The patient's attorney alleged a deficiency against the device.It was reported by the patient¿s attorney that as a result of having the product implanted, the patient has experienced irritation from catheter, vaginal discharge, vaginal pain, chronic granulation tissue in vagina, persistent vaginal irritation, persistent vaginal bleeding, bacterial vaginosis, vaginitis, erythema, chronic low back pain, abdominal pain, mild left lower quadrant discomfort, chronic pelvic pain, suprapubic discomfort, left groin pain and drainage, occult erosion with persistent pain and irritation, pelvic abscess with right groin, tenderness over bladder neck, urinary mixed incontinence, stress urinary incontinence, leakage, urinary frequency, urinary retention, voiding dysfunction, extrinsic sphincter deficiency status-post anterior vaginal wall reconstruction, microhematuria, pyuria, dysuria, trace bacteruria, vaginitis yeast infection, postoperative infection, intermittent fevers, febrile urinary tract infection (pseudomonas), intermittent hematuria, lower urinary tract problems, drainage of bloody fluid, mild bloody drainage from previous drain site, intermittent bleeding from previous groin exploration, draining sinus in intra-abdominal wall, pelvic hematoma, hypermobility of urethra, thickening and change in left lower quadrant area, postsurgical changes at bladder neck, heterotopic ossification related to surgery, ill-defined stranding, soft tissue fullness within subcutaneous fat overlying low left pelvis, changes in left hemipelvis, hyperplastic tissue, granulation tissue in urethra very thin, involved bladder neck, collection of pelvilace material in suprapubic area, small capsular area in suprapubic area, exposed mesh on right side near bladder neck, unspecified extrusion, unspecified bowel problems, unspecified recurrence, dyspareunia, vaginal scarring, back aches, depression, vaginal and bladder infections, inability to hold bladder, painful intercourse, left groin abscess, closure of anterior wall, residual graft material with removal and sling redo and required multiple surgical interventions.
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