|
BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
|
Back to Search Results |
|
| Model Number M0068507000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Anemia (1706); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
|
| Event Date 09/05/2018 |
|
Event Type
Injury
|
|
Event Description
|
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04888 for the associated device information.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient experienced an unknown injury.
|
| |
|
Manufacturer Narrative
|
|
Date of event: date of event was approximated to (b)(6) 2018, procedure date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).
|
| |
|
Manufacturer Narrative
|
|
Block b3 date of event: date of event was approximated to september 5, 2018, procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6), md, (b)(6) medical center usa.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h11: block a1 and h10 have been corrected have been updated based on the additional information received on october 10, 2022.Blocks a2, b2, b5, b7, h6, and h10 have been updated based on the additional information received on october 10, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6), md (b)(6) medical center.(b)(6), usa 85122-5303.Block h6: patient code e232402 captures the reportable event of "frequency." patient code e2330 capture the reportable events of "pelvic pain," and "myofascial component to her pain." patient code e1405 capture the reportable event of "reported to have some pain with intercourse." patient code e1301 capture the reportable events of "reported occasional dysuria," and "dysuria." impact code f1905 capture the reportable event of device revision procedure.Impact code f1901 capture the reportable event of additional surgery required.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
|
| |
|
Event Description
|
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04887 and 3005099803-2022-04888 for the associated device information.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on october 10, 2022.The patient underwent a robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling, and cystoscopy procedures performed on september 5, 2018 to treat a patient with vaginal vault prolapse, cystocele, rectocele, overactive bladder, and incontinence.At the end the procedure, cystoscopy was done using 30 and 70-degree lens and the entire bladder was visualized.No injury to bladder was noted.There was normal reflux of urine from both openings.Foley catheter was placed at appropriate times of the procedure.Patient was brought to recovery in stable condition.The patient was seen and examined on (b)(6), 2020.The patient complained of vaginal itching, prolapse and leaking of urine with coughing, sneezing, or laughing.The patient had hysterectomy and anterior repair for prolapse and the few years ago, another surgery for prolapse.She was not sure what was done at the second surgery.It was done by the urologist.Review of the operative report showed that in 2018 she had robotic-assisted laparoscopic sacrocolpopexy using upsylon mesh and solyx mini-sling were placed.In the physician's assessment, the patient has an unspecified type, female genital prolapse and vaginal itching.The patient was noted to have vaginal vault prolapse with the lowest point 2.5 cm outside the hymenal ring.There was moderate cystocele after reducing the apical prolapse.Suburethral sling was not felt on exam.Explained to her that the vaginal apex was detached from the mesh that she had placed in 2018.Apparently, the mini sling hasn't reduced significantly her incontinence and it can become even worse after reducing the apical prolapse and cystocele.The patient referred to a urogynecologist.Wet preparation was sent for vaginal itching.The discharge appears normal.On (b)(6), 2021, the patient presented with vaginal vault prolapse, cystocele and rectocele.The patient had a grade 2 to 3 vaginal wall prolapse.The patient had history of repair in the past but has had recurrence even with synthetic mesh.The patient was asked to avoid lifting, straining, pushing or pulling.The patient was considering a surgical intervention.In the physician's assessment, the patient had vaginal vault prolapse, cystocele, rectocele, overactive bladder and incontinence.A robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling and cystoscopy procedures were scheduled.During the procedure, the patient was brought to the operating room and anesthesia was applied.The patient was placed in dorsal lithotomy position and all pressure points were very well-padded.The patient was prepped and draped in a sterile fashion.Preoperative products were given.All the robotic ports were placed by the gynecologist.The cuff was closed by using ov lock suture with two layers.The lateral cuff was closed well to minimize delayed bleeding.The bladder was lifted away from the anterior cuff, and the rectum from the posterior cuff.There was no injury to the bowel and was in excellent hemostasis.The sacral promontory was identified.The sigmoid was pulled towards the left laterally away from the pelvis.The right ureter was clearly identified.The capsule on wire mesh was attached using #2-0 ethibond sutures.The old mesh had this engaged from the cuff.This was removed.Mesh was trimmed to one centimeter by centimeter by