The new recall covers all large oval and large circle models of the Kugel mesh patch manufactured before October 2005.

This latest hernia patch recall is the third that has been issued by the FDA and Davol. The first recall was issued in December 2005, after tests performed by Davol revealed that the “memory-recoil ring” in the larger models of the Kugel hernia patch had a tendency to break after surgery. When this occurs, a patient is susceptible to serious hernia patch side effects, including bowel perforation, bowel obstruction and chronic enteric fistulas.

The FDA has advised any patients who experience serious hernia patch side effects to seek medical attention immediately. Symptoms of a broken hernia patch include abdominal pain, fever and tenderness near the area where the patch was implanted. According to the FDA, several patients have died after suffering hernia patch side effects.

The first hernia patch lawsuit was filed in December 2006 by a Rhode Island man who was injured after suffering hernia patch side effects. Since then, a number of other patients have filed hernia patch lawsuit against Davol and its parent company, C.R. Bard Inc., alleging that they marketed the Kugel mesh patch despite knowing the risk of hernia patch side effects.