MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Fever (1858); Micturition Urgency (1871); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Rash (2033); Scar Tissue (2060); Tachycardia (2095); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Dysuria (2684); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient code e2401 captures the reportable event of unknown injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient experienced an unknown injury.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system device was implanted into the patient during a tension-free vaginal tape placement (solyx), cystoscopy and hydrodistention of the bladder, instillation of intravesical medications, and urethral dilation procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence, urinary frequency, and interstitial cystitis.During the hydrodistention of the bladder, which began at 80 cm of water pressure, the patient's bladder was held at maximum capacity for 2 minutes.The only finding of note was a 2 cm cluster of numerous blood vessels on the posterior aspect of the bladder, consistent with hunner's lesion; otherwise, there were no other abnormalities.The patient's bladder was then emptied with 1450 ml of clear irrigant.Another look was undertaken, and this revealed scattered petechiae bilateral to each ureteral orifice and the trigone, but no other interesting findings.The scope was removed, and the urethra was gently dilated to 30-french using van buren sounds.A final look was undertaken with the cystoscope, and this revealed an unscathed urethra, certainly with no evidence of bladder trauma.On (b)(6) 2020, the patient complained of urinary incontinence and pelvic pain for 2 months, which worsened today.The patient reported that she had bladder mesh implanted at the beginning of the year.She had a history of hypothyroidism and was presented to the emergency department (ed) for complaints of llq (left lower quadrant) pain and back pain radiating down to the left leg for over 2 weeks.Moreover, the patient was negative for kidney stones, and the pelvic ultrasound was unremarkable.She had a history of hysterectomy and had follow-up with her urologist due to a history of mesh sling and a single episode of incontinence.She was advised by her physician to see a pain specialist with a pending appointment.Additionally, the patient tried gabapentin and percocet without improvement.The patient was diagnosed with pelvic pain, ovarian cyst, abdominal pain, urinary tract infection, uterine fibroid, and radiculopathy.On (b)(6) 2020, the patient presented to the emergency department for continued electrical shock-like abdominal and pelvic pain that had been ongoing for several weeks now.She had a low-grade fever of 100.0 f this morning with nausea and diarrhea.In addition, the patient received ct scans and ultrasounds, as well as pain medications, before being discharged home after receiving morphine.The patient continued to have severe abdominal pain and described it as similar to an electric shock.It was rated 10/10 for pain and was unbearable.She stated that she previously had an allergic reaction to breast implants and believed that she could be having some sort of reaction as she did have bladder mesh, but her ct scan was repeated, and the patient had no acute findings and was discharged home.She is now requesting an mri of her abdomen.The patient has not been able to follow-up with the ob/gyn.She stated that she was waiting for a referral from her pcp, but she was prescribed percocet, and this was not taking care of her pain.She continues to have tenderness and pain despite taking the percocet at home.The patient stated that she was treated for yeast infection, started on steroids, and was given diflucan and a week's course of over-the-counter treatment.The patient had no new sexual partners and no history of stis.The patient had tvh (total vaginal hysterectomy) radiology to examine her for her generalized abdominal pain.Then, transabdominal real-time grayscale echograms of the pelvis were obtained and showed that her uterus was surgically absent, her ovaries were not seen secondary to bowel gas, her urinary bladder was grossly normal, and there was no adnexal mass or free fluid.On (b)(6) 2020, the patient was seen for chronic pelvic pain, an interstitial cystitis flare-up, and possible bladder mesh irritation.She presented with 10 months of pelvic/abdominal pain.The patient did have a history of interstitial cystitis, diagnosed and managed by her urologist.She had a hysterectomy in 2014 for fibroids, and a bladder repair in 2020.She reported that since her bladder repair with sling mesh insertion, she has had a constant, 8/10 feeling of being "electrocuted" throughout her pelvic area, which radiates to her lower back, and it worsens when she moves.She is a nurse and has been out of work for several months due to pain.The patient mentioned that she does not feel that this pain is solely related to her underlying diagnosis of interstitial cystitis as it was not present prior to the transobturator tape (tot) sling mesh procedure.Between her urologist and her pcp, she had tried steroids, levaquin, over the counter azos, 2 heparin instills, gabapentin, and amitriptyline, none of which had helped.Moreover, the patient stated that her body does not react well with foreign objects, e.G., she had "breast implant syndrome" and required explantation of silicone breast implants in the past.She mentioned that she has had a persistent vaginal discharge since the sling mesh surgery that does not resolve with medications.The patient would like to discuss bladder mesh removal.In addition, during the review of systems, the patient was positive for fever, cough, shortness of breath, chest pain, and palpitations.She also has abdominal pain, dysuria, frequency, urgency, back pain, joint pain, myalgias and polydipsia.On (b)(6) 2020, the patient underwent complete sling excision, cystoscopy, and treatment of interstitial cystitis lesions due to rejection and allergy.On (b)(6) the patient underwent a physical therapy initial examination for her neuralgia and neuritis.She reported residual pain and tension.Her pain was constant.The patient started walking a couple of months ago and was noticing a lot of left hip pain.She was then referred to physical therapy for treatment.On (b)(6) 2021, the patient had a follow-up visit and reported that her herpes/shingles was resolved.However, the pain was still there and was worsening constantly with a rate of 9/10, and it felt like a knife was stabbing her over and over.She had to leave her shift early as a nurse multiple times last week because her pain was so severe.The patient took flexeril, but it knocked her out, so she could only take it at night, which did help some, but sometimes wakes up during the night still.Gabapentin helped her minimally.The patient took percocet when she got home from work.The pain was severe, but lately it feels like it hasn't been helping as much.The pain remained mostly in the llq (left lower quadrant) abdomen, and she also had a burning sensation in all of her right-sided abdomen and radiated to the left groin.She sometimes has burns inside her vagina as well.She felt like she was losing the ability to function because of this pain.During assessment, the patient had neuropathy of the left ilioinguinal nerve, chronic pelvic pain, and an overactive bladder.On (b)(6) 2021, the patient experienced left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.Her symptoms started after the pelvic mesh was inserted in (b)(6) 2020.The patient had mesh removal surgery on (b)(6) 2020.She still felt pain.She also experiences left pelvic pain, lower back pains, abdominal bloating, constipation, vaginal discharge, stress, and urges of incontinence in a few drops during sneezes/laughs/coughs/jumping/fatigue/sweats.The patient underwent acupuncture and heat treatment.On (b)(6) 2021, the patient experienced left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.Her symptoms have been relieved for up to 2 days.She experiences left pelvic pain and lower back pain.Soft stools occur every day after her previous treatment.She has made plans to have a 3d-ultrasound regarding her condition.The patient underwent acupuncture and heat treatment on both sides.On (b)(6) 2021, the patient had persistent pelvic pain involving distribution of left ilioinguinal nerve s/p sling mesh and breast implant removals.Moreover, she mentioned that she could barely stay at work long enough to meet the minimum requirements due to the llq pain problems.The pain has a crampy nature and extends to the pelvis.There was no fever, vomiting, dysuria, or diarrhea experienced.The patient is not currently sexually active.Additionally, she has a persistent yeast type vulvovaginal irritation that has not responded to standard treatment.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402 and e2326 capture the reportable event of pain (pelvic pain, llq pain, back pain, joint pain, myalgias, muscle tension pain, pain to abdominal pelvis and bladder), abdominal pain, nerve damage (neuralgia, neuritis, and back pain radiating down left leg x2 weeks, "electrocuted" throughout her pelvic area, radiates to her lower back), neuropathy of left ilioinguinal nerve, urinary tract infection, infection (candidiasis, yeast infection), allergic reaction, and inflammation (interstitial cystitis flare up), respectively.Impact codes f1903, f19, f23 and f2303 capture the reportable events of device explantation, surgical intervention, unexpected medical intervention and medication required, respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system device was implanted into the patient during a tension-free vaginal tape placement (solyx), cystoscopy and hydrodistention of the bladder, instillation of intravesical medications, and urethral dilation procedure performed on (b)(6), 2020, for the treatment of stress urinary incontinence, urinary frequency, and interstitial cystitis.During the hydrodistention of the bladder, which began at 80 cm of water pressure, the patient's bladder was held at maximum capacity for 2 minutes.The only finding of note was a 2 cm cluster of numerous blood vessels on the posterior aspect of the bladder, consistent with hunner's lesion; otherwise, there were no other abnormalities.The patient's bladder was then emptied with 1450 ml of clear irrigant.Another look was undertaken, and this revealed scattered petechiae bilateral to each ureteral orifice and the trigone, but no other interesting findings.The scope was removed, and the urethra was gently dilated to 30-french using van buren sounds.A final look was undertaken with the cystoscope, and this revealed an unscathed urethra, certainly with no evidence of bladder trauma.On (b)(6) 2020, the patient presented to the emergency department (ed) with pelvic pain for 2 months, which worsened that day.She also reported an episode of urinary incontinence that day.The patient reported a history of hypothyroidism and presented to the ed for complaints of llq (left lower quadrant) pain and back pain radiating down to the left leg for over 2 weeks.Moreover, the patient was negative for kidney stones, and pelvic ultrasound was unremarkable at a previous ed visit., the patient had tried gabapentin and percocet without improvement.Ct of the abdomen and pelvis showed no abnormalities.Ct of the left spine showed 2mm disc bulge at l2-l3 and spondylosis at left l5.The impression was lumbosacral degenerative disc disease (ddd), back pain, disc bulge l2-l3, and spondylosis l5.The patient was prescribed diflucan and cyclobenzaprine and provided information about ddd and lumbar radiculopathy.She was to follow-up with her urologist due to a history of mesh sling and a single episode of incontinence.She was advised by her physician to see a pain specialist with a pending appointment.On (b)(6), 2020, the patient presented to the emergency department for continued electrical shock-like abdominal and pelvic pain that had been ongoing for several weeks now.She had a low-grade fever of 100.0 f that morning with nausea and diarrhea.The patient had been seen at eds previously where she underwent ct scans and ultrasounds, received pain medications, and was discharged home after receiving morphine.The patient continued to have severe abdominal pain and described it as similar to an electric shock.It was rated 10/10 for pain and was unbearable.She stated that she previously had an allergic reaction to breast implants and believed that she could be having some sort of reaction as she did have bladder mesh.She was requesting an mri of her abdomen.The patient has not been able to follow-up with the ob/gyn.She stated that she was waiting for a referral from her pcp, but she was prescribed percocet, and this was not taking care of