The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the ajust® sling system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over-correction/typically too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, vagina, rectum or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." (b)(4).
|
The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vaginal and left labial swelling, vaginal pressure, vaginal bleeding, diarrhea, nausea, vomiting, hematoma in the ajust space with discomfort, drainage of peritoneal hematoma, erythema on the second surgery incisional site, multiple suture removals, questionable urinary tract infections, perineal and anal bruising, urinary retention, urinary difficulties, splinting to urinate, bleeding and pain after sex, difficulty starting stream, stress urinary incontinence, cramping, dyspareunia, positional voiding, weak stream, grade one cystocele, suprapubic tenderness, chronic vaginal discharge, tenderness to palpation at the vaginal cuff, banding of the sling, dysuria, frequency, anxiety, panic attacks, chronic bacterial vaginosis, odorous discharge, pelvic pain, fatigued, vaginal foreign body in the form of a retained suture in the vaginal cuff, small superficial (vaginal cuff) ulcerations with significant amount of inflammation, granulation tissue treated with silver nitrate, emotional difficulties, difficulty with bowel movements, constipation and required nonsurgical and multiple surgical interventions.
|