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BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068505110 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Stenosis (2263); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 05/17/2021 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.On (b)(6) 2021, the patient underwent mesh removal surgery.
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date of mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant facility is: (b)(6).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.
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Event Description
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It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.On (b)(6) 2021, the patient underwent mesh removal surgery.Boston scientific received additional information on june 16, 2022 as follows: on (b)(6) 2016, the patient underwent a transobturator mid-urethral sling (obtryx) placement for the treatment of stress urinary incontinence and rectocele.The patient had already planned to undergo a rectocele repair with another physician, and was consulted for possible sling placement.Before the surgery, the risks, benefits, and possible complications were explained to her in detail.The risks include, but are not limited to, bleeding, infection, damage to surrounding structures including the urethra, bladder, ureters, potential persistence of the stress urinary incontinence, potential erosion of the sling into the vaginal or into the bladder, potential resultant urgency and irritating urinary symptoms, and the need for future procedures.The patient elected to proceed with transobturator midurethral synthetic sling.The rectocele repair was completed prior to the sling placement part of the procedure.During the surgery, the obtryx sling had been placed through a buttonhole through the vaginal wall as it appeared to go outside of the anterior wall incision.The surgeon stated that the rectocele's tight closure made it challenging to reach the proximal part of the vagina.The left trocar was then reinserted using a finger to bring it out via the anterior vaginal incision to protect the bladder or urethra when the sling was taken off.A second cystoscopy was conducted, and this time it revealed no damage to the bladder or urethra.Additionally, the left ureter was effluxing clean urine, and the surgeon made a thorough examination of the proximal vaginal tissue and found no signs of a buttonhole.Then the trocars were attached to a second obtryx sling, which was brought out through the stab incisions.When the surgeon thoroughly examined the left and right sides, there was no sign of a sling in the anterior vagina.When the plastic piece of the sling was released, it sat very comfortably along the mid-urethra with no tension.According to reports, the patient responded favorably to the treatment, awoke easily from anesthesia, and was transferred to the recovery area in stable condition.Following the treatment, a dense band that caused the vagina to have a very tiny caliber, an angular entrance far anteriorly, and a positive rectocele was discovered during the lysis of vaginal stenotic bands and colporrhaphy procedure in (b)(6) 2016.Vicryl 2-0 was used to relieve scar tissue and treat rectocele.Additionally, during a patient visit in 2018, the patient still has a complaint of dyspareunia.The patient was also given a prescription for a vaginal dilator, but she rarely uses it.A vaginal lesion was discovered in the left side of her vaginal wall during her pelvic exam.The lesion was friable and bled when touched.The following procedures were carried out on the patient on (b)(6) 2021: complex cystometry, complex uroflowmetry, electromyography with surface electrodes, pressure voiding flow study, abdominal pressure measurement, and leak point pressure measurement.Since her previous surgery in (b)(6) 2016, it has reportedly been reported that the patient has started bleeding during sexual activity and bowel movements.Additionally, the patient had an incomplete defecation, and she needed a splint to assist her.The patient claims that when having sex, she had pain as well, which did not go away with lubricant.Additionally, she also experienced vaginal dryness.On (b)(6) 2021, the patient was seen for pelvic floor physical therapy.She reports moderate to severe pain during intercourse and was described as ripping sensation with vaginal bleeding.In addition to frequent urination, she also struggles to fully empty her bladder and feels moderate to intense urgency just before urinating.Patient mentions dribbling or intermittent leakage.Patient has difficulty having a bowel movements with bleeding and manual pressure along perineum required for full evacuation.The patient, a truck driver, is reportedly on a short disability to address the aforementioned difficulties.The assessment of the physical therapist was that the patient presents with high high tone of the