Composix Kugel: Bard Hernia Patch Lawsuit

Kugel Hernia Mesh Lawsuit

Composix Kugel Logo

 

ePTFE side of the Kugel Composix hernia mesh

The Kugel hernia mesh was one of the earliest and most used hernia meshes in the United States. The first Kugel hernia patch was approved in the 1990s. Over a million Kugel patches have been implanted nationwide. There have been issues with the Kugel hernia patch since its inception. Many patients and physicians have reported the internal ring of the Kugel breaking and perforating the bowel or other organs. Bard and its subsidiary Davol recalled limited lots of the Kugel hernia patch in 2005, 2006 and again in 2007. Bard assured the FDA and the public that the problem was limited to a few defective rings inside of a limited number of Kugel hernia patches. However, rings continue to break and patients continue to get injured. The real defect of the Kugel hernia patch is that the ring is inside of a polypropylene mesh. Once the Kugel mesh is implanted, the body begins to attack and break down the polypropylene. As the polypropylene degrades, it also shrinks. The smaller the polypropylene mesh gets, the more force the ring must sustain. Eventually the polypropylene mesh shrinks to a size smaller than the ring, at which point the ring either buckles or breaks. Bard needs to stop scapegoating the ring as the problem. Polypropylene is the problem.

As of March 31, 2012, Davol discontinued the Composix Kugel Patch and suggested replacing the product with the Ventrio or Ventrio ST Hernia Patch products. Davol noted that the newer hernia meshes utilize a lighter-weight mesh and absorbable materials, which leave less implant material behind in patients.

March 31, 2012 Market Withdrawal Letter for the Composix Kugel

Polypropylene side of the Kugel Composix hernia mesh

 

 

For more information on hernia mesh, please visit our hernia mesh lawsuit page.