FDA Recalls Large Sized Composix Kugel Patches from Market
On December 22, 2005 the FDA issued a recall of Composix Kugel Mesh Patches used to repair ventral (incisional) hernias. Kugel Mesh Patches are manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc. The Kugel Mesh Patches were recalled because the "memory recoil ring" that opens the Patch can break after it has been inserted in the intra-abdominal (inside the belly area) space. This can lead to serious injuries, including bowel perforations and/or chronic intestinal problems, including abnormal connections between the intestines and other organs. Since the date of the initial recall, it has been determined that additional manufactured lots of the Patches were also defective and therefore, the recall notice has been expanded on multiple occasions, with the most recent recall date of January 10, 2007. Davol, Inc. has notified surgeons and hospitals to stop using the recalled products and return unused units to the company. The FDA has issued warnings to patients who have been implanted with these recalled devices to seek immediate medical attention 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.
Schlichter Bogard & Denton is reviewing these cases for individuals who have been affected by the Composix Kugel Mesh Patch and its adverse consequences. Please contact attorneys Kristine Kraftor for additional information.