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BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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| Model Number M0068318170 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Fecal Incontinence (4571)
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| Event Date 08/27/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Additional information: blocks a2: date of birth, b2 outcomes attrib to adv event, b3, b5, b7, d1, d4, e1 and h6: patient codes blocks 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 representation.The surgeon is: dr.Michael lemmers legacy silverton hospital block h6: patient codes e2006, e0123, e2330, and e0127 capture the reportable events of mesh erosion, nerve damage, pain, and numbness.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post-implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.
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Manufacturer Narrative
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Block e1: this event was reported by the patient's legal representation.The surgeon is: dr.(b)(6).(b)(6) hospital.Block h6: patient codes e2006, e0123, e2330, and e0127 capture the reportable events of mesh erosion, nerve damage, pain, and numbness.Impact codes f1204, f2303 and f1201 capture the reportable events of permanent pain, chronic nerve injury and medications.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post-implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.
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Manufacturer Narrative
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Additional information: blocks a4, b3, b5, b6, b7 and h6: patient codes and impact codes.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Mesh excision surgeon is: (b)(6).Block h6: patient codes e2006, e0123, e2330, e0127, e2006, e0123, e2330, e0127, e1715, e0126, e1302, e2328, e2311, e1405, e1301, e232401, e1906, e1901, e1309, e2015 and e2326 capture the reportable events of mesh erosion, nerve damage, pain, numbness, nerve damage, scar tissue, neuropathy, hematuria, obstruction, discomfort, dyspareunia, dysuria, fecal incontinence, infection, bacterial infection, urinary retention, inflammation and tissue injury.Impact codes f1204, f2303, f1201, f1901 and f19 capture the reportable events of permanent pain, chronic nerve injury, medications, other medically necessary procedures and 6 pudendal blocks.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post-implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.Additional information received july 13, 2022.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during a cystoscopy + suprapubic cystostomy tube placement and drainage + cystocele repair + proximal sub-urethral sling procedure performed on (b)(6) 2019 for recurrent cystocele with partial bladder outlet obstruction; proximal urethral hypermobility with stress incontinence.Prior to surgery, the patient had a sling placement of a non-bsc device in 2016 to treat urinary incontinence and started experiencing issues since then.The symptoms became worse after the prolapse repair in (b)(6) 2019.During an office visit on (b)(6) 2019, the patient reported her urgency became worse and was then taking toviaz 8mg and myrbetriq 25mg.Patient had loss of sensation since her prolapse repair - could not feel when her bladder is full.Not able to respond to sensory signals of bladder fullness.The patient reported hematuria, incontinence, nocturia, pelvic pain, urgency, retention, glaucoma, dizziness, headache, hearing loss, abdominal pain, diarrhea, back pain, bone pain, skin rash, memory loss, syncope.Urinary symptoms were better controlled during the day because of toviaz and myrbetriq in the morning but despite that, she still used 200 briefs per month.The patient also applied vaginal estrogen cream on.Patient active problem list: chronic pain disorder, mixed stress and urge urinary incontinence, neuropathy, herpes simplex vulvovaginitis.Physical exam showed area of eroded mesh to the left of the patient's urethra/bladder neck.No mesh erosion deeper in the vaginal vault.No rectocele.Vaginal estrogenization is fair.When asked to perform a kegel maneuver, the patient actually performed a valsalva maneuver.With coaching she was able to do an appropriate pelvic floor muscle contraction.On (b)(6) 2019, the patient was experiencing significant hypertension and so was advised to discontinue the myrbetriq.Prior to her prolapse repair in (b)(6) 2019, she underwent a cmg that demonstrated severe overactive bladder.Cmg was repeated on (b)(6) 2019 and the flow curve was intermittent.On this study, the patient did not have stress incontinence but did have oab with associated urgency.On exam she has mesh erosion near her bladder neck consistent with her past mesh sling.She is using vaginal estrogen now 3 days per week.Mesh excision may need to be considered in the future.Moreover, tertiary line options were discussed for treating her overactive bladder - ptns, botox and interstim.The patient would like to proceed with botox injections and understood the risks.On (b)(6) 2020, the patient had 100 units botox and reported improvement in her urinary symptoms.There was less frequency and urgency.Noted slight urgency and need for valsalva voiding procedure.No feelings of incomplete bladder emptying.She had slight dysuria but improving gradually.On (b)(6) 2020, the patient reported to have incomplete bladder emptying after the botox and was catheterizing three times a day and was only draining 40-60cc of fluid.Self-catheterization made the patient feel much comfortable.She felt botox was only helpful for about a month and would like to try an alternative medication.Prior to botox injections, on (b)(6) 2020 urine culture grew mixed gram-positive and gram-negative flora.The patient also complained of pelvic discomfort and dyspareunia.Additionally, she also developed atrophic vaginitis and should continue vaginal estrogen cream.Review of systems gastrointestinal: positive for constipation genitourinary: positive for frequency, pelvic pain, urgency and vaginal pain.During an office visit on (b)(6) 2020, it was reported that the patient sustained some nerve damage with these 3 previous surgeries.She was seeing urology and having some nerve stimulation performed for her bladder.Lost sensation during intercourse, bowel movements and voiding.She had some concern over vaginal spotting and suture material or mesh that is coming through the vagina.Overall she was concerned with the mesh erosion but likewise concerned with her pelvic pain and discomfort.General examination showed slight prolapse with what appears to be grade 2 enterocele.On (b)(6) 2020, patient stated rectal and inguinal pain as well as pain with urination (rated as 6/10).Patient was scheduled for the removal of the vaginal part of the mesh on (b)(6) 2020.Patient tried multiple courses of pelvic floor physical therapy and takes oral baclofen with improvement.The botox injection into pelvic floor muscles improved her urination but made her pain worse.Assessment showed pudendal neuralgia and obturator neuralgia.Plan: 1.Patient is going to have vaginal part of the mesh removed on (b)(6) at (b)(6).2.If no improvement of pain, patient will be a candidate for the removal of the growing part of the tvt-o and caldera mesh.3.If she continues to be in pain patient may be a candidate for transgluteal pudendal neurolysis.On (b)(6) 2020, the patient eventually underwent mesh excision surgery.Preoperative diagnosis: 1.Exposure of vaginal mesh.2.Chronic pelvic pain with pain reproduced when palpating right arm of vaginal mesh to ssl.3.Stage 