Kugel Mesh Patch
The Kugel Mesh Patch was used to repair ventral hernias, where the patch is surgically placed inside the abdominal cavity and positioned behind the hernia. The patch consists of two layers of synthetic mesh that are surrounded by a flexible plastic “memory-recoil ring” that is implanted at the site of a repaired hernia. The ring then springs into place, allowing the hernia to heal and regrow around the flattened patch.
But it was this "memory recoil ring" issue that sparked the recall. According to reports, the recoil ring has a tendency to break, sometimes during surgery, which can lead to bowel perforations, bowel obstructions or chronic intestinal fistulae. Because of this, the Federal Drug Administration (FDA) and Davol, the manufacturer of the patch, have told surgeons and hospitals to stop using it.
Kugel Mesh Patch Linked to Serious Health Issues
The Kugel Mesh Patch has been linked to:
- Chronic Enteric Fistula
- Infection
- Bowel Obstructions
- Bowel Perforations
Kugel Mesh Patch Recall
According to the FDA Recall Notice: "Patients who have been implanted with a 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
In December 2005, Davol issued a recall for the extra-large model of the Kugel Mesh Patch in response to design and manufacturing flaws uncovered in company tests. Not long after, Davol issued two more Kugel Mesh Patch recalls in March 2006 and January 2007, at the prompting of the FDA after reports linked the patch to more than 80 health issues and possibly death.
In early 2006, the FDA inspected Davol’s manufacturing plant, where the agency discovered major flaws in the tracking and reporting system for patient complaints about the Kugel mesh hernia patch side effects. Because of this, FDA inspectors determined that Davol had been downplaying the severity of issues related to the patch.
