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FDA Announces Recall of Kugel Hernia Repair Mesh

Davol Admits Of Product Defect In December 2005

The surgical repair of an abdominal hernia is a relatively common operation, with over 750,000 such procedures performed annually in the U.S. A hernia is a protrusion of tissue through an opening in the muscle or membrane in which it is normally contained. In recent years, the use of hernia repair mesh to aid in these repairs has become commonplace, as well. Unfortunately, defects in some of these mesh products have necessitated multiple recalls, and have led to serious injuries for some patients.

The Bard Composix Kugel hernia repair mesh is manufactured by Davol, Inc. This product is used most frequently to repair incisional (ventral) hernias. These are openings that occur around the scar tissue from a previous surgery. A surgeon may elect to repair this condition through a more traditional “open” surgery, which requires a larger incision and is somewhat more invasive. However, many hernia patients now opt for the minimally invasive laparoscopic repair surgery which offers the benefit of smaller incisions and faster recovery. In both types of surgeries, the use of hernia repair mesh is common.

The Kugel hernia repair mesh is a patch with a flexible memory recoil ring around its perimeter. The surgical technique used in implanting the device involves folding the patch to fit it through the surgical incision. Once the patch is correctly positioned, the memory recoil ring causes it to spring back into its flat profile, effectively covering the hernia opening. Unfortunately, the stress of folding and insertion has caused many of the rings to fracture, causing severe abdominal injuries and in some cases, death.

Davol first admitted to the product defect in December 2005, when reports of ring breakage were confirmed by their own testing. At that time, they issued a recall for large and extra-large oval patches, as those models seemed to be the most problematic. However, further FDA investigation of Davol manufacturing processes and its tracking of reported problems exposed the company’s failure to ensure the safety of consumers. The recall was expanded twice to include other sizes and models of the Kugel hernia repair mesh. The FDA criticized Davol for their slow response to the problems.

The serious injuries suffered by mesh patch recipients coupled with information about the company’s failures to ensure the safety of its product have led to a growing number of lawsuits. Many patients who received the Kugel hernia repair mesh during their surgeries suffered bowel obstruction, bowel perforations, and chronic enteric fistulas caused by the broken rings. These painful injuries have often necessitated additional surgeries, and have led to other tragic health consequences. In the worst cases, these complications have led to death.

To date, over 2,000 lawsuits have been filed by consumers against the manufacturer of the Kugel Mesh Patch. The lawsuits assert that the company is liable for the injuries, including associated medical costs, pain and suffering, and needed future medical care. Attorneys specializing in drug and product liability litigation are representing these individuals and fighting for the compensation they deserve.

If you’ve undergone a hernia repair in which the Kugel hernia repair mesh was used, report any troubling symptoms such as abdominal pain, fever, or other gastrointestinal problems to your physicians. These could indicate a serious problem which requires prompt attention.

The legal counsel you need is available through one of the experienced attorneys on Legal Tube. Let our database of legal professionals help you find the right representative to handle your case and protect your future.

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