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Composix Kugel Mesh Patch

The Kugel Mesh patch was first recalled in 2005, after the FDA received reports that the Composix Kugel Mesh patch had caused many severe injuries. Two more Kugel Mesh recalls followed. Since that time, thousands of Kugel Mesh lawsuits have been filed against Davol, Inc. and its parent company Bard, and many more hernia patients with Composix Kugel Mesh may be entitled to file a Kugel Mesh lawsuit.

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Kugel Mesh Patch

The US Food and Drug Administration first approved the Kugel Mesh Patch in 1996. The Composix Kugel Mesh patch is surgically implanted via a small incision, positioned behind the hernia, and its ‘memory coil ring’ opens the patch behind the herniated area. The mesh patch is then supposed to repair the hernia.

The memory ring is designed to aid in deployment of the patch, but it can break when increased stress is placed on it during certain surgical placement techniques. If the ring should break, the broken ends could poke through the mesh and create bowel perforations and/or a condition called "chronic enteric fistulae."

Kugel Mesh Recalls

kugel meshThe first Kugel Mesh recall occurred in 2005. It was recalled again in 2006 and 2007, both times to recall several other sizes of the device. The FDA, along with Davol, Inc., a subsidiary of C.R. Bard, Inc., recalled certain models of the Bard Composix Kugel Mesh Patch (below) after reports that the memory ring had broken, causing a number of painful and serious injuries in hernia patients.

Because the reports of side effects were so severe, the FDA designated specific lots of the Kugel Mesh X-Large Patch as a Class I recall.  This level of recall is defined as a product that is dangerous or defective and could cause serious health problems or death.

According to the FDA Recall Notice, "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include the following:
  • unexplained or persistent abdominal pain
  • fever
  • tenderness at the surgery site or other unusual symptoms
In a March 24, 2006 recall notice, Bard recommended that health care professionals "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall."

The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:

PC#0010206 Bard Composix Kugel Extra Large Oval 8.7" x 10.7"
PC#0010207 Bard Composix Kugel Extra Large Oval 10.8" x 13.7"
PC#0010208 Bard Composix Kugel Extra Large Oval 7.7" x 9.7"
PC#0010209 Bard Composix Kugel Oval 6.3" x 12.3"
PC#0010202 Bard Composix Kugel Large Oval 5.4" x 7"
PC#0010204 Bard Composix Kugel Large Circle 4.5"

Kugel Mesh attorneys are also investigating the following hernia mesh patches manufactured by Davol and Bard that have not been recalled, but defects have been reported.

0010203 Bard ® Composix ® Kugel Small Circle 7.6 cm
0010201 Bard ® Composix ® Kugel Small Oval 8 cm x 12 cm
0010205 Bard ® Composix ® Kugel Medium Oval 11 cm x 14 cm
Bard® Kugel® Hernia Patch All sizes
Bard® VentraleX® Hernia Patch All sizes
Bard® Modified Kugel™ Patch All sizes
Bard® Composix® E/X Mesh All sizes

For further information on the three recalls, visit the FDA website.

Kugel Mesh Lawsuits

In its second-quarter filings, C.R. Bard reported it settled some lawsuits related to use of the Composix Kugel Mesh Patch. According to The Providence Journal (07/06/11), Bard will pay $184 million to settle 2,600 of approximately 3,600 lawsuits filed against the company to date. The lawsuits claimed that the company's Composix Kugel Mesh hernia patch caused serious medical complications including bowel perforation, sepsis, intestinal fistulas and abdominal abscess formation.

In 2010 a jury in the U.S. District Court for the District of Rhode Island found Davol and Bard liable for injuries suffered by plaintiffs Christopher Thorpe and Laure Thorpe. The drug device company was also found liable for the failure to warn of dangers associated with the patch. The Thorpe case resulted in a $1.5 million verdict for the plaintiffs. Christopher Thorpe’s attorneys claimed that he suffered severe internal injuries caused by a broken plastic ring on the hernia repair mesh, which included an abdominal wall abscess and fistula and resulted in him undergoing a number of surgeries to repair the damage. The jury award $1.3 million by the jury for personal injury damages and $200,000 for loss of consortium.

Thousands of cases are pending and underway against the Kugel Mesh manufacturer in Rhode Island federal court’s first consolidated multidistrict litigation (MDL). Almost 2,000 more cases are pending in Rhode Island Superior Court.

By the time of the first recall in December 2005, Davol had sold about 32,000 of its Kugel Mesh Patches worldwide since 2002. In 2005 alone, the device sales reached $11 million.

Kugel Mesh Legal Help

If you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please send your complaint to a Kugel Mesh attorney by clicking the link below. Your claim will be reviewed by a Kugel Mesh lawyer at no cost.

Last updated on Feb-1-12


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