MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Burning Sensation (2146); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of the first mesh removal surgery.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The provided healthcare facility is: (b)(4).(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.

Event Description

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) 2019.The patient has experienced an unspecified injury and underwent surgeries on (b)(6) 2020 and (b)(6) 2020 to remove portions of the mesh.

Manufacturer Narrative

Block h2: blocks d4 and h10 have been updated based on additional information received on january 25, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of the first mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(4).Block h6: patient code of e2401 captures the reportable event of unspecified injury.Impact code of f1905 captures the surgeries to remove portions of the mesh.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

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) 2019.The patient has experienced an unspecified injury and underwent surgeries on (b)(6), 2020 and (b)(6) 2020 to remove portions of the mesh.

Manufacturer Narrative

Block h2: blocks a2, a3, b3, b5, d6b and h6 have been updated based on additional information received on march 23, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the first mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) dr.(b)(6) hospital.(b)(6).(b)(6).The explanting surgeon is: (b)(6) dr.(b)(6).(b)(6).Block h6: patient code of e1405, e1715, e1310, e2326, e020202, e2101, e2330, e2006 capture the reportable events of dyspareunia, scar tissue, urinary tract infection, inflammation, depression, adhesions, pain and erosion.Impact code of f1905, f1903 and f2303 captures the removal portions of the mesh, complete mesh explantation and medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

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) 2019.The patient has experienced an unspecified injury and underwent surgeries on (b)(6) 2020 and (b)(6) 2020 to remove portions of the mesh.Boston scientific has received an additional information on 23mar2022 as follows: on (b)(6) 2019, the patient was implanted with a solyx sis device during a mid-urethral sling insertion, myosure polypectomy and diagnostic cystoscopy procedure for the treatment of endometrial polyps, abnormal uterine bleeding, and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.On (b)(6) 2019, the patient sought for a second opinion about her prolapse.The patient is status post endometrial polyp and mid-urethral sling placement.The patient also reports that she had a urinary tract infection symptom and is in the clinic seeking for relief.Findings of physical examination of the patient's genitourinary system are as follows: - stage 1-2 distal rectocele however vaginal curve is reasonable and levator muscle are intact.- the uterus is 10-week size slightly bulky.- mid-urethral area there is palpable band of sling which is superficial.- there is no evidence of mesh erosion.- the left junction of sling to the left rami is very tender to palpation.- there is stage 1 uterine prolapse.- no urethral hypermobility.- repeated exam in standing position and there is no evidence of pelvic organ prolapse.- only stage 1 uterine prolapse and stage 1 rectocele.Additionally, result of urinalysis showed a trace of leukocytes and patient had to start taking gabapentin.However, if pain gets worse despite taking gabapentin, the patient may have to consider a removal of mid-urethral sling.On (b)(6) 2019, had to undergo a removal of vaginal mesh, lysis of vaginal adhesions and cystoscopy procedure for the treatment of pelvic pain and pelvic floor dysfunction status post sling placement.Intraoperative findings revealed that there was a dense scarring on the left side of the patient with more adhesions to the left ischiopubic rami.There was evidence of mild urethral hypermobility.The cervix was within the normal limits.There was no evidence of pelvic organ prolapse except for mild stage 1 cystocele and ureterocele and stage 1 rectocele.On (b)(6) 2020, the patient had self-referred for physical therapy after undergoing two surgeries that includes polyp removal with a sling placement that caused her to have a severe pelvic pain and bladder dysfunction.Patient's current complaint are as follows: - vaginal tension and discomfort.- urinary tract infection and irritated vagina.- still feels like a twinge of nerve sensation that shoots to her vagina - avoids sex.- cannot do vigorous activity.According to the patient, the surgeon came to her pre-op bed and requested a permission to perform a sling despite that fact that she was given no previous information or testing to determine if it was medically necessary.The second procedure was performed by a different surgeon who told her that the sling was placed without a cause and in fact, she did not have a prolapse.After the mesh removal, the patient is still had a left sided pelvic pain where the second surgeon reportedly said the suture was incorrectly placed.Additionally, the patient's exam revealed a significant for a left side pelvic floor muscle (pfm) pain and tenderness and positive for a 0-tip test along the distribution of perineal nerve.On (b)(6) 2020, the patient went for a consultation on chronic pain following the insertion and removal of bladder sling.The patient still reports severe pain on the left side of the vagina and pelvic wall and is very worried about the status of her prolapse.She was informed that it was a stage 1, but she is very worried that it is getting worse.The patient is taking diazepam suppositories and a topical cream with gabapentin as well as cbd cream for the external pelvis.After the most recent re-assessment of the patient, she was informed that while her pain was still sharp and severe, the therapist did not feel any restrictions in the tissues or spasm or trigger points.Her pelvic floor muscle function appears good, but the therapist feels a difference in muscle bulk i.E., atrophy on the left side which may be a contributing factor on the continuation of the nerve like sensations of pain that the patient is still experiencing.The therapist will consult with (b)(6) dr.And come back to the with an updated plan of care going forward.On (b)(6) 2020, the patient went in for a clinic visit.Review of the patient's systems were positive of the following symptoms: - abdominal pain.- prolapse uterus.- anxiety, depression.- back pain.- seasonal allergies.- dyspareunia, history of abnormal pap smear.Surgery has been offered to the patient for a removal of the previous solyx sling mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, as well as removal of anchors from obturators and adductors.The patient was extensively counseled that even with removal of her mesh that she may continue to have pain and there is no guarantee that she will be pain free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.It was also discussed that after partial removals, it can be difficult to find the mesh and it is a possibility that the mesh may not be found.The patient has been counseled on the risks and benefits of surgery, alternate approaches, and procedures as well as complications which include but are not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2020, the patient underwent a sling removal, urethral lysis, anterior colporrhaphy, vaginal paravaginal and removal of mesh anchor from obturator internus muscle for the treatment of vaginal pain, pain with intercourse, foreign material in vaginal and in the pelvic muscles.The patient was taken to the operating room and placed on the operating room table in comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for abdominal-vaginal surgery.The foley was inserted and noted to be draining clear yellow urine.The anterior vaginal wall was grasped with two allis clamps and opened.The sling mesh was noted to be missing in the midline from previous surgical removal.The scar tissue and cystocele were dissected cephalad, caudad and laterally.A urethral lysis was performed using sharp dissection to further free the scar tissue and located the mesh lateral to the urethra.The mesh was identified after developing the paravaginal space that was opened for exposure, bilaterally.On the right the dissection identified the mesh and the trajectory, and an incision was made into the obturator intern us muscle and the anchor were freed from the scar tissue on the right.The mesh and anchor were removed, on the patients left the remaining arm.Was much deeper.This dissection on the left was more difficult and tedious in the obturator internus muscle.The remaining mesh was freed and with traction the attachment points on the anchor was identified, the obturator muscle was incised and with sharp dissection and the anchor on the left was freed.Both anchors were removed as well as the remaining mesh.The anterior vaginal wall was closed with a running locked layer 2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

