Hernia Mesh Information
The Bard Kugel hernia patch was designed by Dr. Robert D. Kugel as an alternative treatment for hernia repair. The Bard Composix Kugel hernia patch is manufactured by Davol, a subsidiary of C. R. Bard, Inc. More than 78,000 Bard Composix hernia patches were distributed by Davol between 2001-2006.
According to the Hernia Resource Center, a website sponsored by Davol, the Bard Composix Kugel hernia mesh patch was designed for use in open ventral hernia repair in an effort to eliminate the tension and strain on surrounding muscles and ligaments, and therefore reducing discomfort after surgery. The hernia mesh patch is designed to be inserted through a relatively small incision and is intended to lie flat against the abdominal wall so as to require fewer sutures. The procedure takes an average of one to two hours to complete, and requires general anesthesia.
Hernia Mesh Recall
On December 22, 2005, the FDA and Davol/Bard notified healthcare professionals of a class 1 recall of the Bard Composix Kugel Hernia Mesh Patch (X-Large Patch Oval with ePTFE). The recall was issued because of reports that the “memory recoil ring” that opens the Bard Composix Kugel Hernia 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).
On March 31, 2006, the FDA expanded the original hernia mesh patch recall to include Oval, Large Oval and Large Circle Kugel hernia mesh patches.
The hernia mesh 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, 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 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.
Patients who have who have been implanted with one of the recalled hernia mesh patches should seek medical attention immediately if they experience symptoms that could be associated with hernia mesh patch failure such as:
- unexplained or persistent abdominal pain;
- tenderness at the implant site;
- other unusual symptoms.
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.