her pain.She continues to have tenderness and pain despite taking the percocet at home.The patient stated that she was treated for yeast infection, started on steroids, and was given diflucan and a week's course of over-the-counter treatment.The patient had no new sexual partners and no history of stis.The patient declined a vaginal exam.Pelvic ultrasound showed no abnormalities, lab work was unremarkable, and there were no acute findings to warrant further evaluation.It was noted that the patient's behavior was somewhat strange as she was requesting narcotics and had been seen at 2 different eds recently.The patient was given toradol but no narcotics were given as she had pain medication at home and a plan for follow-up pending.On (b)(6) 2020, the patient was seen for chronic pelvic pain, an interstitial cystitis flare-up, and possible bladder mesh irritation.She presented with 10 months of pelvic/abdominal pain.The patient did have a history of interstitial cystitis, diagnosed and managed by her urologist.She had a hysterectomy in 2014 for fibroids, and a bladder repair in 2020.She reported that since her bladder repair with sling mesh insertion, she has had a constant, 8/10 feeling of being "electrocuted" throughout her pelvic area, which radiates to her lower back, and it worsens when she moves.She is a nurse and has been out of work for several months due to pain.The patient mentioned that she does not feel that this pain is solely related to her underlying diagnosis of interstitial cystitis as it was not present prior to the transobturator tape (tot) sling mesh procedure.Between her urologist and her pcp, she had tried steroids, levaquin, over the counter azos, 2 heparin instills, gabapentin, and amitriptyline, none of which had helped.Moreover, the patient stated that her body does not react well with foreign objects, e.G., she had "breast implant syndrome" and required explantation of silicone breast implants in the past.She mentioned that she has had a persistent vaginal discharge since the sling mesh surgery that does not resolve with medications.The patient would like to discuss bladder mesh removal.In addition, during the review of systems, the patient was positive for fever, cough, shortness of breath, chest pain, and palpitations, abdominal pain, dysuria, frequency, urgency, back pain, joint pain, myalgias and polydipsia.Exam revealed well healed tot scars in the groin, well-estrogenized vaginal walls, thick white discharge, tenderness at the vaginal apex and at the internal obturator muscles lateral to the sling pathway on both sides, and pelvic floor muscle strength 2/5.Diagnoses included pelvic pain, interstitial cystitis, and complication of implanted vaginal mesh.The plan included lifestyle changes including weight loss, timed voiding, pelvic floor muscle exercises, and avoiding bladder irritants.The patient consented to and was scheduled for complete sling excision (both intra and extra pelvic components of the transobturator sling), cystoscopy, and treatment of interstitial cystitis.On (b)(6), 2020, the patient underwent complete excision of the sub-urethral sling, kelly plication of the urethra, cystourethroscopy with bladder installation, and treatment of interstitial cystitis lesions.The patient had a history of bladder and pelvic pain, possibly related to a previously inserted polypropylene mid-urethral sling.She also had a history of bladder pain, but with normal findings on cystourethroscopy today, and had a history of breast implant syndrome.According to the findings, the patient's uterus was surgically absent with no significant pelvic organ prolapses or pelvic masses.The single incision sling was located lying flat at the normal mid sub-urethral location with no visible tissue reaction except for thickening of scar tissue along the left periurethral fornix adjacent to the sling.The sling appeared to have been previously cut through in the midline, apparently to release tension, but both arms were fully intact, extending out to the anchor points in the obturator internus muscle on either side.Also, the sling was able to be fully removed, including the anchoring tips.Furthermore, there was normal appearance of the urethral canal, trigone structures, and bladder urothelial surfaces with bilateral ureteric efflux seen after sling removal, but no glomerulations, hunner's ulcers, or other signs of disease were found.Additionally, 60cc of 2% lidocaine with 10cc of sodium bicarb and 40mg of kenalog were used for the bladder installation at the end of the case.Surgical pathological findings revealed foreign material (mesh) being removed from the patient's sub-urethral region secondary to bladder pain.On (b)(6) 2020, 2 weeks and 4 days post-op, the patient had complaints of pelvic burning but was manageable with pain meds and not as severe as prior to the sling removal surgery.She had concerns about when she could return to work as a nurse.She had urinary incontinence and urinary urgency, which occurred with a new urgency where if she does not make it to the bathroom fast enough, she leaks a small amount of urine.During this time, the patient reported pain in the llq pelvis but improved from 10/10 electrocution pain to a 7/10 burning sensation which worsened over the course of the day.She had to take a tablet of percocet to help her sleep, with no other medications during the day.On (b)(6), 2021, 6 weeks postoperative, the patient still had burning where the mesh was at the llq abdominal wall.She still had urinary urgency and urinary frequency.During the physical exam, it was observed that the patient had signs of a yeast infection.Her vaginal walls were well healed with non-tender periurethral tissues.The only site of tenderness was at her upper left vaginal apex in the region of innervation of the left ilioinguinal nerve.The patient had appropriate postoperative progress but has persistent pelvic pain involving left ilioinguinal neuralgia with trigger point.She had to do a follow-up check-up in 1 week for left ilioinguinal neuralgia tp injection using kenalog and lidocaine 2% with epi2.The physician and the patient discussed pelvic floor muscle exercises for the future and appropriate postoperative activities.The physician had written a note expecting the patient to be able to return to work as an or/pacu nurse within 3 to 4 weeks.The patient was given medication, diflucan 150mg per oral.Furthermore, in (b)(6) 2021, the patient had ilioinguinal neurectomy and lysis of adhesions intra-abdominal without any improvement in pain.She is currently complaining of a shooting pain in her vagina, especially on the left side, and pain in her tailbone.There is some pain in the groin and inside of the leg.The patient has severe hypersensitivity to touch in the perineal area and has been wearing baggy pants, long skirts, and no underwear.She had one botox injection by the provider who removed the mesh, but it was 100 units done in the office, which again was extremely painful.On (b)(6) 2021, the patient had trigger point injections (tpi) for neuropathy of left ilioinguinal nerve.Following the tpi, the patient had a severe herpes/shingles outbreak (her first one).On (b)(6) 2021, the patient underwent a physical therapy initial examination for residual pelvic pain (described as burning pelvic floor pain between 5 and 7 on a scale from 1-10) and tension following mesh excision.Her pain was constant.The patient started walking a couple of months ago and was noticing a lot of left hip pain.She was then referred to physical therapy for treatment.The diagnosis was documented as neuralgia and neuritis, unspecified.Patient problems were noted as limited range of motion, limited strength, and pelvic floor dysfunction.The plan was for pt to gain pain free lumbar range of motion, improve left extremity strength, and improve pelvic floor function.On (b)(6), 2021, the patient had a follow-up visit and reported that her herpes/shingles was resolved.However, the pain was still there and was worsening constantly with a rate of 9/10, and it felt like a knife was stabbing her over and over.She had to leave her shift early as a nurse multiple times last week because her pain was so severe.The patient took flexeril, but it knocked her out, so she could only take it at night, which did help some, but sometimes wakes up during the night still.Gabapentin helped her minimally.The patient took percocet when she got home from work if her pain was severe, but lately it feels like it hasn't been helping as much.The pain remained mostly in the llq (left lower quadrant) abdomen, and she also had a burning sensation in all of her right-sided abdomen that radiated to the left groin.She sometimes has burning inside her vagina as well.She felt like she was losing the ability to function because of this pain.On physical exam, the patient was exquisitely tender on palpation of her left abdomen, greatest in the llq.The assessment was neuropathy of the left ilioinguinal nerve, chronic pelvic pain, and an overactive bladder.The patient was not a candidate for repeat tpi given her severe herpetic breakout.With continued pain after mesh removal and neuralgia type pain, continued after mesh removal, she was referred to pain management.If pain cannot be controlled, it was noted she may need laparoscopic lysis of adhesions (for suspected post tvh/bso adhesions contributing to the pain), possible release of left ilioinguinal nerve entrapment, and cystoscopy with treatment of interstitial cystitis.The plan also included 3d pelvic ultrasound to evaluate for pelvic sling mesh remnants that might be causing pain, continue flexeril at night, prescribe lidocaine patches and tramadol tid prn, continue myrbetriq 50mg mdaily for urge symptoms.Patient wanted to try acupuncture and the physician was going to arrange that.On (b)(6) 2021, the patient presented for acupuncture for left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.She also experienced left pelvic pain, lower back pains, abdominal bloating, constipation, vaginal discharge, stress, and urges of incontinence in a few drops during sneezes/laughs/coughs/jumping/fatigue/sweats.The patient underwent acupuncture and heat treatment.On (b)(6), 2021, the patient returned for acupuncture.Her symptoms have been relieved for up to 2 days.Soft stools occur every day after her previous treatment.She has made plans to have a 3d-ultrasound regarding her condition.The patient underwent acupuncture and heat treatment on both sides.On (b)(6) 2021, the patient presented to her obgyn for persistent pelvic pain involving distribution of left ilioinguinal nerve s/p sling mesh and breast implant removals.Moreover, she mentioned that she could barely stay at work long enough to meet the minimum requirements due to the llq pain problems.The pain has a crampy nature and extends to the pelvis.There was no fever, vomiting, dysuria, or diarrhea experienced.The patient is not currently sexually active.Additionally, she has a persistent yeast type vulvovaginal irritation that has not responded to standard treatment.The diagnoses included pelvic pain, neuropathy of left ilioinguinal nerve, and myalgia for which lido 2% with epi, kenalog, and bicarb trigger point injection into the left ilioinguinal tender point was done with good effect.The diagnoses also included muscle tension pain for which she was prescribed valium 5mg po bid as needed and valium rectal gel 10 mg to insert daily as needed, and candidiasis for which voriconazole 200mg po bid x 5 days was prescribed.The patient was to return in one week.On (b)(6), 2021, the patient had complaints of pelvic pain.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.The patient continues to have significant pain, which is most likely due to the pelvic floor muscle spasm and possibly to an element of pudendal neuralgia.During the counseling with the physician, she understood that it would be best to first address her muscles, and if there is no improvement, proceed with her nerve treatment.The proposed treatment was discussed with the patient.She understood, and she's going to look for a sola therapy provider in southern california.She will then decide whether she wants to proceed with sola or botox.On (b)(6), 2021, the patient underwent ultrasound guided left obturator nerve block, bilateral pudendal nerve block, and botox injection to the pelvic floor muscles r-50 units and l-150 units.Verbal consent was obtained before the procedure.The patient was found not to be allergic to betadine, local anesthetic or botox.The patient was brought to the procedure room.She was placed in a supine position and anesthesia was given.Under ultrasound guidance, the anterior branch of the left obturator nerve was blocked with 10 ml of 2% lidocaine.The patient was woken up.She had complete relief of pain in the left groin area.The patient was placed in a dorsal lithotomy position.She was examined and bilateral spasm of pelvic floor muscles was found from left to right.The patient was then again placed under general anesthesia.A bilateral pudendal nerve block was then done using a total of 20ml of 2% lidocaine.A pudendal nerve block needle was used to inject 10 ml into each ischial spine.The left obturator internus muscle was palpated again and there was no bead from the mesh identified.There was a significant spasm of the left obturator internus muscle with a band of tissue (spasming muscle) traversing the obturator foramen.200 units of botox were then resuspended in 20ml of normal sterile saline.They were injected into pelvic floor muscles bilaterally at a volume of 1 ml per injection.There were approximately 15 injections done on the left and 5 on the right.Care was taken to inject into the spasming band of the obturator internus muscle on the left.This concluded the procedure.The patient tolerated the procedure well.She was taken to recovery room in stable condition.