pfm with sensitivity to palpation and a delayed relaxation response.The patient will benefit from a progressive exercise program beginning with down-training and then re-education with application to functional movement patterns when tolerated.They then will utilize internal tp releases as well as aim to assist in reduction of muscle spasms.The patient was also encouraged to use vaginal dilators to assist.The patient's main complaint on (b)(6) 2021, is persistent lower suprapubic pain.Since beginning physical therapy, the patient has not engaged in sexual activity.She also claims that with a modest decrease in urgency, her ability to initiate urine flow has improved.According to the report, the patient underwent physical treatment for pelvic floor muscle dysfunction over the course of eight visits.Her therapy has included hip stretches for the obturator, piriformis, and iliopsoas as well as a progressive down training program, internal tp release with contract/relax stretching, and other soft tissue work.She has demonstrated a decrease in pelvic floor muscle tone and decreased sensitivity to palpation during the course of her treatment.The patient appears to be very compliant at home and is tolerating a progression of dilators.Due to the tone, she still has trouble identifying the right slow twitch contraction, but after treatment, she gets better at contracting and relaxing.For 2-day intervals, the patient's symptoms of pain and bleeding have been slightly reduced, but then they come back.The patient was extremely frustrated despite her slow but steady improvement in the strength and tone of her pelvic floor muscles.The patient also indicated she was being referred to physical therapy prior to an upcoming surgery to remove mesh (then scheduled for (b)(6) 2021).On (b)(6) 2021, the patient underwent an excision of vaginal mesh, bilateral urethrolysis and cystourethroscopy procedure.Her diagnosis at that time was dyspareunia, vaginal mesh exposure, vaginal atrophy, tobacco use, pelvic myalgia, urge incontinence, incomplete defecation, constipation, perineal body defect, and concern for voiding dysfunction.On (b)(6) 2021, the patient was seen for a post-op visit.She reported aching abdominal pain which radiates to her back and is relieved with bentyl qid.It was above the surgical site and the physician does not believe it is related to surgery.The physician noted she was healing well post-op.Impression: myalgia of pelvic floor, chronic constipation, pelvic pain, incomplete defecation, tobacco use.She was recommended to restart pelvic floor physical therapy for levator muscle tension, and to restart using 0.5 g vaginal estrogen before bed x/week for vaginal dryness.On (b)(6) 2021, the patient was seen for physical therapy (following removal of mesh on (b)(6) 2016).The patient reports mild pain with intercourse described as stretch and burn.Patient had difficulty having a bowel movement with manual pressure along perineum required or full evacuation.Otherwise, perineal pain, urinary frequency/urgency are normal.She denies urinary incontinence as well as heaviness.Patient continues with gastrointestinal pain in lower abdomen which is being successfully treated with bentyl.Patient also was recently diagnosed with irritable bowel syndrome.The assessment at that visit was that the patient presents with pfm dysfunction and will benefit from pt treatments which will consist of a progressive down training program, internal tp release with contract/relax stretching, as well as hip stretching for obturator, piriformis, and iliopsoas.She will also benefit from general core strengthening and functional strengthening with application to core when tolerated.It was noted the patient has had a substantial improvement in her symptoms since having had surgery.The patient has accomplished half of her objectives as of (b)(6) 2021.She reportedly just felt a little pressure during sex and appears to be taking medicine to manage her irritable bowel syndrome.Although the patient's pelvic floor muscle is still weak and stiff, she has shown improvement in her ability to contract and relax it.
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Manufacturer Narrative
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Block h2: block a2, a3, b5, b7 and h6 have been updated based on the additional information received on june 14, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 17, 2021 was chosen as a best estimate based on the date of mesh removal surgery.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.Initial reporter address 1: (b)(6).The surgeons are: dr.(b)(6).Physical therapy referring physician: dr.(b)(6).Block h6: patient code e1405, e2015, e2328, e2330, e2006 captures the reportable events of dyspareunia, atrophy, bowel obstruction, pain and erosion.Impact code f1903 and f1202 captures the reportable event of mesh removal surgery and short disability.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.
