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It was reported to boston scientific corporation that an uphold vaginal support system was used during a tension-free vaginal tape procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on march 20, 2023.On an unspecified date in 2008, the patient underwent a procedure to place "posterior vaginal prolapse mesh, uphold apical mesh and midurethral sling".On (b)(6) 2021, the patient had mesh erosion, vaginal discharge and recurrent vaginal vault prolapse.The patient underwent a removal of vaginal prolapse mesh, cystourethroscopy, and small bowel resection procedures.Findings include a posterior mesh 3-4 mm from the rectal mucosa without fistula present.The uphold mesh adhered to the small bowel with fistula from the small bowel to the vagina.The mesh noted to be intraabdominal.Cystoscopy revealed no lesions, masses, stones or abnormal vascular patterns.Bilateral efflux of the urine was seen from the ureteral orifices at the end of the case.The urethra was intact.Rectal examination revealed no rectal sutures and no defects.During the procedure, an examination was performed, and stone was seen in the posterior vaginal epithelium at midline 3 cm from the hymenal ring with mesh palpated in the entire posterior compartment.The mesh was palpated at the apex with puckering seen at the apex that was not previously visualized in the office.A lonestar retractor was placed for visualization.Allis clamps were placed, and a vertical incision was made over the exposed mesh.The mesh was carefully dissected away from the vaginal epithelium distally and left index finger was placed into the rectum to determine distance from the rectum to the mesh.It was found to be 3-4 mm with rectal submucosa involved in mesh.Care was taken to carefully dissect the entire mesh sheet away from the rectum and no defect was seen in the rectum.Once the entire width of the mesh was exposed, the mesh was transected in the midline with mayo scissors.The mesh was then dissected toward the right obturator space and carefully removed from the vaginal epithelium and underlying tissue.The mesh sheets were removed, and irrigation was performed.Hemostasis was maintained with sutures.The rectum was oversewn with sutures.The vaginal epithelium was trimmed and closed with sutures.Attention was then turned to the apical mesh excision.A vertical midline incision was made over the apical uphold mesh.This was dissected off the vaginal epithelium.The posterior mesh was found to be intraabdominal and adhered to both peritoneum and small bowel.This was carefully dissected off bowel, however, there was a small area that was tightly adhered and upon further inspection, a few strands of mesh were seen on the small bowel and a fistula was present.This was separated from the mesh and the defect in bowel was seen and irrigated.The repair commenced with two interrupted sutures, however, another area of adhesion was seen, and decision was made to call in colorectal surgery.The physician dissected the bowel out of the vagina and decision was made to perform small bowel resection.Copious irrigation was performed, and hemostasis was noted.The peritoneum and the vaginal epithelium were then closed with sutures.The patient tolerated the procedure well and went to the recovery room in stable condition.Additional information received on june 22, 2023.On june 22, 2023, additional information was received about a patient who had been seen and examined on (b)(6) 2021.The patient complained of leakage that she thought was urine, but wasn't sure.She used three regular pads daily and experienced urinary urgency, frequency, and nocturia once a night.She also had a sensation of incomplete bladder emptying and experienced dysuria and vaginal irritation occasionally.The patient admitted to having a vaginal bulge, constipation, and dyspareunia.Upon examination, the physician noted that the patient's vagina was tender with erythema and abnormal vaginal discharge.The mesh was palpated under the anterior and posterior vagina, and a 0.1 mm exposed mesh with stone present noted at the posterior vaginal wall.The physician recommended that the patient undergo urine culture and urinalysis with microscopic analysis and provided care instructions for dysuria.The physician also discussed the need to remove the mesh before surgical repair of the prolapse and recommended cystoscopy prior to the surgery.The patient was informed about all options for treatment, including conservative measures such as expectant management, pelvic floor physical therapy, and pessary placement, as well as surgical interventions such as native vaginal tissue repair and sacral colpopexy with mesh graft.The physician performed in and out catheterization, and a clear and yellow urine sample was collected.On (b)(6) 2021, a pathology report from the explanted vaginal mesh revealed that it measured at 6.5 x 4.5 x 0.6 cm in aggregate, with slight areas of blue discoloration.Scant surrounding rubbery densely attached fibrous tissue was present, and the specimen was for