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); Abscess (1690); Anemia (1706); Autoimmune Disorder (1732); Bacterial Infection (1735); Erosion (1750); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Headache (1880); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Tinnitus (2103); Vomiting (2144); Hot Flashes/Flushes (2153); Chills (2191); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Disability (2371); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Sleep Dysfunction (2517); Cognitive Changes (2551); Bronchospasm (2598); Weight Changes (2607); Dysuria (2684); Fibrosis (3167); Unspecified Heart Problem (4454); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, (implant date), as no event date was reported.This event was reported by the patient's legal representation.Patient's additional lawyer: (b)(6).Surgeon: (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.

Event Description

It was reported to boston scientific corporation that a solyx sling device was implanted into the patient on (b)(6) 2016.As per reported by the patient's attorney, since the implantation of the mesh, the patient has suffered dyspareunia, severe pain, further urinary problems, and infections.The patient also claims to have suffered mental anguish, physical impairment and medical care expenses.

Event Description

It was reported to boston scientific corporation that a solyx sling device was implanted into the patient on (b)(6) 2016.As per reported by the patient's attorney, since the implantation of the mesh, the patient has suffered dyspareunia, severe pain, further urinary problems, and infections.The patient also claims to have suffered mental anguish, physical impairment and medical care expenses.Additional information received on april 10, 2023.It was reported to boston scientific corporation that a solyx sling system device was implanted into the patient during a cystoscopy + transobturator tape procedure performed on (b)(6) 2016 due to stress urinary incontinence.The patient was awakened, extubated and brought to the recovery room in satisfactory condition.On (b)(6) 2019, patient had an office visit for urge incontinence.She came for urogynecologic evaluation.Patient claimed to have experienced dyspareunia, urgency, frequency, nocturia, pain with full bladder and pain relief after bladder emptying at times, urine leakage.She described pain as sharp, stabbing, throbbing and worse after a pelvic exam.Her pelvic floor symptoms have become increasingly bothersome and negatively impacting her quality of life.She had pelvic pain since her transobturator sling in (b)(6) 2016.She was evaluated in nyc and diagnosed with mast cell activation syndrome and would like the sling removed.The patient also developed worsening tinnitus but is unsure whether this was due to ivf treatments or foreign mesh material.Assessments: 1.Mixed incontinence.2.Other specified complications due to other genitourinary prosthetic materials.3.Pelvic and perineal pain.Treatment: mixed incontinence - imaging: uroflow equivocal.Pelvic and perineal pain - imaging: pelvis ultrasound and transvaginal ultrasound a pelvic ultrasound performed on (b)(6) 2019 showed a right ovarian cyst.On (b)(6) 2019, patient presented for mesh problems.She previously had leakage of urine when running and leakage was improved with sling placement.She did report some recent urge symptoms.The symptoms began 3 years ago.The symptoms were reported as being moderate and occurred constantly.She stated that the symptoms were chronic and uncontrollable.She complained of primarily left groin pain but still had right sided groin pain.Pain was radiating down the back of both legs and into lower back bilaterally.Patient not currently sexually active but denies severe dyspareunia.Review of systems: review of systems was positive for chills, fatigue, fever, night sweats, weight gain, weight loss, hearing loss, sinus pressure, dyspnea, wheezing, chest pain, palpitations, nocturia, prolapsed uterus, stress incontinence, urge incontinence, urgency, dizziness, headache, memory impairment, numbness in extremity, abdominal pain, diarrhea, fecal incontinence, nausea, vomiting, anxiety, depression, insomnia.Patient indicated fecal incontinence is solid.Patient was also positive for back pain, joint pain, muscle weakness.On (b)(6) 2019, patient had the entire solyx and both anchors removed during a sling revision, urethral lysis, anterior colporrhaphy, vaginal paravaginal, and removal of mesh anchor from obturator internus muscle procedure.A urethral lysis was performed using sharp dissection to further free the scar tissue and the mesh from the urethra.It was noted that the left arm of the mesh was extremely deep in the obturator internus muscle and the dissection on this side was difficult.Per the physician, the patient tolerated the procedure well and was transferred to the recovery room in excellent condition.Pathology reported fibrous tissue with giant cell reaction to foreign material.After the mesh removal procedure, the patient was evaluated by cardiology on (b)(6) 2019.The patient felt dizzy upon walking and reported intermittent heart palpitations post procedure.She denied chest pain or syncope.The patient did not believe this was related to the procedure.The physician assessed that the patient had post op anemia and hypotension.The clinical note noted that patient had eroded bladder suspension mesh.Office visit on (b)(6) 2019 reported a hospital follow up for post surgical abdominal hematoma.Patient stated that she was in pain and controlling it with tylenol and cbd, cannabidiol oil.She also stated she was tolerating zosyn.Patient had complicated pelvic surgery and removal of the mesh.She was admitted with lower abdominal pain and found a fluid collection anterior to the bladder which was about 7.8 x 9.2 cm.She underwent ct guided aspiration of the fluid and culture did grow enterococcus faecalis.She had been on zosyn for the last more than 10 days.She was also complaining of pain and discomfort during urination and bowel movement and urine analysis showed pyuria and bacteriuria, but culture came back negative.Her repeat ct scan shows slight decrease of size of complex mass with air fluid presence.Review of system: gu: reported dysuria and polyuria.Assessment: 1.Hematoma.2.Pelvic abscess.3.Long term use of antibiotics.On (b)(6) 2023, patient had a phone consultation and stated she had hematoma on top of the bladder, size of a tennis ball and was painful.A ct scan found the hematoma had enlarged to a size larger than her bladder.Patient showed some sign of infection.Mesh was also reported to be clearly out of place, dominantly in the left lower quadrant.Per patient account dated (b)(6) 2023, she was diagnosed with incurable autoimmune disease, removal surgery nearly killed her, and she lost half the blood in her body.She reports she had a large hematoma that was infected with enterococcus and was on iv antibiotics for weeks along with a drain in her stomach.

Manufacturer Narrative

Blocks a1, a2, a4, b5, b6, b7, d6b, e1 below, e4 and h6 patient codes and impact codes have been updated based on the additional information received on april 10, 2023.Block b3 date of event: date of event was approximated to august 19, 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Patient's additional lawyer: (b)(6).Implant surgeon: (b)(6).Explant surgeon: dr.(b)(6).Block g2: report source.Voluntary user medwatch number mw516333.Block h6: imdrf patient codes e2006, e2330, e1002, e1405, e0402, e1906, e2328, e172001, e1301, e1715, e232401, e1621, e2401, e0127, e2313, e1901, e0401 and e0505 capture the reportable events of eroded bladder suspension mesh; pain; abdominal pain; dyspareunia, mast cell activation syndrome; hematoma on top of the bladder; infection, pus in urine; urethral lysis; discomfort during urination; scar tissue; fecal incontinence; muscle weakness; other specified complications due to other genitourinary prosthetic materials, autoimmune issues, numbness, fibrosis, bacterial infection and hematoma.Imdrf impact codes f1203, f1903 and f1901 capture the reportable events of life threatening, entire solyx and both anchors were removed and urethral lysis.Block h11: blocks e4 and g2 have been corrected.

• 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: 9872144
• MDR Text Key: 189609670
• Report Number: 3005099803-2020-01229
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00003076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 57 KG