2 pop with posterior wall at 0 apex at -1 and with aa -3 but ba -1.Postoperative diagnosis: same plus bladder diverticulum.Procedure performed: 1.Exam under anesthesia.2.Excision of exposed vaginal mesh 3.Cystourethroscopy.On examination under anesthesia, there was an easily palpable area of exposed sub-urethral mesh on the anatomic left approximately 2 cm of which was palpable.On further vaginal examination there was noted to be a tight band extending from the right ischial spine likely in the area of the sacrospinous ligament.Both areas were excised with no residual palpable mesh following excision.Bladder noted to have small diverticulum about the right bladder dome posteriorly.Bilateral ureteral efflux noted.Normal urethra without obvious mesh exposure on cystourethroscopy.During the procedure, the exposed sub-urethral mesh was grasped with an allis clamp and the surrounding vaginal mucosa was injected using dilute vasopressin.A transverse incision was then carried out about the right inferior aspect of the exposed mesh towards the midline and allis clamps were used to expose the tissue.Then, using metzenbaum scissors and a #15 blade, the sub-urethral mesh was exposed both towards the midline and back laterally towards the patient's left side.About 3 cm of mesh was ultimately exposed and was clamped and incised to release the tension on the mesh as well as the area of exposure.The mesh was dissected on the patient's left to the level of the obturator interus, on the right the mesh was released after it coursed beyond the midline of the urethra and vagina.On each free arm of the mesh, further dissection was carried out to maximize the amount of mesh removal.All exposed mesh was excised using metzenbaum scissors.There was also noted to be an additional piece of mesh deep to the excised portion.This appeared to be twisted and was tight across the urethra this was elevated with an allis clamp and pick-ups and was excised after further exposure using a #15 blade.This additional piece of mesh was approximately 2 cam and blue in color.It was also sent for pathology.Once all palpable and visible mesh had been removed suburethral, the vagina was closed in layers using 2-0 polysorb in interrupted fashion with adequate approximation and hemostasis.Attention was then turned to the tight band of vaginal tissue identified on examination on the patient's right.This was suspected to be further mesh and given the patient's history of pain on the right side and on examination in the ambulatory setting, decision was made to proceed with dissection of this area.The tight band of tissue was grasped with an allis and the area was injected with dilute vasopressin.A transverse incision was made with a #15 blade overlying this area and further explored using sharp and blunt dissection with metzenbaum scissors.An underlying mesh was identified in this area and further dissection was undertaken in the direction of the ischial spine and towards the right sacrospinous ligament.4-5 cm of mesh was ultimately dissected using metzenbaum scissors and a #15 blade and once we determined our dissection had reached near the sacrospinous ligament, the decision was made to stop the dissection at this point to prevent further surgical morbidity.The mesh was excised thus from the level of the right ssl to the left side of the vagina just beyond the midline.The vagina was then closed using 2-0 polysorb in interrupted fashion and was noted to be hemostatic.A full survey of the bladder was performed without evidence of injury or mesh but presence of a bladder diverticulum was noted about the right posterior bladder dome.The bilateral ureters were identified with adequate efflux.The cystoscope was withdrawn and urethra inspected and found to be normal.The foley catheter was replaced.Rectal exam was negative.Patient was taken to the pacu in stable condition.No complications reported.Consent for interstim stage 1 was signed and the patient was scheduled on (b)(6) 2021.Discussion was made regarding the role of interstim sacral neuromodulation and how it works for the patient's overactive bladder, urge incontinence and/or urinary retention.The patient underwent cystocopy with botox 200 units on (b)(6) 2021 and on follow up visit on (b)(6) 2021, patient reported to be doing a lot better.Was not leaking and the frequency and urgency seems normal, timed voids also helped, q2hrs, but had to press on abdomen to fully empty and sit forward.The botox 200 worked much better than the previous botox attempt.Pain has been reduced by 25-30% since mesh excision.She had tried extensive pfpt and water therapy.Biggest concern was stabbing pelvic pain; has reduced gabapentin.Patient was having some gi issues, complicated by gastric sleeve.Discussed pudendal block and possible resuming pfpt or adding kenalog to pudendal block.Counseled that a series of 6 pudendal blocks to perform with the goal of breaking the pain cycle and allowing the pelvic floor to relax.Will also perform trigger point injection along obturator interus at same time.Number 1 of 6 bilateral pudendal blocks completed - trigger point injection along obturator interus using a mixture of kenalog of marcaine was also performed reportedly due to pelvic floor muscle pain and spasm.The patient tolerated the procedure well.The vagina was noted to be hemostatic at the end of the procedure.6 pudendal blocks was eventually completed on (b)(6) 2022 also with no complications.On (b)(6) 2022, the patient had another mesh revision surgery.Revision of vaginal scarring, zero mesh found, cystoscopy with botulinum toxin injection and levator botox injection procedures.Findings showed thickening on right periurethral area which had previously produced pain in the clinic cystoscopy: trabeculations noted at a bladder volume of 350ml, with petechiae noted after filled to capacity and emptied.Bladder capacity of 350ml.No foreign bodies or lesions seen in the bladder.Mesh excision: during the procedure, the area on the right of the urethra that was ttp was located and under anesthesia felt more like scarring rather than mesh.The scar area that was suspected to include mesh was grasped with an allis clamp.The scarring h was dissected off the underlying tissue in a superficial manner and excised.Approximately 1cm of of scarred vaginal mucosa were removed to give fresh edges.No mesh was seen or palpated.But the firm, painful area in clinic was removed and no longer palpable.The vaginal edges were then closed with 2-0 polysorb.Hemostasis was achieved.Cystoscopy with botulinum toxin injection: cystoscopy was performed with 70 degree rigid cystoscope and the bladder was inspected systematically from the base and trigone to the air bubble in the dome on both sides.No mucosal lesions, stones or foreign body present.Normal, bilateral ureteral jets were seen.The patient was awoken from anesthesia and transferred to the pacu.Patient tolerated the procedure well.A return visit on (b)(6) 2022, the patient had urine culture to evaluate potential ongoing urge urinary incontinence.Had a discussion for potential additional bladder botox injection for her ongoing uui symptoms, however will wait until follow-up to see if symptoms improve prior to pursuing further interventions.Recommended increased fiber intake for treatment of her fecal incontinence and provided with handout.On pelvic exam external genitalia normal in appearance.No prolapse appreciated.No rectal prolapse noted.Small amount of fecal matter on buttocks.No fecal incontinence observed with valsalva.Suture in place to the right of the urethra.Minimal soreness along the suture line upon palpation but not overt pain.No ttp of bilateral levator ani complexes.
