Kugel Mesh—Erosion and Litigation

Houston, TXAlthough the Composix Kugel Mesh hernia patch was recalled in 2005, and in its wake the manufacturer offered settlements in about 2,600 lawsuits, claims are still being filed. Earlier this year, The American Surgeon reported a case of mesh migration several years after a woman had hernia surgery.

(The mesh was recalled because the memory recoil ring that opens the patch after placement can break and/or buckle under stress and cause serious complications.)

In the report (February 2014), surgeons said the 58-year-old woman underwent laparoscopic incisional hernia repair with Bard Composix Kugel Patch and it was the first case report of mesh erosion into the transverse colon after incisional hernia repair.

A colonoscopy revealed that the mesh had protruded through the patient’s colon. Surgery involved removal of the mesh, partial removal of the colon, small bowel resection, and finally repairing the hernia without mesh.

Last October a woman filed a Kugel mesh lawsuit against Davol Inc. and C. R. Bard Inc. requesting a jury trial (Case No. 6:13-cv-00747). Alicia Daniel was implanted with Kugel mesh to repair ventral hernias. The lawsuit accuses the medical device makers of negligence “for failing to adequately and properly test and inspect the Kugel Mesh to determine whether or not it was safe for the purpose for which it was designed, failing to utilize and implement reasonably safe design practices in the manufacture of mesh so as to avoid an unsafe finished product, failing to have adequate safety measures in place and for failing to timely warn physicians.”

Daniel is seeking an award of damages for medical expenses, loss of earning capacity, physical pain and suffering, mental anguish, disfigurement, physical impairment, medical and pecuniary losses, and court costs.

C.R. Bard has settled more than $184 million in about 2,600 lawsuits filed due to severe medical complications such as bowel perforation, sepsis, intestinal fistulas and abdominal abscess formation allegedly caused by the company’s Composix Kugel Mesh hernia patch.

The first Kugel Mesh Hernia Patch bellwether case resulted in the nine-person jury finding that the hernia patch implanted in more than 100,000 patients was defective and unreasonably dangerous due to its propensity to change shape and buckle in the body.

Many of those patients suffered serious hernia mesh complications such as hernia mesh infection, bowel perforations, bowel obstructions and chronic enteric fistulas. In the US alone, approximately 600,000 hernia operations are performed each year.