Kugel Mesh Patch Recall

Breakage of Kugel Mesh Patch “memory recoil ring” component can lead to injury including bowel rupture or perforation, and/or chronic intestinal fistulae.

Bard® Composix® Kugel® Mesh Patch Recall Expanded a Second Time

On January 24, 2007, The U.S. Food & Drug Administration updated the recall notice first initiated on December 22, 2005 by expanding it to include additional product codes and lot numbers. Read the full notice.

Bard Composix Kugel Mesh Patch

Hernia formation is a common risk following surgical procedures. The Bard® Composix® Kugel® Mesh Patch (commonly the “Kugel Mesh Patch” or “Kugel Patch”) is marketed as “the first self expanding patch designed to address both sides of open ventral hernia repair”. It is intended for use in repairing ventral (incisional) hernias caused by the thinning or stretching of post-operative scar tissue. To place the patch, a small incision is made and the patch is positioned behind the hernia. 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 is supposed to hold the patch in place and maintain the hernia repair.

The Bard Composix Kugel Mesh Patch was recalled due to a faulty "memory recoil ring" that can break or fail under pressure. Incidents of ring migration, intestinal fistulae, bowel perforation and even death have been reported as a result of this failure. Davol, Inc. and C.R. Bard, Inc., the companies responsible for the manufacture and distribution of the Kugel patch knew or should have known that it would cause serious injury, yet they failed to disclose the risks associated with its use.

Initial Recall of Kugel Mesh Patch

On December 22, 2005, Davol, Inc. (a subsidiary of C.R. Bard, Inc.) issued its first recall of the Kugel Mesh Patch. An advisory to healthcare professional indicated that the "memory recoil ring" that opens the Kugel Patch can break under the stress of placement of the large sized products in the abdominal cavity or inside the belly area. The breakage can then lead to bowel rupture or perforations and / or recurring intestinal fistulae or abnormal connections that form between the intestines and other organs.

Kugel Mesh Patch Recall Expanded... Twice

More than a year later, on March 24, 2006, the Kugel Patch recall was expanded to include additional product codes and lot numbers. Then most recently, on January 10, 2007, Davol, Inc. sent letters to health care professionals and distributors notifying them of yet another expansion of the recall of specific lots of Kugel Mesh Patches. Surgeons and hospitals were advised to stop using the recalled product and return any unused units to the company.

Patients who have been implanted with one of the recalled Kugel Mesh Patch products should pay close attention to symptoms that may indicate a developing problem with the patch. Patients are advised to seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

Recalled Kugel Mesh Patch Products

Following is a listing of the Bard Composix Kugel patch recalls to date:

Product Code	Description	Lot Numbers Recalled	Date Recalled
0010206	Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010207	Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010208	Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010209	Bard® Composix® Kugel® Oval, 6.3” x 12.3”	All Lot Numbers manufactured before March 2006	March, 24, 2006
0010202	Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007
0010204	Bard® Composix® Kugel® Large Circle, 4.5”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007

Injured by a Kugel Mesh Patch?

If you or a loved one has received a recalled Kugel Patch product, or if you have been injured due to complications from a Kugel Mesh Patch, you may be entitled to compensation from those responsible for your injury. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large medical device manufacturers like Davol, Inc. and hold them accountable for their actions.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

More information about defective Kugel Mesh Patch Products

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch – Expansion

FDA.gov – Updated January 24, 2007

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch

FDA.gov – Updated March 31, 2006

Class 1 Recall: Bard® Composix® Kugel® Mesh X-Large Patch

FDA.gov – December 22, 2005