gross examination only.On (b)(6) 2021, the patient presented at the emergency department with complaints of abdominal pain which started the previous night.Prior to ed visit, the patient developed constipation and took miralax.She reported dark purple/"black" loose stools.Three nights prior to ed consult, the patient started to experience nausea.She then developed increased pelvic/rectal pain that she described as intermittent "labor pains through my rectum" which continued and worsened.At the ed, the patient's sepsis screen (sirs screen) was negative.The patient's temperature was not greater than 38.3 degrees c (100.9 degrees f) or less than 36 degrees c (96.8 degrees f).Heart rate was not greater than 90.Respiratory rate was not greater than 20.The patient was given synthroid oral, zofran (ondansetron hci) ivp 4 mg over 2 minutes, dilaudid (hydromorphone hci) ivp 1 mg over 2 minutes, and zosyn (piperacillin sod-tazobactam so) ivpb in bag 100 ml at 200 ml per hour over 30 minutes.She was afebrile with stable vital signs.H/h 8.6/27.4, wbc 13.7, cmp wnl.Ct of the abdomen/pelvis revealed a "5.5 x 4.3 cm collection abutting the sigmoid colon concerning for diverticulitis with abscess formation".In the physician's assessment, the patient was experiencing post operative pelvic abscess.The patient was then transferred from the ed to the healthcare facility where her explant procedure on (b)(6) 2021 was performed.On (b)(6) 2021, the patient was seen and examined for six weeks postop.The patient was doing very well.No nausea nor vomiting was reported.The patient had normal bowel movement with stool softeners.She felt bulge and would like surgical repair.During the follow-up examination on (b)(6) 2021, the patient presented with vaginal prolapse and was fitted with a pessary.She reported experiencing discomfort due to a vaginal bulge that worsened when standing and feeling as if her bladder was not being completely emptied.There was no vaginal bleeding or spotting, and she denied experiencing dysuria.The patient also had stage 3 cystocele and atrophy but no vaginal lesions.The patient was fitted with a #5 short stem gellhorn pessary that successfully reduced the prolapse without causing pain or hypermobility.She was able to walk, squat, stand and void without difficulty before leaving the office.She was advised on how to maintain the pessary and instructed to contact the office if she experienced any pain, bleeding, expulsion or odorous discharge.The patient was also informed that she may experience an increase in urinary incontinence with a reduction in the bladder prolapse.She will return for in-office pessary maintenance visits as per the instructions given.The patient is scheduled for prolapse repair in (b)(6) 2022.During the follow-up visit on (b)(6) 2021, the patient reported prolapse and requested a pessary check.At her last visit, she was fitted with a #5 short stem gellhorn which was expelled after one day.However, the patient did not experience any pain or bleeding.Today, during the visit, the patient requested to try another pessary.The patient had previously tried the #5 short stem gellhorn, which did not work.However, the #6 short stem gellhorn was successful in reducing the prolapse without any discomfort or hypermobility.The patient was able to stand, squat, walk, and void without any difficulty before leaving the office.The patient was given counseling on pessary maintenance, including instructions to call if there were any pain, bleeding, expulsion, or odorous discharge.The patient was also informed that there might be an increase in urinary incontinence with a reduction in bladder prolapse.The patient will return for in-office pessary maintenance visits as scheduled.During a virtual visit on (b)(6) 2022, the patient actively participated and provided consent for the visit, which was conducted through real-time audio and video.The purpose of the visit was to prepare for a preoperative procedure involving sslf, a/p colporrhaphy, and cystoscopy.Previously, the patient had undergone mesh excision, which had been attached to the bowel and required a small bowel resection.However, there have been no problems since the resection, and the patient confirmed that both kidneys are functioning properly.Additionally, there was no history of myocardial infarction, cva, or thromboembolism.On (b)(6) 2022, the patient underwent a post-operative check-up after a sacrospinous ligament suspension, anterior colporrhaphy, enterocele suspension, and cystoscopy on (b)(6) 2022.Initially, the patient experienced severe rectal pain and bowel movement two days after surgery, but the pain has since improved.The patient also reported vaginal tenderness, which is slowly improving.Pain medication was prescribed as needed.The patient has been taking colace bid and miralax as needed, resulting in soft bowel movements without straining.The patient did not report dysuria, but experienced a small amount of uui when delaying voiding, which is improving.There was no occurrence of sui.The patient felt like she was emptying her