H6 device code a1502 (positioning problem) added to capture the sling placed very close to the bladder.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the first mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Block h6: patient code of e1405, e1715, e1310, e2326, e020202, e2101, e2330, e2006 capture the reportable events of dyspareunia, scar tissue, urinary tract infection, inflammation, depression, adhesions, pain and erosion.Impact code of f1905, f1903 and f2303 captures the removal portions of the mesh, complete mesh explantation and medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

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) 2019.The patient has experienced an unspecified injury and underwent surgeries on (b)(6) 2020 and (b)(6) 2020 to remove portions of the mesh.Boston scientific has received an additional information on 23mar2022 as follows: medical history included mixed urinary incontinence with a strong stress urinary incontinence component.On (b)(6) 2019, the patient was implanted with a solyx sis device during a mid-urethral sling insertion, myosure polypectomy and diagnostic cystoscopy procedure for the treatment of endometrial polyps, abnormal uterine bleeding, and stress urinary incontinence.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in a stable condition.On (b)(6) 2019, the patient sought for a second opinion about her prolapse.The patient is status post endometrial polyp and mid-urethral sling placement.The patient also reports that she had urinary tract infection symptoms and is in the clinic seeking for relief.Findings of physical examination of the patient's genitourinary system are as follows: stage 1-2 distal rectocele however vaginal curve is reasonable and levator muscle are intact; the uterus is 10-week size slightly bulky; mid-urethral area there is palpable band of sling which is superficial; there is no evidence of mesh erosion; the left junction of sling to the left rami is very tender to palpation; there is stage 1 uterine prolapse; no urethral hypermobility; repeated exam in standing position and there is no evidence of pelvic organ prolapse; only stage 1 uterine prolapse and stage 1 rectocele.Urinalysis showed a trace of leukocytes, and a urine culture was submitted.The diagnoses included disorder of muscle unspecified and pelvic floor dysfunction.The patient was prescribed gabapentin.However, if pain gets worse despite taking gabapentin, the patient may have to consider removal of mid-urethral sling.On (b)(6) 2019, the patient underwent removal of vaginal mesh, lysis of vaginal adhesions and cystoscopy procedure for the treatment of pelvic pain and pelvic floor dysfunction status post sling placement.Intraoperative findings revealed that the sling had been placed very close to the bladder neck.On the left side of the urethra, the sling was more superficial and closer to the vaginal epithelium.There was dense scarring on the left side of the patient with more adhesions to the left ischiopubic rami.There was evidence of mild urethral hypermobility.The cervix was within normal limits.There was no evidence of pelvic organ prolapse except for mild stage 1 cystocele and ureterocele and stage 1 rectocele.On (b)(6) 2020, the patient had self-referred for physical therapy after undergoing two surgeries that includes polyp removal with a sling placement that caused her to have a severe pelvic pain and bladder dysfunction.Patient's current complaint are as follows: vaginal tension and discomfort; urinary tract infection and irritated vagina.; still feels like a twinge of nerve sensation that shoots to her vagina; avoids sex ; cannot do vigorous activity.According to the patient, the surgeon came to her pre-op bed and requested a permission to perform a sling despite that fact that she was given no previous information or testing to determine if it was medically necessary.The second procedure was performed by a different surgeon who told her that the sling was placed without a cause and in fact, she did not have a prolapse.After the mesh removal, the patient is still had a left sided pelvic pain where the second surgeon reportedly said the suture was incorrectly placed.Additionally, the patient's exam revealed a significant for left sided pelvic floor muscle (pfm) pain and tenderness and positive for a q-tip test along the distribution of the perineal nerve.The goals of physical therapy were noted as reduction in pelvic floor spasm and pain to 1/10, > 80% of the time; eliminate bladder urgency completely and eliminate sensation of uti> 80%; and eliminate vaginal irritation and tenderness along