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 postoperative groin pain and a vaginal collection of hematoma and abscess, recurrent stress urinary incontinence, chronic pelvic pain syndrome, marked descent of the urethrovesical junction, mild cystocele deformity, tight scar in area of mid urethra, and a labial benign papillary hidradenoma.She has required multiple surgical interventions.
|