FDA Still Receiving Reports of Kugel Mesh Problems

Rockville, MDEven now, almost two years after Davol Inc. first recalled its Composix Kugel Mesh Patch, the FDA is receiving reports of problems with the defective product. In fact, the FDA has received adverse event reports as recently as October 24, 2007. Unfortunately, despite the patch being recalled so long ago, people with the Kugel Mesh patch implanted, even years ago, are still suffering serious side effects.

In one report received by the FDA on October 24, the patient allegedly died despite having surgery to correct problems with the hernia repair patch. According to the family's attorney, the patient had chronic pain and discharge that was caused by an infection in the area of the patch. The patient had the mesh explanted, was admitted twice to the hospital in 2007 for an infection and later died.

In some cases, the broken ring and mesh problems result in portions of the patient's bowel being removed. The problem is that the mesh can adhere to the patient's bowel, causing very serious problems. In one case reported to the FDA, a patient suffered an alleged bowel obstruction and had a clear plastic fiber in her small bowel. Ultimately, she required multiple mesh ex-plant and bowel repair procedures and a bowel resection (where part of the large or small intestine is removed) to treat her problems.

One adverse event report contained allegations that a patient suffered liver tearing, a septic episode (where the blood pressure drops drastically due to bacteria in the blood) and mesh eroded into his bowel because of a faulty Kugel Mesh Patch. The patient's situation was considered life-threatening and required bowel resection and mesh ex-plant.

Serious consequences can occur as a result of a Kugel Mesh Patch memory recoil ring break. These include bowel perforation, bowel obstruction, infections, chronic fistula and septic episodes. Depending on how the ring breaks and where the mesh migrates to, patients who have a memory recoil ring break are also at a risk of developing further hernias. The symptoms of a ring break can be traumatic as well, including vomiting, severe abdominal pain and swelling, nausea, fever, fluid retention, and constipation.

Kugel Mesh patches were created to repair hernias and eliminate hernia repair surgery complications. The patches are made with two pieces of mesh around a plastic ring, known as the memory recoil ring. The ring holds the two mesh pieces together until the patch is implanted, at which point the ring springs open, allowing the Kugel Mesh Patch to lay flat behind the incision. However, a defect in the design of the memory recoil ring means that the ring can break, causing serious complications for patients.

Patients with the Kugel Mesh patch still implanted are understandably concerned about future problems they may encounter. If the memory recoil ring does break, the results can be devastating. Unfortunately, there is no way for patients to know whether or not their ring will break, so they must adopt a wait-and-see approach, which can be incredibly stressful and unnerving. Meanwhile, those who have had their Kugel Mesh Patch break report that it is an incredibly painful and very traumatic experience.