Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

This study has suspended participant recruitment.
(Because of the product recall 2005/2006.)
Sponsor:
Information provided by (Responsible Party):
PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01520168
First received: January 24, 2012
Last updated: March 12, 2012
Last verified: March 2012

January 24, 2012
March 12, 2012
October 2003
July 2011   (final data collection date for primary outcome measure)
Early postoperative complications [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]
Assessment of postoperative complications (wound complication, mesh infection, seroma)
Same as current
Complete list of historical versions of study NCT01520168 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

Explanted meshes

Non-Probability Sample

Adult patients (>18 years) with the diagnosis of symptomatic incisional hernia.

Incisional Hernia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
21
March 2012
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Incisional hernia

Exclusion Criteria:

  • Younger than 18 years
  • Peritonitis
  • Intestinal fistula
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01520168
UD 069/11
No
PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg
University of Wuerzburg
Not Provided
Principal Investigator: Ulrich A. Dietz, MD, PhD University of Wuerzburg
University of Wuerzburg
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP