FDA Warned Kugel Mesh Patch Maker of Serious Violation

June 21, 2007, 8:15AM. By Heidi Turner

Rockville MDDavol Inc., maker of the Bard Composix Kugel Mesh Patch, was issued a warning letter in 2006 from the FDA, citing serious problems with quality assurance systems used during the manufacturing process of the patch. The FDA also found that Davol did not report the possible severity of complaints that it received.

According to the warning letter, the FDA found serious problems at the Davol headquarters as well as problems with the system used by the company to track complaints. The FDA warned Davol that problems must be investigated and fixed or regulatory actions could be taken.

The FDA received many reports of adverse events related to the Kugel Mesh Patch. Even in 2007, patient deaths related to Kugel Mesh Patches have been reported, although what role the patches played in their deaths are under investigation. One patient died in March 2007 after developing a fistula and infection. The patient had experienced pain and tenderness following her hernia surgery. In another case, a patient died after subsequent surgery that left the mesh compromised. During the surgery, the surgeon had to cut through mesh to perform a small bowel resection. The patient developed a fistula and died after emergency surgery.

In fact, adverse event reports have also been received regarding serious injury, and as recently as March 2007. In one situation, the patient had hernia repair surgery in 2006 and returned a year later because of a painful lump. The surgeon found plastic wire over the mesh and a lab investigation discovered that the memory ring was broken.

In March 2006, a patient returned after hernia surgery with "bowel obstruction and recurrent hernia." The surgeon found the Kugel Mesh ring was exposed. It was two-and-a-half years between the time the patient had the hernia surgery and the time he or she returned with serious problems. Also in March 2006, a different patient required surgery because part of the mesh had adhered to her bowel and her intestine.

In a letter sent March 24, 2006, Davol Inc. informed physicians about the decision to recall Kugel Mesh Patches. The letter noted 20 incidents of patient injury including seven cases of bowel perforation, one case where the ring migrated into the patient's vagina, and one reported case where the patient developed septic shock and died.

Not all adverse effects from the Kugel Mesh Patch occur immediately. In some cases, patients did not have problems for a year or more after the patch was implanted. If you have any unexplained abdominal pain, tenderness or fever, contact a doctor to discuss whether or not to have the Kugel Mesh Patch removed.