The US Food and Drug Administration along with Davol, Inc., a subsidiary of C.R. Bard, Inc., have recalled Bard Composix Kugel Mesh Patches indicated for the repair of ventral hernias caused by thinning or stretching of scar tissue that forms after hernia surgery.
The patch is placed behind the hernia defect through a small incision. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and to later spring open and lay flat once it is in place.
The ventral hernia repair device was recalled because the memory recoil ring can break. If the memory recoil ring breaks it can lead to bowel perforation and/or chronic enteric fistulae. The plastic coil ring is designed to aid in its deployment but can break when increased stress is placed on it from certain surgical placement techniques.
According to the FDA Recall Notice "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include:unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms."
In a March-24-06 recall notice, Bard recommends that health care professionals "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall."
The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:
PC#0010206 Bard Composix Kugel Extra Large Oval 8.7" x 10.7"
PC#0010207 Bard Composix Kugel Extra Large Oval 10.8" x 13.7"
PC#0010208 Bard Composix Kugel Extra Large Oval 7.7" x 9.7"
PC#0010209 Bard Composix Kugel Oval 6.3" x 12.3"
PC#0010202 Bard Composix Kugel Large Oval 5.4" x 7"
PC#0010204 Bard Composix Kugel Large Circle 4.5"
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Kugel Mesh Hernia Repair Patch in the News
DEC-18-06: Missouri man, whose inserted Kugel Mesh Patch failed following a product recall, causing severe abdominal pain and resulting in bowel dissection surgery to remove the failed patch, has filed a lawsuit against Davol, Inc..
MAR-24-06: Kugel Mesh recall notice sent by Bard to healthcare professionals. [BARD: KUGEL MESH PATCH RECALL]