The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infection, sinus tract, abdominal wall sinus drainage, adhesions, bowel obstruction, nonhealing surgical wound, inflammation, fibrohistiocytic reaction, (b)(6), seroma, debris, serosal tears, and recurrence.Post-operative patient treatment included revision surgery, removal of infected mesh, removal of sinus tract in abdominal wall, excised nonhealing surgical wound, lysis of adhesions, closure of abdominal fascia with component separation technique bilaterally, serosal tears repaired, and repair of hernia with new mesh.
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