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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2020 for the treatment of stress urinary incontinence.Reportedly, the patient had a transvaginal sling revision operation on (b)(6) 2021, in an attempt to relieve the patient's vaginal pain, groin pain, leg pain, and dyspareunia.Furthermore, the patient has experienced significant physical injuries as well as mental and physical pain and suffering, including obturator neuralgia, pudendal neuralgia, nerve pain, incontinence recurrence, and urine issues.Additional information received on august 9, 2023.On (b)(6) 2020, patient came for a post operative evaluation.She stated she could feel the mesh since procedure as well as pressure and some discharge that developed 5 days ago.Urine analysis was normal.On (b)(6) 2020, patient came for a postoperative follow-up visit.She had a robotic hysterectomy with bs and tot.The indication for that procedure was chronic pelvic pain and stress urinary incontinence.She reported still being able to feel the mesh like a wire in her vagina, it felt like a brillo pad in her vagina that developed 1 and a half weeks ago.Physical examination included vaginal exposure on the left side.On (b)(6) 2020, the patient with extrusion of vaginal mesh called crying because she was in a lot of pain.She stated her pain is in her left groin and it travels down to her left leg 8-10/10 on pain scale.She has been using ice/hot packs to help with the pain along with alternating tylenol and ibuprofen.She stated she gets some relief, but it doesn't last long.Her nausea and diarrhea have improved as of that day.The patient asked if she could get a 10-day prescription for hydrocodone to help her with pain until her surgery.She stated her previous gynecologist had prescribed them and it helped with her pain.The physician provided a prescription for acetaminophen-hydrocodone325 mg-5 mg oral tablet, 1 tablet to be taken every 6 hours.The patient was informed that if the pain is so severe 10/10 and pain meds don't help and if she develops fever she will need to go to er.On (b)(6) 2020, the patient visited to the emergency department due to pain in the groin area.She presented to the er for the evaluation of pelvic pain, mostly affecting the left wall of her vagina and left side of the pelvis, onset 2 days ago.She reported a temperature of 100 at home, but denies any dysuria, hematuria, vaginal discharge, flank pain, nausea, vomiting, weakness, dizziness, or other complaints.The pain is sharp and constant, worse when she walks.She denies other complaints or similar symptoms in the past.The patient had surgical mesh eroding through her vaginal wall after a bladder sling procedure and presented with acute worsening of pelvic and vaginal pain that has been ongoing for a few weeks.On examination there is no abdominal tenderness, but she does have pelvic tenderness of the left side of the perineum near the inguinal ligament.There is no bartholin cyst or abscess, no mass, no induration/warmth, no rash to account for this finding.There is no frank purulent vaginal discharge, but there is some vaginitis.The patient was very tender to palpation of the left lateral wall of her vagina, where there is palpable surgical mesh exposed, but there was no obvious fistula tract or abnormal discharge.A swab was sent to evaluate for bacterial vaginosis, yeast infection.The result was mild leukocytosis, small amount of clue cells, which is normal; otherwise unremarkable labs.A ct of the abdomen and pelvis was done and showed no acute surgical pathology.The clinical impression was vaginal erosion due to surgical mesh.The patient's pain improved with treatment in the emergency department that day.Her ct showed no acute surgical pathology.She did have exposed mesh on her vaginal exam, but in reviewing her ob/gyn's note from her last visit, this is stable compared to her prior exam.The patient was discharged home in stable condition.On (b)(6) 2020, it was mentioned in a phone message that right sided groin pain started that week.The patient was concerned about her sex life after the surgery.She was informed that she would be able to resume sexual intercourse after 8 weeks of recovery.Patient wanted pelvic floor physical therapy once healed from surgery.On (b)(6) 2020, the patient underwent mesh revision surgery.Two fragments of mesh material with adherent soft tissue (3.0 x 1.5 x 0.2 cm in aggregate) were removed and sent to pathology.On november 5, 2020, it was stated in a phone message that the patient was very uncomfortable with vaginal pressure and pain in her vagina.She was taking tylenol and ibuprofen.It was normal to have pain for several weeks after surgery but if the pain would not resolve she may need pelvic floor physical therapy, but she would need to be 6 weeks out of surgery prior to that.Patient experienced pain and discomfort in pelvic area two weeks after mesh excision surgery.At times, her hips hurt and her rectum area.Rated her pain as 10/10 in some days, other days pain was less.She had been taking ibuprofen in the morning and after breakfast and norco if she has pain by lunch.Clinical concern included severe pain in her groin area and felt like sawing pain inside her.On december 21, 2020, the patient called and stated that she was having pain which started last monday after going back to work last monday.Surgery was 10/23/20 for mesh excision.After being at work 1 day she had pain radiating from groin up into buttocks and down thighs as well; yesterday this pain was a 10.She was using ice packs for relief.She had some urethral stinging but no pain with urination.No difficulty urinating.Pain level the day of the call was 5, but she took ibuprofen.The patient asked for "pain" med that she can take for level 10 pain.Has not started pf rehab yet.The physician spoke with the patient.The patient was to start pfpt (pelvic floor physical therapy) on january 11.The physician sent in a prescription for vaginal valium suppositories for her to use at night as well as hydrocodone.In a phone message on february 26, 2021, the patient reported she has been having some groin pain that is on and off.There are days that she feels fine but there are other days she has an aching, throbbing pain in her groin and inner thighs.She has been doing the pelvic floor therapy.She wants to know if there is a possibility that she developed an autoimmune disorder from having the mesh.On august 10, 2021, the patient had an office visit to discuss injections, issues with mesh.She was doing very well with complete resolution of pain for 2-3 months.However, after