FDA RECALLS MESH PATCH FOR HERNIA REPAIR

A mesh patch used to repair ventral hernias has been recalled by the FDA. The Bard Composix Kugel Mesh X-Large Oval with ePTFE was issued a Class I recall because the "memory recoil ring" that opens the patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae known as abnormal connections or passageways between the intestines and other organs.

The patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect though a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place, the FDA said.

For more information visit, http://www.fda.gov/cdrh/recalls/recall-122205.html (http://www.fda.gov/cdrh/recalls/recall-122205.html).