Bard Composix Mesh Patch has been recalled. The mesh patch was used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch was placed behind the hernia defect through a small incision. The patch was then held open by a “memory recoil ring” that allowed the patch to be folded for insertion and later spring open and lay flat. This memory recoil ring can break under the stess of placement. This then can lead to bowel perforations and/or chronic intestinal fistulae.
On January 10, 2007, the FDA recalled the Bard Composix Kugel Mesh Patch because, when inserted the patch can break, leading to loose mesh going into the bowel – causing bowel perforations, abdominal pain, and requiring necessary bowel dissection surgery to remove the failed patch. The Bard Composix Kugel Mesh Patch is manufactured by Davol Inc., a division of C.R. Bard located in Cranston, Rhode Island. The FDA first issued a Class I Recall of the Bard Composix Kugel Mesh Patch on December 22, 2005. A Class I recall is the strongest recall available to the FDA, reserved for medical devices that are potentially life-threatening or could cause a serious risk to a patient’s health. Shortly after the first recall, an updated recall was issued on March 31, 2006, that included additional Bard Composix Kugel Mesh Patch sizes and lot numbers.