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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068503000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Micturition Urgency (1871); Headache (1880); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Laceration(s) (1946); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Fibrosis (3167); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 08/04/2021 |
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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 lynx system was used during a procedure performed on (b)(6), 2021.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6), 2021, procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to june 22, 2021, 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); (b)(6) medical center.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 has been corrected.Blocks a2, a4, b2, b5, b6, h6, and h10 have been updated based on the additional information received on september 30, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md; (b)(6) medical center.Block h6: patient code e2006 captures the reportable events of "mesh exposure following retropubic midurethral sling," "developed mesh erosion discovered on cystoscopy," and "developed mesh erosion noted at the bladder neck." impact code f1905: device revision or replacement captures the reported event of "excision of sling/exposed mesh - open, transvesical." impact code f12: serious injury/ illness/ impairment has been used in the light of the patient sought legal recourse for a personal injury related to the device.Block h11: blocks b5, h6 and h10 have been corrected based on medical safety review on november 1, 2022.Block h6 (additional reportable codes): patient code e2009 captures the reportable events of "during the cystoscopy, a small tear was noted at the left bladder neck.It was carefully examined and was not deep.There was no perforation of the urethra or bladder" patient code e0506 captures the reportable event of "there was bleeding from the catheter." patient code e2114 captures the reportable event of "the left trocar within the bladder.".
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Event Description
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It was reported to boston scientific corporation that a lynx system was used during a procedure performed on june 22, 2021.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on september 30, 2022: on june 22, 2021, the patient was implanted with a lynx system device during a retropubic midurethral sling and posterior repair to treat her mixed urge and stress urinary incontinence.She has had recurrent stress urinary incontinence (sui) symptoms after previous mid urethral retropubic sling placement.She was noted to have a rectocele as well.Findings include scarring noted due to previous sling placement, on the left side.Two abdominal incisions about 0.5 cm in length were made on either side 2 cm from the midline just superior to the pubic symphysis.There was bleeding from the catheter and it was removed.A cystoscopy was then performed that showed a small tear at the left bladder neck about 2 o'clock.It was carefully examined and was not deep.The bladder was then emptied, leaving the foley catheter in place.After placement of the trocars, cystoscopy was repeated and there was visualization of the left trocar within the bladder.This was removed and replaced.Cystoscopy repeated, and it was confirmed there was no perforation of the urethra or bladder.The mesh placement procedure was continued and completed.Posterior colporrhaphy was then performed with correction of prolapse.On (b)(6) 2021, the patient experienced a mesh exposure following retropubic midurethral sling.She previously had a sling many years ago and developed recurrent stress urinary incontinence (sui).She underwent repeat retropubic midurethral sling and developed mesh erosion noted at the bladder neck.She presented today for lap exploratory laparotomy, mesh excision/removal, cystorrhaphy, and cystoscopy.She took one augmentin 875 mg yesterday.Urine negative for blood, nitrites, and leukocytes.Operative findings includes a previous sling arm encountered more laterally on the left, second sling arm which was eroding into the bladder was then encountered more medially after an anterior cystotomy was performed.Sling material within the bladder lumen and bladder wall was excised in its entirety and the mucosal defect was closed following by a subsequent detrusor closure.Prior to proceeding to the operating room, the procedure was described in detail to the patient, all questions were answered and appropriate consent was obtained.The patient was then taken to the operating room.Thromboembolism-deterrent (teds) and scds were applied and confirmed to be working.Anesthesia was induced and the patient was placed in the lithotomy position.The patient was then prepped in standard sterile fashion.Time-out was held and perioperative antibiotics were confirmed and administered.A flexible cystoscopy was inserted per the urethra.Upon retroflexion the exposed mesh was visualized at the bladder neck on the left.There were no