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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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| Model Number M0068507000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erosion (1750); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Hematuria (2558); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 06/14/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, after the procedure, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6), 2017 (first clinic visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Surgeon: dr.(b)(6).Excision/revision surgery performed at (b)(6) center.Block h6: patient codes e1405, e1302, e1715, e2330, e1310, e2006, f1905, f2303 capture the reportable event of bladder spasm/pelvic pressure after intercourse, hematuria, scar tissue to anterior vaginal wall, hip and vaginal pain, urinary tract infection, extrusion and unspecified injury of muscle/fascia/tendon, excision/revision surgery and required medications.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported that a solyx sis system, single device was implanted during a procedure performed on (b)(6), 2017.As reported by the patient's attorney, after the procedure, the patient had experienced an unknown injury.**additional information received on 14jan2022** it was reported that the patient had been diagnosed with stress urinary incontinence.On (b)(6), 2017, she underwent a solyx midurethral sling placement procedure with cystoscopy.Patient also underwent a right pyeloplasty due to upj obstruction.Cystoscopy revealed stent placement was in good position, from the right ureter.There was no evidence of mesh in the bladder.No urethral or bladder injury reported.On (b)(6), 2017, patient presents for a one month postoperative evaluation.She reports having had a low grade urinary tract infection which has been treated.No complaints today other than wanting stent out as it is causing horrible frequency.She has been having flank pain on the right, described as aching and a severity of 10 out of 10 which ahs been present several days.Current impression: congenital occlusion of uteropelvic junction, stress incontinence, postmenopausal atopic vaginitis.On (b)(6), 2018, her physician noted a small exposure of the edge of the mesh in the midline.Patient underwent mesh excision surgery on (b)(6), 2018.Pre and postop diagnoses include: stress urinary incontinence; extrusion of previously placed vaginal mesh; unspecified injury of muscle, fascia, tendon; microscopic hematuria.The following procedures were performed: excision of previously placed transvaginal mesh, sling revision; bladder neck and urethral repair for stress incontinence; and cystourethroscopy for microscopic hematuria.The right and left arms of the mesh were excised.No complications reported.Patient sent home with norco for pain and a few days of keflex to prevent infection.A month later, patient came back for follow-up and reported she's been doing well since surgery.On (b)(6), 2019, patient presents with symptoms of overactive bladder.She returns to the clinic complaining of intermitted bladder spasms and pelvic pressure after intercourse that tend to wake her up at night.She is also having urgency, frequency and stress urinary incontinence.Since (b)(6) 2019 she has been having hip pain from piriformis on sciatic nerve, but this has been improving since seeing ortho and doing some home stretching exercises.She has had some mild sui since her last operation.She does have urinary urgency.She has enuresis daily.She is having problems with urinary control or incontinence she does leak urine when she coughs, laughs, sneezes r bears down.Restarted oxybutynin er 10mg for urgency and mui.On (b)(6), 2020, patient came back with complaints of vaginal pain, incontinence and decreased sensitivity with vaginal intercourse.On exam, there was white thickening of the tissue to the anterior vaginal wall.Assessment finding was a possible scar tissue to the anterior vaginal wall.
