It was reported to boston scientific corporation that an advantage fit blue system device was implanted in a procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.Additionally, during the same surgery, an additional cystocele repair was performed.During the procedure, a cystoscopy was performed confirming correct sling placement and absence of any bladder penetration.On (b)(6) 2024, the patient had a follow-up medical appointment.During consultation, the patient indicated experiencing burning when urinating, nocturnal urinary frequency and pain following the sling placement.The patient noted day-to-day difficulties including asthenia and daily vulvar burns.The patient was admitted at the pain center for follow up as analgesics were not efficient.In (b)(6) 2024, the patient noted that infections and urinary inflammation had become more frequent until becoming daily symptoms.The patient also experienced vulvodynia, pudendal neuralgia, burning, bladder inflammation.The patient alleged the pain had intensified and prevented her from walking and driving which led to anxiety.There have not been any further actions taken in the health care facility for treating the patient.There was no additional information regarding the patient outcome to date.
|