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to january 9, 2020, the date the sling was implanted, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(6).United states phone no:(b)(6).Fax no:(b)(6).(b)(6) university.(b)(6).(b)(6).Phone no: (b)(6).Fax no: (b)(6).(b)(6) center, inc.(b)(6) pt, dpt.Dr.(b)(6) dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402, e2326, e2006, e1715, and e232401 capture the reportable event of pain (pelvic pain, llq pain, back pain, joint pain, myalgias, muscle tension pain, pain to abdominal pelvis and bladder), abdominal pain, nerve damage (neuralgia, neuritis, and back pain radiating down left leg x2 weeks, "electrocuted" throughout her pelvic area, radiates to her lower back), neuropathy of left ilioinguinal nerve, urinary tract infection, infection (candidiasis, yeast infection), allergic reaction, hypersensitivity (severe hypersensitivity to touch in the perineal area), inflammation (interstitial cystitis flare up), erosion (foreign material-mesh), scar tissue (thickening of scar tissue along the left peri-urethral fornix adjacent to the sling),and fecal incontinence, respectively.Impact codes f1202, f1903, f19, f23 and f2303 capture the reportable events of disability (patient has been out of work for several months due to pain), device explantation, surgical intervention, unexpected medical intervention and medication required, respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h11: blocks b5 event description and h6 patient codes have been corrected.Block b5 has been updated based on the additional information received on september 01, 2022.Block b3 date of event: date of event was approximated to january 9, 2020, the date the sling was implanted, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), phone no: (b)(6), fax no: (b)(6).Phone no: (b)(6).Fax no: (b)(6).Dr.(b)(6).Dr.(b)(6) block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402, e2326, and e1715, capture the reportable event of pain (pelvic pain, llq pain, back pain, joint pain, myalgias, muscle tension pain, pain to abdominal pelvis and bladder), abdominal pain, nerve damage (neuralgia, neuritis, and back pain radiating down left leg x2 weeks, "electrocuted" throughout her pelvic area, radiates to her lower back), neuropathy of left ilioinguinal nerve, urinary tract infection, infection (candidiasis, yeast infection), allergic reaction, inflammation (interstitial cystitis flare up), and scar tissue (thickening of scar tissue along the left peri-urethral fornix adjacent to the sling), respectively.Impact codes f1202, f1903, f19, f23 and f2303 capture the reportable events of disability (patient has been out of work for several months due to pain), device explantation, surgical intervention, unexpected medical intervention and medication required, respectively.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system device was implanted into the patient during a tension-free vaginal tape (tvt) placement (solyx), cystoscopy and hydrodistention of the bladder, instillation of intravesical medications, and urethral dilation procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence, urinary frequency, and interstitial cystitis.During the hydrodistention of the bladder, which began at 80 cm of water pressure, the patient's bladder was held at maximum capacity for 2 minutes.The only finding of note was a 2 cm cluster of numerous blood vessels on the posterior aspect of the bladder, consistent with hunner's lesion; otherwise, there were no other abnormalities.The patient's bladder was then emptied with 1450 ml of clear irrigant.Another look was undertaken, and this revealed scattered petechiae bilateral to each ureteral orifice and the trigone, but no other interesting findings.The scope was removed, and the urethra was gently dilated to 30-french using van buren sounds.A final look was undertaken with the cystoscope, and this revealed an unscathed urethra, certainly with no evidence of bladder trauma.On (b)(6) 2020, the patient felt great after hydrodistention and tvt last week.She had a 1450cc capacity and a few scattered petechiae.The patient was already thrilled with the results: no stress urinary incontinence (sui) and much less bladder pain.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient was a status post-tvt and reported 2 episodes of sui since the procedure, but overall was doing well.She reported that the hydrodistention improved her dysuria.She still complained of urgency and the frequency of urination.She was on aloe vera capsules daily.There was no gross hematuria or dysuria.Additionally, the genitourinary was healing well.There was no erosion or extrusion, no coughing leak, and no prolapse.On (b)(6) 2020, the patient presented with pain in llq radiating into her back.She reported that the pain was worse when she stood but that she was constantly in discomfort regardless of her position.She stated that this pain had progressively gotten worse in the past 2-3 weeks.Per patient, she visited the er and had a ct as well as an ultrasound done with no remarkable findings.The patient has also had labs drawn with her primary.She was given morphine as well as an rx for painkillers but stated that nothing was helping with her pain.The patient also reported having urinary frequency all day and nocturia throughout the night.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient presented to the emergency department (ed) with pelvic pain for 2 months, which worsened that day.She also reported an episode of urinary incontinence that day.The patient reported a history of hypothyroidism and presented to the ed for complaints of llq (left lower quadrant) pain and back pain radiating down to the left leg for over 2 weeks.Moreover, the patient was negative for kidney stones, and pelvic ultrasound was unremarkable at a previous ed visit., the patient had tried gabapentin and percocet without improvement.Ct of the abdomen and pelvis showed no abnormalities.Ct of the left spine showed 2mm disc bulge at l2-l3 and spondylosis at left l5.The impression was lumbosacral degenerative disc disease (ddd), back pain, disc bulge l2-l3, and spondylosis l5.The patient was prescribed diflucan and cyclobenzaprine and provided information about ddd and lumbar radiculopathy.She was to follow-up with her urologist due to a history of mesh sling and a single episode of incontinence.She was advised by her physician to see a pain specialist with a pending appointment.On (b)(6) 2020, the patient presented to the emergency department for continued electrical shock-like abdominal and pelvic pain that had been ongoing for several weeks now.She had a low-grade fever of 100.0 f that morning with nausea and diarrhea.The patient had been seen at eds previously where she underwent ct scans and ultrasounds, received pain medications, and was discharged home after receiving morphine.The patient continued to have severe abdominal pain and described it as similar to an electric shock.It was rated 10/10 for pain and was unbearable.She stated that she previously had an allergic reaction to breast implants and believed that she could be having some sort of reaction as she did have bladder mesh.She was requesting an mri of her abdomen.The patient has not been able to follow-up with the ob/gyn.She stated that she was waiting for a referral from her pcp, but she was prescribed percocet, and this was not taking care of her pain.She continues to have tenderness and pain despite taking the percocet at home.The patient stated that she was treated for yeast infection, started on steroids, and was given diflucan and a week's course of over-the-counter treatment.The patient had no new sexual partners and no history of stis.The patient declined a vaginal exam.Pelvic ultrasound showed no abnormalities, lab work was unremarkable, and there were no acute findings to warrant further evaluation.It was noted that the patient's behavior was somewhat strange as she was requesting narcotics and had been seen at 2 different eds recently.The patient was given toradol but no narcotics were given as she had pain medication at home and a plan for follow-up pending.On (b)(6) 2020, the patient was taking oxycodone twice a day for pain.The patient noted that she was consistently taking aloe vera for her interstitial cystitis.The patient denied gross hematuria, infections, stones, incontinence, fever, chills, vomiting, nausea, or infection.The patient did not receive pain management as previously ordered.The patient stated her primary care provider said her pain was not "chronic" and pain management was not warranted at this time.Additionally, the patient was requesting a work note.She continued to take pain medications and gabapentin, which made her very sleepy all day.On (b)(6) 2020, the patient with interstitial cystitis was for follow-up as she had not improved with heparin instillation.She complained of burning in her abdomen as well as pelvic pain.She noted that gabapentin caused tremors.The patient was on aloe vera capsules and urogesic prn.According to her primary care provider, she has been taking vitamin c and narcotics.The pain medication did not help her pain.She previously had good relief for 3 months with hydrodistention.She complained of having an episode of uui when walking.The patient stated that difflucan was used to treat multiple yeast infections.She is not currently sexually active due to pelvic pain.Apparently, the patient denied stress urinary incontinence.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient with pelvic pain is here for follow-up.The patient complains of a burning sensation and a rash from her chest to her thighs for 1 month.The patient noted that she had an allergic reaction to amitriptyline as she felt that she was having a stroke.She was treated for yeast infections, but when she went to the gyn, she was told she didn't have yeast infection based on culture.The patient had tremors with gabapentin.Per her primary care provider, she has been off all medications except zofran (prn) for nausea.The patient complained of chest pain and heart palpitations.The patient noted that she previously had silicone leakage from breast implants, which caused an immune response and had them removed in 2012.The patient had no gross hematuria and dysuria.On (b)(6) 2020, the patient presented for cysto and installation of heparin.She noted that she had not yet gone to pfpt, but she was authorized to make an appointment.She stated that she planned on making an appointment today.She was on metroprolol and aloe vera.The patient had no gross hematuria and dysuria.On (b)(6) 2020, the patient was seen for chronic pelvic pain, an interstitial cystitis flare-up, and possible bladder mesh irritation.She presented with 10 months of pelvic/abdominal pain.The patient did have a history of interstitial cystitis, diagnosed and managed by her urologist.She had a hysterectomy in 2014 for fibroids, and a bladder repair in 2020.She reported that since her bladder repair with sling mesh insertion, she has had a constant, 8/10 feeling of being "electrocuted" throughout her pelvic area, which radiates to her lower back, and it worsens when she moves.She is a nurse and has been out of work for several months due to pain.The patient mentioned that she does not feel that this pain is solely related to her underlying diagnosis of interstitial cystitis as it was not present prior to the transobturator tape (tot) sling mesh procedure.Between her urologist and her pcp, she had tried steroids, levaquin, over the counter azos, 2 heparin instills, gabapentin, and amitriptyline, none of which had helped.Moreover, the patient stated that her body does not react well with foreign objects, e.G., she had "breast implant syndrome" and required explantation of