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Event Description
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It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.On (b)(6) 2021, the patient underwent mesh removal surgery.Boston scientific received additional information on june 16, 2022 as follows: on (b)(6) 2016, the patient underwent a transobturator mid-urethral sling (obtryx) placement for the treatment of stress urinary incontinence and rectocele.The patient had already planned to undergo a rectocele repair with another physician, and was consulted for possible sling placement.Before the surgery, the risks, benefits, and possible complications were explained to her in detail.The risks include, but are not limited to, bleeding, infection, damage to surrounding structures including the urethra, bladder, ureters, potential persistence of the stress urinary incontinence, potential erosion of the sling into the vaginal or into the bladder, potential resultant urgency and irritating urinary symptoms, and the need for future procedures.The patient elected to proceed with transobturator midurethral synthetic sling.The rectocele repair was completed prior to the sling placement part of the procedure.During the surgery, the obtryx sling had been placed through a buttonhole through the vaginal wall as it appeared to go outside of the anterior wall incision.The surgeon stated that the rectocele's tight closure made it challenging to reach the proximal part of the vagina.The left trocar was then reinserted using a finger to bring it out via the anterior vaginal incision to protect the bladder or urethra when the sling was taken off.A second cystoscopy was conducted, and this time it revealed no damage to the bladder or urethra.Additionally, the left ureter was effluxing clean urine, and the surgeon made a thorough examination of the proximal vaginal tissue and found no signs of a buttonhole.Then the trocars were attached to a second obtryx sling, which was brought out through the stab incisions.When the surgeon thoroughly examined the left and right sides, there was no sign of a sling in the anterior vagina.When the plastic piece of the sling was released, it sat very comfortably along the mid-urethra with no tension.According to reports, the patient responded favorably to the treatment, awoke easily from anesthesia, and was transferred to the recovery area in stable condition.Following the treatment, a dense band that caused the vagina to have a very tiny caliber, an angular entrance far anteriorly, and a positive rectocele was discovered during the lysis of vaginal stenotic bands and colporrhaphy procedure in december 2016.Vicryl 2-0 was used to relieve scar tissue and treat rectocele.Additionally, during a patient visit in 2018, the patient still has a complaint of dyspareunia.The patient was also given a prescription for a vaginal dilator, but she rarely uses it.A vaginal lesion was discovered in the left side of her vaginal wall during her pelvic exam in january 2021.The lesion was friable and bled when touched.Biopsy of this lesion showed granulation tissue with no dysplasia or malignancy.On (b)(6) 2021, the patient reported that since her previous surgery in december 2016, she has started bleeding during sexual activity and bowel movements.Additionally, the patient had incomplete defecation, and she needed to splint to assist her and this had never improved after the rectocele repair.The patient claims that when having sex, she had pain as well, which did not go away with lubricant.Additionally, she also experienced vaginal dryness.She experienced urge urinary incontinence and used 1 pad or liner per day, urinary frequency every hour during the day, nocturia x 3, a slow intermittent urine stream , and post-void urgency.Physical exam revealed 0.5 cm area of granulation tissue with blue mesh sling visualized deep at left vaginal sulcus with mild banding that was most tender to palpation, right vaginal sulcus with mild banding but less tender to palpation, atrophy, and posterior banding and tenderness to palpation.The following procedures were carried out on the patient on (b)(6) 2021: complex cystometry, complex uroflowmetry, electromyography with surface electrodes, pressure voiding flow study, abdominal pressure measurement, and leak point pressure measurement.The preoperative diagnoses were listed as dyspareunia, vaginal mesh exposure, vaginal atrophy, tobacco use, pelvic myalgia, urge incontinence, incomplete defecation, constipation, and perineal body defect.Uroflowmetry was normal, the pressure flow study was prolonged with some valsalva to assist near the end, and no detrusor overactivity or stress urinary incontinence.Urethroscopy and cystoscopy were essentially normal.The plan was as follows: for dyspareunia- excision/release of left mesh arm and possibly right mesh arm, possible buccal graft and perineorrhaphy, vaginal estrogen for dryness, stop smoking, and increase levator muscle tone with pelvic floor physical therapy (pfpt); for urge incontinence- urine culture and sensitivity, stop smoking, empty bladder every 3 hours, avoid