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

Model Number M0068507001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Localized Skin Lesion (4542); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/06/2018

Event Type  Injury  

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) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2012, implant 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).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information: blocks a2: date of birth, b2, b3, b5, b7, h6: patient and impact codes.Correction to block g2: report source.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following patient codes capture the reported events below: e1405 - dyspareunia, e1301 - dysuria, e232401 - fecal incontinence , e1906 - vaginal infections, e1310 - urinary tract infection, e0123 - pudendal neuralgia, e1710 - skin lesion, e2006 - extrusion, e2330 - pain.The following impact codes capture the events below: f1901 - leep (loop electrosurgical excision procedure), vulvar biopsy and excision of vulvar lesion, f23 - bactrim, f1905 - sling excision/revision, f1202 - patient cannot work secondary to pain.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 problem 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) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.*additional information received on june 8, 2022: on (b)(6), 2012, the patient was diagnosed with grade 2 cystocele or anterior defect and stress urinary incontinence, and underwent anterior repair and transvaginal tape via obturator approach with solyx midurethral sling system.The procedure was completed with no complications.On (b)(6), 2018, the patient reported that she has had a bladder "tie up," and her boyfriend felt the mesh.She complained of noticing mesh in her vagina from her bladder surgery.It was causing pain in the vagina much worse with intercourse.She had a mirena until two years ago.She was having a small amount of vaginal discharge for about a week but she has been feeling the mesh for a couple of months.The patient reported a lot stress and urge incontinence.On physical exam, the mesh was palpable though very thin vaginal mucosa near the introitus on the patient's left side.No exposed mesh was noted.Assessment at that time included vaginal mucosa thinned over the bladder mesh (postmenopausal atrophic vaginitis) for which the patient was recommended premarin vaginal cream and return to clinic in (b)(6) 2018.On (b)(6) 2018, she presented for a follow-up on her vaginal pain.She reported that she was still feeling the exposed mesh, but the premarin vaginal cream was helping.However, she has not been sexually active.On vaginal exam, there was still exposed mesh noted.On (b)(6) 2020, the patient presented for a follow-up on her bladder mesh erosion.She had a leep (loop electrosurgical excision procedure) in 2014.The patient reported that she could feel the mesh when sitting.She also reported bladder prolapse which was then similar to what it was before her surgery, urge incontinence and stress urinary incontinence.She wore pad daily.She thinks that she can empty properly, but after going to the bathroom, she will often need to go again within five minutes.On physical exam: genitourinary: urinary frequency and urgency; incontinence, sexual: dyspareunia.Female genitalia: raised lesion on the perineum, vagina: stage 1 cystocele and rectocele.Mesh erosion noted on the right side.It was also palpable, but not visible inferior to the urethral meatus.On the left the vaginal mucosa, overlying the mesh was very thin (previously noted).Assessment included: mesh erosion/mixed urinary incontinence, vulvar lesion for which the patient had a vulvar biopsy.Results showed condyloma at the vaginal opening.Difficulty passing urine.On (b)(6), 2020, the patient complained of mesh erosion, stress incontinence, urge incontinence, nocturia, fecal incontinence, daily pain, vaginal infections and urinary tract infections.She recently had intercourse with pain.The patient is diabetic and her last hemoglobin a1c was 10%.Physical exam of the bladder showed the urethra was tender to palpation, atrophic vagina, and 2 buttocks lesions that appeared excoriated and possibly secondarily infected.Mesh was exposed through right peri-urethral sulcus and superficial mesh left periurethral sulcus.Assessments included: 1.Urinary incontinence for which the patient was advised to start premarin vaginal cream with applicator intravaginally once a day (in the evening).2.Mixed incontinence for which treatment options were discussed.These included physical therapy, pessary and surgical correction for stress incontinence.Medical options were ptns (percutaneous tibial nerve stimulation), interstim and botox for urge incontinence.Patient desired for removal of mesh sling as soon as possible due to pain.Patient was advised to take metformin regularly and minimize smoking in order to help healing.Urinalysis and urine culture were submitted.3.Nocturia 4.Frequency of micturition 5.Skin lesion for which the patient was prescribed bactrim.6.Vulvar lesion.Obtained biopsy result-condyloma for which the patient agreed to have a removal surgery.7.Rectocele noted as asymptomatic.On (b)(6), 2020, the patient underwent sling excision, cystoscopy and excision of vulvar lesion-condyloma procedure.Pre and postoperative diagnoses included mesh erosion and vulvar lesion.Findings noted at that time were mesh erosion in right periurethral area; left periurethral mesh was superficial and palpable through the mucosa.The mesh was excised from the right and left periurethral sulci.Cystoscopy was normal.On (b)(6) 2021, the patient presented for evaluation of vaginal pain, groin pain and pudendal neuralgia.Her symptoms were unchanged and worse than before.The patient was under the impression that most of the mesh had been removed during her mesh revision in 2020.However, the physician noted that it was only a very small portion.The patient feels that her sui is worse since that procedure.She continued with vaginal groin and thigh pain.Patient also has some sitting pain.Patient cannot have any sexual activity and cannot work secondary to pain.Physical exam revealed positive skin rolling sensitivity, positive point tenderness along the inferior pubic rami, bilateral sacrospinous ligament complexes were moderately tender, and the mesh was exquisitely tender with bilateral mesh exposure.Impression based on her physical exam: vaginal pain with mesh erosion with evidence of both pudendal and obturator neuralgia.Plan: the patient could consider having the vaginal portion of the mesh removed.If she has persistent symptoms, the physician could then pursue trying to have the surgery done for the groin exploration with mesh excision.The other option is to wait until she has insurance coverage that will allow her to have the procedure with the same physician.In that case, total mesh excision will be performed.