silicone breast implants in the past.She mentioned that she has had a persistent vaginal discharge since the sling mesh surgery that does not resolve with medications.The patient would like to discuss bladder mesh removal.In addition, during the review of systems, the patient was positive for fever, cough, shortness of breath, chest pain, and palpitations, abdominal pain, dysuria, frequency, urgency, back pain, joint pain, myalgias and polydipsia.Exam revealed well healed tot scars in the groin, well-estrogenized vaginal walls, thick white discharge, tenderness at the vaginal apex and at the internal obturator muscles lateral to the sling pathway on both sides, and pelvic floor muscle strength 2/5.Diagnoses included pelvic pain, interstitial cystitis, and complication of implanted vaginal mesh.The plan included lifestyle changes including weight loss, timed voiding, pelvic floor muscle exercises, and avoiding bladder irritants.The patient consented to and was scheduled for complete sling excision (both intra and extra pelvic components of the transobturator sling), cystoscopy, and treatment of interstitial cystitis.On (b)(6) 2020, the patient underwent complete excision of the sub-urethral sling, kelly plication of the urethra, cystourethroscopy with bladder installation, and treatment of interstitial cystitis lesions.The patient had a history of bladder and pelvic pain, possibly related to a previously inserted polypropylene mid-urethral sling.She also had a history of bladder pain, but with normal findings on cystourethroscopy today, and had a history of breast implant syndrome.According to the findings, the patient's uterus was surgically absent with no significant pelvic organ prolapses or pelvic masses.The single incision sling was located lying flat at the normal mid sub-urethral location with no visible tissue reaction except for thickening of scar tissue along the left periurethral fornix adjacent to the sling.The sling appeared to have been previously cut through in the midline, apparently to release tension, but both arms were fully intact, extending out to the anchor points in the obturator internus muscle on either side.Also, the sling was able to be fully removed, including the anchoring tips.Furthermore, there was normal appearance of the urethral canal, trigone structures, and bladder urothelial surfaces with bilateral ureteric efflux seen after sling removal, but no glomerulations, hunner's ulcers, or other signs of disease were found.Additionally, 60cc of 2% lidocaine with 10cc of sodium bicarb and 40mg of kenalog were used for the bladder installation at the end of the case.Surgical pathological findings revealed foreign material (mesh) being removed from the patient's sub-urethral region secondary to bladder pain.On (b)(6) 2020, 2 weeks and 4 days post-op, the patient had complaints of pelvic burning but was manageable with pain meds and not as severe as prior to the sling removal surgery.She had concerns about when she could return to work as a nurse.She had urinary incontinence and urinary urgency, which occurred with a new urgency where if she does not make it to the bathroom fast enough, she leaks a small amount of urine.Patient continued to have pain and she had multiple different trigger point injections to pelvic floor which were excruciating.She started using lidocaine patches on her perineal area which gave her urinary and fecal incontinence when she was using them.During this time, the patient reported pain in the llq pelvis but improved from 10/10 electrocution pain to a 7/10 burning sensation which worsened over the course of the day.She had to take a tablet of percocet to help her sleep, with no other medications during the day.The assessment was appropriate postoperative progress with new urge incontinence.The plan was estrogen cream placed in the vagina nightly, a trial of toviaz for one month, and follow up in 3 weeks.On (b)(6) 2021, 6 weeks postoperative, the patient still had burning where the mesh was at the llq abdominal wall.She still had urinary urgency and urinary frequency.During the physical exam, it was observed that the patient had signs of a yeast infection.Her vaginal walls were well healed with non-tender periurethral tissues.The only site of tenderness was at her upper left vaginal apex in the region of innervation of the left ilioinguinal nerve.The patient had appropriate postoperative progress but has persistent pelvic pain involving left ilioinguinal neuralgia with trigger point.She had to do a follow-up check-up in 1 week for left ilioinguinal neuralgia tp injection using kenalog and lidocaine 2% with epi2.The physician and the patient discussed pelvic floor muscle exercises for the future and appropriate postoperative activities.The physician had written a note expecting the patient to be able to return to work as an or/pacu nurse within 3 to 4 weeks.The patient was given medication, diflucan 150mg per oral.Furthermore, in january 2021, the patient had ilioinguinal neurectomy and lysis of adhesions intra-abdominal without any improvement in pain.On (b)(6) 2021, the patient had trigger point injections (tpi) for neuropathy of left ilioinguinal nerve.Following the tpi, the patient had a severe herpes/shingles outbreak (her first one).On (b)(6) 2021, the patient underwent a physical therapy initial examination for residual pelvic pain (described as burning pelvic floor pain between 5 and 7 on a scale from 1-10) and tension following mesh excision.Her pain was constant.The patient started walking a couple of months ago and was noticing a lot of left hip pain.She was then referred to physical therapy for treatment.The diagnosis was documented as neuralgia and neuritis, unspecified.Patient problems were noted as limited range of motion, limited strength, and pelvic floor dysfunction.The plan was for pt to gain pain free lumbar range of motion, improve left extremity strength, and improve pelvic floor function.On (b)(6) 2021, the patient had a follow-up visit and reported that her herpes/shingles was resolved.However, the pain was still there and was worsening constantly with a rate of 9/10, and it felt like a knife was stabbing her over and over.She had to leave her shift early as a nurse multiple times last week because her pain was so severe.The patient took flexeril, but it knocked her out, so she could only take it at night, which did help some, but sometimes wakes up during the night still.Gabapentin helped her minimally.The patient took percocet when she got home from work if her pain was severe, but lately it feels like it hasn't been helping as much.The pain remained mostly in the llq (left lower quadrant) abdomen, and she also had a burning sensation in all of her right-sided abdomen that radiated to the left groin.She sometimes has burning inside her vagina as well.She felt like she was losing the ability to function because of this pain.On physical exam, the patient was exquisitely tender on palpation of her left abdomen, greatest in the llq.The assessment was neuropathy of the left ilioinguinal nerve, chronic pelvic pain, and an overactive bladder.The patient was not a candidate for repeat tpi given her severe herpetic breakout.With continued pain after mesh removal and neuralgia type pain, continued after mesh removal, she was referred to pain management.If pain cannot be controlled, it was noted she may need laparoscopic lysis of adhesions (for suspected post tvh/bso adhesions contributing to the pain), possible release of left ilioinguinal nerve entrapment, and cystoscopy with treatment of interstitial cystitis.The plan also included 3d pelvic ultrasound to evaluate for pelvic sling mesh remnants that might be causing pain, continue flexeril at night, prescribe lidocaine patches and tramadol tid prn, continue myrbetriq 50mg mdaily for urge symptoms.Patient wanted to try acupuncture and the physician was going to arrange that.On may 4, 2021, the patient presented for acupuncture for left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.She also experienced left pelvic pain, lower back pains, abdominal bloating, constipation, vaginal discharge, stress, and urges of incontinence in a few drops during sneezes/laughs/coughs/jumping/fatigue/sweats.The patient underwent acupuncture and heat treatment.On (b)(6) 2021, the patient returned for acupuncture.Her symptoms have been relieved for up to 2 days.Soft stools occur every day after her previous treatment.She has made plans to have a 3d-ultrasound regarding her condition.The patient underwent acupuncture and heat treatment on both sides.On (b)(6) 2021, the patient presented to her obgyn for persistent pelvic pain involving distribution of left ilioinguinal nerve s/p sling mesh and breast implant removals.Moreover, she mentioned that she could barely stay at work long enough to meet the minimum requirements due to the llq pain problems.The pain has a crampy nature and extends to the pelvis.There was no fever, vomiting, dysuria, or diarrhea experienced.The patient is not currently sexually active.Additionally, she has a persistent yeast type vulvovaginal irritation that has not responded to standard treatment.The diagnoses included pelvic pain, neuropathy of left ilioinguinal nerve, and myalgia for which lido 2% with epi, kenalog, and bicarb trigger point injection into the left ilioinguinal tender point was done with good effect.The diagnoses also included muscle tension pain for which she was prescribed valium 5mg po bid as needed and valium rectal gel 10 mg to insert daily as needed, and candidiasis for which voriconazole 200mg po bid x 5 days was prescribed.The patient was to return in one week.On (b)(6) 2021, the patient had complaints of pelvic pain.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.She reported that soon after mesh placement, she developed a horrific allergic reaction with tachycardia, rash, hair loss, and joint pain that was similar to the allergic reaction she had following breast implants in 2016.The patient continues to have significant pain, which is most likely due to the pelvic floor muscle spasm and possibly to an element of pudendal neuralgia.She is currently complaining of a shooting pain in her vagina, especially on the left side, and pain in her tailbone.There is some pain in the groin and inside of the leg.The patient has severe hypersensitivity to touch in the perineal area and has been wearing baggy pants, long skirts, and no underwear.She had one botox injection by the provider who removed the mesh, but it was 100 units done in the office, which again was extremely painful.The assessment was obturator neuralgia, complex regional pain syndrome type ii lower limb, pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to other genitourinary prosthetic materials sequela.During the counseling with the physician, she understood that it would be best to first address her muscles, and if there is no improvement, proceed with her nerve treatment.The proposed treatment was discussed with the patient.She understood, and she's going to look for a sola therapy provider in southern california.She will then decide whether she wants to proceed with sola or botox.On (b)(6) 2021, the patient underwent ultrasound guided left obturator nerve block, bilateral pudendal nerve block, and botox injection to the pelvic floor muscles r-50 units and l-150 units.Verbal consent was obtained before the procedure.The patient was found not to be allergic to betadine, local anesthetic or botox.The patient was brought to the procedure room.She was placed in a supine position and anesthesia was given.Under ultrasound guidance, the anterior branch of the left obturator nerve was blocked with 10 ml of 2% lidocaine.The patient was woken up.She had complete relief of pain in the left groin area.The patient was placed in a dorsal lithotomy position.She was examined and bilateral spasm of pelvic floor muscles was found from left to right.The patient was then again placed under general anesthesia.A bilateral pudendal nerve block was then done using a total of 20ml of 2% lidocaine.A pudendal nerve block needle was used to inject 10 ml into each ischial spine.The left obturator internus muscle was palpated again and there was no bead from the mesh identified.There was a significant spasm of the left obturator internus muscle with a band of tissue (spasming muscle) traversing the obturator foramen.200 units of botox were then resuspended in 20ml of normal sterile saline.They were injected into pelvic floor muscles bilaterally at a volume of 1 ml per injection.There were approximately 15 injections done on the left and 5 on the right.Care was taken to inject into the spasming band of the obturator internus muscle on the left.This concluded the procedure.The patient tolerated the procedure well.She was taken to recovery room in stable condition.

