& : Business / Business / Hernia Patch Recall for Bard Composix Kugel Mesh - DePuy Hip Recall Lawyers: "The Bard Composix Kugel Mesh Hernia Repair Patch Recall has been upgraded by The United States Food and Drug Administration to 'Class I' because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death.
The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list again on January 10, 2007. (See the Recall Notices and Affected Device List Below).
The 'memory recoil ring' that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.
The FDA has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company. "