the labia minora >80%.On (b)(6) 2020, the patient went for a consultation on chronic pain following the insertion and removal of bladder sling.The patient still reports severe pain on the left side of the vagina and pelvic wall and is very worried about the status of her prolapse.She was informed that it was a stage 1, but she is very worried that it is getting worse.The patient is taking diazepam suppositories and a topical cream with gabapentin as well as cbd cream for the external pelvis.After the most recent re-assessment of the patient, she was informed that while her pain was still sharp and severe, the therapist did not feel any restrictions in the tissues or spasm or trigger points.Her pelvic floor muscle function appears good, but the therapist feels a difference in muscle bulk i.E., atrophy on the left side which may be a contributing factor on the continuation of the nerve like sensations of pain that the patient is still experiencing.The therapist will consult with dr.Howell and come back to the with an updated plan of care going forward.On (b)(6) 2020, the patient went in for a clinic visit.She reported continued left-sided vaginal pain that was severe and chronic, uti symptoms starting 2 weeks post-op, tension and pulling sensations in the pelvic area, and dyspareunia that prevented her from having intercourse.Review of the patient's systems were positive of the following symptoms: abdominal pain; prolapse uterus; anxiety, depression; back pain; seasonal allergies; dyspareunia, history of abnormal pap smear.Exam revealed pain at the obturator internus muscle (l>>r), and severe pain upon palpation of mesh and mesh anchors.The assessment was mesh complication, left thigh pain, pelvic and perineal pain, and introital dyspareunia.Surgery has been offered to the patient for a removal of the previous solyx sling mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, as well as removal of anchors from obturators and adductors.The patient was extensively counseled that even with removal of her mesh that she may continue to have pain and there is no guarantee that she will be pain free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.It was also discussed that after partial removals, it can be difficult to find the mesh and it is a possibility that the mesh may not be found.The patient has been counseled on the risks and benefits of surgery, alternate approaches, and procedures as well as complications which include but are not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2020, the patient underwent a sling removal, urethral lysis, anterior colporrhaphy, vaginal paravaginal and removal of mesh anchor from obturator internus muscle for the treatment of vaginal pain, pain with intercourse, foreign material in vagina and in the pelvic muscles.The patient was taken to the operating room and placed on the operating room table in comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for abdominal-vaginal surgery.The foley was inserted and noted to be draining clear yellow urine.The anterior vaginal wall was grasped with two allis clamps and opened.The sling mesh was noted to be missing in the midline from previous surgical removal.The scar tissue and cystocele were dissected cephalad, caudad and laterally.A urethral lysis was performed using sharp dissection to further free the scar tissue and located the mesh lateral to the urethra.The mesh was identified after developing the paravaginal space that was opened for exposure, bilaterally.On the right the dissection identified the mesh and the trajectory, and an incision was made into the obturator internus muscle and the anchor were freed from the scar tissue on the right.The mesh and anchor were removed.On the patients left the remaining arm was much deeper.This dissection on the left was more difficult and tedious in the obturator internus muscle.The remaining mesh was freed and with traction the attachment points on the anchor was identified, the obturator muscle was incised and with sharp dissection and the anchor on the left was freed.Both anchors were removed as well as the remaining mesh.The anterior vaginal wall was closed with a running locked layer 2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.Pathology of the excised mesh noted fibromuscular tissue with embedded surgical material and accompanying lymph histiocytic inflammation.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12244880
• MDR Text Key: 264049175
• Report Number: 3005099803-2021-03750
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0023140994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female