Manufacturer Narrative

Block d4 (lot number, expiration date) and h4 (device manufacture date) have been updated based on the additional information received on september 20, 2022.Block b3 date of event: date of event was approximated to january 9, 2020, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6) block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402, e2326, and e1715, capture the reportable event of pain (pelvic pain, llq pain, back pain, joint pain, myalgias, muscle tension pain, pain to abdominal pelvis and bladder), abdominal pain, nerve damage (neuralgia, neuritis, and back pain radiating down left leg x2 weeks, "electrocuted" throughout her pelvic area, radiates to her lower back), neuropathy of left ilioinguinal nerve, urinary tract infection, infection (candidiasis, yeast infection), allergic reaction, inflammation (interstitial cystitis flare up), and scar tissue (thickening of scar tissue along the left peri-urethral fornix adjacent to the sling), respectively.Impact codes f1202, f1903, f19, f23 and f2303 capture the reportable events of disability (patient has been out of work for several months due to pain), device explantation, surgical intervention, unexpected medical intervention and medication required, respectively.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system device was implanted into the patient during a tension-free vaginal tape (tvt) placement (solyx), cystoscopy and hydrodistention of the bladder, instillation of intravesical medications, and urethral dilation procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence, urinary frequency, and interstitial cystitis.During the hydrodistention of the bladder, which began at 80 cm of water pressure, the patient's bladder was held at maximum capacity for 2 minutes.The only finding of note was a 2 cm cluster of numerous blood vessels on the posterior aspect of the bladder, consistent with hunner's lesion; otherwise, there were no other abnormalities.The patient's bladder was then emptied with 1450 ml of clear irrigant.Another look was undertaken, and this revealed scattered petechiae bilateral to each ureteral orifice and the trigone, but no other interesting findings.The scope was removed, and the urethra was gently dilated to 30-french using van buren sounds.A final look was undertaken with the cystoscope, and this revealed an unscathed urethra, certainly with no evidence of bladder trauma.On (b)(6) 2020, the patient felt great after hydrodistention and tvt last week.She had a 1450cc capacity and a few scattered petechiae.The patient was already thrilled with the results: no stress urinary incontinence (sui) and much less bladder pain.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient was a status post-tvt and reported 2 episodes of sui since the procedure, but overall was doing well.She reported that the hydrodistention improved her dysuria.She still complained of urgency and the frequency of urination.She was on aloe vera capsules daily.There was no gross hematuria or dysuria.Additionally, the genitourinary was healing well.There was no erosion or extrusion, no coughing leak, and no prolapse.On (b)(6) 2020, the patient presented with pain in llq radiating into her back.She reported that the pain was worse when she stood but that she was constantly in discomfort regardless of her position.She stated that this pain had progressively gotten worse in the past 2-3 weeks.Per patient, she visited the er and had a ct as well as an ultrasound done with no remarkable findings.The patient has also had labs drawn with her primary.She was given morphine as well as an rx for painkillers but stated that nothing was helping with her pain.The patient also reported having urinary frequency all day and nocturia throughout the night.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient presented to the emergency department (ed) with pelvic pain for 2 months, which worsened that day.She also reported an episode of urinary incontinence that day.The patient reported a history of hypothyroidism and presented to the ed for complaints of llq (left lower quadrant) pain and back pain radiating down to the left leg for over 2 weeks.Moreover, the patient was negative for kidney stones, and pelvic ultrasound was unremarkable at a previous ed visit., the patient had tried gabapentin and percocet without improvement.Ct of the abdomen and pelvis showed no abnormalities.Ct of the left spine showed 2mm disc bulge at l2-l3 and spondylosis at left l5.The impression was lumbosacral degenerative disc disease (ddd), back pain, disc bulge l2-l3, and spondylosis l5.The patient was prescribed diflucan and cyclobenzaprine and provided information about ddd and lumbar radiculopathy.She was to follow-up with her urologist due to a history of mesh sling and a single episode of incontinence.She was advised by her physician to see a pain specialist with a pending appointment.On (b)(6) 2020, the patient presented to the emergency department for continued electrical shock-like abdominal and pelvic pain that had been ongoing for several weeks now.She had a low-grade fever of 100.0 f that morning with nausea and diarrhea.The patient had been seen at eds previously where she underwent ct scans and ultrasounds, received pain medications, and was discharged home after receiving morphine.The patient continued to have severe abdominal pain and described it as similar to an electric shock.It was rated 10/10 for pain and was unbearable.She stated that she previously had an allergic reaction to breast implants and believed that she could be having some sort of reaction as she did have bladder mesh.She was requesting an mri of her abdomen.The patient has not been able to follow-up with the ob/gyn.She stated that she was waiting for a referral from her pcp, but she was prescribed percocet, and this was not taking care of her pain.She continues to have tenderness and pain despite taking the percocet at home.The patient stated that she was treated for yeast infection, started on steroids, and was given diflucan and a week's course of over-the-counter treatment.The patient had no new sexual partners and no history of stis.The patient declined a vaginal exam.Pelvic ultrasound showed no abnormalities, lab work was unremarkable, and there were no acute findings to warrant further evaluation.It was noted that the patient's behavior was somewhat strange as she was requesting narcotics and had been seen at 2 different eds recently.The patient was given toradol but no narcotics were given as she had pain medication at home and a plan for follow-up pending.On (b)(6) 2020, the patient was taking oxycodone twice a day for pain.The patient noted that she was consistently taking aloe vera for her interstitial cystitis.The patient denied gross hematuria, infections, stones, incontinence, fever, chills, vomiting, nausea, or infection.The patient did not receive pain management as previously ordered.The patient stated her primary care provider said her pain was not "chronic" and pain management was not warranted at this time.Additionally, the patient was requesting a work note.She continued to take pain medications and gabapentin, which made her very sleepy all day.On (b)(6) 2020, the patient with interstitial cystitis was for follow-up as she had not improved with heparin instillation.She complained of burning in her abdomen as well as pelvic pain.She noted that gabapentin caused tremors.The patient was on aloe vera capsules and urogesic prn.According to her primary care provider, she has been taking vitamin c and narcotics.The pain medication did not help her pain.She previously had good relief for 3 months with hydrodistention.She complained of having an episode of uui when walking.The patient stated that difflucan was used to treat multiple yeast infections.She is not currently sexually active due to pelvic pain.Apparently, the patient denied stress urinary incontinence.There was no gross hematuria or dysuria.On (b)(6) 2020, the patient with pelvic pain is here for follow-up.The patient complains of a burning sensation and a rash from her chest to her thighs for 1 month.The patient noted that she had an allergic reaction to amitriptyline as she felt that she was having a stroke.She was treated for yeast infections, but when she went to the gyn, she was told she didn't have yeast infection based on culture.The patient had tremors with gabapentin.Per her primary care provider, she has been off all medications except zofran (prn) for nausea.The patient complained of chest pain and heart palpitations.The patient noted that she previously had silicone leakage from breast implants, which caused an immune response and had them removed in 2012.The patient had no gross hematuria and dysuria.On (b)(6) 2020, the patient presented for cysto and installation of heparin.She noted that she had not yet gone to pfpt, but she was authorized to make an appointment.She stated that she planned on making an appointment today.She was on metroprolol and aloe vera.The patient had no gross hematuria and dysuria.On (b)(6) 2020, the patient was seen for chronic pelvic pain, an interstitial cystitis flare-up, and possible bladder mesh irritation.She presented with 10 months of pelvic/abdominal pain.The patient did have a history of interstitial cystitis, diagnosed and managed by her urologist.She had a hysterectomy in 2014 for fibroids, and a bladder repair in 2020.She reported that since her bladder repair with sling mesh insertion, she has had a constant, 8/10 feeling of being "electrocuted" throughout her pelvic area, which radiates to her lower back, and it worsens when she moves.She is a nurse and has been out of work for several months due to pain.The patient mentioned that she does not feel that this pain is solely related to her underlying diagnosis of interstitial cystitis as it was not present prior to the transobturator tape (tot) sling mesh procedure.Between her urologist and her pcp, she had tried steroids, levaquin, over the counter azos, 2 heparin instills, gabapentin, and amitriptyline, none of which had helped.Moreover, the patient stated that her body does not react well with foreign objects, e.G., she had "breast implant syndrome" and required explantation of silicone breast implants in the past.She mentioned that she has had a persistent vaginal discharge since the sling mesh surgery that does not resolve with medications.The patient would like to discuss bladder mesh removal.In addition, during the review of systems, the patient was positive for fever, cough, shortness of breath, chest pain, and palpitations, abdominal pain, dysuria, frequency, urgency, back pain, joint pain, myalgias and polydipsia.Exam revealed well healed tot scars in the groin, well-estrogenized vaginal walls, thick white discharge, tenderness at the vaginal apex and at the internal obturator muscles lateral to the sling pathway on both sides, and pelvic floor muscle strength 2/5.Diagnoses included pelvic pain, interstitial cystitis, and complication of implanted vaginal mesh.The plan included lifestyle changes including weight loss, timed voiding, pelvic floor muscle exercises, and avoiding bladder irritants.The patient consented to and was scheduled for complete sling excision (both intra and extra pelvic components of the transobturator sling), cystoscopy, and treatment of interstitial cystitis.On (b)(6) 2020, the patient underwent complete excision of the sub-urethral sling, kelly plication of the urethra, cystourethroscopy with bladder installation, and treatment