dietary irritatants, pfpt, and consider medications; for constipation- hydrate well, stop smoking, fiber supplements, pfpt; and for hemorrhoid- colorectal consult.On (b)(6) 2021, the patient was seen for pelvic floor physical therapy.She reports moderate to severe pain during intercourse and was described as ripping sensation with vaginal bleeding.In addition to frequent urination, she also struggles to fully empty her bladder and feels moderate to intense urgency just before urinating.Patient mentions dribbling or intermittent leakage.Patient has difficulty having a bowel movements with bleeding and manual pressure along perineum required for full evacuation.The patient, a truck driver, is reportedly on a short disability to address the aforementioned difficulties.The assessment of the physical therapist was that the patient presents with high tone of the pfm with sensitivity to palpation and a delayed relaxation response.The patient will benefit from a progressive exercise program beginning with down-training and then re-education with application to functional movement patterns when tolerated.They then will utilize internal tp releases as well as aim to assist in reduction of muscle spasms.The patient was also encouraged to use vaginal dilators to assist.The patient continued with regular pfpt.The patient's main complaint on (b)(6) 2021 at pfpt was persistent lower suprapubic pain.Since beginning physical therapy, the patient has not engaged in sexual activity.She also claims that with a modest decrease in urgency, her ability to initiate urine flow has improved.According to the report, the patient underwent physical treatment for pelvic floor muscle dysfunction over the course of eight visits.Her therapy has included hip stretches for the obturator, piriformis, and iliopsoas as well as a progressive down training program, internal tp release with contract/relax stretching, and other soft tissue work.She has demonstrated a decrease in pelvic floor muscle tone and decreased sensitivity to palpation during the course of her treatment.The patient appears to be very compliant at home and is tolerating a progression of dilators.Due to the tone, she still has trouble identifying the right slow twitch contraction, but after treatment, she gets better at contracting and relaxing.For 2-day intervals, the patient's symptoms of pain and bleeding have been slightly reduced, but then they come back.The patient was extremely frustrated despite her slow but steady improvement in the strength and tone of her pelvic floor muscles.The patient also indicated she was being referred to physical therapy prior to an upcoming surgery to remove mesh (then scheduled for (b)(6) 2021).On (b)(6) 2021, the patient underwent an excision of vaginal mesh, bilateral urethrolysis and cystourethroscopy procedure.Her diagnosis at that time was dyspareunia, vaginal mesh exposure, vaginal atrophy, tobacco use, pelvic myalgia, urge incontinence, incomplete defecation, constipation, perineal body defect, and concern for voiding dysfunction.On (b)(6) 2021, the patient was seen for a post-op visit.She reported aching abdominal pain which radiates to her back and is relieved with bentyl qid.It was above the surgical site and the physician does not believe it is related to surgery.The patient denied urinary urgency, frequency, dysuria, or urgency incontinence.She did have some urgency at the toilet but reported complete emptying.Her constipation was reported as intermittent and managed with daily fiber and stool softeners.It was also noted that the patient quit smoking on (b)(6) 2021.Physical exam showed vaginal atrophy, surgical incisions healed well, and tenderness to palpation of the levator ani (l>r).The physician noted she was healing well post-op.Impression: myalgia of pelvic floor, chronic constipation, pelvic pain, incomplete defecation, tobacco use.She was recommended to restart pelvic floor physical therapy for levator muscle tension, and to restart using 0.5 g vaginal estrogen before bed x/week for vaginal dryness.On (b)(6) 2021, the patient was seen for physical therapy (following removal of mesh on (b)(6) 2016).The patient reports mild pain with intercourse described as stretch and burn.Patient had difficulty having a bowel movement with manual pressure along perineum required for full evacuation.Otherwise, perineal pain, urinary frequency/urgency are normal.She denies urinary incontinence as well as heaviness.Patient continues with gastrointestinal pain in lower abdomen which is being successfully treated with bentyl.Patient also was recently diagnosed with irritable bowel syndrome.The assessment at the pfpt visit was that the patient presents with pfm dysfunction and will benefit from pt treatments which will consist of a progressive down training program, internal tp release with contract/relax stretching, as well as hip stretching for obturator, piriformis, and iliopsoas.She will also benefit from general core strengthening and functional strengthening with application to core when tolerated.It was noted the patient has had a substantial improvement in her symptoms since having had surgery.The patient has accomplished half of her objectives as of (b)(6) 2021.She reportedly just felt a little pressure during sex and appears to be taking medicine to manage her irritable bowel syndrome.Although the patient's pelvic floor muscle is still weak and stiff, she has shown improvement in her ability to contract and relax it.