NCT01520168

Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: University of Wuerzburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Incisional Hernia

Timeline

• Start date: 2003-10-01
• Primary completion: 2011-07-01
• Completion: 2012-03-01
• First posted: 2012-01-27
• Last updated: 2012-03-13

Locations

1 site across 1 country: Germany