of interstitial cystitis lesions.The patient had a history of bladder and pelvic pain, possibly related to a previously inserted polypropylene mid-urethral sling.She also had a history of bladder pain, but with normal findings on cystourethroscopy today, and had a history of breast implant syndrome.According to the findings, the patient's uterus was surgically absent with no significant pelvic organ prolapses or pelvic masses.The single incision sling was located lying flat at the normal mid sub-urethral location with no visible tissue reaction except for thickening of scar tissue along the left periurethral fornix adjacent to the sling.The sling appeared to have been previously cut through in the midline, apparently to release tension, but both arms were fully intact, extending out to the anchor points in the obturator internus muscle on either side.Also, the sling was able to be fully removed, including the anchoring tips.Furthermore, there was normal appearance of the urethral canal, trigone structures, and bladder urothelial surfaces with bilateral ureteric efflux seen after sling removal, but no glomerulations, hunner's ulcers, or other signs of disease were found.Additionally, 60cc of 2% lidocaine with 10cc of sodium bicarb and 40mg of kenalog were used for the bladder installation at the end of the case.Surgical pathological findings revealed foreign material (mesh) being removed from the patient's sub-urethral region secondary to bladder pain.On (b)(6) 2020, 2 weeks and 4 days post-op, the patient had complaints of pelvic burning but was manageable with pain meds and not as severe as prior to the sling removal surgery.She had concerns about when she could return to work as a nurse.She had urinary incontinence and urinary urgency, which occurred with a new urgency where if she does not make it to the bathroom fast enough, she leaks a small amount of urine.Patient continued to have pain and she had multiple different trigger point injections to pelvic floor which were excruciating.She started using lidocaine patches on her perineal area which gave her urinary and fecal incontinence when she was using them.During this time, the patient reported pain in the llq pelvis but improved from 10/10 electrocution pain to a 7/10 burning sensation which worsened over the course of the day.She had to take a tablet of percocet to help her sleep, with no other medications during the day.The assessment was appropriate postoperative progress with new urge incontinence.The plan was estrogen cream placed in the vagina nightly, a trial of toviaz for one month, and follow up in 3 weeks.On (b)(6) 2021, 6 weeks postoperative, the patient still had burning where the mesh was at the llq abdominal wall.She still had urinary urgency and urinary frequency.During the physical exam, it was observed that the patient had signs of a yeast infection.Her vaginal walls were well healed with non-tender periurethral tissues.The only site of tenderness was at her upper left vaginal apex in the region of innervation of the left ilioinguinal nerve.The patient had appropriate postoperative progress but has persistent pelvic pain involving left ilioinguinal neuralgia with trigger point.She had to do a follow-up check-up in 1 week for left ilioinguinal neuralgia tp injection using kenalog and lidocaine 2% with epi2.The physician and the patient discussed pelvic floor muscle exercises for the future and appropriate postoperative activities.The physician had written a note expecting the patient to be able to return to work as an or/pacu nurse within 3 to 4 weeks.The patient was given medication, diflucan 150mg per oral.Furthermore, in (b)(6) 2021, the patient had ilioinguinal neurectomy and lysis of adhesions intra-abdominal without any improvement in pain.On (b)(6) 2021, the patient had trigger point injections (tpi) for neuropathy of left ilioinguinal nerve.Following the tpi, the patient had a severe herpes/shingles outbreak (her first one).On (b)(6) 2021, the patient underwent a physical therapy initial examination for residual pelvic pain (described as burning pelvic floor pain between 5 and 7 on a scale from 1-10) and tension following mesh excision.Her pain was constant.The patient started walking a couple of months ago and was noticing a lot of left hip pain.She was then referred to physical therapy for treatment.The diagnosis was documented as neuralgia and neuritis, unspecified.Patient problems were noted as limited range of motion, limited strength, and pelvic floor dysfunction.The plan was for pt to gain pain free lumbar range of motion, improve left extremity strength, and improve pelvic floor function.On (b)(6) 2021, the patient had a follow-up visit and reported that her herpes/shingles was resolved.However, the pain was still there and was worsening constantly with a rate of 9/10, and it felt like a knife was stabbing her over and over.She had to leave her shift early as a nurse multiple times last week because her pain was so severe.The patient took flexeril, but it knocked her out, so she could only take it at night, which did help some, but sometimes wakes up during the night still.Gabapentin helped her minimally.The patient took percocet when she got home from work if her pain was severe, but lately it feels like it hasn't been helping as much.The pain remained mostly in the llq (left lower quadrant) abdomen, and she also had a burning sensation in all of her right-sided abdomen that radiated to the left groin.She sometimes has burning inside her vagina as well.She felt like she was losing the ability to function because of this pain.On physical exam, the patient was exquisitely tender on palpation of her left abdomen, greatest in the llq.The assessment was neuropathy of the left ilioinguinal nerve, chronic pelvic pain, and an overactive bladder.The patient was not a candidate for repeat tpi given her severe herpetic breakout.With continued pain after mesh removal and neuralgia type pain, continued after mesh removal, she was referred to pain management.If pain cannot be controlled, it was noted she may need laparoscopic lysis of adhesions (for suspected post tvh/bso adhesions contributing to the pain), possible release of left ilioinguinal nerve entrapment, and cystoscopy with treatment of interstitial cystitis.The plan also included 3d pelvic ultrasound to evaluate for pelvic sling mesh remnants that might be causing pain, continue flexeril at night, prescribe lidocaine patches and tramadol tid prn, continue myrbetriq 50mg mdaily for urge symptoms.Patient wanted to try acupuncture and the physician was going to arrange that.On (b)(6) 2021, the patient presented for acupuncture for left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.She also experienced left pelvic pain, lower back pains, abdominal bloating, constipation, vaginal discharge, stress, and urges of incontinence in a few drops during sneezes/laughs/coughs/jumping/fatigue/sweats.The patient underwent acupuncture and heat treatment.On (b)(6) 2021, the patient returned for acupuncture.Her symptoms have been relieved for up to 2 days.Soft stools occur every day after her previous treatment.She has made plans to have a 3d-ultrasound regarding her condition.The patient underwent acupuncture and heat treatment on both sides.On (b)(6) 2021, the patient presented to her obgyn for persistent pelvic pain involving distribution of left ilioinguinal nerve s/p sling mesh and breast implant removals.Moreover, she mentioned that she could barely stay at work long enough to meet the minimum requirements due to the llq pain problems.The pain has a crampy nature and extends to the pelvis.There was no fever, vomiting, dysuria, or diarrhea experienced.The patient is not currently sexually active.Additionally, she has a persistent yeast type vulvovaginal irritation that has not responded to standard treatment.The diagnoses included pelvic pain, neuropathy of left ilioinguinal nerve, and myalgia for which lido 2% with epi, kenalog, and bicarb trigger point injection into the left ilioinguinal tender point was done with good effect.The diagnoses also included muscle tension pain for which she was prescribed valium 5mg po bid as needed and valium rectal gel 10 mg to insert daily as needed, and candidiasis for which voriconazole 200mg po bid x 5 days was prescribed.The patient was to return in one week.On (b)(6) 2021, the patient had complaints of pelvic pain.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.She reported that soon after mesh placement, she developed a horrific allergic reaction with tachycardia, rash, hair loss, and joint pain that was similar to the allergic reaction she had following breast implants in 2016.The patient continues to have significant pain, which is most likely due to the pelvic floor muscle spasm and possibly to an element of pudendal neuralgia.She is currently complaining of a shooting pain in her vagina, especially on the left side, and pain in her tailbone.There is some pain in the groin and inside of the leg.The patient has severe hypersensitivity to touch in the perineal area and has been wearing baggy pants, long skirts, and no underwear.She had one botox injection by the provider who removed the mesh, but it was 100 units done in the office, which again was extremely painful.The assessment was obturator neuralgia, complex regional pain syndrome type ii lower limb, pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to other genitourinary prosthetic materials sequela.During the counseling with the physician, she understood that it would be best to first address her muscles, and if there is no improvement, proceed with her nerve treatment.The proposed treatment was discussed with the patient.She understood, and she's going to look for a sola therapy provider in southern california.She will then decide whether she wants to proceed with sola or botox.On (b)(6) 2021, the patient underwent ultrasound guided left obturator nerve block, bilateral pudendal nerve block, and botox injection to the pelvic floor muscles r-50 units and l-150 units.Verbal consent was obtained before the procedure.The patient was found not to be allergic to betadine, local anesthetic or botox.The patient was brought to the procedure room.She was placed in a supine position and anesthesia was given.Under ultrasound guidance, the anterior branch of the left obturator nerve was blocked with 10 ml of 2% lidocaine.The patient was woken up.She had complete relief of pain in the left groin area.The patient was placed in a dorsal lithotomy position.She was examined and bilateral spasm of pelvic floor muscles was found from left to right.The patient was then again placed under general anesthesia.A bilateral pudendal nerve block was then done using a total of 20ml of 2% lidocaine.A pudendal nerve block needle was used to inject 10 ml into each ischial spine.The left obturator internus muscle was palpated again and there was no bead from the mesh identified.There was a significant spasm of the left obturator internus muscle with a band of tissue (spasming muscle) traversing the obturator foramen.200 units of botox were then resuspended in 20ml of normal sterile saline.They were injected into pelvic floor muscles bilaterally at a volume of 1 ml per injection.There were approximately 15 injections done on the left and 5 on the right.Care was taken to inject into the spasming band of the obturator internus muscle on the left.This concluded the procedure.The patient tolerated the procedure well.She was taken to recovery room in stable condition.

