It was reported to boston scientific corporation that an uphold vaginal support system was implanted into the patient during a sacrospinous ligament fixation, anterior compartment anterior repair with graft placement, suburethral sling, cystoscopy procedure performed on (b)(6), 2011 for the treatment of vaginal wall prolapse, symptomatic cystocele and stress urinary incontinence.There were no complications during the implant procedure.On (b)(6), 2018, the patient underwent a revision procedure due to a diagnosis of postmenopausal vaginal mesh erosion.The procedure consisted of 1.Examination under anesthesia, 2.Excision of vaginal mesh erosion approximately 3 x 3 cm, and 3.Complex closure and imbrication of vaginal cuff.During the procedure, examination under anesthesia revealed at the vaginal apex had a significant laceration approximately 3 x 3 cm.There was also mesh erosion present in this area.A small amount of inflammatory response was noted as well.The area was infiltrated with marcaine solution and subsequently incised in elliptical fashion and the tissue in mesh were subsequently removed without difficulty.Good hemostasis was noted.No evidence of injury to surrounding structures such as bowel or bladder.The vaginal cuff was then closed with an imbricating layer of 2-0 vicryl ligature in a running locking fashion.Retention sutures of 2-0 vicryl ligature in a vertical mattress fashion was performed totaling 4 sutures in addition.The vaginal cuff was then irrigated and noted to be hemostatic.Vaginal packing was subsequently placed to be discontinued at home.The patient was then awoken and went to recovery room in stable condition.She was noted to have tolerated the procedure well.
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The exact event onset date is unknown.The provided event date of (b)(6), 2018 was chosen as a best estimate based on the date of the mesh revision procedure.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Revision procedure performed by same surgeon, dr.Kent childs at: (b)(6).(b)(4).
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