The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a metro-menorrhagia, pelvic prolapse, and stress urinary incontinence.The device was implanted during a laparoscopic-assisted total vaginal hysterectomy.The procedure included bilateral sacrospinous fixation using ivs tunneller, posterior repair, and pubovaginal sling using the ivs tunneller sling.Post-procedure complications included vaginal bleeding, bleeding with urine, tenderness in the area of the posterior repair, urinary urgency, irritable bladder symptoms, urinary tract infection, dysuria, and urinary frequency.After surgical treatment of the symptoms, the patient continued to experience stress incontinence, prolapse of vaginal walls, hematuria, dysuria, urinary tract infection and small graft anterior erosion.After a third mesh revision surgery and other surgical treatment for the symptoms, the patient experienced urinary frequency, dysuria, urine leakage, urinary hesitancy, incomplete voiding, increased bladder sensation, rectal bleeding, protrusion out of the anal canal and chronic constipation, left lower abdominal pain, hemorrhoids, recurrent uti, proteinuria, hematuria, bladder outlet obstruction, supra-pubic pain, pain with intercourse, irritative voiding symptoms, uti, bladder disorder, and stress incontinence.After a fourth surgery, the patient reported depression, anxiety, scarring, currently having pacemaker on bladder, bowel perforation, and retention.
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