other abnormalities.A midline incision was marked from pubis to just below the umbilicus.This was incised with a #10 blade.Electrocautery was used to dissect down to the anterior rectus fascia.This was divided with electrocautery in the midline between the rectus muscles.The bladder was dropped and the space of retzius was entered.The bladder was mobilized laterally on both sides.A mesh sling was encountered laterally and isolated.At this point, it was unclear if this was her initially placed mesh or the subsequent mesh.The balfour retractor was placed.The physician attempted to trace the mesh toward the bladder neck / urethra but the visibility was difficult with this approach.The physician then elected to perform an anterior cystotomy to perform a transvesical excision and repair.The bladder was opened anteriorly using electrocautery.#2-0 vicryl sutures were placed laterally to aid with retraction.A #2-0 vicryl suture was placed at the inferior apex to prevent splitting of the detrusor toward the bladder neck and urethra.The mesh was able to be visualized at the expected location near the bladder neck.A right angle was used to get circumferential access and a vessel loop was placed to traction.The superior portion of the mesh was dissected from the bladder and excised.The inferior portion of the mesh was placed on traction and a combination of blunt and sharp dissection was used.The extravesical portion of the mesh was isolated as well and cut near the exterior surface of the bladder.The intravesical portion was then able to be removed sharply.There was no residual mesh within the bladder lumen or bladder wall.The bladder neck mucosa was then re-approximated with #3-0 monocryl in a simple running fashion.This brought the urothelium together well.We then turned our attention extravesically and closed both defects in the detrusor with #2-0 monocryl.The pelvis was inspected and hemostasis was obtained and satisfactory.The physician then began with his cystorrhaphy.This was closed in 2 layers with running #3-0 monocryl for the mucosa and #2-0 monocryl for the detrusor closed in a lembert fashion.The bladder was leak tested for 180 cc and was found to be water-tight.A #15-french blake drain was placed in the llq and secured with a #2-0 nylon.The rectus bellies were reapproximated with #2-0 vicryl.The fascia was closed with #1 looped pds.The subcutaneous tissues were approximated with #2-0 vicryl.The skin was closed with #4-0 monocryl.Sterile dressing was applied.All needle and lap counts were correct.The patient tolerated the procedure well.No complications occurred during or immediately after the procedure.The patient was taken to the pacu satisfactory condition.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2021, 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).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 has been corrected.Blocks a2, a4, b2, b5, b6, h6, and h10 have been updated based on the additional information received on september 30, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2006 captures the reportable events of "mesh exposure following retropubic midurethral sling," "developed mesh erosion discovered on cystoscopy," and "developed mesh erosion noted at the bladder neck." impact code f1905: device revision or replacement captures the reported event of "excision of sling/exposed mesh - open, transvesical." impact code f12: serious injury/ illness/ impairment has been used in the light of the patient sought legal recourse for a personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that a lynx system was used during a procedure performed on (b)(6) 2021.As reported by the patient's attorney, the patient experienced an unknown injury.On (b)(6) 2021, the patient was implanted with a lynx system device during a retropubic midurethral sling and posterior repair to treat her mixed urge and stress urinary incontinence.She has had recurrent stress urinary incontinence (sui) symptoms after previous mid urethral retropubic sling placement.She was noted to have a rectocele as well.Findings include scarring noted due to previous sling placement, on the left side.Posterior colporrhaphy performed with correction of prolapse.During the cystoscopy, a small tear was noted at the left bladder neck.It was carefully examined and was not deep.There was no perforation of the urethra or bladder.There were no patient complications noted at the conclusion of the procedure.On (b)(6) 2021, the patient experienced a mesh exposure following retropubic midurethral sling.She previously had a sling many years ago and developed recurrent stress urinary incontinence (sui).She underwent repeat retropubic midurethral sling and developed mesh erosion noted at the bladder neck.She presented today for lap exploratory laparotomy, mesh excision/removal, cystorrhaphy, and cystoscopy.She took one augmentin 875 mg yesterday.Urine negative for blood, nitrites, and leukocytes.Operative findings includes a previous sling arm encountered more laterally on the left, second sling arm which was eroding into the bladder was then encountered more medially after an anterior cystotomy was performed.Sling material