---additional information received on september 1, 2022--- on december 30, 2020, it was stated on a progress note that the patient was complaining of postmenopausal bleeding.It was also reported that the patient had surgery for vaginal polypoid lesion (0.5cm) removal.It was then sent to urogyn for further evaluation for possible suture/mesh erosion.A possible blue stitch was noted after the lesion was removed.Patient tolerated the procedure well with no immediate complications.History of prolapse : - complained of dyspareunia and scar tissue after hysterectomy.- corrected the repair and scar tissue so she could have intercourse.- admits to persistent scar tissue.- complains of bleeding with intercourse and bowel movement.- scheduled colonoscopy in january.- denies using vaginal estrogen.On january 8, 2021, the patient telephoned the office requesting for biopsy results.The patient was seeking medical advice due to nagging pain, "like something is sticking her" and thick whitish/yellow discharge.Patient was concerned about getting infection due to mesh being exposed.On march 4, 2021, she was diagnosed with dysuria.On may 17, 2021, the patient underwent mesh removal surgery with possible use of biologic graft and cystoscopy.On exam under anesthesia, 0.5 cm area of granulation tissue with blue mesh sling visualized deeply at left vaginal sulcus with mild banding.Right sulcus with mild banding at arc of pubic ramus.On cystoscopy, the bladder mucosa was normal.2cm x 2 pieces of mesh had been excised, and these were submitted to pathology for further evaluation.At this point, cystourethroscopy was performed with normal findings.After excision of vaginal mesh, there was no suture or mesh within the bladder mucosa.The ureteral orifices were visualized bilaterally with noted good efflux x 2.On a systematic survey of the bladder dome to the base of the urethrovesical junction, there were not other abnormalities noted.The urethra was normal on retraction of the scope.There was no urethral defect after excision of sling mesh.The patient was awakened from general endotracheal anesthesia and was taken to the recovery room in stable condition.She tolerated the procedure well.
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Manufacturer Narrative
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Blocks a1, b5, d6b and h6: patient codes and impact codes have been updated based on the additional information received on september 1, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 17, 2021 was chosen as a best estimate based on the date of mesh removal surgery.Block e1: this event was reported by the patient's legal representation.Initial reporter address 1: (b)(6).The surgeons are: dr.(b)(6) (sling placement); dr.(b)(6) (rectocele repair); dr.(b)(6).(b)(6) hospital.Physical therapy referring physician: dr.(b)(6).(b)(6) therapy.(b)(6).Block h6: patient code e1405, e2015, e2328, e2330, e2006, e2114, e2015, e2337, e2326, e1309, e2340, e1301 and e1401 captures the reportable events of dyspareunia, atrophy, bowel obstruction, pain and erosion, perforation, scar tissue, stenosis, inflammation, urinary retention, vaginal polypoid lesion, dysuria and thick whitish/yellow discharge.Impact code f1905, f1202 and f1901 captures the reportable event of mesh excision surgery, short disability and vaginal polypoid lesion removal.
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Manufacturer Narrative
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Block h2: correction.Block b5 narrative updated.Block d1 and d4 device information updated.Block g1 device manufacturing site updated.Block g4 (pma/510 (k) updated.Block h4device manufacture date updated.H6 (patient code) e2114, e2015, e2337, e2326, e1309 added to capture the events of perforation, scar tissue, stenosis, inflammation and urinary retention.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 17, 2021 was chosen as a best estimate based on the date of mesh removal surgery.Block e1: this event was reported by the patient's legal representation.Initial reporter address 1: (b)(6).The surgeons are: (b)(6).(b)(6) hospital.Physical therapy referring physician: (b)(6).Block h6: patient code e1405, e2015, e2328, e2330, e2006 captures the reportable events of dyspareunia, atrophy, bowel obstruction, pain and erosion.Impact code f1903 and f1202 captures the reportable event of mesh removal surgery and short disability.