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

On December 22, 2005, the FDA and Davol/Bard notified healthcare professionals of a class 1 recall of the Bard Composix Kugel Mesh hernia patch (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 mesh hernia 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 recall was issued.

According to the March 24, 2006 Dear Chief of Surgery letter, at 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 mesh (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 hernia patch failure such as:

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

reason for hernia patch recall

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 hernia 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.