Incisional Hernia
Conditions
Keywords
Incisional hernia, Mesh, Surgery, Composix Kugel, IPOM technique
Brief 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.
Interventions
None listed
Sponsors
University of Wuerzburg
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Incisional hernia
Exclusion criteria
* Younger than 18 years * Peritonitis * Intestinal fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative complications | 6 months postoperative | Assessment of postoperative complications (wound complication, mesh infection, seroma) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term postoperative complications | 6 months to 5 years | Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula |
Countries
Germany
Outcome results
None listed