Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01520168
• Other study ID #: UD 069/11
• Status: Suspended
• Phase: N/A
• First received: January 24, 2012
• Last updated: March 12, 2012
• Start date: October 2003
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 21
• Est. completion date: March 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Incisional hernia

Exclusion Criteria:

• Younger than 18 years

• Peritonitis

• Intestinal fistula

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Incisional Hernia

Locations

Country	Name	City	State
Germany	Department of General, Visceral, Vascular and Pediatric Surgery	Wurzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. Review. German. — View 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. — View 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. Epub 2002 Sep 11. — View 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. — View 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. Epub 2005 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early postoperative complications	Assessment of postoperative complications (wound complication, mesh infection, seroma)	6 months postoperative	Yes
Secondary	Long-term postoperative complications	Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula	6 months to 5 years	Yes

External Links

•   Research page of the Department