Manufacturer Narrative

Block d4 (lot number, expiration date) and h4 (device manufacture date) have been updated based on the additional information received on september 20, 2022.Block b3 date of event: date of event was approximated to january 9, 2020, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402, e2326, and e1715, capture the reportable event of pain (pelvic pain, llq pain, back pain, joint pain, myalgias, muscle tension pain, pain to abdominal pelvis and bladder), abdominal pain, nerve damage (neuralgia, neuritis, and back pain radiating down left leg x2 weeks, "electrocuted" throughout her pelvic area, radiates to her lower back), neuropathy of left ilioinguinal nerve, urinary tract infection, infection (candidiasis, yeast infection), allergic reaction, inflammation (interstitial cystitis flare up), and scar tissue (thickening of scar tissue along the left peri-urethral fornix adjacent to the sling), respectively.Impact codes f1202, f1903, f19, f23 and f2303 capture the reportable events of disability (patient has been out of work for several months due to pain), device explantation, surgical intervention, unexpected medical intervention and medication required, respectively.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on october 26, 2022.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system device was implanted into the patient during a tension-free vaginal tape (tvt) placement (solyx), cystoscopy and hydrodistention of the bladder, instillation of intravesical medications, and urethral dilation procedure performed on january 9, 2020, for the treatment of stress urinary incontinence, urinary frequency, and interstitial cystitis.During the hydrodistention of the bladder, which began at 80 cm of water pressure, the patient's bladder was held at maximum capacity for 2 minutes.The only finding of note was a 2 cm cluster of numerous blood vessels on the posterior aspect of the bladder, consistent with hunner's lesion; otherwise, there were no other abnormalities.The patient's bladder was then emptied with 1450 ml of clear irrigant.Another look was undertaken, and this revealed scattered petechiae bilateral to each ureteral orifice and the trigone, but no other interesting findings.The scope was removed, and the urethra was gently dilated to 30-french using van buren sounds.A final look was undertaken with the cystoscope, and this revealed an unscathed urethra, certainly with no evidence of bladder trauma.On (b)(6) 2020 the patient felt great after hydrodistention and tvt last week.She had a 1450cc capacity and a few scattered petechiae.The patient was already thrilled with the results: no stress urinary incontinence (sui) and much less bladder pain.There was no gross hematuria or dysuria.On (b)(6) 2020 the patient was a status post-tvt and reported 2 episodes of sui since the procedure, but overall was doing well.She reported that the hydrodistention improved her dysuria.She still complained of urgency and the frequency of urination.She was on aloe vera capsules daily.There was no gross hematuria or dysuria.Additionally, the genitourinary was healing well.There was no erosion or extrusion, no coughing leak, and no prolapse.On (b)(6) 2020 the patient presented with pain in llq radiating into her back.She reported that the pain was worse when she stood but that she was constantly in discomfort regardless of her position.She stated that this pain had progressively gotten worse in the past 2-3 weeks.Per patient, she visited the er and had a ct as well as an ultrasound done with no remarkable findings.The patient has also had labs drawn with her primary.She was given morphine as well as an rx for painkillers but stated that nothing was helping with her pain.The patient also reported having urinary frequency all day and nocturia throughout the night.There was no gross hematuria or dysuria.On (b)(6) 2020 the patient presented to the emergency department (ed) with pelvic pain for 2 months, which worsened that day.She also reported an episode of urinary incontinence that day.The patient reported a history of hypothyroidism and presented to the ed for complaints of llq (left lower quadrant) pain and back pain radiating down to the left leg for over 2 weeks.Moreover, the patient was negative for kidney stones, and pelvic ultrasound was unremarkable at a previous ed visit., the patient had tried gabapentin and percocet without improvement.Ct of the abdomen and pelvis showed no abnormalities.Ct of the left spine showed 2mm disc bulge at l2-l3 and spondylosis at left l5.The impression was lumbosacral degenerative disc disease (ddd), back pain, disc bulge l2-l3, and spondylosis l5.The patient was prescribed diflucan and cyclobenzaprine and provided information about ddd and lumbar radiculopathy.She was to follow-up with her urologist due to a history of mesh sling and a single episode of incontinence.She was advised by her physician to see a pain specialist with a pending appointment.On (b)(6) 2020 the patient presented to the emergency department for continued electrical shock-like abdominal and pelvic pain that had been ongoing for several weeks now.She had a low-grade fever of 100.0 f that morning with nausea and diarrhea.The patient had been seen at eds previously where she underwent ct scans and ultrasounds, received pain medications, and was discharged home after receiving morphine.The patient continued to have severe abdominal pain and described it as similar to an electric shock.It was rated 10/10 for pain and was unbearable.She stated that she previously had an allergic reaction to breast implants and believed that she could be having some sort of reaction as she did have bladder mesh.She was requesting an mri of her abdomen.The patient has not been able to follow-up with the ob/gyn.She stated that she was waiting for a referral from her pcp, but she was prescribed percocet, and this was not taking care of her pain.She continues to have tenderness and pain despite taking the percocet at home.The patient stated that she was treated for yeast infection, started on steroids, and was given diflucan and a week's course of over-the-counter treatment.The patient had no new sexual partners and no history of stis.The patient declined a vaginal exam.Pelvic ultrasound showed no abnormalities, lab work was unremarkable, and there were no acute findings to warrant further evaluation.It was noted that the patient's behavior was somewhat strange as she was requesting narcotics and had been seen at 2 different eds recently.The patient was given toradol but no narcotics were given as she had pain medication at home and a plan for follow-up pending.On (b)(6) 2020 the patient was taking oxycodone twice a day for pain.The patient noted that she was consistently taking aloe vera for her interstitial cystitis.The patient denied gross hematuria, infections, stones, incontinence, fever, chills, vomiting, nausea, or infection.The patient did not receive pain management as previously ordered.The patient stated her primary care provider said her pain was not "chronic" and pain management was not warranted at this time.Additionally, the patient was requesting a work note.She continued to take pain medications and gabapentin, which made her very sleepy all day.On (b)(6) 2020 the patient with interstitial cystitis was for follow-up as she had not improved with heparin instillation.She complained of burning in her abdomen as well as pelvic pain.She noted that gabapentin caused tremors.The patient was on aloe vera capsules and urogesic prn.According to her primary care provider, she has been taking vitamin c and narcotics.The pain medication did not help her pain.She previously had good relief for 3 months with hydrodistention.She complained of having an episode of uui when walking.The patient stated that difflucan was used to treat multiple yeast infections.She is not currently sexually active due to pelvic pain.Apparently, the patient denied stress urinary incontinence.There was no gross hematuria or dysuria.On (b)(6) 2020 the patient with pelvic pain is here for follow-up.The patient complains of a burning sensation and a rash from her chest to her thighs for 1 month.The patient noted that she had an allergic reaction to amitriptyline as she felt that she was having a stroke.She was treated for yeast infections, but when she went to the gyn, she was told she didn't have yeast infection based on culture.The patient had tremors with gabapentin.Per her primary care provider, she has been off all medications except zofran (prn) for nausea.The patient complained of chest pain and heart palpitations.The patient noted that she previously had silicone leakage from breast implants, which caused an immune response and had them removed in 2012.The patient had no gross hematuria and dysuria.On (b)(6) 2020 the patient presented for cysto and installation of heparin.She noted that she had not yet gone to pfpt, but she was authorized to make an appointment.She stated that she planned on making an appointment today.She was on metroprolol and aloe vera.The patient had no gross hematuria and dysuria.On (b)(6) 2020 the patient was seen for chronic pelvic pain, an interstitial cystitis flare-up, and possible bladder mesh irritation.She presented with 10 months of pelvic/abdominal pain.The patient did have a history of interstitial cystitis, diagnosed and managed by her urologist.She had a hysterectomy in 2014 for fibroids, and a bladder repair in 2020.She reported that since her bladder repair with sling mesh insertion, she has had a constant, 8/10 feeling of being "electrocuted" throughout her pelvic area, which radiates to her lower back, and it worsens when she moves.She is a nurse and has been out of work for several months due to pain.The patient mentioned that she does not feel that this pain is solely related to her underlying diagnosis of interstitial cystitis as it was not present prior to the transobturator tape (tot) sling mesh procedure.Between her urologist and her pcp, she had tried steroids, levaquin, over the counter azos, 2 heparin instills, gabapentin, and amitriptyline, none of which had helped.Moreover, the patient stated that her body does not react well with foreign objects, e.G., she had "breast implant syndrome" and required explantation of silicone breast implants in the past.She mentioned that she has had a persistent vaginal discharge since the sling mesh surgery that does not resolve with medications.The patient would like to discuss bladder mesh removal.In addition, during the review of systems, the patient was positive for fever, cough, shortness of breath, chest pain, and palpitations, abdominal pain, dysuria, frequency, urgency, back pain, joint pain, myalgias and polydipsia.Exam revealed well healed tot scars in the groin, well-estrogenized vaginal walls, thick white discharge, tenderness at the vaginal apex and at the internal obturator muscles lateral to the sling pathway on both sides, and pelvic floor muscle strength 2/5.Diagnoses included pelvic pain, interstitial cystitis, and complication of implanted vaginal mesh.The plan included lifestyle changes including weight loss, timed voiding, pelvic floor muscle exercises, and avoiding bladder irritants.The patient consented to and was scheduled for complete sling excision (both intra and extra pelvic components of the transobturator sling), cystoscopy, and treatment of interstitial cystitis.On (b)(6) 2020 the patient underwent complete excision of the sub-urethral sling, kelly plication of the urethra, cystourethroscopy with bladder installation, and treatment of interstitial cystitis lesions.The patient had a history of bladder and pelvic pain, possibly related to a previously inserted polypropylene mid-urethral sling.She also had a history of bladder pain, but with normal findings on cystourethroscopy today, and had a history of breast implant syndrome.According to the findings, the patient's uterus was surgically absent with no significant pelvic organ prolapses or pelvic masses.The single incision sling was located lying flat at the normal mid sub-urethral location with no visible tissue reaction except for thickening of scar tissue along the left periurethral fornix adjacent to the sling.The sling appeared to have been previously cut through in the midline, apparently to release tension, but both arms were fully intact, extending out to the anchor points in the obturator internus muscle on either side.Also, the sling was able to be fully removed, including the anchoring tips.Furthermore, there was normal appearance of the urethral canal, trigone structures, and bladder urothelial surfaces with bilateral ureteric efflux seen after sling removal, but no glomerulations, hunner's ulcers, or other signs of disease were found.Additionally, 60cc of 2% lidocaine with 10cc of sodium bicarb and 40mg of kenalog were used for the bladder installation at the end of the case.Surgical pathological findings revealed foreign material (mesh) being removed from the patient's sub-urethral region secondary to bladder pain.On (b)(6) 2020 2 weeks and 4 days post-op, the patient had complaints of pelvic burning but was manageable with pain meds and not as severe as prior to the sling removal surgery.She had concerns about when she could return to work as a nurse.She had urinary incontinence and urinary urgency, which occurred with a new urgency where if she does not make it to the bathroom fast enough, she leaks a small amount of urine.Patient continued to have pain and she had multiple different trigger point injections to pelvic floor which were excruciating.She started using lidocaine patches on her perineal area which gave her urinary and fecal incontinence when she was using them.During this time, the patient reported pain in the llq pelvis but improved from 10/10 electrocution pain to a 7/10 burning sensation which worsened over the course of the day.She had to take a tablet of percocet to help her sleep, with no other medications during the day.The assessment was appropriate postoperative progress with new urge incontinence.The plan was estrogen cream placed in the vagina nightly, a trial of toviaz for one month, and follow up in 3 weeks.On (b)(6) 2021, 6 weeks postoperative, the patient still had burning