The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of incontinence, prolapse, and urethral stricture.The procedure involved a total vaginal hysterectomy, cystoscopy, urethral dilation, anterior repair with the mesh, pubovaginal sling implant, posterior repair, and sacrospinous ligament fixation.Difficulty with urethral stricture and mild trabeculation of the bladder was noted.After implant, the patient experienced chronic pelvic/abdominal, buttock/perineal/pudendal nerve/ischial tuberosity/labia/bladder/myofascial/urethral pain, vaginal discharge, urethral stricture, pudendal nerve entrapment, vaginal/pelvic discomfort, urgency, frequency of urination, nocturia, mesh erosion at the anterior apex, ulceration, colpospasm, blood loss, dyspareunia, urinary retention, vulvar/leg numbness and burning, neuropathy/neuralgia/neuritis, rectal/vaginal spasms, recurrence of incontinence, recurrence of prolapse, diarrhea, chronic constipation, and colitis.Symptoms began within two months after implant.Treatment provided after the initial procedure includes surgical release of the sacrospinous ligament fixation ((b)(6) 2009), mesh revision ((b)(6) 2011, (b)(6) 2011, (b)(6) 2017, and (b)(6) 2017), pudendal nerve blocks ((b)(6) 2012, (b)(6) 2012, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2016, late 2016, (b)(6) 2017, (b)(6) 2018, and (b)(6) 2018), diagnostic bilateral l3-l5 medial branch nerve block ((b)(6) 2015, (b)(6) 2015), physical therapy ((b)(6) 2010 - (b)(6) 2010), prolonged hospital stay ((b)(6) 2017), bilateral l3-l5 nerve radiofrequency denervation ((b)(6) 2018), multiple medical consultations between 2009 to present, and prescription of medical marijuana in 2018 for pain.Mesh revision on (b)(6) 2017 involved revision of sacrospinous fixation, vaginal graft revision, posterior repair, cystoscopy, and labial biopsy.Revision on (b)(6) 2017 involved laparoscopic colpopexy, enterocele repair, cystoscopy, anterior repair, vaginal graft revision, sling revision, and release of sacrospinous fixation.Admitted to the hospital for abdominal pain and diarrhea from (b)(6) 2017 to (b)(6) 2017, found to have colitis; sigmoidoscopy performed and patient administered probiotics.
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