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Manufacturer Narrative
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Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) at (b)(6) hospital.Mesh excision surgeon is: dr.(b)(6).Block h6: patient codes e2006, e0123, e2330, e0127, e2006, e0123, e2330, e0127, e1715, e0126, e1302, e2328, e2311, e1405, e1301, e232401, e1906, e1901, e1309, e2015 and e2326 capture the reportable events of mesh erosion and exposure of implanted vaginal mesh, nerve damage, pain, numbness, nerve damage, scar tissue, neuropathy, hematuria, obstruction, discomfort, dyspareunia, dysuria, fecal incontinence, infection, bacterial infection, urinary retention, inflammation and tissue injury.Impact codes f1204, f2303, f1201, f1901 and f19 capture the reportable events of permanent pain, chronic nerve injury, medications, other medically necessary procedures and 6 pudendal blocks.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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The patient was diagnosed with pelvic organ prolapse and stress urinary incontinence in 2016 and was implanted with an ethicon tvt-o on (b)(6) 2016 during a cystocele repair.On april 29, 2019, at the time the patient was implanted with the uphold lite device, she was also implanted with a desara caldera sling.The patient had hysterectomy in 1993 and gastric sleeve procedure in 2015.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post-implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.---additional information received july 13, 2022--- it was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during a cystoscopy + suprapubic cystostomy tube placement and drainage + cystocele repair + proximal sub-urethral sling procedure performed on april 29, 2019 for recurrent cystocele with partial bladder outlet obstruction; proximal urethral hypermobility with stress incontinence.Prior to surgery, the patient had a sling placement of a non-bsc device in 2016 to treat urinary incontinence and started experiencing issues including voiding difficulty, marked urgency, and mixed incontinence.Urodynamics showed recurrence of grade 2 cystocele, proximal urethral hypermobility with consequent kinking behind her old sling that was in a relatively distal location, and she also had marked idiopathic detrusor overactivity causing urgency.The symptoms became worse after the prolapse repair in april 2019.During an office visit on (b)(6) 2019, the patient reported her urgency became worse and was then taking toviaz 8mg and myrbetriq 25mg.Patient had loss of sensation since her prolapse repair - could not feel when her bladder is full.Not able to respond to sensory signals of bladder fullness.The patient reported hematuria, incontinence, nocturia, pelvic pain, urgency, retention, glaucoma, dizziness, headache, hearing loss, abdominal pain, diarrhea, back pain, bone pain, skin rash, memory loss, syncope.Urinary symptoms were better controlled during the day because of toviaz and myrbetriq in the morning but despite that, she still used 200 briefs per month.The patient also applied vaginal estrogen cream.It was noted that the patient had white matter disease and struggled with memory issues.Patient active problem list included: - chronic pain disorder, - mixed stress and urge urinary incontinence, - neuropathy, - herpes simplex vulvovaginitis, - morbid obesity, - chronic neck and back pain.Physical exam showed area of eroded mesh to the left of the patient's urethra/bladder neck.No mesh erosion deeper in the vaginal vault.No rectocele.Vaginal estrogenization is fair.When asked to perform a kegel maneuver, the patient actually performed a valsalva maneuver.With coaching she was able to do an appropriate pelvic floor muscle contraction.Urine dip was positive for trace blood and trace leukocytes.The assessment was mixed stress and urge urinary incontinence.The patient was referred to urology and cystometrogram (cmg) study was planned.On (b)(6) 2019, the patient was experiencing significant hypertension and so was advised to discontinue the myrbetriq.Prior to her prolapse repair in (b)(6) 2019, she underwent a cmg that demonstrated severe overactive bladder.Cmg was repeated on (b)(6) 2019 and the flow curve was intermittent.On this study, the patient did not have stress incontinence but did have oab with associated urgency.On exam she has mesh erosion near her bladder neck consistent with her past mesh sling.The assessment was mixed stress and urge urinary incontinence, atrophic vaginitis, and erosion of bladder suspension mesh.She is using vaginal estrogen now 3 days per week.Mesh excision may need to be considered in the future.Moreover, tertiary line options were discussed for treating her overactive bladder - ptns, botox and interstim.The patient would like to proceed with botox injections and understood the risks.On (b)(6) 2020 urine culture grew mixed gram-positive and gram-negative flora.On (b)(6) 2020, the patient had 100 units botox and reported improvement in her urinary symptoms.There was less frequency and urgency.Noted slight urgency and need for valsalva voiding procedure.Post void residual (pvr) was initially 365 cc, but she was able to double void to 183 cc.No feelings of incomplete bladder emptying.She had slight dysuria but was improving gradually.The patient was advised that the toviaz may be contributing to incomplete emptying and discussed a trial of discontinuing this medication.Additionally, the patient was advised to continue timed and double voiding and was taught clean intermittent catheterization (cic) in case of worsening symptoms.On (b)(6) 2020, the patient reported to have incomplete bladder emptying after the botox and was catheterizing three times a day and was only draining 40-60cc of fluid.Self-catheterization made the patient feel much comfortable.She felt botox was only helpful for about a month and would like to try an alternative medication.The patient also complained of pelvic discomfort and dyspareunia.Additionally, she also developed atrophic vaginitis and should continue vaginal estrogen cream.Review of systems: gastrointestinal: positive for constipation.Genitourinary: positive for frequency, pelvic pain, urgency and vaginal pain.During an office visit on (b)(6) 2020 for dyspareunia and pelvic pain, the patient reported fairly significant chronic daily pain which was sharper at times.The patient reported that she sustained some nerve damage with these 3 previous bladder surgeries.She was seeing urology and reported having some nerve stimulation performed for her bladder, but when the physician consulted with urology, they confirmed no formal nerve stimulation or interstim treatment had been performed.The patient reported that she had lost sensation during intercourse, bowel movements and voiding.She had some concern over vaginal spotting and suture material or mesh that is coming through the vagina.Overall she was concerned with the mesh erosion but likewise concerned with her pelvic pain and discomfort.General examination showed slight prolapse with what appears to be grade 2 enterocele.On (b)(6) 2020, the patient had an office visit with the assessments of dyspareunia, exposure of implanted vaginal mesh, urge urinary incontinence, ua concerning for infection, obesity, fecal smearing with evidence of prior anal sphincter injury and bowel leakage secondary to stool consistency (recommended psyllium husk), and rectocele that may contribute to accidental bowel leakage.On december 9, 2020, the patient was seen at a chronic pelvic pain center.The patient stated she had rectal and inguinal pain as well as pain with urination (rated as 6/10) in addition to the pelvic pain, pain with intercourse, and pain with sitting.Patient was scheduled for the removal of the vaginal part of the mesh on (b)(6) 2020.Patient tried multiple courses of pelvic floor physical therapy and takes oral baclofen with improvement.The botox injection into pelvic floor muscles improved her urination but made her pain worse.Assessment was pudendal neuralgia and obturator neuralgia.Plan: 1.Patient is going to have vaginal part of the mesh removed on (b)(6).2.If no improvement of pain, patient will be a candidate for the removal of the groin part of the tvt-o and caldera mesh.3.If she continues to be in pain patient may be a candidate for transgluteal pudendal neurolysis.On (b)(6) 2020, the patient eventually underwent mesh excision surgery.Preoperative diagnosis: 1.Exposure of vaginal mesh.2.Chronic pelvic pain with pain reproduced when palpating right arm of vaginal mesh to ssl.3.Stage 2 pop with posterior wall at 0 apex at -1 and with aa -3 but ba -1.Postoperative diagnosis: same plus bladder diverticulum.Procedure performed: 1.Exam under anesthesia.2.Excision of exposed vaginal mesh.3.Cystourethroscopy.On examination under anesthesia, there was an easily palpable area of exposed sub-urethral mesh on the anatomic left approximately 2 cm of which was palpable.On further vaginal examination there was noted to be a tight band extending from the right ischial spine likely in the area of the sacrospinous ligament.Both areas were excised with no residual palpable mesh following excision.Bladder noted to have small diverticulum about the right bladder dome posteriorly.Bilateral ureteral efflux noted.Normal urethra