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, 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 obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.On (b)(6) 2021, the patient underwent mesh removal surgery.Boston scientific received additional information on june 16, 2022 as follows: on (b)(6) 2016, the patient underwent a transobturator mid-urethral sling (obtryx) placement for the treatment of stress urinary incontinence and rectocele.The patient had already planned to undergo a rectocele repair with another physician, and was consulted for possible sling placement.Before the surgery, the risks, benefits, and possible complications were explained to her in detail.The risks include, but are not limited to, bleeding, infection, damage to surrounding structures including the urethra, bladder, ureters, potential persistence of the stress urinary incontinence, potential erosion of the sling into the vaginal or into the bladder, potential resultant urgency and irritating urinary symptoms, and the need for future procedures.The patient elected to proceed with transobturator midurethral synthetic sling.The rectocele repair was completed prior to the sling placement part of the procedure.During the surgery, the obtryx sling had been placed through a buttonhole through the vaginal wall as it appeared to go outside of the anterior wall incision.The surgeon stated that the rectocele's tight closure made it challenging to reach the proximal part of the vagina.The left trocar was then reinserted using a finger to bring it out via the anterior vaginal incision to protect the bladder or urethra when the sling was taken off.A second cystoscopy was conducted, and this time it revealed no damage to the bladder or urethra.Additionally, the left ureter was effluxing clean urine, and the surgeon made a thorough examination of the proximal vaginal tissue and found no signs of a buttonhole.Then the trocars were attached to a second obtryx sling, which was brought out through the stab incisions.When the surgeon thoroughly examined the left and right sides, there was no sign of a sling in the anterior vagina.When the plastic piece of the sling was released, it sat very comfortably along the mid-urethra with no tension.According to reports, the patient responded favorably to the treatment, awoke easily from anesthesia, and was transferred to the recovery area in stable condition.Following the treatment, a dense band that caused the vagina to have a very tiny caliber, an angular entrance far anteriorly, and a positive rectocele was discovered during the lysis of vaginal stenotic bands and colporrhaphy procedure in (b)(6) 2016.Vicryl 2-0 was used to relieve scar tissue and treat rectocele.Additionally, during a patient visit in 2018, the patient still has a complaint of dyspareunia.The patient was also given a prescription for a vaginal dilator, but she rarely uses it.A vaginal lesion was discovered in the left side of her vaginal wall during her pelvic exam in (b)(6) 2021.The lesion was friable and bled when touched.Biopsy of this lesion showed granulation tissue with no dysplasia or malignancy.On (b)(6) 2021, the patient reported that since her previous surgery in (b)(6) 2016, she has started bleeding during sexual activity and bowel movements.Additionally, the patient had incomplete defecation, and she needed to splint to assist her and this had never improved after the rectocele repair.The patient claims that when having sex, she had pain as well, which did not go away with lubricant.Additionally, she also experienced vaginal dryness.She experienced urge urinary incontinence and used 1 pad or liner per day, urinary frequency every hour during the day, nocturia x 3, a slow intermittent urine stream , and post-void urgency.Physical exam revealed 0.5 cm area of granulation tissue with blue mesh sling visualized deep at left vaginal sulcus with mild banding that was most tender to palpation, right vaginal sulcus with mild banding but less tender to palpation, atrophy, and posterior banding and tenderness to palpation.The following procedures were carried out on the patient on (b)(6) 2021: complex cystometry, complex uroflowmetry, electromyography with surface electrodes, pressure voiding flow study, abdominal pressure measurement, and leak point pressure measurement.The preoperative diagnoses were listed as dyspareunia, vaginal mesh exposure, vaginal atrophy, tobacco use, pelvic myalgia, urge incontinence, incomplete defecation, constipation, and perineal body defect.Uroflowmetry was normal, the pressure flow study was prolonged with some valsalva to assist near the end, and no detrusor overactivity or stress urinary incontinence.Urethroscopy and cystoscopy were essentially normal.The plan was as follows: for dyspareunia- excision/release of left mesh arm and possibly right mesh arm, possible buccal graft and perineorrhaphy, vaginal estrogen for dryness, stop smoking, and increase levator muscle tone with pelvic floor physical therapy (pfpt); for urge incontinence- urine culture and sensitivity, stop smoking, empty bladder every 3 hours, avoid dietary irritatants, pfpt, and consider medications; for constipation- hydrate well, stop smoking, fiber supplements, pfpt; and for hemorrhoid- colorectal consult.On (b)(6) 2021, the patient was seen for pelvic floor physical therapy.She reports moderate to severe pain during intercourse and was described as ripping sensation with vaginal bleeding.In addition to frequent urination, she also