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Manufacturer Narrative
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Correction: b5 block b3 date of event: date of event was approximated to (b)(6), 2017 (first clinic visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Surgeon: dr.(b)(6).Excision/revision surgery performed at (b)(6) surgery center.Block h6: patient codes e1405, e1302, e1715, e2330, e1310, e2006, f1905, f2303 capture the reportable event of bladder spasm/pelvic pressure after intercourse, hematuria, scar tissue to anterior vaginal wall, hip and vaginal pain, urinary tract infection, extrusion and unspecified injury of muscle/fascia/tendon, excision/revision surgery and required medications.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported that a solyx sis system, single device was implanted during a procedure performed on (b)(6), 2017.As reported by the patient's attorney, after the procedure, the patient had experienced an unknown injury.**additional information received on 14jan2022** it was reported that the patient had been diagnosed with stress urinary incontinence.Additional medical history includes postmenopausal atrophic vaginitis and unspecified abdominal pain.On (b)(6), 2017, she underwent a solyx midurethral sling placement procedure with cystoscopy.Patient also underwent a right pyeloplasty due to upj obstruction.Cystoscopy revealed stent placement was in good position, from the right ureter.There was no evidence of mesh in the bladder.No urethral or bladder injury reported.On (b)(6), 2017, patient presents for a one-month postoperative evaluation.She reports having had a low-grade urinary tract infection which has been treated.No complaints today other than wanting stent out as it is causing horrible frequency.She has been having flank pain on the right, described as aching and a severity of 10 out of 10 which has been present several days.Exam revealed sutures still present at proximal aspect of the midurethral sling incision.Current impression: congenital occlusion of uteropelvic junction, stress incontinence, postmenopausal atrophic vaginitis.The ureteral stent was removed.The patient was to use estrace over sling incision site until healed.On (b)(6), 2018, the patient was seen for a small exposure of the edge of the mesh in the midline that had been noted by her gynecologist.The patient was not having any pain with intercourse and had not noticed it.She reported a touch of sui with hard sneeze and a bubble after voiding leaving a drip of moisture in her underwear.The plan was for the patient to resume vaginal estrace daily for next few months and return in 2-3 months for a repeat exam.If still exposed, depending on severity, options for clinic excision versus formal repair in the or will be discussed.She will work on kegels for the mild persistent sui.If this does not resolve her leakage, will have her get urodynamic studies - uds prior to considering a repeat surgical repair.Patient underwent mesh excision surgery on (b)(6), 2018.Pre and postop diagnoses include: stress urinary incontinence; extrusion of previously placed vaginal mesh; unspecified injury of muscle, fascia, tendon; microscopic hematuria.The following procedures were performed: excision of previously placed transvaginal mesh, sling revision; bladder neck and urethral repair for stress incontinence; and cystourethroscopy for microscopic hematuria.Cystourethroscopy was normal.The right and left arms of the mesh were excised, left taken all the way back to the obturator internus, right about halfway back.No complications reported.Patient sent home with norco for pain and a few days of keflex to prevent infection.A month later, patient came back for follow-up and reported she has been doing well since surgery with improved bladder emptying and no incontinence.Exam showed one small suture remained, but the tissue looked great and there was no prolapse.On (b)(6), 2019, patient presents with symptoms of overactive bladder.She returns to the clinic complaining of intermittent bladder spasms and pelvic pressure after intercourse that tend to wake her up at night.She is also having urgency, frequency, and stress urinary incontinence.Since (b)(6) 2019 she has been having hip pain from piriformis on sciatic nerve, but this has been improving since seeing ortho and doing some home stretching exercises.She has had some mild sui since her last operation.She does have urinary urgency.She has enuresis daily.She is having problems with urinary control or incontinence.She does leak urine when she coughs, laughs, sneezes, or bears down.Exam revealed tight and tense hypertonic pelvic floor muscles.Restarted oxybutynin er 10mg for urgency and mixed urinary incontinence mui.She was also referred to pelvic floor physical therapy, pfpt for hypertonicity of pelvic floor muscles.On (b)(6), 2020, patient presented for complaints of vaginal pain, incontinence and decreased sensitivity with vaginal intercourse.On exam, there was white thickening of the tissue to the anterior vaginal wall.Assessment finding was a possible scar tissue to the anterior vaginal wall.On (b)(6), 2020 and (b)(6), 2020, the patient underwent vaginal restoration using laser, radiofrequency and platelet rich plasma.Patient was educated that collagen remodeling is temporary and annual treatments are recommended.
