Kugel Mesh Hernia Patch

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Drug Description: The Bard® Composix® Kugel”Mesh 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 2/1/07:

The FDA issued the following Kugel 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.”
Source: FDA 2007 Safety Information Alert. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Composix

Incisional hernias occur specifically when a previous operation leaves an abdominal hole through which tissue and organs protrude. 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 Patchthe strongest recall available to the FDAreserved 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:

  • Persistent or unexplained abdominal pain
  • Fever
  • Tenderness at implant site
  • Any other unusual symptoms

Free Consultation

If you or someone you care about had a hernia surgery where a Bard Composix Kugel Mesh Patch was used and suffered from abdominal pain, fever, tenderness at the incision site, or painful lumps or bulges where surgery occurred, contact your doctor immediately. You may be entitled to compensation, even if you have an implanted device on the recall list but have not experienced any symptoms. Contact our law firm today for a free and confidential case evaluation. We have intake specialists standing by to take your call.

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

Product Code

Description

LotNumbers Recalled

Date Recalled

0010206 Bard ® Composix ® Kugel Extra Large Oval, 8.7x 10.7 AllLotNumbers December 2005 and January 2006
0010207 Bard ® Composix ® Kugel Extra Large Oval, 10.8x 13.7 AllLotNumbers December 2005 and January 2006
0010208 Bard ® Composix ® Kugel Extra Large Oval, 7.7x 9.7 AllLotNumbers December 2005 and January 2006
0010209 Bard ® Composix ® Kugel Oval, 6.3x 12.3 AllLotNumbers March 24, 2006
0010202 Bard ® Composix ® Kugel Large Oval, 5.4x 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 Web site (http://www.kugelherniapatch.com) accessed 11/01/06.
  2. Class 1 Recall: Bard Composix Kugel Mesh Patch, from the Food and Drug Administration Web site (www.fda.gov) accessed 11/01/06.

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.

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