five to six centimeter in approximate measurements.The posterior peritoneum was opened over the sacral promontory.The mesh was attached in figure of eight x2 sutures to the promontory.An eea bowel sizer was used to help lift the cuff towards the promontory.The area was thoroughly irrigated.The physician reduced cystocele/rectocele and supported with the sutures.The rectocele was brought together by bringing the puborectalis fascia together using #2-0 vicryl suture.The physician closed the posterior peritoneal over the sacral promontory using #2 ov lock suture.The mesh was complete covered - retroperitonealized.All ports were removed under direct vision.There was excellent hemostasis.The physician closed the ports using #4-0 monocryl and dermabond was applied.The applied for allises and the intravaginal mucosa 1% lidocaine with epinephrine was applied for hydrodissection incision was carried towards the lateral endopelvic fascia and superior medial corner of the obturator foramen.The physician then placed a single incision solyx sling in this location and was sutured with #2-0 vicryl to the mid portion of the urethra.Appropriate tensioning was done.The pubocervical fascia was brought together using #2-0 vicryl suture.The vaginal mucosa was closed also using #0 vicryl.There was excellent hemostasis.At the end of the procedure, cystoscopy was done using 30 and 70-degrees lens.The entire bladder was visualized.There was no injury to the bladder noted.There was normal reflux of urine from both openings.A foley catheter was placed at appropriate times of the procedure.The patient was brought to recovery in stable condition.The excised old mesh was sent to pathology for gross examination.An elongated portion of the blue interwoven plastic with adherent tan-brown friable tissue, suggestive of mesh was 9.2 x 0.4 x 0.2 cm.On (b)(6), 2022, the patient was seen and examined for urgency, frequency and incontinence.The patient has issues with diabetic control and glucose control.The patient was also seen for a follow up status post colpopexy, sling and cystoscopy.The patient reported to use five to six pads daily for stress incontinence.The patient did not report any bowel movement problems.The patient reported occasional dysuria the previous month but none lately.In the physician's assessment, the patient has cystocele, other microscopic hematuria (glucosuria only) but has resolved, unspecified urinary incontinence, gastro-esophageal reflux disease with esophagitis and type 2 diabetes mellitus without complications.On (b)(6), 2022, the patient sought consult for pelvic pain and urinary incontinence.The patient also reported dysuria and she felt that something was tearing.The patient continued to have urinary incontinence.She stated that she did have stress incontinence but also has significant urgency incontinence with urgency being more bothersome.The patient tried oxybutynin, which caused dry mouth without improving her symptoms.The patient also reported to have some pain with intercourse.The patient was taking ibuprofen, hydrocodone and oxycodone for her pain management.Given the patient's symptoms, in the physician's assessment, the patient needed multichannel urodynamics for further evaluation of her bladder function.However, in order to offer any surgical treatment the physician advised that she would have to get better control of her diabetes.The physician recommended for the patient to consider a less invasive approach with bulking agents such as bulk amid.As for the patient's significant urgency incontinence, trospium was prescribed to see if this will improve her symptoms.The patient did have a myofascial component to her pain.The physician recommended starting with pelvic floor physical therapy given her poorly controlled diabetes.If the patient was able to control her diabetes better, the physician would consider whether partial mesh removal of the anterior vaginal wall would be appropriate.A cystoscopy was also recommended to evaluate her bladder to ensure that there was no other mesh erosion protruding into the bladder.
|
| |
|
Manufacturer Narrative
|
|
Block b3 date of event: date of event was approximated to (b)(6) 2018, procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: biren patel, md banner casa grande medical center usa block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h11: block a1 and h10 have been corrected have been updated based on the additional information received on october 10, 2022.Blocks a2, b2, b5, b7, h6, and h10 have been updated based on the additional information received on october 10, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e232402 captures the reportable event of "frequency." patient code e2330 capture the reportable events of "pelvic pain," and "myofascial component to her pain." patient code e1405 capture the reportable event of "reported to have some pain with intercourse." patient code e1301 capture the reportable events of "reported occasional dysuria," and "dysuria." impact code f1905 capture the reportable event of device revision procedure.Impact code f1901 capture the reportable event of additional surgery required.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information received on november 15, 2022.Block h6: patient code e1310 captures the reportable event of "urinary tract infection.".
