Use surgimend (collagen matrix for soft tissue reconstruction), 3 cases out of 4 caused delay wound healing and patients returned to operating room for interventions.All 4 cases were done by different surgeons.We cannot attribute a cause and effect relationship but our surgeons have decided to stop using the product.Date of procedure: (b)(6) 2016; surgimend; model: surgimend ref 606-400-009; lot number: 1511004; serial number: none; provisional diagnosis: erosion of other implanted mesh and other prosthetic materials to surrounding.Date of procedure: (b)(6) 2016; surgimend; model: surgimend ref 606-400-016; size 25cm x 40cm; lot number: 1601020; serial number: none.Provisional diag: unspecified abdominal hernia without obstruction or gangrene.Date of procedure: (b)(6) 2016; surgimend, model: surgimend ref 606-400-009; size 13cm x 25cm; lot number: 1608015; serial number: none.Provisional diag: ventral hernia without obstruction of gangrene.Reference report numbers: mw5068786 and mw5068787.
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