It was reported that the patient underwent an unknown hernia repair procedure on (b)(6) 2014 and mesh was implanted.A few months following the procedure, the patient experienced colon cramps and pain.The patient reported that it was determined that the mesh had migrated to the patient's stomach.The patient reports that they continue to experience unspecified issues with mesh migration, but the mesh remains implanted.There has been no report of intervention at this time.Additional information will be requested.
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Pc(b)(4) date sent to fda: (b)(6)2018.Patient codes: (b)(4)- surgical intervention.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The following additional information was obtained: procedure date: (b)(6)2014 procedure type: repair of ventral hernia with mesh indication: ventral bulge. procedure details: the onlay portion of the mesh was stitched to the fascia with simple, interrupted o polysorb stitches.There were no complications. procedure date: (b)(6)2015 procedure type: separation of omental adhesions and recurrent hernia repair procedure details: the patient had evidence of recurrent hernia in the midepigastric region with incarcerated omentum and the falciform ligament.However, the lateral aspect of the abdomen cavity was free of any adhesions. the omental adhesions along with the falciform ligament were sharply taken down from the anterior abdominal wall.The incarcerated fat was reduced from the hernia defect.At this time, it was noted the patient had multiple hernia defects.There was also evidence of a prior mesh that was noted to be partially covering the hernia defects and it was pretty much embedded in the falciform ligament.This was taken down with the scar tissue in the falciform ligament.There was also another small 5 mm hernia with incarcerated fat.Once adequate area was created for the mesh, it was decided to repair the multiple hernias using an 18 cm x 15 cm symbotex mesh.There were no immediate intraoperative complications. procedure date: (b)(6)2016 procedure type: repair of recurrent incisional hernia, extensive lysis of bowel adhesions procedure details: excision of old mesh (symbotex) and placement of bard mesh.Mesh was found to be unincorporated and pulled away from one area on the left lateral side, resulting in recurrent hernia.
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