without obvious mesh exposure on cystourethroscopy.During the procedure, the exposed sub-urethral mesh was grasped with an allis clamp and the surrounding vaginal mucosa was injected using dilute vasopressin.A transverse incision was then carried out about the right inferior aspect of the exposed mesh towards the midline and allis clamps were used to expose the tissue.Then, using metzenbaum scissors and a #15 blade, the sub-urethral mesh was exposed both towards the midline and back laterally towards the patient's left side.About 3 cm of mesh was ultimately exposed and was clamped and incised to release the tension on the mesh as well as the area of exposure.The mesh was dissected on the patient's left to the level of the obturator internus, on the right the mesh was released after it coursed beyond the midline of the urethra and vagina.On each free arm of the mesh, further dissection was carried out to maximize the amount of mesh removal.All exposed mesh was excised using metzenbaum scissors.There was also noted to be an additional piece of mesh deep to the excised portion.This appeared to be twisted and was tight across the urethra this was elevated with an allis clamp and pick-ups and was excised after further exposure using a #15 blade.This additional piece of mesh was approximately 2 cam and blue in color.It was also sent for pathology.Once all palpable and visible mesh had been removed suburethral, the vagina was closed in layers using 2-0 polysorb in interrupted fashion with adequate approximation and hemostasis.Attention was then turned to the tight band of vaginal tissue identified on examination on the patient's right.This was suspected to be further mesh and given the patient's history of pain on the right side and on examination in the ambulatory setting, decision was made to proceed with dissection of this area.The tight band of tissue was grasped with an allis and the area was injected with dilute vasopressin.A transverse incision was made with a #15 blade overlying this area and further explored using sharp and blunt dissection with metzenbaum scissors.An underlying mesh was identified in this area and further dissection was undertaken in the direction of the ischial spine and towards the right sacrospinous ligament.4-5 cm of mesh was ultimately dissected using metzenbaum scissors and a #15 blade and once we determined our dissection had reached near the sacrospinous ligament, the decision was made to stop the dissection at this point to prevent further surgical morbidity.The mesh was excised thus from the level of the right ssl to the left side of the vagina just beyond the midline.The vagina was then closed using 2-0 polysorb in interrupted fashion and was noted to be hemostatic.A full survey of the bladder was performed without evidence of injury or mesh but presence of a bladder diverticulum was noted about the right posterior bladder dome.The bilateral ureters were identified with adequate efflux.The cystoscope was withdrawn and urethra inspected and found to be normal.The foley catheter was replaced.Rectal exam was negative.Patient was taken to the pacu in stable condition.No complications reported.On (b)(6) 2021, the patient was seen for a urogynecology pre-operative visit for planned interstim stage 1.Consent was signed and the patient was scheduled on (b)(6) 2021.Discussion was made regarding the role of interstim sacral neuromodulation and how it works for the patient's overactive bladder, urge incontinence and/or urinary retention.The patient underwent cystocopy with botox 200 units on (b)(6) 2021 and on follow up visit on (b)(6) 2021, patient reported to be doing a lot better.Was not leaking and the frequency and urgency seems normal, timed voids also helped, q2hrs, but had to press on abdomen to fully empty and sit forward.The botox 200 worked much better than the previous botox attempt.Pain has been reduced by 25-30% since mesh excision.She had tried extensive pfpt and water therapy.On (b)(6) 2021, the patient presented for an initial physical therapy exam.Diagnoses noted in the records included low back pain, pelvic and perineal pain, pain in the right hip, and urge incontinence.The primary concern was pelvic floor pain.The patient reported her medical history included fibromyalgia.Exam revealed tenderness to palpation throughout the internal pelvic floor musculature (r>l) with posterior wall more tender than lateral wall.The assessment noted that the patient's signs and symptoms were consistent with pelvic floor and low back/right hip pain secondary to hypertonicity and pelvic floor dysfunction.Impairments also included impaired hip strength, core strength, pelvic floor endurance, and ability to relax pelvic floor musculature.The plan was for physical therapy (pt) 2 times per week for 8 weeks.On (b)(6) 2021, the patient was seen by urogynelcology and reported ongoing pelvic pain and urinary urge incontinence.Her biggest concern was stabbing pelvic pain; the patient had reduced gabapentin because she was having some gi issues, complicated by gastric sleeve.Discussed pudendal block and possible resuming pfpt or adding kenalog to pudendal block.Counseled that a series of 6 pudendal blocks to perform with the goal of breaking the pain cycle and allowing the pelvic floor to relax.Will also perform trigger point injection along obturator interus at same time.Number 1 of 6 bilateral pudendal blocks completed - trigger point injection along obturator interus using a mixture of kenalog and marcaine was also performed reportedly due to pelvic floor muscle pain and spasm.The patient tolerated the procedure well.The vagina was noted to be hemostatic at the end of the procedure.Six pudendal blocks were completed on (b)(6) 2022 also with no complications.On (b)(6) 2022, the patient had another mesh revision surgery.Revision of vaginal scarring, zero mesh found, cystoscopy with botulinum toxin injection and levator botox injection procedures.Findings showed thickening on right periurethral area which had previously produced pain in the clinic; cystoscopy: trabeculations noted at a bladder volume of 350ml, with petechiae noted after filled to capacity and emptied.Bladder capacity of 350ml.No foreign bodies or lesions seen in the bladder.Mesh excision: during the procedure, the area on the right of the urethra that was ttp was located and under anesthesia felt more like scarring rather than mesh.The scar area that was suspected to include mesh was grasped with an allis clamp.The scarring was dissected off the underlying tissue in a superficial manner and excised.Approximately 1cm of scarred vaginal mucosa was removed to give fresh edges.No mesh was seen or palpated.But the firm, painful area in clinic was removed and no longer palpable.The vaginal edges were then closed with 2-0 polysorb.Hemostasis was achieved.Cystoscopy with botulinum toxin injection: cystoscopy was performed with 70 degree rigid cystoscope and the bladder was inspected systematically from the base and trigone to the air bubble in the dome on both sides.No mucosal lesions, stones or foreign body present.Normal, bilateral ureteral jets were seen.The patient was awoken from anesthesia and transferred to the pacu.Patient tolerated the procedure well.A return visit on (b)(6) 2022, the patient presented for a follow-up after her procedure.She reported significant improvement in her vaginal pain since the procedure, a 50% reduction in her urge urinary incontinence which was not as significant as her prior success with this therapy, and also now had daily fecal incontinence.Urine culture was submitted to evaluate potential cause for ongoing urge urinary incontinence.Had a discussion for potential additional bladder botox injection for her ongoing uui symptoms, however will wait until follow-up to see if symptoms improve prior to pursuing further interventions.Recommended increased fiber intake for treatment of her fecal incontinence and provided with handout.On pelvic exam, external genitalia were normal in appearance, there was no prolapse appreciated, and no rectal prolapse noted.There was a small amount of fecal matter on the buttocks, but no fecal incontinence observed with valsalva.Suture in place to the right of the urethra.Minimal soreness along the suture line upon palpation but not overt pain.No ttp of bilateral levator ani complexes.
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Manufacturer Narrative
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Block b5 has been updated based on the additional information received on november 15, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Mesh excision surgeon is: (b)(6).Block h6: imdrf patient codes e2006, e0123, e2330, e0127, e2006, e0123, e2330, e0127, e1715, e0126, e1302, e2328, e2311, e1405, e1301, e232401, e1906, e1901, e1309, e2015 and e2326 capture the reportable events of mesh erosion and exposure of implanted vaginal mesh, nerve damage, pain, numbness, nerve damage, scar tissue, neuropathy, hematuria, obstruction, discomfort, dyspareunia, dysuria, fecal incontinence, infection, bacterial infection, urinary retention, inflammation and tissue injury.Imdrf impact codes f1204, f2303, f1201, f1901 and f19 capture the reportable events of permanent pain, chronic nerve injury, medications, other medically necessary procedures and 6 pudendal blocks.
