Use : The Composix Kugel Mesh Patch is used to fix ventral hernias due to thinning or stretching of scar tissue that forms following surgery. The patch is placed behind the hernia defect thru a little incision. The patch is then held open by a “memory recoil ring” that permits the patch to be folded for insertion and later spring open and lay flat once it is ready. Recalling Firm : Davol, Incorporated , Sub. C.R.
Bard, Incorporated . One hundred Sockanossett Crossroad Cranston, RI 02920 Reason for Recall : The “memory recoil ring” that opens the Composix Kugel Mesh Patch can break under the strain of placement of the giant sized products in the intra-abdominal space. This leads to bowel punctures and / or persistent abdominal fistulae ( unusual connections or passages between the gut and other organs ). FDA Comments : Surgeons and hospices should cease using the recalled product and return new units to the company. Patients who’ve who’ve been implanted with one of the recalled devices should seek medical aid instantly if they suffer symptoms that might be linked with ring breakage like unexplained or determined intestinal agony, fever, sensitivity at the implant site or other peculiar symptoms. Davol, Incorporated .
( a division of C.R. Bard ) alerted U.S. Clients of the recall by letter on twelve / twenty-seven / 05 thru Fed Express.
On March twenty-four, 2006, Bard issued letters to infirmaries and medicare executives warning them to the extra recalled products. The letters included updated Directions to be used clarifying the right insertion method and Supplemental Patient Management Info .