struggles to fully empty her bladder and feels moderate to intense urgency just before urinating.Patient mentions dribbling or intermittent leakage.Patient has difficulty having a bowel movements with bleeding and manual pressure along perineum required for full evacuation.The patient, a truck driver, is reportedly on a short disability to address the aforementioned difficulties.The assessment of the physical therapist was that the patient presents with high tone of the pfm with sensitivity to palpation and a delayed relaxation response.The patient will benefit from a progressive exercise program beginning with down-training and then re-education with application to functional movement patterns when tolerated.They then will utilize internal tp releases as well as aim to assist in reduction of muscle spasms.The patient was also encouraged to use vaginal dilators to assist.The patient continued with regular pfpt.The patient's main complaint on (b)(6) 2021 at pfpt was persistent lower suprapubic pain.Since beginning physical therapy, the patient has not engaged in sexual activity.She also claims that with a modest decrease in urgency, her ability to initiate urine flow has improved.According to the report, the patient underwent physical treatment for pelvic floor muscle dysfunction over the course of eight visits.Her therapy has included hip stretches for the obturator, piriformis, and iliopsoas as well as a progressive down training program, internal tp release with contract/relax stretching, and other soft tissue work.She has demonstrated a decrease in pelvic floor muscle tone and decreased sensitivity to palpation during the course of her treatment.The patient appears to be very compliant at home and is tolerating a progression of dilators.Due to the tone, she still has trouble identifying the right slow twitch contraction, but after treatment, she gets better at contracting and relaxing.For 2-day intervals, the patient's symptoms of pain and bleeding have been slightly reduced, but then they come back.The patient was extremely frustrated despite her slow but steady improvement in the strength and tone of her pelvic floor muscles.The patient also indicated she was being referred to physical therapy prior to an upcoming surgery to remove mesh (then scheduled for (b)(6) 2021).On (b)(6) 2021, the patient underwent an excision of vaginal mesh, bilateral urethrolysis and cystourethroscopy procedure.Her diagnosis at that time was dyspareunia, vaginal mesh exposure, vaginal atrophy, tobacco use, pelvic myalgia, urge incontinence, incomplete defecation, constipation, perineal body defect, and concern for voiding dysfunction.On (b)(6) 2021, the patient was seen for a post-op visit.She reported aching abdominal pain which radiates to her back and is relieved with bentyl qid.It was above the surgical site and the physician does not believe it is related to surgery.The patient denied urinary urgency, frequency, dysuria, or urgency incontinence.She did have some urgency at the toilet but reported complete emptying.Her constipation was reported as intermittent and managed with daily fiber and stool softeners.It was also noted that the patient quit smoking on (b)(6) 2021.Physical exam showed vaginal atrophy, surgical incisions healed well, and tenderness to palpation of the levator ani (l>r).The physician noted she was healing well post-op.Impression: myalgia of pelvic floor, chronic constipation, pelvic pain, incomplete defecation, tobacco use.She was recommended to restart pelvic floor physical therapy for levator muscle tension, and to restart using 0.5 g vaginal estrogen before bed x/week for vaginal dryness.On (b)(6) 2021, the patient was seen for physical therapy (following removal of mesh on (b)(6) 2016).The patient reports mild pain with intercourse described as stretch and burn.Patient had difficulty having a bowel movement with manual pressure along perineum required for full evacuation.Otherwise, perineal pain, urinary frequency/urgency are normal.She denies urinary incontinence as well as heaviness.Patient continues with gastrointestinal pain in lower abdomen which is being successfully treated with bentyl.Patient also was recently diagnosed with irritable bowel syndrome.The assessment at the pfpt visit was that the patient presents with pfm dysfunction and will benefit from pt treatments which will consist of a progressive down training program, internal tp release with contract/relax stretching, as well as hip stretching for obturator, piriformis, and iliopsoas.She will also benefit from general core strengthening and functional strengthening with application to core when tolerated.It was noted the patient has had a substantial improvement in her symptoms since having had surgery.The patient has accomplished half of her objectives as of (b)(6) 2021.She reportedly just felt a little pressure during sex and appears to be taking medicine to manage her irritable bowel syndrome.Although the patient's pelvic floor muscle is still weak and stiff, she has shown improvement in her ability to contract and relax it.
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