|
| |
|
Event Description
|
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04887 and 3005099803-2022-04888 for the associated device information.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on october 10, 2022.The patient underwent a robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling, and cystoscopy procedures performed on (b)(6) 2018 to treat a patient with vaginal vault prolapse, cystocele, rectocele, overactive bladder, and incontinence.At the end the procedure, cystoscopy was done using 30 and 70-degree lens and the entire bladder was visualized.No injury to bladder was noted.There was normal reflux of urine from both openings.Foley catheter was placed at appropriate times of the procedure.Patient was brought to recovery in stable condition.The patient was seen and examined on (b)(6) 2020.The patient complained of vaginal itching, prolapse and leaking of urine with coughing, sneezing, or laughing.The patient had hysterectomy and anterior repair for prolapse and the few years ago, another surgery for prolapse.She was not sure what was done at the second surgery.It was done by the urologist.Review of the operative report showed that in 2018 she had robotic-assisted laparoscopic sacrocolpopexy using upsylon mesh and solyx mini-sling were placed.In the physician's assessment, the patient has an unspecified type, female genital prolapse and vaginal itching.The patient was noted to have vaginal vault prolapse with the lowest point 2.5 cm outside the hymenal ring.There was moderate cystocele after reducing the apical prolapse.Suburethral sling was not felt on exam.Explained to her that the vaginal apex was detached from the mesh that she had placed in 2018.Apparently, the mini sling hasn't reduced significantly her incontinence and it can become even worse after reducing the apical prolapse and cystocele.The patient referred to a urogynecologist.Wet preparation was sent for vaginal itching.The discharge appears normal.On (b)(6) 2021, the patient presented with vaginal vault prolapse, cystocele and rectocele.The patient had a grade 2 to 3 vaginal wall prolapse.The patient had history of repair in the past but has had recurrence even with synthetic mesh.The patient was asked to avoid lifting, straining, pushing or pulling.The patient was considering a surgical intervention.In the physician's assessment, the patient had vaginal vault prolapse, cystocele, rectocele, overactive bladder and incontinence.A robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling and cystoscopy procedures were scheduled.During the procedure, the patient was brought to the operating room and anesthesia was applied.The patient was placed in dorsal lithotomy position and all pressure points were very well-padded.The patient was prepped and draped in a sterile fashion.Preoperative products were given.All the robotic ports were placed by the gynecologist.The cuff was closed by using ov lock suture with two layers.The lateral cuff was closed well to minimize delayed bleeding.The bladder was lifted away from the anterior cuff, and the rectum from the posterior cuff.There was no injury to the bowel and was in excellent hemostasis.The sacral promontory was identified.The sigmoid was pulled towards the left laterally away from the pelvis.The right ureter was clearly identified.The capsule on wire mesh was attached using #2-0 ethibond sutures.The old mesh had this engaged from the cuff.This was removed.Mesh was trimmed to one centimeter by centimeter by five to six centimeter in approximate measurements.The posterior peritoneum was opened over the sacral promontory.The mesh was attached in figure of eight x2 sutures to the promontory.An eea bowel sizer was used to help lift the cuff towards the promontory.The area was thoroughly irrigated.The physician reduced cystocele/rectocele and supported with the sutures.The rectocele was brought together by bringing the puborectalis fascia together using #2-0 vicryl suture.The physician closed the posterior peritoneal over the sacral promontory using #2 ov lock suture.The mesh was complete covered - retroperitonealized.All ports were removed under direct vision.There was excellent hemostasis.The physician closed the ports using #4-0 monocryl and dermabond was applied.The applied for allises and the intravaginal mucosa 1% lidocaine with epinephrine was applied for hydrodissection incision was carried towards the lateral endopelvic fascia and superior medial corner of the obturator foramen.The physician then placed a single incision solyx sling in this location and was sutured with #2-0 vicryl to the mid portion of the urethra.Appropriate tensioning was done.The pubocervical fascia was brought together using #2-0 vicryl suture.The vaginal mucosa was closed also using #0 vicryl.There was excellent hemostasis.At the end of the procedure, cystoscopy was done using 30 and 70-degrees lens.The entire bladder was visualized.There was no injury to the bladder noted.There was normal reflux of urine from both openings.A foley catheter was placed at appropriate times of the procedure.The patient was brought to recovery in stable condition.The excised old mesh was sent to pathology for gross examination.An elongated portion of the blue interwoven plastic with adherent tan-brown friable tissue, suggestive of mesh was 9.2 x 0.4 x 0.2 cm.On (b)(6) 2022, the patient was seen and examined for urgency, frequency and incontinence.The patient has issues with diabetic control and glucose control.The patient was also