Clinical trial NCT01520168: Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
Official title: The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Incisional Hernia
Keywords: Incisional hernia
Mesh
Surgery
Composix Kugel
IPOM technique
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) with the diagnosis of symptomatic incisional hernia.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Incisional hernia

Exclusion Criteria:

* Younger than 18 years
* Peritonitis
* Intestinal fistula

Primary outcomes:
measure: Early postoperative complications
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Long-term postoperative complications
timeFrame: 6 months to 5 years
Other outcomes:
Locations:
city: Wurzburg
country: Germany
facility: Department of General, Visceral, Vascular and Pediatric Surgery
state: Bavaria
Study officials:
affiliation: University of Wuerzburg
name: Ulrich A. Dietz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011 Aug;15(4):463-8. doi: 10.1007/s10029-010-0692-x. Epub 2010 Jun 17.
citation: LeBlanc KA, Whitaker JM. Management of chronic postoperative pain following incisional hernia repair with Composix mesh: a report of two cases. Hernia. 2002 Dec;6(4):194-7. doi: 10.1007/s10029-002-0075-z. Epub 2002 Sep 11.
citation: Hope WW, Iannitti DA. An algorithm for managing patients who have Composix Kugel ventral hernia mesh. Hernia. 2009 Oct;13(5):475-9. doi: 10.1007/s10029-009-0498-x. Epub 2009 Apr 4.
citation: Robinson TN, Clarke JH, Schoen J, Walsh MD. Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surg Endosc. 2005 Dec;19(12):1556-60. doi: 10.1007/s00464-005-0120-y. Epub 2005 Oct 5.
citation: Dietz UA, Spor L, Germer CT. [Management of mesh-related infections]. Chirurg. 2011 Mar;82(3):208-17. doi: 10.1007/s00104-010-2013-4. German.