bladder well, voiding every few hours during the day, with nocturia only once.Vaginal spotting is resolving, pvr is at 50 ml, support is good, and healing is progressing well.A urine culture was sent, post-operative precautions were reinforced, and follow-up is scheduled.During her 6-week postoperative visit on (b)(6) 2022, the patient reported positive progress since her surgery on (b)(6) 2022, which included sacrospinous ligament fixation, anterior colporrhaphy, enterocele suspension, and cystourethroscopy.She confirmed that her pain was under control, and she was able to urinate spontaneously.The patient also mentioned that she did not experience any vaginal bleeding or urinary urgency.She was urinating every 3 hours during the day without any incontinence.Her urinary symptoms had improved significantly, and she was having bowel movements without difficulty.The patient reported that she had not been sexually active before surgery and that her right buttock pain had significantly reduced.On (b)(6) 2022, the patient was here for six-month visit.She thought she can feel it at the vaginal opening but was not feeling it to come out.She was not disappointed about this since she had mesh that was removed requiring bowel resection and now just has a little bit of tissue just inside.During the one-year follow-up appointment on (b)(6) 2022, the patient reported experiencing bleeding and spotting once again.She mentioned taking metamucil for constipation.The patient received treatment for a vaginal polyp with silver nitrate, and although she could feel it, it was not causing any discomfort.However, if the bleeding persists, it may be necessary to remove the polyp in-office.
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It was reported to boston scientific corporation that an uphold vaginal support system was used during a tension-free vaginal tape procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on march 20, 2023: on an unspecified date in 2008, the patient underwent a procedure to place "posterior vaginal prolapse mesh, uphold apical mesh and midurethral sling".On (b)(6) 2021, the patient had mesh erosion, vaginal discharge and recurrent vaginal vault prolapse.The patient underwent a removal of vaginal prolapse mesh, cystourethroscopy, and small bowel resection procedures.Findings include a posterior mesh 3-4 mm from the rectal mucosa without fistula present.The uphold mesh adhered to the small bowel with fistula from the small bowel to the vagina.The mesh noted to be intraabdominal.Cystoscopy revealed no lesions, masses, stones or abnormal vascular patterns.Bilateral efflux of the urine was seen from the ureteral orifices at the end of the case.The urethra was intact.Rectal examination revealed no rectal sutures and no defects.During the procedure, an examination was performed, and stone was seen in the posterior vaginal epithelium at midline 3 cm from the hymenal ring with mesh palpated in the entire posterior compartment.The mesh was palpated at the apex with puckering seen at the apex that was not previously visualized in the office.A lonestar retractor was placed for visualization.Allis clamps were placed, and a vertical incision was made over the exposed mesh.The mesh was carefully dissected away from the vaginal epithelium distally and left index finger was placed into the rectum to determine distance from the rectum to the mesh.It was found to be 3-4 mm with rectal submucosa involved in mesh.Care was taken to carefully dissect the entire mesh sheet away from the rectum and no defect was seen in the rectum.Once the entire width of the mesh was exposed, the mesh was transected in the midline with mayo scissors.The mesh was then dissected toward the right obturator space and carefully removed from the vaginal epithelium and underlying tissue.The mesh sheets were removed, and irrigation was performed.Hemostasis was maintained with sutures.The rectum was oversewn with sutures.The vaginal epithelium was trimmed and closed with sutures.Attention was then turned to the apical mesh excision.A vertical midline incision was made over the apical uphold mesh.This was dissected off the vaginal epithelium.The posterior mesh was found to be intraabdominal and adhered to both peritoneum and small bowel.This was carefully dissected off bowel, however, there was a small area that was tightly adhered and upon further inspection, a few strands of mesh were seen on the small bowel and a fistula was present.This was separated from the mesh and the defect in bowel was seen and irrigated.The repair commenced with two interrupted sutures, however, another area of adhesion was seen, and decision was made to call in colorectal surgery.The physician dissected the bowel out of the vagina and decision was made to perform small bowel resection.Copious irrigation was performed, and hemostasis was noted.The peritoneum and the vaginal epithelium were then closed with sutures.The patient tolerated the procedure well and went to the recovery room in stable condition.
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