seen for a follow up status post colpopexy, sling and cystoscopy.The patient reported to use five to six pads daily for stress incontinence.The patient did not report any bowel movement problems.The patient reported occasional dysuria the previous month but none lately.In the physician's assessment, the patient has cystocele, other microscopic hematuria (glucosuria only) but has resolved, unspecified urinary incontinence, gastro-esophageal reflux disease with esophagitis and type 2 diabetes mellitus without complications.On (b)(6) 2022, the patient sought consult for pelvic pain and urinary incontinence.The patient also reported dysuria and she felt that something was tearing.The patient continued to have urinary incontinence.She stated that she did have stress incontinence but also has significant urgency incontinence with urgency being more bothersome.The patient tried oxybutynin, which caused dry mouth without improving her symptoms.The patient also reported to have some pain with intercourse.The patient was taking ibuprofen, hydrocodone and oxycodone for her pain management.Given the patient's symptoms, in the physician's assessment, the patient needed multichannel urodynamics for further evaluation of her bladder function.However, in order to offer any surgical treatment the physician advised that she would have to get better control of her diabetes.The physician recommended for the patient to consider a less invasive approach with bulking agents such as bulk amid.As for the patient's significant urgency incontinence, trospium was prescribed to see if this will improve her symptoms.The patient did have a myofascial component to her pain.The physician recommended starting with pelvic floor physical therapy given her poorly controlled diabetes.If the patient was able to control her diabetes better, the physician would consider whether partial mesh removal of the anterior vaginal wall would be appropriate.A cystoscopy was also recommended to evaluate her bladder to ensure that there was no other mesh erosion protruding into the bladder.Additional information received on november 15, 2022.On (b)(6) 2022, the patient was seen and examined status post colpopexy, sling implant and cystoscopy procedures performed on (b)(6) 2021 and (b)(6) 2018.The patient has problems with diabetic control.The patient has urgency frequency and incontinence.The patient also reported occasional stress and urge incontinence.She used two pads daily and reported frequency, but sugars were not controlled.The patient reported hgba1c in 9 range.The patient denied gross hematuria.The patient reported dysuria and itching in the vaginal area and urinary tract infection was suspected.Upon review of symptoms, the patient experienced frequent urination and urinary incontinence.In the physician's assessment, the patient has cystocele at midline.The patient also had other microscopic hematuria.In addition, the patient was experiencing unspecified urinary incontinence, gastro-esophageal reflux disease without esophagitis and type ii diabetes mellitus without complications.The physician instructed the patient to use fiber and to avoid bending and lifting straining for the patient's cystocele.On exam, the patient had no significant prolapse but when she pushed, she did have a grade 1 cystourethocele despite use of mesh.The physician instructed the patient to continue kegel exercises.For the patient's other microscopic hematuria, the physician noted that the patient had no microscopic hematuria.The patient had a history of negative cystoscopy in the past.For the patient's unspecified urinary incontinence, the physician noted that the patient had urgency frequency or urge incontinence.The physician instructed the patient to use kegel exercise.Diet instructions were also given.If the problem persisted, the physician was considering further evaluation and see if placing any support under the bladder would improve her bladder dysfunction.
|
| |
|
Manufacturer Narrative
|
|
Block b3 date of event: date of event was approximated to (b)(6) 2018, procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6), usa.Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.Block h11: block a1 and h10 have been corrected have been updated based on the additional information received on october 10, 2022.Blocks a2, b2, b5, b7, h6, and h10 have been updated based on the additional information received on october 10, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e232402 captures the reportable event of "frequency." patient code e2330 capture the reportable events of "pelvic pain," and "myofascial component to her pain." patient code e1405 capture the reportable event of "reported to have some pain with intercourse." patient code e1301 capture the reportable events of "reported occasional dysuria," and "dysuria." impact code f1905 capture the reportable event of device revision procedure.Impact code f1901 capture the reportable event of additional surgery required.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information received on november 15, 2022.Block h6: patient code e1310 captures the reportable event of "urinary tract infection." block h11: blocks b5, h6, and h10 have been updated based on the additional information received on september 19, 2023.Block h6: imdrf patient code e2321 captures the reportable event of hypotension.Imdrf patient code e0301 captures the reportable event of anemia.Imdrf patient code e2321 captures the reportable event of hemoperitoneum.