within the bladder lumen and bladder wall was excised in its entirety and the mucosal defect was closed following by a subsequent detrusor closure.Prior to proceeding to the operating room, the procedure was described in detail to the patient, all questions were answered and appropriate consent was obtained.The patient was then taken to the operating room.Thromboembolism-deterrent (teds) and scds were applied and confirmed to be working.Anesthesia was induced and the patient was placed in the lithotomy position.The patient was then prepped in standard sterile fashion.Time-out was held and perioperative antibiotics were confirmed and administered.A flexible cystoscopy was inserted per the urethra.Upon retroflexion the exposed mesh was visualized at the bladder neck on the left.There were no other abnormalities.A midline incision was marked from pubis to just below the umbilicus.This was incised with a #10 blade.Electrocautery was used to dissect down to the anterior rectus fascia.This was divided with electrocautery in the midline between the rectus muscles.The bladder was dropped and the space of retzius was entered.The bladder was mobilized laterally on both sides.A mesh sling was encountered laterally and isolated.At this point, it was unclear if this was her initially placed mesh or the subsequent mesh.The balfour retractor was placed.The physician attempted to trace the mesh toward the bladder neck / urethra but the visibility was difficult with this approach.The physician then elected to perform an anterior cystotomy to perform a transvesical excision and repair.The bladder was opened anteriorly using electrocautery.#2-0 vicryl sutures were placed laterally to aid with retraction.A #2-0 vicryl suture was placed at the inferior apex to prevent splitting of the detrusor toward the bladder neck and urethra.The mesh was able to be visualized at the expected location near the bladder neck.A right angle was used to get circumferential access and a vessel loop was placed to traction.The superior portion of the mesh was dissected from the bladder and excised.The inferior portion of the mesh was placed on traction and a combination of blunt and sharp dissection was used.The extravesical portion of the mesh was isolated as well and cut near the exterior surface of the bladder.The intravesical portion was then able to be removed sharply.There was no residual mesh within the bladder lumen or bladder wall.The bladder neck mucosa was then re-approximated with #3-0 monocryl in a simple running fashion.This brought the urothelium together well.We then turned our attention intravesically and closed both defects in the detrusor with #2-0 monocryl.The pelvis was inspected and hemostasis was obtained and satisfactory.The physician then began with his cystorrhaphy.This was closed in 2 layers with running #3-0 monocryl for the mucosa and #2-0 monocryl for the detrusor closed in a lembert fashion.The bladder was leak tested for 180 cc and was found to be water-tight.A #15-french blake drain was placed in the llq and secured with a #2-0 nylon.The rectus bellies were reapproximated with #2-0 vicryl.The fascia was closed with #1 looped pds.The subcutaneous tissues were approximated with #2-0 vicryl.The skin was closed with #4-0 monocryl.Sterile dressing was applied.All needle and lap counts were correct.The patient tolerated the procedure well.No complications occurred during or immediately after the procedure.The patient was taken to the pacu satisfactory condition.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to june 22, 2021, 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).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 has been corrected.Blocks a2, a4, b2, b5, b6, h6, and h10 have been updated based on the additional information received on september 30, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code (b)(6) captures the reportable events of "mesh exposure following retropubic midurethral sling," "developed mesh erosion discovered on cystoscopy," and "developed mesh erosion noted at the bladder neck." impact code (b)(6): device revision or replacement captures the reported event of "excision of sling/exposed mesh - open, transvesical." impact code f12: serious injury/ illness/ impairment has been used in the light of the patient sought legal recourse for a personal injury related to the device.Block h11: blocks b5, h6 and h10 have been corrected based on medical safety review on november 1, 2022.Block h6 (additional reportable codes): patient code e2009 captures the reportable events of "during the cystoscopy, a small tear was noted at the left bladder neck.It was carefully examined and was not deep.There was no perforation of the urethra or bladder" patient code e0506 captures the reportable event of "there was bleeding from the catheter." patient code e2114 captures the reportable event of "the left trocar within the bladder." block h11: blocks e1 and h6 (patient code) have been corrected.Blocks b7, h6 (component code, evaluation method code, evaluation result code and evaluation conclusion codes), and h10 have been updated based on the additional information received on february 20, 2023.
