Kugel Mesh Patients Not Out of the Woods Yet

September 20, 2007, 9:00AM. By Heidi Turner

Rockville, MDJust because the Kugel Mesh Patch was recalled over a year ago does not mean that adverse event reports regarding the hernia patch are no longer being submitted to the U.S. Food and Drug Administration (FDA). In fact, the FDA received numerous reports in August of serious problems with the Kugel Mesh Patch, some of them life-threatening incidents.

The reason that people are still suffering serious complications from the hernia patch is that when the recall was announced, doctors were told to weigh the risks of leaving the patch in with the risks of explanting it. Patients who were not suffering side effects indicating that their patch malfunctioned likely did not have the patch removed because they were not considered at risk for ring breakage. However, even now after the recall is well over a year old, the FDA is receiving reports about defective Kugel Mesh Patches and broken memory rings.

One report, received on August 24, 2007, noted that a woman who became pregnant after having the Kugel Mesh Patch implanted, began experiencing pain. The ring was explanted and was apparently "bent and ready to break" in two places. The report does not indicate whether or not the added pressure of the pregnancy caused the ring to malfunction or if it had already malfunctioned when she became pregnant.

Another report noted that the patient had "chronic, constant abdominal pain, sharp and stabbing," since hernia surgery. The patient required surgery to remove the patch's mesh from his bowel in order to relieve his pain. Yet another report notes that a patient required two surgeries and has been on pain pills since his first surgery in which the Kugel Mesh Patch was implanted.

One patient, who required surgical intervention to fix problems allegedly caused by the Kugel Mesh Patch, reported "abdominal pains, fever, wound drainage, abscesses, the mesh folding into a wad, bowel adhesions, fistula, bowel resection, infection and mesh explant." Still another report, this one indicating a life-threatening event, noted the memory ring allegedly broke, perforating and strangling the patient's bowel and resulting in infection and necrosis of the bowel.

In another situation, the broken ring allegedly perforated a patient's bowel in three places. The patient wound up in the hospital with "vomiting, pain in the abdomen, and fatigue." Still another life-threatening incident report was submitted, this one reporting a broken ring that allegedly caused a perforated bowel and fistula. The patient's abdomen turned red and developed a draining wound.

Patients who have had Kugel Mesh Patches implanted and not yet had them removed may think they are in the clear and will not have any problems with the patch. However, adverse event reports are still being submitted to the FDA regarding hernia patches, some of them reporting events occurring in 2007. Furthermore, some patients may have suffered adverse side effects of the Kugel Mesh Patch without realizing it.

Anyone who has had a Kugel Mesh Patch implanted and experiences pain or tenderness at the implant site, abdominal swelling, unexplained fever, or any other unusual pain in the abdomen should seek medical attention and discuss the possibility of removing the hernia patch with a doctor. It is important to remember that some of the FDA's adverse event reports concerning the Kugel Mesh Patch were deemed life threatening, so any unusual symptoms should be dealt with immediately.