|
| |
|
Event Description
|
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04887 and 3005099803-2022-04888 for the associated device information.It was reported to boston scientific corporation that a solyx sis system and an upsylon y mesh were used during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on october 10, 2022: the patient underwent a robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling, and cystoscopy procedures performed on (b)(6) 2018 to treat a patient with vaginal vault prolapse, cystocele, rectocele, overactive bladder, and incontinence.At the end the procedure, cystoscopy was done using 30 and 70-degree lens and the entire bladder was visualized.No injury to bladder was noted.There was normal reflux of urine from both openings.Foley catheter was placed at appropriate times of the procedure.Patient was brought to recovery in stable condition.The patient was seen and examined on (b)(6) 2020.The patient complained of vaginal itching, prolapse and leaking of urine with coughing, sneezing, or laughing.The patient had hysterectomy and anterior repair for prolapse and the few years ago, another surgery for prolapse.She was not sure what was done at the second surgery.It was done by the urologist.Review of the operative report showed that in 2018 she had robotic-assisted laparoscopic sacrocolpopexy using upsylon mesh and solyx mini-sling were placed.In the physician's assessment, the patient has an unspecified type, female genital prolapse and vaginal itching.The patient was noted to have vaginal vault prolapse with the lowest point 2.5 cm outside the hymenal ring.There was moderate cystocele after reducing the apical prolapse.Suburethral sling was not felt on exam.Explained to her that the vaginal apex was detached from the mesh that she had placed in 2018.Apparently, the mini sling hasn't reduced significantly her incontinence and it can become even worse after reducing the apical prolapse and cystocele.The patient referred to a urogynecologist.Wet preparation was sent for vaginal itching.The discharge appears normal.On (b)(6) 2021, the patient presented with vaginal vault prolapse, cystocele and rectocele.The patient had a grade 2 to 3 vaginal wall prolapse.The patient had history of repair in the past but has had recurrence even with synthetic mesh.The patient was asked to avoid lifting, straining, pushing or pulling.The patient was considering a surgical intervention.In the physician's assessment, the patient had vaginal vault prolapse, cystocele, rectocele, overactive bladder and incontinence.A robotic-assisted abdominal sacrocolpopexy, cystocele, rectocele, enterocele repair, sling and cystoscopy procedures were scheduled.During the procedure, the patient was brought to the operating room and anesthesia was applied.The patient was placed in dorsal lithotomy position and all pressure points were very well-padded.The patient was prepped and draped in a sterile fashion.Preoperative products were given.All the robotic ports were placed by the gynecologist.The cuff was closed by using ov lock suture with two layers.The lateral cuff was closed well to minimize delayed bleeding.The bladder was lifted away from the anterior cuff, and the rectum from the posterior cuff.There was no injury to the bowel and was in excellent hemostasis.The sacral promontory was identified.The sigmoid was pulled towards the left laterally away from the pelvis.The right ureter was clearly identified.The capsule on wire mesh was attached using #2-0 ethibond sutures.The old mesh had this engaged from the cuff.This was removed.Mesh was trimmed to one centimeter by centimeter by five to six centimeter in approximate measurements.The posterior peritoneum was opened over the sacral promontory.The mesh was attached in figure of eight x2 sutures to the promontory.An eea bowel sizer was used to help lift the cuff towards the promontory.The area was thoroughly irrigated.The physician reduced cystocele/rectocele and supported with the sutures.The rectocele was brought together by bringing the puborectalis fascia together using #2-0 vicryl suture.The physician closed the posterior peritoneal over the sacral promontory using #2 ov lock suture.The mesh was complete covered - retro peritonealized.All ports were removed under direct vision.There was excellent hemostasis.The physician closed the ports using #4-0 monocryl and dermabond was applied.The applied for allises and the intravaginal mucosa 1% lidocaine with epinephrine was applied for hydro dissection incision was carried towards the lateral endopelvic fascia and superior medial corner of the obturator foramen.The physician then placed a single incision solyx sling in this location and was sutured with #2-0 vicryl to the mid portion of the urethra.Appropriate tensioning was done.The pubocervical fascia was brought together using #2-0 vicryl suture.The vaginal mucosa was closed also using #0 vicryl.There was excellent hemostasis.At the end of the procedure, cystoscopy was done using 30 and 70-degrees lens.The entire bladder was visualized.There was no injury to the bladder noted.There was normal reflux of urine from both openings.A foley catheter was placed at appropriate times of the procedure.The patient was brought to recovery in stable condition.The excised old mesh was sent to pathology for gross examination.An elongated portion of the blue interwoven plastic with adherent tan-brown friable tissue, suggestive of mesh was 9.2 x 0.4 x 0.2 cm.On (b)(6) 