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Manufacturer Narrative
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Blocks a1, b5, b7 and g2 have been updated based on the additional information received on july 25, 2023.Block b3 date of event: date of event was approximated to june 14, 2017 (first clinic visit post implant), as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6) center austin, tx revision surgery: dr.(b)(6) (b)(6) center.Block h6: patient codes e1405, e1302, e1715, e2330, e1310, e2006, f1905, f2303 capture the reportable event of bladder spasm/pelvic pressure after intercourse, hematuria, scar tissue to anterior vaginal wall, hip and vaginal pain, urinary tract infection, extrusion and unspecified injury of muscle/fascia/tendon, excision/revision surgery and required medications.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported that a solyx sis system, single device was implanted during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, after the procedure, the patient had experienced an unknown injury.**additional information received on 14jan2022** it was reported that the patient had been diagnosed with stress urinary incontinence.Additional medical history include postmenopausal atrophic vaginitis and unspecified abdominal pain.On (b)(6) 2017, she underwent a solyx midurethral sling placement procedure with cystoscopy.Patient also underwent a right pyeloplasty due to upj obstruction.Cystoscopy revealed stent placement was in good position, from the right ureter.There was no evidence of mesh in the bladder.No urethral or bladder injury reported.On (b)(6) 2017, patient presents for a one-month postoperative evaluation.She reports having had a low-grade urinary tract infection which has been treated.No complaints today other than wanting stent out as it is causing horrible frequency.She has been having flank pain on the right, described as aching and a severity of 10 out of 10 which has been present several days.Exam revealed sutures still present at proximal aspect of the midurethral sling incision.Current impression: congenital occlusion of uteropelvic junction, stress incontinence, postmenopausal atrophic vaginitis.The ureteral stent was removed.The patient was to use estrace over sling incision site until healed.On (b)(6) 2018, the patient was seen for a small exposure of the edge of the mesh in the midline that had been noted by her gynecologist.The patient was not having any pain with intercourse and had not noticed it.She reported a touch of sui with hard sneeze and a bubble after voiding leaving a drip of moisture in her underwear.The plan was for the patient to resume vaginal estrace daily for next few months and return in 2-3 months for a repeat exam.If still exposed, depending on severity, options for clinic excision versus formal repair in the or will be discussed.She will work on kegels for the mild persistent sui.If this does not resolve her leakage, will have her get urodynamic studies (uds) prior to considering a repeat surgical repair.Patient underwent mesh excision surgery on (b)(6) 2018.Pre and postop diagnoses include: stress urinary incontinence; extrusion of previously placed vaginal mesh; unspecified injury of muscle, fascia, tendon; microscopic hematuria.The following procedures were performed: excision of previously placed transvaginal mesh, sling revision; bladder neck and urethral repair for stress incontinence; and cystourethroscopy for microscopic hematuria.Cystourethroscopy was normal.The right and left arms of the mesh were excised (left taken all the way back to the obturator internus, right about halfway back).No complications reported.Patient sent home with norco for pain and a few days of keflex to prevent infection.A month later, patient came back for follow-up and reported she's been doing well since surgery with improved bladder emptying and no incontinence.Exam showed one small suture remained, but the tissue looked great and there was no prolapse.On (b)(6) 2019, patient presents with symptoms of overactive bladder.She returns to the clinic complaining of intermittent bladder spasms and pelvic pressure after intercourse that tend to wake her up at night.She is also having urgency, frequency, and stress urinary incontinence.Since february 2019 she has been having hip pain from piriformis on sciatic nerve, but this has been improving since seeing ortho and doing some home stretching exercises.She has had some mild sui since her last operation.She does have urinary urgency.She has enuresis daily.She is having problems with urinary control or incontinence.She does leak urine when she coughs, laughs, sneezes, or bears down.Exam revealed tight and tense (hypertonic) pelvic floor muscles.Restarted oxybutynin er 10mg for urgency and mixed urinary incontinence (mui).She was also referred to pelvic floor physical therapy (pfpt) for hypertonicity of pelvic floor muscles.On (b)(6) 2020, patient presented for complaints of vaginal pain, incontinence and decreased sensitivity with vaginal intercourse.On exam, there was white thickening of the tissue to the anterior vaginal wall.Assessment finding was a possible scar tissue to the anterior vaginal wall.On (b)(6) 2020 and (b)(6) 2020, the patient underwent vaginal restoration using laser, radiofrequency and platelet rich plasma.Patient was educated that collagen remodeling is temporary and annual treatments are recommended.The device was implanted and is not expected to be returned.---additional information received on july 25, 2023--- patient started e2, estradiol vaginal inserts at her last telemed in december 2022 due to increased stress incontinence.She was also referred to pft, pelvic floor therapy but patient was waiting as her insurance changes on (b)(6) 2023.The improvement has not noticed yet from vaginal e2, estradiol; however, wishes to continue as she thought it would help in future with consistent use.
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