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Event Description
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It was reported to boston scientific corporation that a lynx system was used during a procedure performed on (b)(6) 2021.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on september 30, 2022.On (b)(6) 2021, the patient was implanted with a lynx system device during a retropubic midurethral sling and posterior repair to treat her mixed urge and stress urinary incontinence.She has had recurrent stress urinary incontinence (sui) symptoms after previous mid urethral retropubic sling placement.She was noted to have a rectocele as well.Findings include scarring noted due to previous sling placement, on the left side.Two abdominal incisions about 0.5 cm in length were made on either side 2 cm from the midline just superior to the pubic symphysis.There was bleeding from the catheter and it was removed.A cystoscopy was then performed that showed a small tear at the left bladder neck about 2 o'clock.It was carefully examined and was not deep.The bladder was then emptied, leaving the foley catheter in place.After placement of the trocars, cystoscopy was repeated and there was visualization of the left trocar within the bladder.This was removed and replaced.Cystoscopy repeated, and it was confirmed there was no perforation of the urethra or bladder.The mesh placement procedure was continued and completed.Posterior colporrhaphy was then performed with correction of prolapse.On (b)(6) 2021, the patient experienced a mesh exposure following retropubic midurethral sling.She previously had a sling many years ago and developed recurrent stress urinary incontinence (sui).She underwent repeat retropubic midurethral sling and developed mesh erosion noted at the bladder neck.She presented today for lap exploratory laparotomy, mesh excision/removal, cystorrhaphy, and cystoscopy.She took one augmentin 875 mg yesterday.Urine negative for blood, nitrites, and leukocytes.Operative findings includes a previous sling arm encountered more laterally on the left, second sling arm which was eroding into the bladder was then encountered more medially after an anterior cystotomy was performed.Sling material within the bladder lumen and bladder wall was excised in its entirety and the mucosal defect was closed following by a subsequent detrusor closure.Prior to proceeding to the operating room, the procedure was described in detail to the patient, all questions were answered and appropriate consent was obtained.The patient was then taken to the operating room.Thromboembolism-deterrent (teds) and scds were applied and confirmed to be working.Anesthesia was induced and the patient was placed in the lithotomy position.The patient was then prepped in standard sterile fashion.Time-out was held and perioperative antibiotics were confirmed and administered.A flexible cystoscopy was inserted per the urethra.Upon retroflexion the exposed mesh was visualized at the bladder neck on the left.There were no other abnormalities.A midline incision was marked from pubis to just below the umbilicus.This was incised with a #10 blade.Electrocautery was used to dissect down to the anterior rectus fascia.This was divided with electrocautery in the midline between the rectus muscles.The bladder was dropped and the space of retzius was entered.The bladder was mobilized laterally on both sides.A mesh sling was encountered laterally and isolated.At this point, it was unclear if this was her initially placed mesh or the subsequent mesh.The balfour retractor was placed.The physician attempted to trace the mesh toward the bladder neck / urethra but the visibility was difficult with this approach.The physician then elected to perform an anterior cystotomy to perform a transvesical excision and repair.The bladder was opened anteriorly using electrocautery.#2-0 vicryl sutures were placed laterally to aid with retraction.A #2-0 vicryl suture was placed at the inferior apex to prevent splitting of the detrusor toward the bladder neck and urethra.The mesh was able to be visualized at the expected location near the bladder neck.A right angle was used to get circumferential access and a vessel loop was placed to traction.The superior portion of the mesh was dissected from the bladder and excised.The inferior portion of the mesh was placed on traction and a combination of blunt and sharp dissection was used.The extravesical portion of the mesh was isolated as well and cut near the exterior surface of the bladder.The intravesical portion was then able to be removed sharply.There was no residual mesh within the bladder lumen or bladder wall.The bladder neck mucosa was then re-approximated with #3-0 monocryl in a simple running fashion.This brought the urothelium together well.We then turned our attention extravesically and closed both defects in the detrusor with #2-0 monocryl.The pelvis was inspected and hemostasis was obtained and satisfactory.The physician then began with his cystorrhaphy.This was closed in 2 layers with running #3-0 monocryl for the mucosa and #2-0 monocryl for the detrusor closed in a lembert fashion.The bladder was leak tested for 180 cc and was found to be water-tight.A #15-french blake drain was placed in the llq and secured with a #2-0 nylon.The rectus bellies were reapproximated with #2-0 vicryl.The fascia was closed with #1 looped pds.The subcutaneous tissues were approximated with #2-0 vicryl.The skin was closed with #4-0 monocryl.Sterile dressing was applied.All needle and lap counts were correct.The patient tolerated the procedure well.No complications occurred during or immediately after the procedure.The patient was taken to the pacu satisfactory condition.