2022, the patient was seen and examined for urgency, frequency and incontinence.The patient has issues with diabetic control and glucose control.The patient was also seen for a follow up status post colpopexy, sling and cystoscopy.The patient reported to use five to six pads daily for stress incontinence.The patient did not report any bowel movement problems.The patient reported occasional dysuria the previous month but none lately.In the physician's assessment, the patient has cystocele, other microscopic hematuria (glucosuria only) but has resolved, unspecified urinary incontinence, gastro-esophageal reflux disease with esophagitis and type 2 diabetes mellitus without complications.On (b)(6) 2022, the patient sought consult for pelvic pain and urinary incontinence.The patient also reported dysuria and she felt that something was tearing.The patient continued to have urinary incontinence.She stated that she did have stress incontinence but also has significant urgency incontinence with urgency being more bothersome.The patient tried oxybutynin, which caused dry mouth without improving her symptoms.The patient also reported to have some pain with intercourse.The patient was taking ibuprofen, hydrocodone and oxycodone for her pain management.Given the patient's symptoms, in the physician's assessment, the patient needed multichannel urodynamics for further evaluation of her bladder function.However, in order to offer any surgical treatment the physician advised that she would have to get better control of her diabetes.The physician recommended for the patient to consider a less invasive approach with bulking agents such as bulk amid.As for the patient's significant urgency incontinence, trospium was prescribed to see if this will improve her symptoms.The patient did have a myofascial component to her pain.The physician recommended starting with pelvic floor physical therapy given her poorly controlled diabetes.If the patient was able to control her diabetes better, the physician would consider whether partial mesh removal of the anterior vaginal wall would be appropriate.A cystoscopy was also recommended to evaluate her bladder to ensure that there was no other mesh erosion protruding into the bladder.Additional information received on november 15, 2022: on (b)(6) 2022, the patient was seen and examined status post colpopexy, sling implant and cystoscopy procedures performed on (b)(6) 2021 and (b)(6) 2018.The patient has problems with diabetic control.The patient has urgency frequency and incontinence.The patient also reported occasional stress and urge incontinence.She used two pads daily and reported frequency, but sugars were not controlled.The patient reported hgba1c in 9 range.The patient denied gross hematuria.The patient reported dysuria and itching in the vaginal area and urinary tract infection was suspected.Upon review of symptoms, the patient experienced frequent urination and urinary incontinence.In the physician's assessment, the patient has cystocele at midline.The patient also had other microscopic hematuria.In addition, the patient was experiencing unspecified urinary incontinence, gastro-esophageal reflux disease without esophagitis and type ii diabetes mellitus without complications.The physician instructed the patient to use fiber and to avoid bending and lifting straining for the patient's cystocele.On exam, the patient had no significant prolapse but when she pushed, she did have a grade 1 cystourethrocele despite use of mesh.The physician instructed the patient to continue kegel exercises.For the patient's other microscopic hematuria, the physician noted that the patient had no microscopic hematuria.The patient had a history of negative cystoscopy in the past.For the patient's unspecified urinary incontinence, the physician noted that the patient had urgency frequency or urge incontinence.The physician instructed the patient to use kegel exercise.Diet instructions were also given.If the problem persisted, the physician was considering further evaluation and see if placing any support under the bladder would improve her bladder dysfunction.Additional information received on september 19 2023: the patient was diagnosed with post-operative hypotension, post-operative anemia, and hemoperitoneum and so underwent a total vaginal hysterectomy as well as a bladder sling in the morning of (b)(6) 2012.While in the recovery room, she was having intermittent atrial fibrillation and other unrelated problems, and then she had a drop in her blood pressure.Her immediate postoperative hemoglobin was 9, and then she subsequently dropped it to 6.4 and was symptomatic.Therefore, an intraperitoneal bleed was suspected, and the patient was brought emergently back to the or for diagnostic laparoscopic after obtaining informed consent in the pacu.At the time of laparoscopy, there was noted to be a small amount of free blood as well as some clotted blood in the cul-de-sac, all accumulated on the right side.Once the pelvis was irrigated, we were able to see there was a lucent stitch on the right utero-ovarian pedicle where all the clots had risen from.The patient tolerated the procedure well under general anesthesia.She was awakened and taken back to the recovery room in good condition.On (b)(6) 2018, a solyx sis system with upn (m00685070000) and lot number (22116503) was implanted in the patient.Additionally, the patient was also diagnosed with old mesh excision on (b)(6) 2021.
|
| |
|
Search Alerts/Recalls
|
|
|
