Bard Composix Kugel Mesh Patch Claims Attorneys

Mobile, Alabama

On January 10, 2007 Davol, Inc. and the Food and Drug Administration (FDA) announced an expansion of the existing recall of the Bard Composix Kugel Mesh Patch, the patch used in hernia repair surgery. Prior to the 2007 recall expansion, recalls of the device began in 2005 and were expanded in 2006.

How the Kugel Mesh Patch is Used

The Bard Composix Kugel Mesh Patch is a medical device used to repair ventral hernias. Ventral hernias are caused by the thinning or stretching of scar tissue formed after surgery. If left untreated, ventral hernias can lead to many painful and dangerous medical problems.

Ventral hernias can be repaired surgically using the Kugel Mesh Patch. Since the tissue is weakened, the mesh patch is used to reinforce and strengthen the area to prevent recurrence of the hernia. During surgery, a small incision is made. The patch is folded, inserted through the incision, and positioned behind the hernia. Once in place, the memory recoil ring opens the patch and keeps it open.

The Problem with the Kugel Mesh Patch

The patch has been recalled because the welds of the memory recall ring can break when placed under stress during placement. When this happens, the exposed broken ends can tear through the mesh causing serious internal injuries including bowel perforations and/or chronic enteric fistulae, a condition involving abnormal connections or passageways between the intestines and other organs. Bowel perforations and enteric fistulae can result in serious and sometimes fatal infections.

Side Effects and Complications

According to the FDA, symptoms which may indicate the presence of a broken memory recall ring include:

Persistent abdominal pain
Fever
Tenderness at the implant site

If you experience any of these symptoms following hernia surgery, you should seek immediate medical attention.

Recalled Kugel Mesh Patches

Only some of the patches have been recalled, and re-designed versions of some of the devices have been produced. Davol began receiving complaints about the defect in 2002, but did not recall the product until 2005, after 24 reports of broken rings. The entire recall includes:

Extra Large Oval, 8.7" x 10.7" (product code 0010206), recalled in December, 2005
Extra Large Oval, 10.8" x 13.7" (product code 0010207), recalled in December, 2005
Extra Large Oval, 7.7" x 9.7" (product code 0010208), recalled in December, 2005
Oval, 6.3" x 12.3" (product code 0010209), recalled in March, 2006
Large Oval, 5.4" x 7.0" (product code 0010202), recalled in January, 2007
Large Circle, 4.5" (product code 0010204), recalled in January, 2007

Replacement Surgery may be Required

Some hernia surgery patients will require surgery to replace the defective device. In some cases, if the ring is broken, it may be possible to remove just the broken ring and leave the patch in place. If you do not show symptoms of ring breakage, your doctor may feel that it is in your best interest to leave the recalled device in place.

If you or a loved one has suffered a serious complication or death following hernia repair surgery, you may have a claim for damages from a defective Kugel Mesh Patch. Please contact our Mobile, Alabama defective medical device attorneys today to arrange a free, no-obligation consultation.

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