recall, our attorneys wish with to speak with you if you’ve been injured by a Kugel Mesh Hernia Patch.

Update II:

The FDA issued the following Kugel Mesh Hernia Patch safety alert on 2/1/07: “Recall classified as Class I because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death (3).”

Incisional hernias occur specifically when a previous operation leaves an abdominal hole that tissue and organs protrude out of. Hernias are usually repaired by a simple operation in which a surgeon stitches the stomach muscles back together, but this is not always possible because the stomach muscles are often too weak or thin for the surgery, in which case a Bard Composix Kugel Mesh Patch may be used (1).

The Bard Composix Kugel Mesh Patch is inserted into the body through a small incision made by the doctor and placed behind the hernia.The “memory recoil ring” opens the patch after it has been inserted into the body. The patch then lays flat against the inner body cavity, preventing the hernia from pushing through the weakened tissue wall (1).

The Composix Kugel Mesh Patch can break, however, leading to bowel perforations and chronic intestinal fistulae (2). These are very serious conditions that pose a pronounced health risk to affected patients.

Symptoms may include severe pain, nausea, vomiting, or a large bulge at the site of the previous surgery.

The patch is manufactured by Davol, Inc., a division of C.R. Bard, and is under a Class I recall by the Food and Drug Administration (FDA).

FDA Class I Hernia Patch Recall

The FDA issued a Class I recall for the Composix Kugel Mesh Patch—the strongest recall available to the FDA—reserved for dangerous or defective products that predictably could cause serious health problems or death. The Class I recall was issued on December 22, 2005, and then updated on March 31, 2006, to include additional lots of defective patches (2).

The FDA says surgeons and hospitals should immediately stop using the recalled products and return the unused patches to the company.

Patients who have been implanted with one of the recalled devices should seek immediate medical attention if they experience:

  • fever
  • persistent or unexplained abdominal pain
  • tenderness at implant site
  • any other unusual symptoms

The list below includes all recalled product codes and lot numbers.

Product Code

Description

Lot Numbers Recalled

Date Recalled

0010206 Bard ® Composix ® Kugel Extra Large Oval, 8.7” x 10.7” All lot numbers December 2005 and January 2006
0010207 Bard ® Composix ® Kugel Extra Large Oval, 10.8” x 13.7” All lot numbers December 2005 and January 2006
0010208 Bard ® Composix ® Kugel Extra Large Oval, 7.7” x 9.7” All lot numbers December 2005 and January 2006
0010209 Bard ® Composix ® Kugel Oval, 6.3” x 12.3” All lot numbers March 24, 2006
0010202 Bard ® Composix ® Kugel Large Oval, 5.4” x 7” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006
0010204 Bard ® Composix ® Kugel Large Circle, 4.5” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006

Davol® and Bard® are registered trademarks of C. R. Bard, Inc., or an affiliate. Kugel™ and Bard, The Hernia Repair Company, are trademarks of C. R. Bard, Inc., or an affiliate.

This article is for informational purposes and does not constitute medical advice. For all health-related concerns, contact your doctor or surgeon.

Sources:

  1. Kugel Repair Benefits, from the Bard Kugel Hernia Patch Information Center website accessed 11/01/06.
  2. Class 1 Recall: Bard Composix Kugel Mesh Patch, from the Food and Drug Administration website accessed 11/01/06.
  3. FDA 2007 Safety Information Alert

This law firm is not associated with, sponsored by, or affiliated with Davol, The Hernia Repair Company, C. R. Bard or any of its subsidiaries, or the Food and Drug Administration.