The Bard Composix Kugel Mesh Patch is used during surgery to repair ventral (incisional) hernias. When using the patch, the surgeon will insert the folded patch behind the hernia defect, and a “memory recoil ring” allows the patch to spring open and lay flat after insertion. On December 22, 2005, Davol, Inc., a subsidiary of C.R. Bard, Inc. issued a recall of the patch, because the “memory recoil ring” could break during insertion and cause bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The United States Food and Drug Administration (FDA) has issued the following statementregarding this patch: “Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.” The FDA also noted the following: “An upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity.” If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.”
If you live in California and your surgeon used the older Bard Composix Kugel Mesh Patch during your hernia repair surgery, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of this patch. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.