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Event Description
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The patient was diagnosed with pelvic organ prolapse and stress urinary incontinence in 2016 and was implanted with an ethicon tvt - o on (b)(6) 2016 during a cystocele repair.On (b)(6) 2019, at the time the patient was implanted with the uphold lite device, she was also implanted with a desara caldera sling.The patient had hysterectomy in 1993 and gastric sleeve procedure in 2015.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post - implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.Additional information received july 13, 2022.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during a cystoscopy + suprapubic cystostomy tube placement and drainage + cystocele repair + proximal sub - urethral sling procedure performed on (b)(6) 2019 for recurrent cystocele with partial bladder outlet obstruction; proximal urethral hypermobility with stress incontinence.Prior to surgery, the patient had a sling placement of a non - bsc device in 2016 to treat urinary incontinence and started experiencing issues including voiding difficulty, marked urgency, and mixed incontinence.Urodynamics showed recurrence of grade 2 cystocele, proximal urethral hypermobility with consequent kinking behind her old sling that was in a relatively distal location, and she also had marked idiopathic detrusor overactivity causing urgency.The symptoms became worse after the prolapse repair in (b)(6) 2019.During an office visit on (b)(6) 2019, the patient reported her urgency became worse and was then taking toviaz 8mg and myrbetriq 25mg.Patient had loss of sensation since her prolapse repair - could not feel when her bladder is full.Not able to respond to sensory signals of bladder fullness.The patient reported hematuria, incontinence, nocturia, pelvic pain, urgency, retention, glaucoma, dizziness, headache, hearing loss, abdominal pain, diarrhea, back pain, bone pain, skin rash, memory loss, syncope.Urinary symptoms were better controlled during the day because of toviaz and myrbetriq in the morning but despite that, she still used 200 briefs per month.The patient also applied vaginal estrogen cream.It was noted that the patient had white matter disease and struggled with memory issues.Patient active problem list included: chronic pain disorder, mixed stress and urge urinary incontinence, neuropathy, herpes simplex vulvovaginitis, morbid obesity, chronic neck and back pain.Physical exam showed area of eroded mesh to the left of the patient's urethra/bladder neck.No mesh erosion deeper in the vaginal vault.No rectocele.Vaginal estrogenization is fair.When asked to perform a kegel maneuver, the patient actually performed a valsalva maneuver.With coaching she was able to do an appropriate pelvic floor muscle contraction.Urine dip was positive for trace blood and trace leukocytes.The assessment was mixed stress and urge urinary incontinence.The patient was referred to urology and cystometrogram (cmg) study was planned.On (b)(6) 2019, the patient was experiencing significant hypertension and so was advised to discontinue the myrbetriq.Prior to her prolapse repair in (b)(6) 2019, she underwent a cmg that demonstrated severe overactive bladder.Cmg was repeated on (b)(6) 2019 and the flow curve was intermittent.On this study, the patient did not have stress incontinence but did have oab with associated urgency.On exam she has mesh erosion near her bladder neck consistent with her past mesh sling.The assessment was mixed stress and urge urinary incontinence, atrophic vaginitis, and erosion of bladder suspension mesh.She is using vaginal estrogen now 3 days per week.Mesh excision may need to be considered in the future.Moreover, tertiary line options were discussed for treating her overactive bladder - ptns, botox and interstim.The patient would like to proceed with botox injections and understood the risks.On (b)(6) 2020 urine culture grew mixed gram - positive and gram - negative flora.On (b)(6) 2020, the patient had 100 units botox and reported improvement in her urinary symptoms.There was less frequency and urgency.Noted slight urgency and need for valsalva voiding procedure.Post void residual (pvr) was initially 365 cc, but she was able to double void to 183 cc.No feelings of incomplete bladder emptying.She had slight dysuria but was improving gradually.The patient was advised that the toviaz may be contributing to incomplete emptying and discussed a trial of discontinuing this medication.Additionally, the patient was advised to continue timed and double voiding and was taught clean intermittent catheterization (cic) in case of worsening symptoms.On (b)(6) 2020, the patient reported to have incomplete bladder emptying after the botox and was catheterizing three times a day and was only draining 40 - 60cc of fluid.Self - catheterization made the patient feel much comfortable.She felt botox was only helpful for about a month and would like to try an alternative medication.The patient also complained of pelvic discomfort and dyspareunia.Additionally, she also developed atrophic vaginitis and should continue vaginal estrogen cream.Review of systems gastrointestinal: positive for constipation genitourinary: positive for frequency, pelvic pain, urgency and vaginal pain.During an office visit on (b)(6) 2020 for dyspareunia and pelvic pain, the patient reported fairly significant chronic daily pain which was sharper at times.The patient reported that she sustained some nerve damage with these 3 previous bladder surgeries.She was seeing urology and reported having some nerve stimulation performed for her bladder, but when the physician consulted with urology, they confirmed no formal nerve stimulation or interstim treatment had been performed.The patient reported that she had lost sensation during intercourse, bowel movements and voiding.She had some concern over vaginal spotting and suture material or mesh that is coming through the vagina.Overall she was concerned with the mesh erosion but likewise concerned with her pelvic pain and discomfort.General examination showed slight prolapse with what appears to be grade 2 enterocele.On (b)(6) 2020, the patient had an office visit with the assessments of dyspareunia, exposure of implanted vaginal mesh, urge urinary incontinence, ua concerning for infection, obesity, fecal smearing with evidence of prior anal sphincter injury and bowel leakage secondary to stool consistency (recommended psyllium husk), and rectocele that may contribute to accidental bowel leakage.On (b)(6) 2020, the patient was seen at a chronic pelvic pain center.The patient stated she had rectal and inguinal pain as well as pain with urination (rated as 6/10) in addition to the pelvic pain, pain with intercourse, and pain with sitting.Patient was scheduled for the removal of the vaginal part of the mesh on (b)(6) 2020.Patient tried multiple courses of pelvic floor physical therapy and takes oral baclofen with improvement.The botox injection into pelvic floor muscles improved her urination but made her pain worse.Assessment was pudendal neuralgia and obturator neuralgia.Plan: 1.Patient is going to have vaginal part of the mesh removed on (b)(6).2.If no improvement of pain, patient will be a candidate for the removal of the groin part of the tvt - o and caldera mesh.3.If she continues to be in pain patient may be a candidate for transgluteal pudendal neurolysis.On (b)(6) 2020, the patient eventually underwent mesh excision surgery.Preoperative diagnosis: 1.Exposure of vaginal mesh.2.Chronic pelvic pain with pain reproduced when palpating right arm of vaginal mesh to ssl.3.Stage 2 pop with posterior wall at 0 apex at - 1 and with aa - 3 but ba - 1.Postoperative diagnosis: same plus bladder diverticulum.Procedure performed: 1.Exam under anesthesia.2.Excision of exposed vaginal mesh.3.Cystourethroscopy.On examination under anesthesia, there was an easily palpable area of exposed sub - urethral mesh on the anatomic left approximately 2 cm of which was palpable.On further vaginal examination there was noted to be a tight band extending from the right ischial spine likely in the area of the sacrospinous ligament.Both areas were excised with no residual palpable mesh following excision.Bladder noted to have small diverticulum about the right bladder dome posteriorly.Bilateral ureteral efflux noted.Normal urethra without obvious mesh exposure on cystourethroscopy.During the procedure, the exposed sub - urethral mesh was grasped with an allis clamp