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Event Description
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It was reported to boston scientific corporation that a lynx system was used during a procedure performed on (b)(6) 2021.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on september 30, 2022: on (b)(6) 2021, the patient was implanted with a lynx system device during a retropubic midurethral sling and posterior repair to treat her mixed urge and stress urinary incontinence.She has had recurrent stress urinary incontinence (sui) symptoms after previous mid urethral retropubic sling placement.She was noted to have a rectocele as well.Findings include scarring noted due to previous sling placement, on the left side.Two abdominal incisions about 0.5 cm in length were made on either side 2 cm from the midline just superior to the pubic symphysis.There was bleeding from the catheter and it was removed.A cystoscopy was then performed that showed a small tear at the left bladder neck about 2 o'clock.It was carefully examined and was not deep.The bladder was then emptied, leaving the foley catheter in place.After placement of the trocars, cystoscopy was repeated and there was visualization of the left trocar within the bladder.This was removed and replaced.Cystoscopy repeated, and it was confirmed there was no perforation of the urethra or bladder.The mesh placement procedure was continued and completed.Posterior colporrhaphy was then performed with correction of prolapse.On (b)(6) 2021, the patient experienced a mesh exposure following retropubic midurethral sling.She previously had a sling many years ago and developed recurrent stress urinary incontinence (sui).She underwent repeat retropubic midurethral sling and developed mesh erosion noted at the bladder neck.She presented today for lap exploratory laparotomy, mesh excision/removal, cystorrhaphy, and cystoscopy.She took one augmentin 875 mg yesterday.Urine negative for blood, nitrites, and leukocytes.Operative findings includes a previous sling arm encountered more laterally on the left, second sling arm which was eroding into the bladder was then encountered more medially after an anterior cystotomy was performed.Sling material within the bladder lumen and bladder wall was excised in its entirety and the mucosal defect was closed following by a subsequent detrusor closure.Prior to proceeding to the operating room, the procedure was described in detail to the patient, all questions were answered and appropriate consent was obtained.The patient was then taken to the operating room.Thromboembolism-deterrent (teds) and scds were applied and confirmed to be working.Anesthesia was induced and the patient was placed in the lithotomy position.The patient was then prepped in standard sterile fashion.Time-out was held and perioperative antibiotics were confirmed and administered.A flexible cystoscopy was inserted per the urethra.Upon retroflexion the exposed mesh was visualized at the bladder neck on the left.There were no other abnormalities.A midline incision was marked from pubis to just below the umbilicus.This was incised with a #10 blade.Electrocautery was used to dissect down to the anterior rectus fascia.This was divided with electrocautery in the midline between the rectus muscles.The bladder was dropped and the space of retzius was entered.The bladder was mobilized laterally on both sides.A mesh sling was encountered laterally and isolated.At this point, it was unclear if this was her initially placed mesh or the subsequent mesh.The balfour retractor was placed.The physician attempted to trace the mesh toward the bladder neck / urethra but the visibility was difficult with this approach.The physician then elected to perform an anterior cystotomy to perform a transvesical excision and repair.The bladder was opened anteriorly using electrocautery.#2-0 vicryl sutures were placed laterally to aid with retraction.A #2-0 vicryl suture was placed at the inferior apex to prevent splitting of the detrusor toward the bladder neck and urethra.The mesh was able to be visualized at the expected location near the bladder neck.A right angle was used to get circumferential access and a vessel loop was placed to traction.The superior portion of the mesh was dissected from the bladder and excised.The inferior portion of the mesh was placed on traction and a combination of blunt and sharp dissection was used.The extravesical portion of the mesh was isolated as well and cut near the exterior surface of the bladder.The intravesical portion was then able to be removed sharply.There was no residual mesh within the bladder lumen or bladder wall.The bladder neck mucosa was then re-approximated with #3-0 monocryl in a simple running fashion.This brought the urothelium together well.We then turned our attention extravesically and closed both defects in the detrusor with #2-0 monocryl.The pelvis was inspected and hemostasis was obtained and satisfactory.The physician then began with his cystorrhaphy.This was closed in 2 layers with running #3-0 monocryl for the mucosa and #2-0 monocryl for the detrusor closed in a lembert