where the mesh was at the llq abdominal wall.She still had urinary urgency and urinary frequency.During the physical exam, it was observed that the patient had signs of a yeast infection.Her vaginal walls were well healed with non-tender periurethral tissues.The only site of tenderness was at her upper left vaginal apex in the region of innervation of the left ilioinguinal nerve.The patient had appropriate postoperative progress but has persistent pelvic pain involving left ilioinguinal neuralgia with trigger point.She had to do a follow-up check-up in 1 week for left ilioinguinal neuralgia tp injection using kenalog and lidocaine 2% with epi2.The physician and the patient discussed pelvic floor muscle exercises for the future and appropriate postoperative activities.The physician had written a note expecting the patient to be able to return to work as an or/pacu nurse within 3 to 4 weeks.The patient was given medication, diflucan 150mg per oral.Furthermore, in (b)(6) 2021 the patient had ilioinguinal neurectomy and lysis of adhesions intra-abdominal without any improvement in pain.On (b)(6) 2021the patient had trigger point injections (tpi) for neuropathy of left ilioinguinal nerve.Following the tpi, the patient had a severe herpes/shingles outbreak (her first one).On (b)(6) 2021 the patient underwent a physical therapy initial examination for residual pelvic pain (described as burning pelvic floor pain between 5 and 7 on a scale from 1-10) and tension following mesh excision.Her pain was constant.The patient started walking a couple of months ago and was noticing a lot of left hip pain.She was then referred to physical therapy for treatment.The diagnosis was documented as neuralgia and neuritis, unspecified.Patient problems were noted as limited range of motion, limited strength, and pelvic floor dysfunction.The plan was for pt to gain pain free lumbar range of motion, improve left extremity strength, and improve pelvic floor function.On (b)(6) 2021 the patient had a follow-up visit and reported that her herpes/shingles was resolved.However, the pain was still there and was worsening constantly with a rate of 9/10, and it felt like a knife was stabbing her over and over.She had to leave her shift early as a nurse multiple times last week because her pain was so severe.The patient took flexeril, but it knocked her out, so she could only take it at night, which did help some, but sometimes wakes up during the night still.Gabapentin helped her minimally.The patient took percocet when she got home from work if her pain was severe, but lately it feels like it hasn't been helping as much.The pain remained mostly in the llq (left lower quadrant) abdomen, and she also had a burning sensation in all of her right-sided abdomen that radiated to the left groin.She sometimes has burning inside her vagina as well.She felt like she was losing the ability to function because of this pain.On physical exam, the patient was exquisitely tender on palpation of her left abdomen, greatest in the llq.The assessment was neuropathy of the left ilioinguinal nerve, chronic pelvic pain, and an overactive bladder.The patient was not a candidate for repeat tpi given her severe herpetic breakout.With continued pain after mesh removal and neuralgia type pain, continued after mesh removal, she was referred to pain management.If pain cannot be controlled, it was noted she may need laparoscopic lysis of adhesions (for suspected post tvh/bso adhesions contributing to the pain), possible release of left ilioinguinal nerve entrapment, and cystoscopy with treatment of interstitial cystitis.The plan also included 3d pelvic ultrasound to evaluate for pelvic sling mesh remnants that might be causing pain, continue flexeril at night, prescribe lidocaine patches and tramadol tid prn, continue myrbetriq 50mg mdaily for urge symptoms.Patient wanted to try acupuncture and the physician was going to arrange that.On (b)(6) 2021 the patient presented for acupuncture for left lower abdominal (pelvic) pain.The pain extends from the lower back towards the groins and vagina.She would experience constant sharp pains, stabbing pains, and burning sensations.She also experienced left pelvic pain, lower back pains, abdominal bloating, constipation, vaginal discharge, stress, and urges of incontinence in a few drops during sneezes/laughs/coughs/jumping/fatigue/sweats.The patient underwent acupuncture and heat treatment.On (b)(6) 2021 the patient returned for acupuncture.Her symptoms have been relieved for up to 2 days.Soft stools occur every day after her previous treatment.She has made plans to have a 3d-ultrasound regarding her condition.The patient underwent acupuncture and heat treatment on both sides.On (b)(6) 2021 the patient presented to her obgyn for persistent pelvic pain involving distribution of left ilioinguinal nerve s/p sling mesh and breast implant removals.Moreover, she mentioned that she could barely stay at work long enough to meet the minimum requirements due to the llq pain problems.The pain has a crampy nature and extends to the pelvis.There was no fever, vomiting, dysuria, or diarrhea experienced.The patient is not currently sexually active.Additionally, she has a persistent yeast type vulvovaginal irritation that has not responded to standard treatment.The diagnoses included pelvic pain, neuropathy of left ilioinguinal nerve, and myalgia for which lido 2% with epi, kenalog, and bicarb trigger point injection into the left ilioinguinal tender point was done with good effect.The diagnoses also included muscle tension pain for which she was prescribed valium 5mg po bid as needed and valium rectal gel 10 mg to insert daily as needed, and candidiasis for which voriconazole 200mg po bid x 5 days was prescribed.The patient was to return in one week.On (b)(6) 2021 the patient had complaints of pelvic pain.The patient was not examined since this consultation was done using telemedicine.The patient will be seen in the physician's office prior to any surgical intervention and examined then.She reported that soon after mesh placement, she developed a horrific allergic reaction with tachycardia, rash, hair loss, and joint pain that was similar to the allergic reaction she had following breast implants in 2016.The patient continues to have significant pain, which is most likely due to the pelvic floor muscle spasm and possibly to an element of pudendal neuralgia.She is currently complaining of a shooting pain in her vagina, especially on the left side, and pain in her tailbone.There is some pain in the groin and inside of the leg.The patient has severe hypersensitivity to touch in the perineal area and has been wearing baggy pants, long skirts, and no underwear.She had one botox injection by the provider who removed the mesh, but it was 100 units done in the office, which again was extremely painful.The assessment was obturator neuralgia, complex regional pain syndrome type ii lower limb, pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to other genitourinary prosthetic materials sequela.During the counseling with the physician, she understood that it would be best to first address her muscles, and if there is no improvement, proceed with her nerve treatment.The proposed treatment was discussed with the patient.She understood, and she's going to look for a sola therapy provider in southern california.She will then decide whether she wants to proceed with sola or botox.On (b)(6) 2021 the patient underwent ultrasound guided left obturator nerve block, bilateral pudendal nerve block, and botox injection to the pelvic floor muscles r-50 units and l-150 units.Verbal consent was obtained before the procedure.The patient was found not to be allergic to betadine, local anesthetic or botox.The patient was brought to the procedure room.She was placed in a supine position and anesthesia was given.Under ultrasound guidance, the anterior branch of the left obturator nerve was blocked with 10 ml of 2% lidocaine.The patient was woken up.She had complete relief of pain in the left groin area.The patient was placed in a dorsal lithotomy position.She was examined and bilateral spasm of pelvic floor muscles was found from left to right.The patient was then again placed under general anesthesia.A bilateral pudendal nerve block was then done using a total of 20ml of 2% lidocaine.A pudendal nerve block needle was used to inject 10 ml into each ischial spine.The left obturator internus muscle was palpated again and there was no bead from the mesh identified.There was a significant spasm of the left obturator internus muscle with a band of tissue (spasming muscle) traversing the obturator foramen.200 units of botox were then resuspended in 20ml of normal sterile saline.They were injected into pelvic floor muscles bilaterally at a volume of 1 ml per injection.There were approximately 15 injections done on the left and 5 on the right.Care was taken to inject into the spasming band of the obturator internus muscle on the left.This concluded the procedure.The patient tolerated the procedure well.She was taken to recovery room in stable condition.***additional information received on october 26, 2022*** on november 8, 2020, the patient was seen and examined at the emergency department for complaints of pelvic pain.The patient was reported to have been seen at the ed last month for the same complaint, continues to have pain, had bladder mesh 10 months ago and been seen multiple times in the office for this pain.The patient noted not being able to move arms and said her chest was on fire.She stated that her right arm was burning and has neck pain.She also stated having leg pain with numbness to her feet.The patient was experiencing tingly sensation and felt weakness.The patient denied smoking or drinking.There were no other complaints at this time and the patient presented to the ed for further evaluation.The patient had a ct of the abdomen and pelvis with contrast.Findings include: the liver was enlarged, spleen was prominent, pancreas was unremarkable, gallbladder was present, no hydronephrosis was identified, no renal mass was seen and the abdominal aorta was normal in caliber, urinary bladder was prominent, right ureteral jet was noted.There was somewhat of an unusual appearance involving the posterior aspect of the urinary bladder related to probable layering of contrast.No definite free fluid was seen within the pelvis.The appendix was normal in appearance and were visualized.In the physician's assessment, the patient has mild hepatomegaly.There was somewhat of an unusual appearance of the posterior aspect of the urinary bladder probably related to layering of contrast.Ct chest findings include: a bilateral dependent density was present, no pleural effusion or pneumothorax was identified, degenerative changes were seen within the thoracic spine, no discrete fracture was identified, the thoracic aorta was normal in caliber, no dissection flap or hematoma was identified, no filling defects were identified within the pulmonary arteries to suggest acute pulmonary embolus.In the physician's assessment, there were no evidence for a pulmonary embolism.Ct head findings include: a visualized brain unremarkable in appearance without evidence of mass or mass effect, no hemorrhage was identified, no extra-axial fluid collection was seen, pineal and cord plexus calcifications were present, there appears to have been surgical change seen involving the ethmoid sinuses bilaterally and involving the medial wall of both maxillary sinuses, the right frontal sinus was hypoplastic, mastoid sinuses are unremarkable, no fractures identified.In the physician's assessment, there was evidence of previous sinus surgery.Ct spine findings include mild degenerative changes involving the thoracic spine diffusely, no fracture or focal destructive process was identified, mild to side degenerative changes were present, osteophyte formation was seen, no paraspinal masses identified.In the physician's assessment, no ct evidence for fracture of the thoracic spine.Degenerative changes were present.The patient's ultrasound pelvic mass evaluation using real-time grayscale and color doppler sonographic imaging of the pelvis was performed using both transabdominal and endovaginal technique.Findings include interpretation of this study was based on images provided by the ultrasound technologist.The uterus was absent.No free fluid seen within the pelvis.The ovaries are unremarkable.There were relatively small.The right ovary measures 2.9 x 1.4 x 1.6 centimeters.The left ovary measures 3 x 1.3 x 2.9 cm.In the physician's assessment, the patient was status post hysterectomy.No free fluid or adnexal mass identified.Ct hyperacute stroke angio head findings include: both cavernous internal carotid arteries distal vertebral arteries and the basilar artery were patent.The anterior cerebral arteries were patent bilaterally.Both middle cerebral arteries were patent proximally and their major vessels were patent.No discrete aneurysm or vascular malformation was identified.In the physician's assessment, unremarkable intracranial vasculature with no intracranial arterial aneurysm, proximal arterial thrombosis or arteriovenous malformation.In the physician's assessment, unremarkable ct angiography of the neck.The patient was informed to follow up with her physician in 1 day and is to return to the ed if symptoms worsen.In the physician's assessment the patient has hypokalemia, pelvic pain, carpopedal spasms, and respiratory alkalosis.The patient was discharged home with continued outpatient follow up with her physician in 1 day.The patient was counseled regarding diagnosis, diagnostic results, treatment plan, prescription and patient understood.The patient was discharged in stable condition.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13550236
• MDR Text Key: 285758824
• Report Number: 3005099803-2022-00719
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0024250470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 06/16/2022; 07/18/2022; 08/16/2022; 09/20/2022; 10/26/2022
• Supplement Dates FDA Received: 07/14/2022; 08/15/2022; 09/13/2022; 10/12/2022; 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability; Other
• Patient Age: 49 YR
• Patient Sex: Female