The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of cystocele, vaginal vault prolapse and stress urinary incontinence.
It was reported that after implant, the patient experienced pain, nausea, recurrent prolapse, recurrent urinary tract infections, dysuria, lower abdominal cramping, urinary urgency, urinary frequency, fecal incontinence, nocturia, incomplete emptying of bladder, vaginal bruising, mesh erosion (at vaginal apex/proximal anterior wall/top of vagina at cervical vaginal junction/cuff), atrophic vaginitis, acute cystitis (inflammation), vaginal pressure, stricture, vaginal discharge, hyperkeratosis, cracking of skin on genitalia, infection, pelvic organ prolapse, extrusion, increased urinary stream, pressure and discomfort between the rectum and vagina, discomfort riding any distance in a car, small rectocele, fecal incontinence, feeling as though there was a small lemon down below that feels like pressure when she is standing which makes her want to sit down, left labial minora with small area of bruising, stage 1 vaginal prolapse, slight sense of stool trapping, minimal recurrent cystocele between 2 and 3, unspecified bladder issues, pelvic relaxation symptoms, digital defecation, introitus irritation, rectal pain, chills, backache, stricture above the cervix, cracking of the skin noted at the posterior fourchette from hyperkeratosis induced by the discharge from the eroded graft and yellow discharge around the graft.
The device had been used with align® to urethral support system.
Post-operative patient treatment includes multiple non-surgical interventions but no surgical interventions to date.
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