fashion.The bladder was leak tested for 180 cc and was found to be water-tight.A #15-french blake drain was placed in the llq and secured with a #2-0 nylon.The rectus bellies were reapproximated with #2-0 vicryl.The fascia was closed with #1 looped pds.The subcutaneous tissues were approximated with #2-0 vicryl.The skin was closed with #4-0 monocryl.Sterile dressing was applied.All needle and lap counts were correct.The patient tolerated the procedure well.No complications occurred during or immediately after the procedure.The patient was taken to the pacu satisfactory condition.Additional information received on february 20, 2023: patient history: on (b)(6) 2014, the patient underwent a urethrovesical sling implant using a non-boston scientific device and a cystoscopy procedure to treat the patient's urinary stress incontinence and cystocele.Additional information received on september 12, 2023: on (b)(6) 2021 clinical notes, it was reported that the patient had a new overactive bladder and stress urinary incontinence noted on (b)(6) 2021.She had a history of mid-urethral sling placed in 2014 and had improvement for one and a half years but became worse in (b)(6) 2021.She was seen by a physician on (b)(6) 2021 and was still having incontinence related to her mid-urethral sling in 2014.On (b)(6) 2021, the patient was complaining of slow stream and worsening leaking.She started to take imipramine when cath urine culture resulted in enterococcus but no improvement.It made her headaches worse.She was then scheduled for sling release and suds (single-use device).During this consultation, she stated she voided 25 to 30 times a day.She felt like she was emptying.She voided sometimes because she was worried she was going to leak.When she moved, she leaked but not urinating when she sat still.She was using 3 to 4 pads a day wet and heavy.Urinalysis showed small leukocytes.She felt she had uti.Urine history also reported small leukocytes.Cath urine was sent for urinalysis, microbiology, and culture.It was also reported that on (b)(6) 2021, the patient was diagnosed with enterococcus faecalis.Pelvic exam (b)(6) 2021: negative stress test with coughing supine, neg stress test with valsalva supine in and out cath performed with 10cc residual-urine was sent for sample.The first sensation to void felt at 50 cc.Significant urge felt at 150cc.Bladder filled to 150 cc.The catheter was then removed.Negative stress test with coughing supine, + small volume stress test with valsalva supine.Negative stress test with coughing and + valsalva standing.Rectocele.No obvious cystocele or obstruction + atrophic vaginitis.No vaginal discharge.Mesh not eroded.Pelvic exam (b)(6) 2021: negative stress test with coughing supine, negative stress test with valsalva supine in and out cath performed with 20cc residual - cath urine was sent for sample.The first sensation to void felt at 100 cc.Significant urge felt at 130cc.Bladder filled to 150 cc.The catheter was then removed.Negative stress test with coughing supine, negative stress test with valsalva supine.Negative stress test with coughing or valsalva standing.However, leaked some drops after standing some time.Assessment/plan: patient came to office with persistent mixed incontinence after sling in (b)(6) 2021.No improvement with imipramine.On cystometrogram, she doesn't leak with 150 with valsalva laying down or standing, previously she did.Did have a few drops afterward.Her biggest concern is pad usage.Explained not going to get pad-free, but the patient says she is going through 3-4 thick wet pads a day.I think she should proceed with suds to determine if she has an elevated detrusor pressure, check for abnormal contractions (especially stress-induced detrusor overactivity) with slow flow, and if so, then could be obstructed even though residuals are low.Obstruction could result in worsening oab/doa.However, wonder if she would benefit from trying an oab medication now that she is unobstructed.If she continues to void every time she feels urine in the urethra, may develop dysfunctional voiding but she says if she holds longer, she has larger pads.Mixed stress and urge urinary incontinence plan: send cath urine for urinalysis, microbiology, and culture macrobid twice a day for 3 days.Suds tomorrow.Consider oab med depending on findings before scheduling sling release.On (b)(6) 2021, the patient underwent exploratory laparotomy, excision of sling/exposed mesh (open trans vesical), cystorrhaphy, and cystoscopy due to exposure of implanted urethral mesh, mixed stress and urge urinary incontinence, prolapse of posterior vaginal wall, and history of abdominal supracervical subtotal hysterectomy.Findings showed normal contour of bladder, no evidence of extravasation on filling or post void films, and left vur vesicoureteral reflux noted with accompanying bladder spasms.Operative findings showed previous sling arm encountered more laterally on the left, second sling arm which was eroding into the bladder was then encountered more medially after an anterior cystotomy was performed.Siing material within the bladder lumen and bladder wall was excised in