Introduction: From its introduction in 2000 until its US recall in December 2005, the Composix Kugel mesh was implanted in an estimated 350,000 patients worldwide. In our patients, minor postoperative complications were followed after a few years by more serious problems (persistent abdominal pain, infections, intestinal perforations). In this study, we take stock after a 5-year follow-up and issue a plea for improved product development strategies and the creation of hernia registries.
Patients and methods: Between 2003 and 2006, we implanted the Bard(®) Composix(®) Kugel(®) mesh in 21 patients (11 men, 10 women, mean age 63.2 ± 13.7 years) with incisional hernias using the open intraperitoneal onlay mesh technique. The mesh is made on one side of ePTFE and on the other of polypropylene and is expanded by a polyethylene (PET) memory recoil ring. The average follow-up was 45.5 months. All patients had at least one risk factor for hernia recurrence. Explanted prostheses were analyzed by scanning electron microscopy (SEM) and subjected to mechanical strength tests.
Results: During the postoperative course, six patients suffered a wound healing disorder. Ten patients complained of persistent abdominal wall pain and four experienced recurrence of the hernia. In one patient, the mesh had to be explanted due to chronic infection. In one patient, the PET memory recoil ring broke after 5 years of follow-up with consequent small bowel perforation. The PET memory recoil ring exhibited clear signs of degradation on SEM and unmistakable signs of material fatigue in a materials testing machine.
Conclusions: Patients with recalled Composix Kugel meshes face a singular risk for complications that may occur even many years after implantation. The most serious complication is the breakage of its PET memory recoil ring. Since the recall of the Composix Kugel Mesh, we have discontinued its use. It is necessary that future complications are documented in a common post-market surveillance registry. Algorithms need to be developed and promoted to support affected patients and surgeons.