and the surrounding vaginal mucosa was injected using dilute vasopressin.A transverse incision was then carried out about the right inferior aspect of the exposed mesh towards the midline and allis clamps were used to expose the tissue.Then, using metzenbaum scissors and a #15 blade, the sub - urethral mesh was exposed both towards the midline and back laterally towards the patient's left side.About 3 cm of mesh was ultimately exposed and was clamped and incised to release the tension on the mesh as well as the area of exposure.The mesh was dissected on the patient's left to the level of the obturator internus, on the right the mesh was released after it coursed beyond the midline of the urethra and vagina.On each free arm of the mesh, further dissection was carried out to maximize the amount of mesh removal.All exposed mesh was excised using metzenbaum scissors.There was also noted to be an additional piece of mesh deep to the excised portion.This appeared to be twisted and was tight across the urethra this was elevated with an allis clamp and pick - ups and was excised after further exposure using a #15 blade.This additional piece of mesh was approximately 2 cam and blue in color.It was also sent for pathology.Once all palpable and visible mesh had been removed suburethral, the vagina was closed in layers using 2 - 0 polysorb in interrupted fashion with adequate approximation and hemostasis.Attention was then turned to the tight band of vaginal tissue identified on examination on the patient's right.This was suspected to be further mesh and given the patient's history of pain on the right side and on examination in the ambulatory setting, decision was made to proceed with dissection of this area.The tight band of tissue was grasped with an allis and the area was injected with dilute vasopressin.A transverse incision was made with a #15 blade overlying this area and further explored using sharp and blunt dissection with metzenbaum scissors.An underlying mesh was identified in this area and further dissection was undertaken in the direction of the ischial spine and towards the right sacrospinous ligament.4 - 5 cm of mesh was ultimately dissected using metzenbaum scissors and a #15 blade and once we determined our dissection had reached near the sacrospinous ligament, the decision was made to stop the dissection at this point to prevent further surgical morbidity.The mesh was excised thus from the level of the right ssl to the left side of the vagina just beyond the midline.The vagina was then closed using 2 - 0 polysorb in interrupted fashion and was noted to be hemostatic.A full survey of the bladder was performed without evidence of injury or mesh but presence of a bladder diverticulum was noted about the right posterior bladder dome.The bilateral ureters were identified with adequate efflux.The cystoscope was withdrawn and urethra inspected and found to be normal.The foley catheter was replaced.Rectal exam was negative.Patient was taken to the pacu in stable condition.No complications reported.On (b)(6) 2021, the patient was seen for a urogynecology pre - operative visit for planned interstim stage 1.Consent was signed and the patient was scheduled on (b)(6) 2021.Discussion was made regarding the role of interstim sacral neuromodulation and how it works for the patient's overactive bladder, urge incontinence and/or urinary retention.The patient underwent cystocopy with botox 200 units on (b)(6) 2021 and on follow up visit on (b)(6) 2021, patient reported to be doing a lot better.Was not leaking and the frequency and urgency seems normal, timed voids also helped, q2hrs, but had to press on abdomen to fully empty and sit forward.The botox 200 worked much better than the previous botox attempt.Pain has been reduced by 25 - 30 percent since mesh excision.She had tried extensive pfpt and water therapy.On (b)(6) 2021, the patient presented for an initial physical therapy exam.Diagnoses noted in the records included low back pain, pelvic and perineal pain, pain in the right hip, and urge incontinence.The primary concern was pelvic floor pain.The patient reported her medical history included fibromyalgia.Exam revealed tenderness to palpation throughout the internal pelvic floor musculature (r greater than l) with posterior wall more tender than lateral wall.The assessment noted that the patient's signs and symptoms were consistent with pelvic floor and low back/right hip pain secondary to hypertonicity and pelvic floor dysfunction.Impairments also included impaired hip strength, core strength, pelvic floor endurance, and ability to relax pelvic floor musculature.The plan was for physical therapy (pt) 2 times per week for 8 weeks.On (b)(6) 2021, the patient was seen by urogynelcology and reported ongoing pelvic pain and urinary urge incontinence.Her biggest concern was stabbing pelvic pain; the patient had reduced gabapentin because she was having some gi issues, complicated by gastric sleeve.Discussed pudendal block and possible resuming pfpt or adding kenalog to pudendal block.Counseled that a series of 6 pudendal blocks to perform with the goal of breaking the pain cycle and allowing the pelvic floor to relax.Will also perform trigger point injection along obturator interus at same time.Number 1 of 6 bilateral pudendal blocks completed - trigger point injection along obturator interus using a mixture of kenalog and marcaine was also performed reportedly due to pelvic floor muscle pain and spasm.The patient tolerated the procedure well.The vagina was noted to be hemostatic at the end of the procedure.Six pudendal blocks were completed on (b)(6) 2022 also with no complications.On (b)(6) 2022, the patient had another mesh revision surgery.Revision of vaginal scarring, zero mesh found, cystoscopy with botulinum toxin injection and levator botox injection procedures.Findings showed thickening on right periurethral area which had previously produced pain in the clinic; cystoscopy: trabeculations noted at a bladder volume of 350ml, with petechiae noted after filled to capacity and emptied.Bladder capacity of 350ml.No foreign bodies or lesions seen in the bladder.Mesh excision: during the procedure, the area on the right of the urethra that was ttp was located and under anesthesia felt more like scarring rather than mesh.The scar area that was suspected to include mesh was grasped with an allis clamp.The scarring was dissected off the underlying tissue in a superficial manner and excised.Approximately 1cm of scarred vaginal mucosa was removed to give fresh edges.No mesh was seen or palpated.But the firm, painful area in clinic was removed and no longer palpable.The vaginal edges were then closed with 2 - 0 polysorb.Hemostasis was achieved.Cystoscopy with botulinum toxin injection: cystoscopy was performed with 70 degree rigid cystoscope and the bladder was inspected systematically from the base and trigone to the air bubble in the dome on both sides.No mucosal lesions, stones or foreign body present.Normal, bilateral ureteral jets were seen.The patient was awoken from anesthesia and transferred to the pacu.Patient tolerated the procedure well.A return visit on (b)(6) , 2022, the patient presented for a follow - up after her procedure.She reported significant improvement in her vaginal pain since the procedure, a 50 percent reduction in her urge urinary incontinence which was not as significant as her prior success with this therapy, and also now had daily fecal incontinence.Urine culture was submitted to evaluate potential cause for ongoing urge urinary incontinence.Had a discussion for potential additional bladder botox injection for her ongoing uui symptoms, however will wait until follow - up to see if symptoms improve prior to pursuing further interventions.Recommended increased fiber intake for treatment of her fecal incontinence and provided with handout.On pelvic exam, external genitalia were normal in appearance, there was no prolapse appreciated, and no rectal prolapse noted.There was a small amount of fecal matter on the buttocks, but no fecal incontinence observed with valsalva.Suture in place to the right of the urethra.Minimal soreness along the suture line upon palpation but not overt pain.No ttp of bilateral levator ani complexes.Additional information received on november 15, 2022.It was reported in notes dated april 5, 2021 that the patient had been suffering from urine and stool incontinence after pelvic mesh procedure in 2018.She had a spinal stimulator which had controlled her symptoms she was no longer on anticholinergics.
