Composix Hernia Patch Recall

the fda issued a class 1 of the bard composix hernia patch

bard composix hernia patchOn December 22, 2005, the FDA and Davol/Bard notified healthcare professionals of a class 1 of the Bard Composix Kugel (X-Large Patch Oval with ePTFE).

On March 31, 2006, the FDA expanded the original hernia patch recall to include Oval, Large Oval and Large Circle Kugel patches.

The hernia patch recall was further updated on January 24, 2007, to include additional product codes (0010202 and 0010204) and lot numbers recalled by Davol/Bard since the first was issued.

According to the March 24, 2006 Dear Chief of Surgery letter, a total of 34 ring breaks were reported to Davol. Of those 34 reported ring breaks, 21 resulted in patient injury, including:

  • 12 cases where the broken ring migrated into or through the patient’s abdominal wall, with associated infection in 2 cases;
  • 1 case where the ring reportedly migrated into the vagina;
  • 7 cases of bowel perforation reported in association with a broken ring;
  • 1 case of bowel obstruction, which was repaired without removal of the (causality to the broken ring has not been clearly established in this case);
  • 1 reported death where the patient reportedly developed septic shock, consumptive coagulopathy and acute myocardial infarction after surgery to repair small and large bowel fistulas reportedly caused by perforation by the broken ring.

patient information

Patients who have who have been implanted with one of the recalled hernia patches should seek medical attention immediately if they experience symptoms that could be associated with failure such as:

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

reason for

The “memory recoil ring” that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

free legal consultation

If you or a loved one have been injured by a recalled hernia patch, or if you are experiencing the symptoms associated with hernia patch failure, you may have a claim against the manufacturers of these recalled patches.

Please contact us today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost no-obligation evaluation of your case.

Latest News

What is a hernia and how is it treated?

The Bard Composix Kugel hernia patch (X-Large Patch Oval with ePTFE) is used to repair scar tissue, which occurs after  repair surgery.  After a small incision, the patch is placed behind the defect. A “memory recoil ring” allows the patch to be folded for an insertion. When in place, the patch will later spring open and lay flat.

The Bard Composix Kugel (X-Large Patch Oval with ePTFE) was recalled on December 22, 2005. According to the FDA, “The “memory recoil ring” that opens the Bard® Composix® Kugel® Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”

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Hernia patch recall long awaited

With the constant advancements in medical practices and technology, it is sometimes easy for medical professionals to become too confident in their abilities and overlook the underlying facts that are in front of them. This degree of confidence may have been the case for the on the Kugel hernia patch made by Davol, a subsidiary of C.R. Bard Inc., which now is paying for its apparent lack of concern over product safety.

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Hernia patch and other mesh implants pose problems

We live in a time when ultramodern technology permeates every aspect of our lives at blistering speeds. Nearly every day we hear of yet another advancement that promises to better our lives in some way. Medicine and medical technologies, such as the Kugel Mesh Patch used to treat hernias, stand on the forefront of medicine’s quantum push forward. Manufactured by Devol, Inc., the consists of a circle or oval of that is surrounded by a plastic ring. The device is engineered and folded so that it may be surgically inserted into a small incision. Once in place, the patch unfolds and expands and the abdominal wall is reinforced.

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