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) 2012.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on june 8, 2022: on (b)(6) 2012, the patient was diagnosed with grade 2 cystocele or anterior defect and stress urinary incontinence, and underwent anterior repair and transvaginal tape via obturator approach with solyx midurethral sling system.The procedure was completed with no complications.On (b)(6) 2018, the patient reported that she has had a bladder "tie up," and her boyfriend felt the mesh.She complained of noticing mesh in her vagina from her bladder surgery.It was causing pain in the vagina much worse with intercourse.She had a mirena until two years ago.She was having a small amount of vaginal discharge for about a week but she has been feeling the mesh for a couple of months.The patient reported a lot stress and urge incontinence.On physical exam, the mesh was palpable though very thin vaginal mucosa near the introitus on the patient's left side.No exposed mesh was noted.Assessment at that time included vaginal mucosa thinned over the bladder mesh (postmenopausal atrophic vaginitis) for which the patient was recommended premarin vaginal cream and return to clinic in (b)(6) 2018.On (b)(6) 2018, she presented for a follow-up on her vaginal pain.She reported that she was still feeling the exposed mesh, but the premarin vaginal cream was helping.However, she has not been sexually active.On vaginal exam, there was still exposed mesh noted.On (b)(6) 2020, the patient presented for a follow-up on her bladder mesh erosion.She had a leep (loop electrosurgical excision procedure) in 2014.The patient reported that she could feel the mesh when sitting.She also reported bladder prolapse which was then similar to what it was before her surgery, urge incontinence and stress urinary incontinence.She wore pad daily.She thinks that she can empty properly, but after going to the bathroom, she will often need to go again within five minutes.On physical exam: genitourinary: urinary frequency and urgency; incontinence.Sexual: dyspareunia.Female genitalia: raised lesion on the perineum.Vagina: stage 1 cystocele and rectocele.Mesh erosion noted on the right side.It was also palpable, but not visible inferior to the urethral meatus.On the left the vaginal mucosa, overlying the mesh was very thin (previously noted).Assessment included: mesh erosion/mixed urinary incontinence.Vulvar lesion for which the patient had a vulvar biopsy.Results showed condyloma at the vaginal opening.Difficulty passing urine.On (b)(6) 2020, the patient complained of mesh erosion, stress incontinence, urge incontinence, nocturia, fecal incontinence, daily pain, vaginal infections and urinary tract infections.She recently had intercourse with pain.The patient is diabetic and her last hemoglobin a1c was 10%.Physical exam of the bladder showed the urethra was tender to palpation, atrophic vagina, and 2 buttocks lesions that appeared excoriated and possibly secondarily infected.Mesh was exposed through right peri-urethral sulcus and superficial mesh left periurethral sulcus.Assessments included: 1.Urinary incontinence for which the patient was advised to start premarin vaginal cream with applicator intravaginally once a day (in the evening).2.Mixed incontinence for which treatment options were discussed.These included physical therapy, pessary and surgical correction for stress incontinence.Medical options were ptns (percutaneous tibial nerve stimulation), interstim and botox for urge incontinence.Patient