(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: arch surg/vol 144 (no.11), nov 2009.Please see article attached.(b)(4).
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It was reported in a journal article title: abdominal wall reconstruction this comprehensive retrospective medical record review aimed to determine the efficacy and describe the evolution of the ¿components separation¿ technique for abdominal wall repair in 200 consecutive patients.Between 02aug1996 and 02jul2007, 200 patients (n=115 male and n=85 female; mean age of 54.2 years) underwent ventral hernia repair using components separation technique for midline abdominal wall defects.These patient were divided based on the technique: no mesh (n=158); and primary underlay mesh repair (n=42) using prolene mesh (n=6; n=4 male and n=2 female; mean age of 48.5 [10.4] years [ranged 31-59 years]), human acellular cadaveric dermis (n=18) and soft polypropylene mesh (n=18; n=9 male and n=9 female; mean age of 53.8 [sd13] years [ranged 27-73 years]).In patients who utilized soft polypropylene mesh, prolene soft mesh and proceed surgical mesh; ethicon inc, (b)(6)) was used as an intra-abdominal reinforcement of the midline closure in clean cases without bowel injury and when the omentum could be situated under much of the mesh.Postoperatively, in patients who utilized prolene mesh, complications included hernia recurrence (n=1), major complications (n=1) and minor complications (n=2).While in patients who utilized either prolene soft mesh or proceed surgical mesh, complications included major complications (n=3) and minor complications (n=3).Most of the aforementioned hernia recurrences were successfully treated by direct reapproximation of the rectus abdominis muscles in the midline, reinforced by a non bridging intra-abdominal soft polypropylene mesh.Large complex hernias can be reliably repaired using the components separation technique despite the presence of open wounds, the need for bowel surgery, and numerous comorbidities.
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