FDA Updates Recall Information About Bard Surgical PatchFeb 1, 2007
On Thursday, the U.S. Food and Drug Administration (FDA) informed medical professionals that the recall of the Bard Composix Kugel Mesh Large Patch is now classified as a “Class 1” recall, meaning that the recalled product may pose serious danger to patients who are still using it.
The FDA noted that “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. Customers should stop using the recalled product and return unused units to the company.”
The recall by Bard, a subsidiary of Davol Inc., was originally initiated in December of 2005 and has been expanded several times since then. The original recall applied to Bard Composix Kugel Extra Large Oval, 8.7” x 10.7”, Bard Composix Kugel Extra Large Oval, 10.8” x 13.7”, and Bard Composix Kugel Extra Large Oval, 7.7” x 9.7”. In March of 2006, the voluntary recall was expanded to include Bard Composix Kugel Oval, 6.3” x 12.3”, and it was expanded again in January of 2007 to include Bard Composix Kugel Large Oval, 5.4” x 7.0” and Bard Composix Kugel Large Circle, 4.5”.
According to the FDA, “The ‘memory recoil ring’ that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement of the large-sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”
The agency recommends that “surgeons and hospitals should stop using the recalled product and return unused units to the company. Patients who have 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.”