its entirety and the mucosal defect was closed following by a subsequent detrusor closure.Upon retroflexion, the exposed mesh was visualized at the bladder neck on the left.There were no other abnormalities.It was unclear if it was her initially placed mesh or the subsequent mesh.Tracing the mesh was attempted towards the bladder neck or urethra but the visibility was difficult with this approach.An anterior cystotomy was then performed for a transvesical excision and repair.The mesh was able to be visualized at the expected location, near the bladder neck.The superior portion of the mesh was dissected from the bladder and excised.The inferior portion of the mesh was placed on traction and a combination of blunt and sharp dissection was used.The extravesical portion of the mesh was isolated as well and cut near the exterior surface of the bladder.The intravesical portion was then able to be removed sharply.There was no residual mesh within the bladder lumen or bladder wall.The pelvis was inspected, and hemostasis was obtained and satisfactory.The patient tolerated the procedure well.No complications occurred during or immediately after the procedure.The patient was taken to the post-anesthesia care unit in satisfactory condition and was placed on the urology service for continued monitoring.Final pathology diagnosis: mesh no.1 and mesh no.2 removal - fibrous tissue with chronic inflammation and focal foreign body giant cell reaction.On (b)(6) 2021, the patient had cystogram, fluoroscopy and removal of foley catheter.On (b)(6) 2022, the patient presented for a post-op follow-up after exploratory laparotomy with open excision of mesh from the bladder.She stated that she had two types of pain, one was a sharp shooting pain that occurred in the left lower quadrant.There were no exacerbating or alleviating factors.She did not leak when she had these pains.She had another pain that was worse if she had been out shopping or after walking for 30-45 minutes.It happened most afternoons; she described the pain as her insides falling out.The only alleviating aspect was lying down generally took an hour before she had improvement.She also had ongoing stress incontinence.Review of systems: gastrointestinal: positive for abdominal pain.Genitourinary: positive for urgency.Musculoskeletal: positive for back pain.Impression: * pelvic pain in female.* left lower quadrant abdominal pain.* mixed stress and urge urinary incontinence.* post-operative state.Plan: 1.Bmp blood test, ct abdominal/pelvis.2.Cystoscopy.3.Gabapentin for the pain, checked the drug interaction against topiramate, and gentle dose escalation was prescribed.4.Referred to pt, and the order was placed.5.Paperwork completed for return to work, excused her from work for another 6 weeks.6.Discussed urethral bulking agent but would like to have her heal further before injection.7.Discontinue oxybutynin.On (b)(6) 2022, four months post mesh excision, the patient was seen to check up on acute and chronic conditions.The patient stated that they finally discovered that the mesh had grown into her bladder.Had to have it removed.Having a lot more incontinence.The pain after the surgery was sharp, shooting pains.She is now having nerve pain and taking neurontin 300mg at bedtime, which made an improvement in her pain.Before it, she could not walk around for more than 30 minutes.Had incontinence when she was walking and other times when she was coughing or sneezing.Had both slings removed.Had been to her back doctor to check up on her ddd degenerative disc disease, to make sure it was not the cause of her incontinence.Physician did not think it was the cause.The patient did not bend over, she did squat due to her back pain.She was sent to pelvic floor physical therapy and had been doing it since (b)(6) 2022.Pain was improved.The patient went back to work last week and had a lot more incontinence because she was walking more.It was emotionally hard because she was doing things and urinating on herself at the same time.She also resumed taking vyvanse.Blood pressure and headaches were okay.She had been taking estrogen cream in the vaginal area.Assessment: 1.Essential hypertension.2.Mixed stress and urge urinary incontinence.3.Migraine without status migrainosus, not intractable, unspecified migraine type.4.Attention deficit disorder, unspecified hyperactivity presence.5.Postnasal drip.6.Long-term use of high-risk medication.7.Screening for endocrine disorder.8.Screening for ischemic heart disease (ihd).9.Screening for blood or protein in urine.Plan: 1.Essential hypertension - controlled.Will continue to monitor bp on current medication regimen.Orders: comprehensive metabolic panel; future; expected date: (b)(6) 2022.Lipid panel; future; expected date: (b)(6) 2022.Microalbumin/creatinine ratio, urine; future; expected date: (b)(6) 2022.Tsh with reflex to ft 4; future; expected date: (b)(6) 2022.Urinalysis, reflex to urine culture urine, clean catch; future; expected date: (b)(6) 2022 cbc auto differential; future; expected date: (b)(6) 2022.2.Mixed stress and urge urinary incontinence symptomatic.Patient to continue pelvic floor