As reported to coloplast though not verified, the legal representative stated on (b)(6) 2019 patient had a revision as altis was exposed in the vagina.Doctor created an inverted "u" dissection at the level of the bladder neck proximal to the sling.Doctor freed the urethra from the fibrosis that had developed secondary to the altis.Once the fibrosis had been freed doctor created an incision at the level of the mid-urethra and cut the altis out of the vagina from sulcus to sulcus.Anchors were not removed and cause pain with sitting, intercourse, leg and other chronic pain after surgery.After altis was removed doctor harvested fascia from the patient's thigh and implanted it under the urethra to correct the recurrent stress urinary incontinence.(b)(6) 2019 returned to operating room due to altis eroding into vagina, excised the visible portion of altis and closed the vagina at the level of the sling.The patient also had a restorelle revised on (b)(6) 2019 - noted in 21250050-2020-00431.Experienced degradation of the polypropylene mesh and the pelvic tissue, chronic inflammation of the pelvic tissue, mesh shrinkage or mesh contraction of the mesh causing chronic pain, mesh deformation causing chronic pain, nerve entrapment, chronic inflammation, chronic infectious response, significant urinary dysfunction, vaginal shortening, vaginal and rectal anatomic deformation, and sever adverse reactions to the mesh.Suffered and will suffer apprehension of increased risk for injuries, infections, bodily disfigurement.
|
Additional information received reported that between 07dec2018 and 03mar2020, the patient experienced urinary leakage, sling tightened with tensioning suture, overactive bladder, midline posterior mesh and midline urethral mesh exposure, superficial separation of posterior incision line, mesh trimmed at posterior line (b)(6) 2019, pain with sitting for extended periods of time, vaginal swelling and pressure, trimming of mid-urethral sling exposure in office (b)(6) 2019, vulvar itching, dysuria, pain and irritation after sex, numbing pain from the lower bottom area to the clitoris, dysuria, stress urinary incontinence, erythema of labia majora, mesh trimmed in office (b)(6) 2019, husband feels poling during intercourse, mesh exposure at left sulcus removed in office (b)(6) 2019, heavy incontinence with coughing and sneezing, sling exposure in the left sulcus, urinary hesitancy with weak stream, urge incontinence, popular lesion at right labia, bladder spams, small hole in vulva, vulvar fistula vs nerve bundle, right buttock pain, constipation, incomplete rectal emptying, and microscopic hematuria.On (b)(6) 2019 a 0.25 cm circular midurethral sling exposure from altis sling.(b)(6) 2019- sling exposure in the left sulcus, sui with suspected intrinsic sphincter deficiency of the urethra.The patient also experienced pelvic and vaginal pain that began after bladder sling repair and mesh removal surgery, urinary tract infection positive for escherichia coli, scar tissue, recurrent stage two vaginal vault prolapse, foreign body type inflammatory reaction, hemorrhoids, and hypertonic left levator ani muscles.The patient underwent pudendal nerve block, botox injection, and partial mesh excision.It was further reported that there was urethral stinging, pinching, burning, and spasming, as well as disrupted stream when urinating.
|