desired for removal of mesh sling as soon as possible due to pain.Patient was advised to take metformin regularly and minimize smoking in order to help healing.Urinalysis and urine culture were submitted.3.Nocturia.4.Frequency of micturition.5.Skin lesion for which the patient was prescribed bactrim.6.Vulvar lesion.Obtained biopsy result-condyloma for which the patient agreed to have a removal surgery.7.Rectocele noted as asymptomatic.On (b)(6) 2020, the patient underwent sling excision, cystoscopy and excision of vulvar lesion-condyloma procedure.Pre and postoperative diagnoses included mesh erosion and vulvar lesion.Findings noted at that time were mesh erosion in right periurethral area; left periurethral mesh was superficial and palpable through the mucosa.The mesh was excised from the right and left periurethral sulci.Cystoscopy was normal.On (b)(6) 2021, the patient presented for evaluation of vaginal pain, groin pain and pudendal neuralgia.Her symptoms were unchanged and worse than before.The patient was under the impression that most of the mesh had been removed during her mesh revision in 2020.However, the physician noted that it was only a very small portion.The patient feels that her sui is worse since that procedure.She continued with vaginal groin and thigh pain.Patient also has some sitting pain.Patient cannot have any sexual activity and cannot work secondary to pain.Physical exam revealed positive skin rolling sensitivity, positive point tenderness along the inferior pubic rami, bilateral sacrospinous ligament complexes were moderately tender, and the mesh was exquisitely tender with bilateral mesh exposure.Impression based on her physical exam: vaginal pain with mesh erosion with evidence of both pudendal and obturator neuralgia.Plan: the patient could consider having the vaginal portion of the mesh removed.If she has persistent symptoms, the physician could then pursue trying to have the surgery done for the groin exploration with mesh excision.The other option is to wait until she has insurance coverage that will allow her to have the procedure with the same physician.In that case, total mesh excision will be performed.Additional information received on august 8, 2022.An office visit on (b)(6) 2021, the patient reported to have developed pain as well as urinary dysfunction.Continued with pain especially in the groin and thigh area despite mesh excision in (b)(6) 2020.She also reported urinary frequency with slow voiding and also with some dysuria (improved since mesh excision).

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following patient codes capture the reported events below: e1405 - dyspareunia, e1301 - dysuria, e232401 - fecal incontinence, e1906 - vaginal infections, e1310 - urinary tract infection, e0123 - pudendal neuralgia, e1710 - skin lesion, e2006 - extrusion, e2330 - pain, e1309 - slow voiding, e1311 - urinary dysfunction.The following impact codes capture the events below: f1901 - leep (loop electrosurgical excision procedure), vulvar biopsy and excision of vulvar lesion, f23 - bactrim, f1905 - sling excision/revision, f1202 - patient cannot work secondary to pain.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12881624
• MDR Text Key: 281314504
• Report Number: 3005099803-2021-06042
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: ML00000384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 06/08/2022; 08/08/2022
• Supplement Dates FDA Received: 07/05/2022; 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female