Based on the event description, the dysphagia began two years post-implant, therefore, (b)(6) 2017 is estimated as the date of incident.(b)(4).Possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to adhesions and related harms, bowel obstruction, contamination, defect recurrence and related harms, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh contraction, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, wound dehiscence, and additional intervention including surgery.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, hernia or soft tissue deficiency recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.The gore® dualmesh® biomaterial instructions for use warns, ¿failure to ensure adequate device size or overlap of the defect such as if the device is cut too small or too large, or without consideration of potential surgical mesh / tissue contraction during wound healing, may lead to excessive tension on the suture line.This, may result in recurrence of the original, or development of an adjacent tissue defect and may lead to bowel obstruction, dysphagia, gastroesophageal reflux disease (gerd) recurrence, lung function impairment (e.G.Dyspnea, pleural effusions, and atelectasis), pain, and a secondary procedure.¿ the instructions for use further warns, ¿use of absorbable sutures or suture with a cutting needle to secure the mesh in place may result in inadequate fixation or anchoring or damage to the patch.Ensure adequate fixation through the full thickness of device and tissue.Insufficient fixation of the device may result in mesh migration, erosion or extrusion, hernia recurrence, or recurrence of soft tissue deficiency which may lead to bowel obstruction, dysphagia, fistula, gerd recurrence, pain, and additional intervention including surgery.¿ articles that indicate mesh ¿movement¿ may be a function of a patient¿s poor tissue quality leading to loss of anchorage of fixation, or may be related to the defect type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.
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