Hernia Patch Recalls
Shortly after the extra large model of the Composix Kugel mesh patch was released in 2002, its manufacturer, Davol Inc., began receiving a disproportionately high number of reports of problems with the device.
Many patients who were using the extra large version of the Kugel mesh patch reported breaks in the “memory-recoil ring” which surrounds the patch and holds it in place. Some patients experienced severe side effects—including bowel obstruction, bowel perforation or chronic enteric fistulas—when the ring around the Kugel mesh hernia patch broke.
Despite the unusually high rate of injuries among Kugel patients, Davol initially blamed mistakes by doctors during surgery for the number of broken patches.
First recall
In December 2005, and Class 1 hernia patch recall was issued for some lot numbers of the extra large versions of the patch. This was later expanded to include all extra large Kugel hernia patches in January 2006. [Timeline of events]
Second recall
In March 2006, Davol issued a second hernia patch recall to include the oval version of the Composix Kugel mesh patch because of a number of injuries that had been linked to the device. Some lot numbers of the large oval and large circle versions of the patch were also listed in the second hernia patch recall.
Third recall
Davol issued a third hernia patch recall in January 2007 for all of the large oval and large circle versions after it received more reports from consumers of broken patches. The FDA then warned patients to be alert for persistent abdominal pain, fever, tenderness where the patch was implanted or other unexplained symptoms, which could indicate a broken hernia patch.
So far, there have been at least 80 cases of problems or injuries among patients who have used the Kugel mesh hernia patch, including several fatalities. [Kugel hernia patch statistics]
The first hernia patch lawsuit was filed in December 2006 by a Rhode Island man who required surgery to remove a broken patch from his abdomen. Lawyers for the man say that Davol was aware of the risks of the Kugel mesh patch well before the first recall was issued, but failed to properly warn patients of its potential for injury.