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

Model Number M0068507000

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 was implanted on (b)(6)2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh).Back pain, vaginal pain, pelvic pain,groin pain, anal pain, and thigh pain.Other pain: pain down front of legs,painful intercourse,inability to have intercourse,difficulties with bowel motions,recurrent incontinence,aggravated incontinence,damage, and psychiatric injury.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: partial removal to be able to pass urine - pain and obstructive voiding.Nonsurgical treatments: on (b)(6)2017 the patient commenced pain medication: lyrica - twice a day for the treatment of: nerve pain.Treatment duration: 4 years.On (b)(6) 2011 the patient commenced psychological medication: fluoxetine for the treatment of: anxiety and depression.Treatment duration: 10 years.On (b)(6) 2017 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises.Treatment duration: 2 attendances.On (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): vagifem pessary for the treatment of: keep lubricated and helps with pain.Treatment duration: 5 years.On (b)(6) 2020 the patient commenced other (please specify) for the treatment of: extreme pain following intercourse in (b)(6)2020.Treatment duration: few months.On (b)(6)2017 the patient commenced pain medication: amitriptyline - at night for the treatment of: nerve pain.Treatment duration: 4 years.On (b)(6)2016 the patient commenced pain medication: panadeine forte for the treatment of: pain - didn't work.Treatment duration: not using as much (replaced with panadeine extra).On (b)(6) 2021 the patient commenced pain medication: panadeine extra - at night if needed for the treatment of: pain.Treatment duration: 2-3 months.On (b)(6)2017 the patient commenced pain medication: celebrex for the treatment of: pain.Treatment duration: 4 years - on and off now.On (b)(6) 2017 the patient commenced pain medication: lignocaine gel (internally) for the treatment of: pain.Treatment duration: 4 years.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: mesh treatment.Treatment duration: 5 months.On (b)(6)2020 the patient commenced other (please specify) for the treatment of: use on right side of buttock - helps with nerve pain, now uses with internal probe as per charlotte burton recommendation.Treatment duration: few months.

Manufacturer Narrative

Block a1: (b)(6).Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6); (b)(6) hospital.Mesh excision surgeon ((b)(6) 2019): dr.(b)(6).Block h6: the following patient codes capture the reportable events of: e1715 - scarring; e2006 - erosion; e0206 - psychiatric injury; e2328 - obstructed voiding; e2330 - pain; e1309 - urinary retention; e1309 - inability to have sexual activity; e2401 - "damage" the following impact codes capture the reportable events of: f1905: mesh excision; f2303 - medications; f12 has been used in the light of the patient seeking legal recourse for complications related to the device.

Event Description

It was reported to boston scientific corporation that a solyx was implanted on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; thigh pain; other pain: pain down front of legs; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: partial removal to be able to pass urine - pain and obstructive voiding.Nonsurgical treatments: on may 1, 2017 the patient commenced pain medication: lyrica - twice a day for the treatment of: nerve pain.Treatment duration: 4 years.On (b)(6) 2011 the patient commenced psychological medication: fluoxetine for the treatment of: anxiety and depression.Treatment duration: 10 years.On (b)(6) 2017 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor exercises.Treatment duration: 2 attendances.On (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): vagifem pessary for the treatment of: keep lubricated and helps with pain.Treatment duration: 5 years.On (b)(6) 2020 the patient commenced other (please specify) for the treatment of: extreme pain following intercourse in october 2020.Treatment duration: few months.On may 1, 2017 the patient commenced pain medication: amitriptyline - at night for the treatment of: nerve pain.Treatment duration: 4 years.On (b)(6) 2016 the patient commenced pain medication: panadeine forte for the treatment of: pain - didn't work.Treatment duration: not using as much (replaced with panadeine extra).On (b)(6) 2021 the patient commenced pain medication: panadeine extra - at night if needed for the treatment of: pain.Treatment duration: 2-3 months.On may 1, 2017 the patient commenced pain medication: celebrex for the treatment of: pain.Treatment duration: 4 years - on and off now.On may 1, 2017 the patient commenced pain medication: lignocaine gel (internally) for the treatment of: pain.Treatment duration: 4 years.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: mesh treatment.Treatment duration: 5 months.On october 1, 2020 the patient commenced other (please specify) for the treatment of: use on right side of buttock - helps with nerve pain, now uses with internal probe as per charlotte burton recommendation.Treatment duration: few months.**additional information received on october 13, 2022: on (b)(6) 2016, the patient was implanted with a solyx device during anterior and posterior vaginal repair, insertion of midurethral sling and cystoscopy procedure for the treatment of stress urinary incontinence and vaginal prolapse.On (b)(6) 2019, the patient underwent division and excision of midurethral sling, anterior repair and cystoscopy procedures to treat her obstructed voiding and grade 3 cystocele.The sling was found at region of midurethra, was divided and dissected as far laterally as possible.Her operative findings at that time included grade 3 cystocele and scarring.

• 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: 12930608
• MDR Text Key: 286855475
• Report Number: 3005099803-2021-06999
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: 07/25/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019515525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 85 KG