a recent exercise class her pain has recurred and is worse than normal.The patient presented with extrusion of vaginal mesh.She had a sling implanted on july 30, 2020 during a robotic hysterectomy with bilateral salpingectomy.Her vaginal incision opened after surgery, and she has a mesh extrusion.She has been using vaginal estrogen cream.She has small volume stress incontinence with large pressures (vomiting).She denies any urge incontinence.Her nocturia has improved to x1-2 since her hysterectomy.She denies any dysuria, recurrent utis, or gross hematuria.She denies any fi and alternates between loose stools and constipation.She denies any feeling of a vaginal bulge.She can feel the mesh in her vagina with her finger.She then underwent a vaginal mesh excision on 10/23/20 and follows up for her post op visit.Her pain has significantly improved pelvic floor pt and valium vaginal suppositories, but she is frustrated that she is not completely back to normal.She is going to start yoga soon.Her pain currently is bilateral groin crease.She underwent a pudendal nerve block in clinic on march 1, 2021 and may 11, 2021.She reports significant pain relief from the block that lasted approximately 6 weeks.Since late april, however, she reports recurrence of her pain, and this point describes her pain as approaching the same severity as before her block.She continues with pfpt weekly and vaginal valium daily, both of which she feels help.Reports worsening of pain with physical activity.Denies any stress incontinence.Normal bms.Sexually active and reports some mild, new dyspareunia.Also reports new non-pruritic rashes on neck and upper extremities.Vaginal exam noted levator ani muscle is still tight but not as tender as previous exams, able to palpate mesh on right above obturator canal, was tender to palpation over the mesh.Pudendal block was performed bilaterally - ischial spine was palpated through the vagina and 5 ml of a mixture of kenelog 40mg and bupivacaine was injected next to the pudendal nerve bilaterally.Assessment/plan - discussed possibility of mesh removal from right obturator canal through groin, she is considering it - pudendal block that day (august 10, 2021) - discussed permanent block by ir (cryoablation).Specifically, discussed that should she elect to pursue bilateral blocks (since her pain is bilateral), she would run the risk of impacting her ability to achieve orgasm and possibly risk incontinence; her pain is now worse on the right so may consider doing unilateral however she would like to wait on that option.- she is interested in a second opinion with another physician.On february 10, 2022, it was mentioned in an email that most of the mesh was removed, and the pain was fairly well controlled with pelvic floor physical therapy, vaginal valium, and pudendal blocks but keeps returning and she has not been able to resume her normal level of activity.The pudendal blocks have worked the best, but the pain returns after 2 months especially when she exercises.Removing the mesh from the obturator canals was discussed but there was no guarantee it would help.Patient came back today for additional pudendal blocks.After risks, benefits and alternatives were discussed and understood, the patient was placed in the dorsal lithotomy position.The scar and perineal body and skin overlying obturator foramen was prepped with iodine x 3.80 mg of kenalog was then mixed with 30 ml of 0.25% marcaine.Then injected 20ml into obturator foramen at 12 o'clock.She tolerated the procedure well.Obturator pain dropped to 0/10.Able to walk ok after procedure.On march 31, 2022, it was reported that the patient has had multiple bilateral pudendal blocks which do resolve her pain temporarily.She has flares of pain after too much exercise, yoga being the most aggravating.She states that the pain does go down the inside of her leg bilaterally.Additional history stated pain was 5/10 located in the groin and down her medial leg bilaterally.At its worst, pain can be 10/10.The pain is worse with activity and significantly impacts her daily function, including walking and intercourse.Assessment/plan: pelvic pain pain and tenderness over superficial and deep perinei, levator ani, and obturator - dense scar tissue felt on left side obturator space - bilateral obturator n.Block w/ kenolog and bupivacaine: immediate pain improvement - patient counseled on timeline tor steroids to work - f/u 1 mo for reassessment and additional injections (patient might have developed some 6"condary vagmismus or have pain along the pudenda! nerve track as well, may do all 4 blocks next time.) on may 5, 2022 the patient had an office visit for mesh problems.History of present illness: the symptoms began 18 months ago and generally lasts 18 months.The symptoms are reported as being moderate.The symptoms occur daily.The location is vagina.Aggravating factors include activity.Relieving factors include not sure.She states the symptoms are chronic and are uncontrolled.July 2020: pt underwent robotic hysterectomy with bs and sling placement.Operative reports states sling was monarc tot however implant log states it is an advantage fit.October 2020: partial removal (3.0 x 1.5 x 0.2 cm) patient reports pain in bilateral hips that feels like barbed wire' wrapped around her hips.She feels pain radiating down the inside of her thighs to her knees on left and right.She reports bilateral groin pain, slightly worse on the right.She feels and points to a knot present on the vulva side in the right groin which she believes is mesh.She reports bilateral buttock pain, worse after sitting for extended periods of time.All pain is worse with squatting or lifting.She is sexually active and reports dyspareunia, pain occurs on the top wall of the vagina.Patient reports she had a discoloration on her neck that began after surgery in 2020.She also reports a feeling that her immune system is not as effective as previously.Patient reports urinary leakage with laugh/cough/sneeze which has worsened since sling placement.Patient also reported nocturia x2.Review of systems: weight gain nocturia, frequency, stress incontinence headache, memory impairment anxiety, depression, insomnia back pain, joint pain, muscle weakness dyspareunia assessment/plan: surgery has been offered for removal of the previous sling mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, as well as removal of the mesh from the obturator and adductor muscle.On may 9, 2022, pathology final diagnosis was polarizable synthetic mesh with foreign body reaction and mild chronic inflammation.
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