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Because of the product recall 2005/2006.
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative complications | Assessment of postoperative complications (wound complication, mesh infection, seroma) | 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term postoperative complications | Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula | 6 months to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (>18 years) with the diagnosis of symptomatic incisional hernia.
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich A. Dietz, MD, PhD | University of Wuerzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Visceral, Vascular and Pediatric Surgery | Würzburg | Bavaria | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20556448 | Background | 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. | |
| 12424601 | Background | 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. |
| Label | URL |
|---|---|
| Research page of the Department | View source |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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Explanted meshes
| 19347564 | Background | 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. |
| 16211441 | Background | 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. |
| 21327906 | Background | 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. |
| D010335 | Pathologic Processes |