The Food and Drug Administration has announced that it is updating the recall on large sized versions of the Bard Composix Kugel Mesh hernia patch to a Class 1 recall. Davol Inc.—the manufacturer of the Kugel hernia patch—has issued three separate hernia patch recalls since December 2005 due to reports that the device could break after it is implanted, leading to serious and potentially deadly hernia patch side effects.

The FDA says that it classified the Kugel patch recall as Class 1 because the problems associated withbroken large sized hernia patches have “a reasonable probability to cause serious adverse health consequences, including death.” The agency advised doctors to stop implanting the device and to return any unused patches to Davol.

The Kugel mesh patch is designed to treat patients with certain types of hernias that can form after surgery. The patch is surrounded by a “memory recoil ring” that holds it in place at the site of the hernia. However, according to a release announcing the Kugel mesh recall, this memory recoil ring can break in the larger versions of the patch. Broken hernia patches can lead to abdominal pain, bowel perforation, bowel obstruction, chronic enteric fistulas or other side effects.