The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision surgery physicians are: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system and solyx sis system devices were implanted into the patient during a sacral spinous ligament fixation + vault suspension + uphold mesh graft for repair + solyx for hypermobility of the urethra procedure performed on (b)(6) 2014 for the treatment of grade lll anterior vaginal wall prolapse with grade ll uterine prolapse.On (b)(6) 2019, the symptoms of dyspareunia, mixed stress and urge urinary incontinence, myofascial muscle pain and pelvic pain were noted.The patient also experienced problems like anxiety, chronic back pain, chronic constipation, depression, fibromyalgia, hyperlipidemia, migraine, postoperative nausea and vomiting.On (b)(6) 2019, the patient underwent vaginal urethrolysis, mesh removal, 50 units botox injection and kelly plication and anterior colporrhaphy.During mesh removal, a scarring underneath the urethra and inflammation around mesh were noted.It was also found that the sling was too close to the bladder neck and on the left side of the patient, there was dense scar and looks like the sling was partially through the periurethral tissue.Body tissue grew into the mesh, so it was generally impossible to remove all of the mesh that was placed during the original sling procedure.Patient awoken from anesthesia and transferred stable to postoperative recovery room.No complications.
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