Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
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.
The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up|
- Early postoperative complications [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]Assessment of postoperative complications (wound complication, mesh infection, seroma)
- Long-term postoperative complications [ Time Frame: 6 months to 5 years ] [ Designated as safety issue: Yes ]Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||March 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520168
|Department of General, Visceral, Vascular and Pediatric Surgery|
|Wurzburg, Bavaria, Germany, 97080|
|Principal Investigator:||Ulrich A. Dietz, MD, PhD||University of Wuerzburg|