exercises.3.Migraine without status migrainosus, not intractable, unspecified migraine type controlled.Will continue to monitor the severity and frequency of headaches.4.Attention deficit disorder, unspecified hyperactivity presence.Focus controlled.Will continue to monitor the tolerability and effectiveness of vyvanse.5.Postnasal drip: acute.To continue over-the-counter meds and will give a shot of steroid.Dexamethasone injection 4 mg.6.Long-term use of high-risk medication: comprehensive metabolic panel; future; expected date: (b)(6) 2022.Lipid panel; future; expected date: (b)(6) 2022.Microalbumin/creatinine ratio, urine; future; expected date: (b)(6) 2022.Tsh with reflex to ft 4; future; expected date: (b)(6) 2022.Urinalysis, reflex to urine culture urine, clean catch; future; expected date: (b)(6) 2022.Cbc auto differential; future; expected date: (b)(6) 2022.7.Screening for endocrine disorder tsh with reflex to ft 4; future; expected date: (b)(6) 2022.8.Screening for ischemic heart disease (iho) comprehensive metabolic panel; future; expected date: (b)(6) 2022.Lipid panel; future; expected date: (b)(6) 2022.9.Screening for blood or protein in urine microalbumin/creatinine ratio, urine; future; expected date: (b)(6) 2022.Urinalysis, reflex to urine culture urine, clean catch; future; expected date: (b)(6) 2022.It was stated in a letter of (b)(6) 2023, that the patient continued to have severe stress-type urinary incontinence symptoms with severe terminal urinary dribbling.The patient had repeatedly stated that after voiding she arose to walk away from the toilet and then noticed continued urinary incontinence.Particularly, after voiding, she noticed urinary incontinence with the slightest physical provocation, as well as what seemed to be some urge-related urinary incontinence at times.She recently rated the urinary incontinence as 9 (on a scale of 1-10) severe.She wore urinary incontinence pads daily and experienced both stress and urge-type symptoms.The patient recently underwent cystourethroscopy showing a normal appearing urethra, no intraurethral foreign body, perhaps some mild urethral stenosis (prior to uneventful urethral dilation), normal-appearing bladder neck, no evident bladder neck contracture, bilateral ureteral orifices of normal shape size and position, clear bilateral ureteral orifice urine efflux, grade1 bladder trabeculation, normal-appearing bladder mucosa (with no grossly evident scarring), no intravesical foreign body, and otherwise no evidence of intravesical mass, rumor, or stone.The patient's cytometric capacity is at least 350cc, as determined by in and out catheterization after the cystoscopy procedure.Given the patient's urological history, the cystoscopic findings, and the physical findings, intrinsic sphincter deficiency is strongly suspected.Some component of urge incontinence is also suspected, given the partial response to gemtesa.The patient has been offered a follow-up urodynamic evaluation, which she has declined to this point, having undergone several urodynamic procedures previously.She has been offered a referral for comprehensive evaluation at academic centers.Options for additional investigation had been comprehensively discussed on numerous occasions including botox, neuromodulation, transurethral bulking agent instillation, urethrolysis, pubovaginal sling revision, and even artificial urinary sphincter placement or urinary diversion.She is frustrated and looking for a less invasive way to manage her condition, even if the treatment is not a permanent solution.In this vein, treatment using bulkamid (axonics, inc.) or similar transurethral bulking instillation has been discussed as a trial of a relatively non-invasive procedure.The patient would like to consider this if indicated.Otherwise, she will continue gemtesa along with behavioral techniques and other recommended conservative measures, along with empiric antibiotic therapy for her infrequently recurrent urinary tract infections.
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Manufacturer Narrative
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Blocks b2, b5, b6, b7, d6b, e1 below, and h6 patient codes and impact codes have been updated based on the additional information received on september 12, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006: erosion - mesh exposure following retropubic midurethral sling; mesh erosion noted at the bladder neck.E2114: perforation - left trocar within the bladder.E2009: laceration - small tear noted at the left bladder neck.E0506: hemorrhage - bleeding from the catheter.E2330: pain.E1002: abdominal pain.E1310: uti.E1901: enterococcus.E2328: obstruction.E2326: chronic inflammation.E232402: recurrent urinary incontinence; voiding dysfunction.E1311: severe terminal urinary dribbling.E1605: spasms.E1304: urinary urgency.E2313: fibrosis.E1307: urethral stenosis/stricture.The following imdrf impact codes capture the reportable events of: f1903: mesh explant.F1202: unable to work for another 6 weeks.
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Search Alerts/Recalls
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