Federal Court Expands Scope of Kugel Mesh Hernia Patch

posted on:
January 9, 2008

author:
Gary K. Shipman

On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol/Bard to cover all Davol Marlex/Teflon products, with or without "memory recoil rings." 

On August 25, 2000, Davol/Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix E/X Mesh Patch was classified as a Class II medical device. The Composix E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.

The Bard Composix mesh for hernia repair was introduced in 1997. It was the first ventral hernia repair prosthesis that combined two biomaterials, Bard polypropylene mesh and expanded polytetrafluoroethylene (ePTFE), in one product. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer, resulting in two different sides to the patch. Davol/Bard use the Composix bi-layer mesh in several of its hernia repair patches including, but not limited to, the Composix E/X Mesh Patch, the Composix Kugel Patch, and the Composix L/P patch. The Composix Kugel Mesh Patch, Composix E/X Patch, and the Composix L/P patch are almost exclusively used to repair ventral, i.e., abdominal, hernias, specifically incisional hernias – hernias caused by the failure of the integrity of a prior surgical incision. The Composix Kugel Mesh Patch is made of bilayered material identical to the Composix E/X and L/P patches, but also contains a "memory recoil ring" that allows the patch to spring into place and lie flat. The Composix E/X Patch and the Composix L/P patch do not contain this ring.

Information gathered from the FDA’s Manufacturer and User Facility Device Experience Database (hereinafter, "MAUDE"), show that at least as early as June 2000, DAVOL and BARD received reports of problems and defects in their Composix mesh patches. These reports advise of bowel adhesions and obstructions and relay surgeons’ findings of the patches being "crumbled" and "delaminated." On December 22, 2005, DAVOL issued a Class I recall notice for several lots of the Composix Kugel Mesh Patch. An FDA Class I recall is issued for problems related to medical devices that are potentially life-threatening or could cause a serious risk to the health of the patients implanted with the devices. Since December 22, 2005, the recall has been expanded twice to include additional shapes, sizes and production lots of the Composix Kugel Mesh Patch. The stated reason for the recall of the Composix Kugel Mesh Patch was a failure in the memory recoil ring contained in the Composix Kugel patches. According to the recall notice, the failure and breakage of the ring "can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs)."

However, lawyers representing patients injured by the defective mesh products have believed that the complications and failures associated with the Composix Patches are not limited to the Composix Kugel Mesh Patches which DAVOL and BARD have already recalled, and are not limited to the memory coil ring contained in the Kugel patch as the Defendants have claimed. Information gathered from MAUDE demonstrates that as early as August 2001, DAVOL has received reports of defects and problems with the Composix Kugel Mesh Patches that not only did not mention breakage or disruption of the memory recoil ring, but did not mention the memory coil ring at all. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix Kugel Mesh Patches.

These reports contain surgeons’ findings of "buckled mesh," "patch shriveling" and "edges curled up," as well as descriptions of the mesh as being "crumpled," "wrinkled," "rolled up," "delaminated" and "folded." At least as early as June 2000, DAVOL and BARD received reports of problems and defects in the Composix E/X Mesh Patch. As with the other reports, these reports for the Composix E/X Mesh Patch advise of bowel adhesions and obstructions, intestinal fistulae, chronic abdominal pain, and separation of the layers of the patch. Both DAVOL and BARD have received reports of failures in the Composix mesh, the Composix E/X Mesh Patch and Composix Kugel Mesh Patch all detailing similar problems of bowel adhesions and obstructions and intestinal fistulae and describing the patches as separated, delaminated, balled up, shriveled and crumpled.

As a result of the various injuries that are alleged to have occured by reason of the defective patches containing the memory recoil rings, litigation was commenced throughout the United States, and on June 22, 2007, the Judicial Panel on Multidistrict Litigation ordered the consolidation and transfer of actions to this Court creating In re Kugel Hernia Repair Patch Litigation, MDL Docket No. 07-1842-ML. This MDL proceeding was originally confined to the patches containing the memory recoil rings, and because of the reported problems with the products without rings, has now been expanded.

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