As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pelvic pain, device revision, cystoscopy, pelvic pain with voiding, painful sitting and performing other enjoyable activities, pain at the vaginal introitus and lateral on the distal vagina, pelvic pain, vaginal pain that shoots into left groin, unable to have sexual intercourse due to pelvic pain, physical therapy visits for pelvic pain, dyspareunia, hypermobile urethra, nocturia three times, mixed urinary incontinence, obturator nerve pain, pelvic floor pain, pudendal neuralgia, groin pain, overactive bladder, pelvic floor dysfunction, myalgia of pelvic floor, muscle spasm, urge incontinence with voiding every 1-2 hours, takes long time to empty, unable to feel urine coming out, constant sharp deep right vaginal pain, dull left groin, vulvar pain radiating out toward hip and down inner thigh, pain worse with full bladder, sitting less than 20 minutes, standing, bowel movement, full stomach, stress, pain wakes her up at night, slow start, intermittent, trickling despite strong urge, stands up before she is done because she cannot feel if urine is still coming out, feels she has loss sensation internally, more sensitive externally, frequency, pelvic floor dysfunction, and mixed urinary incontinence.Patient had a pudendal nerve block.Patient had a physical exam that noted pain in the sub urethral region extending to the obturator internus.Patient had a partial explantation of the device.Intraoperative findings noted minimal scar tissue at site of device placement.Approximately 2.0 cm of the device was removed on the right and 2.0 cm on the left was removed.Pathology report notes synthetic portions of material consistent with surgical mesh measuring 2 x 1.5 x 0.2 cm.Final diagnosis noted fragments of fibrous tissue with foreign body giant cell reaction.Patient had a physical therapy evaluation for severe pelvic and perineal pain.Pain is at the introitus and lateral on the distal vaginal area along with levator spasm.Pain increases as the day progresses.
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