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Event Description
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The patient was diagnosed with pelvic organ prolapse and stress urinary incontinence in 2016 and was implanted with an ethicon tvt - o, on (b)(6) 2016 during a cystocele repair.On (b)(6) 2019, at the time the patient was implanted with the uphold lite device, she was also implanted with a desara caldera sling.The patient had hysterectomy in 1993 and gastric sleeve procedure in 2015.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during suprapubic tube placement and cystocele repair procedures performed on (b)(6) 2019.On (b)(6) 2019, the patient sought treatment for post - implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain and groin pain.The patient was then advised not to undergo mesh removal surgery as it would cause more nerve damage.Since (b)(6) 2019, the patient has had chronic pain in her pelvis, vagina, groin, and leg when the mesh eroded into surrounding tissues.Chronic inflammation and nerve injury had developed and patient's pain has been permanent and affects the pelvis, vagina, groin, leg, back, tailbone and buttocks.Subsequently, the patient has incurred reasonable and necessary medical expenses and reportedly will incur reasonable and necessary medical to care for her injuries over her lifespan.She reportedly has endured physical pain, humiliation, and psychological distress, and has been rendered sick, sore, embarrassed, and anxious.In addition, she has suffered inconvenience, stress and the loss of normal daily activities.Additional information received july 13, 2022.It was reported to boston scientific corporation that a boston scientific uphold lite device was implanted into the patient during a cystoscopy + suprapubic cystostomy tube placement and drainage + cystocele repair + proximal sub - urethral sling procedure performed on april 29, 2019 for recurrent cystocele with partial bladder outlet obstruction; proximal urethral hypermobility with stress incontinence.Prior to surgery, the patient had a sling placement of a non - bsc device in 2016 to treat urinary incontinence and started experiencing issues including voiding difficulty, marked urgency, and mixed incontinence.Urodynamics showed recurrence of grade 2 cystocele, proximal urethral hypermobility with consequent kinking behind her old sling that was in a relatively distal location, and she also had marked idiopathic detrusor overactivity causing urgency.The symptoms became worse after the prolapse repair in april 2019.During an office visit on (b)(6) 2019, the patient reported her urgency became worse and was then taking toviaz 8mg and myrbetriq 25mg.Patient had loss of sensation since her prolapse repair - could not feel when her bladder is full.Not able to respond to sensory signals of bladder fullness.The patient reported hematuria, incontinence, nocturia, pelvic pain, urgency, retention, glaucoma, dizziness, headache, hearing loss, abdominal pain, diarrhea, back pain, bone pain, skin rash, memory loss, syncope.Urinary symptoms were better controlled during the day because of toviaz and myrbetriq in the morning but despite that, she still used 200 briefs per month.The patient also applied vaginal estrogen cream.It was noted that the patient had white matter disease and struggled with memory issues.Patient active problem list included: - chronic pain disorder.- mixed stress and urge urinary incontinence.- neuropathy.- herpes simplex vulvovaginitis.- morbid obesity.- chronic neck and back pain.Physical exam showed area of eroded mesh to the left of the patient's urethra/bladder neck.No mesh erosion deeper in the vaginal vault.No rectocele.Vaginal estrogenization is fair.When asked to perform a kegel maneuver, the patient actually performed a valsalva maneuver.With coaching she was able to do an appropriate pelvic floor muscle contraction.Urine dip was positive for trace blood and trace leukocytes.The assessment was mixed stress and urge urinary incontinence.The patient was referred to urology and cystometrogram (cmg) study was planned.On (b)(6) 2019, the patient was experiencing significant hypertension and so was advised to discontinue the myrbetriq.Prior to her prolapse repair in april 2019, she underwent a cmg that demonstrated severe overactive bladder.Cmg was repeated on november 7, 2019 and the flow curve was intermittent.On this study, the patient did not have stress incontinence but did have oab with associated urgency.On exam she has mesh erosion near her bladder neck consistent with her past mesh sling.The assessment was mixed stress and urge urinary incontinence, atrophic vaginitis, and erosion of bladder suspension mesh.She is using vaginal estrogen now 3 days per week.Mesh excision may need to be considered in the future.Moreover, tertiary line options were discussed for treating her overactive bladder - ptns, botox and interstim.The patient would like to proceed with botox injections and understood the risks.On (b)(6) 2020 urine culture grew mixed gram - positive and gram - negative flora.On (b)(6) 2020, the patient had 100 units botox and reported improvement in her urinary symptoms.There was less frequency and urgency.Noted slight urgency and need for valsalva voiding procedure.Post void residual (pvr) was initially 365 cc, but she was able to double void to 183 cc.No feelings of incomplete bladder emptying.She had slight dysuria but was improving gradually.The patient was advised that the toviaz may be contributing to incomplete emptying and discussed a trial of discontinuing this medication.Additionally, the patient was advised to continue timed and double voiding and was taught clean intermittent catheterization (cic) in case of worsening symptoms.On (b)(6) 2020, the patient reported to have incomplete bladder emptying after the botox and was catheterizing three times a day and was only draining 40 - 60cc of fluid.Self - catheterization made the patient feel much comfortable.She felt botox was only helpful for about a month and would like to try an alternative medication.The patient also complained of pelvic discomfort and dyspareunia.Additionally, she also developed atrophic vaginitis and should continue vaginal estrogen cream.Review of systems gastrointestinal: positive for constipation.Genitourinary: positive for frequency, pelvic pain, urgency and vaginal pain.During an office visit on (b)(6) 2020 for dyspareunia and pelvic pain, the patient reported fairly significant chronic daily pain which was sharper at times.The patient reported that she sustained some nerve damage with these 3 previous bladder surgeries.She was seeing urology and reported having some nerve stimulation performed for her bladder, but when the physician consulted with urology, they confirmed no formal nerve stimulation or interstim treatment had been performed.The patient reported that she had lost sensation during intercourse, bowel movements and voiding.She had some concern over vaginal spotting and suture material or mesh that is coming through the vagina.Overall she was concerned with the mesh erosion but likewise concerned with her pelvic pain and discomfort.General examination showed slight prolapse with what appears to be grade 2 enterocele.On (b)(6) 2020, the patient had an office visit with the assessments of dyspareunia, exposure of implanted vaginal mesh, urge urinary incontinence, ua concerning for infection, obesity, fecal smearing with evidence of prior anal sphincter injury and bowel leakage secondary to stool consistency (recommended psyllium husk), and rectocele that may contribute to accidental bowel leakage.On (b)(6) 2020, the patient was seen at a chronic pelvic pain center.The patient stated she had rectal and inguinal pain as well as pain with urination (rated as 6/10) in addition to the pelvic pain, pain with intercourse, and pain with sitting.Patient was scheduled for the removal of the vaginal part of the mesh on december 21, 2020.Patient tried multiple courses of pelvic floor physical therapy and takes oral baclofen with improvement.The botox injection into pelvic floor muscles improved her urination but made her pain worse.Assessment was pudendal neuralgia and obturator neuralgia.Plan: 1.Patient is going to have vaginal part of the mesh removed on (b)(6).2.If no improvement of pain, patient will be a candidate for the removal of the groin part of the tvt - o and caldera mesh.3.If she continues to be in pain patient may be a candidate for transgluteal pudendal neurolysis.On (b)(6) 2020, the patient eventually underwent mesh excision surgery.Preoperative diagnosis: 1.Exposure of vaginal mesh.2.Chronic pelvic pain with pain reproduced when palpating right arm of vaginal mesh to ssl.3.Stage 2 pop with posterior wall at 0 apex at - 1 and with aa - 3 but ba - 1.Postoperative diagnosis: same plus bladder diverticulum.Procedure performed: 1.Exam under anesthesia.2.Excision of exposed vaginal mesh.3.Cystourethroscopy.On examination under anesthesia, there was an easily palpable area of exposed sub - urethral mesh on the anatomic left approximately 2 cm of which was palpable.On further vaginal examination there was noted to be a tight band extending from the right ischial spine likely in the area of the sacrospinous ligament.Both areas were excised with no residual palpable mesh following excision.Bladder noted to have small diverticulum about the right bladder dome posteriorly.Bilateral ureteral efflux noted.Normal urethra without obvious mesh exposure on cystourethroscopy.During the procedure, the exposed sub - urethral mesh was grasped with an allis clamp and the surrounding vaginal mucosa was injected using dilute vasopressin.A transverse incision was then carried out about the right inferior aspect of the exposed mesh towards the midline and allis clamps were used to expose the tissue.Then, using metzenbaum scissors and a #15 blade, the sub - urethral mesh was exposed both towards the midline and back laterally towards the patient's left side.About 3 cm of mesh was ultimately exposed and was clamped and incised to release the tension on the mesh as well as the area of exposure.The mesh was dissected on the patient's left to the level of the obturator internus, on the right the mesh was released after it coursed beyond the midline of the urethra and vagina.On each free arm of the mesh, further dissection was carried out to maximize the amount of mesh removal.All exposed mesh was excised using metzenbaum scissors.There was also noted to be an additional piece of mesh deep to the excised portion.This appeared to be twisted and was tight across the urethra this was elevated with an allis clamp and pick - ups and was excised after further exposure using a #15 blade.This additional piece of mesh was approximately 2 cam and blue in color.It was also sent for pathology.Once all palpable and visible mesh had been removed suburethral, the vagina was closed in layers using 2 - 0 polysorb in interrupted fashion with adequate approximation and hemostasis.Attention was then turned to the tight band of vaginal tissue identified on examination on the patient's right.This was suspected to be further mesh and given the patient's history of pain on the right side and on examination in the ambulatory setting, decision was made to proceed with dissection of this area.The tight band of tissue was grasped with an allis and the area was injected with dilute vasopressin.A transverse incision was made with a #15 blade overlying this area and further explored using sharp and blunt dissection with metzenbaum scissors.An underlying mesh was identified in this area and further dissection was undertaken in the direction of the ischial spine and towards the right sacrospinous ligament.4 - 5 cm of mesh was ultimately dissected using metzenbaum scissors and a #15 blade and once we determined our dissection had reached near the sacrospinous ligament, the decision was made to stop the dissection at this point to prevent further surgical morbidity.The mesh was excised thus from the level of the right ssl to the left side of the vagina just beyond the midline.The vagina was then closed using 2 - 0 polysorb in interrupted fashion and was noted to be hemostatic.A full survey of the bladder was performed without evidence of injury or mesh but presence of a bladder diverticulum was noted about the right posterior bladder dome.The bilateral ureters were identified with adequate efflux.The cystoscope was withdrawn and urethra inspected and found to be normal.The foley catheter was replaced.Rectal exam was negative.Patient was taken to the pacu in stable condition.No complications reported.On (b)(6) 2021, the patient was seen for a urogynecology pre - operative visit for planned interstim stage 1.Consent was signed and the patient was scheduled on (b)(6) 2021.Discussion was made regarding the role of interstim sacral neuromodulation and how it works for the patient's overactive bladder, urge incontinence and/or urinary retention.The patient underwent cystocopy with botox (b)(4) units on (b)(6) 2021 and on follow up visit on (b)(6) 2021, patient reported to be doing a lot better.Was not leaking and the frequency and urgency seems normal, timed voids also helped, q2hrs, but had to press on abdomen to fully empty and sit forward.The botox 200 worked much better than the previous botox attempt.Pain has been reduced by 25 - 30 percent since mesh excision.She had tried extensive pfpt and water therapy.On (b)(6) 2021, the patient presented for an initial physical therapy exam.Diagnoses noted in the records included low back pain, pelvic and perineal pain, pain in the right hip, and urge incontinence.The primary concern was pelvic floor pain.The patient reported her medical history included fibromyalgia.Exam revealed tenderness to palpation throughout the internal pelvic floor musculature (r greater than l) with posterior wall more tender than lateral wall.The assessment noted that the patient's signs and symptoms were consistent with pelvic floor and low back/right hip pain secondary to hypertonicity and pelvic floor dysfunction.Impairments also included impaired hip strength, core strength, pelvic floor endurance, and ability to relax pelvic floor musculature.The plan was for physical therapy (pt) 2 times per week for 8 weeks.On (b)(6) 2021, the patient was seen by urogynelcology and reported ongoing pelvic pain and urinary urge incontinence.Her biggest concern was stabbing pelvic pain; the patient had reduced gabapentin because she was having some gi issues, complicated by gastric sleeve.Discussed pudendal block and possible resuming pfpt or adding kenalog to pudendal block.Counseled that a series of 6 pudendal blocks to perform with the goal of breaking the pain cycle and allowing the pelvic floor to relax.Will also perform trigger point injection along obturator interus at same time.Number 1 of 6 bilateral pudendal blocks completed - trigger point injection along obturator interus using a mixture of kenalog and marcaine was also performed reportedly due to pelvic floor muscle pain and spasm.The patient tolerated the procedure well.The vagina was noted to be hemostatic at the end of the procedure.Six pudendal blocks were completed on february 16, 2022 also with no complications.On (b)(6) 2022, the patient had another mesh revision surgery.Revision of vaginal scarring, zero mesh found, cystoscopy with botulinum toxin injection and levator botox injection procedures.Findings showed thickening on right periurethral area which had previously produced pain in the clinic; cystoscopy: trabeculations noted at a bladder volume of 350ml, with petechiae noted after filled to capacity and emptied.Bladder capacity of 350ml.No foreign bodies or lesions seen in the bladder.Mesh excision: during the procedure, the area on the right of the urethra that was ttp was located and under anesthesia felt more like scarring rather than mesh.The scar area that was suspected to include mesh was grasped with an allis clamp.The scarring was dissected off the underlying tissue in a superficial manner and excised.Approximately 1cm of scarred vaginal mucosa was removed to give fresh edges.No mesh was seen or palpated.But the firm, painful area in clinic was removed and no longer palpable.The vaginal edges were then closed with 2 - 0 polysorb.Hemostasis was achieved.Cystoscopy with botulinum toxin injection: cystoscopy was performed with 70 degree rigid cystoscope and the bladder was inspected systematically from the base and trigone to the air bubble in the dome on both sides.No mucosal lesions, stones or foreign body present.Normal, bilateral ureteral jets were seen.The patient was awoken from anesthesia and transferred to the pacu.Patient tolerated the procedure well.A return visit on (b)(6) 2022, the patient presented for a follow - up after her procedure.She reported significant improvement in her vaginal pain since the procedure, a 50 percent reduction in her urge urinary incontinence which was not as significant as her prior success with this therapy, and also now had daily fecal incontinence.Urine culture was submitted to evaluate potential cause for ongoing urge urinary incontinence.Had a discussion for potential additional bladder botox injection for her ongoing uui symptoms, however will wait until follow - up to see if symptoms improve prior to pursuing further interventions.Recommended increased fiber intake for treatment of her fecal incontinence and provided with handout.On pelvic exam, external genitalia were normal in appearance, there was no prolapse appreciated, and no rectal prolapse noted.There was a small amount of fecal matter on the buttocks, but no fecal incontinence observed with valsalva.Suture in place to the right of the urethra.Minimal soreness along the suture line upon palpation but not overt pain.No ttp of bilateral levator ani complexes.**additional information received on november 15, 2022.It was reported in notes dated (b)(6) 2021 that the patient had been suffering from urine and stool incontinence after pelvic mesh procedure in 2018.She had a spinal stimulator which had controlled her symptoms she was no longer on anticholinergics.---additional information received on april 22, 2023--- on (b)(6) 2020, the patient presented for consult for overactive bladder and urinary incontinence.The patient reported urinary frequency, urge incontinence, and nocturia.The physician and patient discussed treatment options and decided to proceed with botox injections.
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Manufacturer Narrative
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Block b5, b7, and d6b have been updated based on the additional information received on april 11, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Mesh excision surgeon is: dr (b)(6).Block h6: imdrf patient codes e2006, e0123, e2330, e0127, e2006, e0123, e2330, e0127, e1715, e0126, e1302, e2328, e2311, e1405, e1301, e232401, e1906, e1901, e1309, e2015 and e2326 capture the reportable events of mesh erosion and exposure of implanted vaginal mesh, nerve damage, pain, numbness, nerve damage, scar tissue, neuropathy, hematuria, obstruction, discomfort, dyspareunia, dysuria, fecal incontinence, infection, bacterial infection, urinary retention, inflammation and tissue injury.Imdrf impact codes f1204, f2303, f1201, f1901 and f19 capture the reportable events of permanent pain, chronic nerve injury, medications, other medically necessary procedures and 6 pudendal blocks.
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