MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Positioning Problem (3009)

Patient Problems Fatigue (1849); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Dysuria (2684); Movement Disorder (4412); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)

Event Date 03/16/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit retropubic mid-urethral sling was implanted during an insertion of retropubic mid-urethral sling and cystoscopy procedures performed on (b)(6) 2020, to treat a patient with stress urinary incontinence confirmed urodynamically.No patient complications were reported.The patient tolerated the procedure well and was returned to the recovery room in stable condition.On (b)(6) 2021, the patient recovered well since surgery.She walked daily, though she has noticed with long walks/workouts (>1 hour), she had some discomfort at the suprapubic sites.She has no vaginal bleeding.Has seen some yellowish vaginal discharge.She has no vaginal pain.She does have some external labial pain.She has no vaginal itching.She has no incontinence episodes.She has significant nocturia and gets up "almost every hour during the day and at night." she feels she has some dribbling when she voids and does not always empty completely.The physician decided on a trial of mybetriq 50 mg/day.On (b)(6) 2021, since the patient's last visit, the patient had a burning sensation consistent with a urinary tract infection.It was particularly bothersome when she would void.She was not taking any antibiotics.In the last two days, she has felt better.She was not sure if myrbetriq was helping her overactive bladder symptoms because she had been focused on the dysuria that she was having.Urinalysis performed this day was positive for leukocyte esterase.She did have a uti that was treated with macrobid.On (b)(6) 2021, the patient reported a constellation of symptoms that made her feel worse than before her stress incontinence surgery.She was complaining of significant urinary frequency and urgency.She took myrbetriq 50 mg daily for about four months, which did not help her.She recently stopped it.She was also complaining of a slow and intermittent urinary stream.Finally, she was having postvoid dribbling, which was quite bothersome.She also has an occasional leak associated with postvoid dribbling if she bends in a certain direction.Overall, she was very unhappy with the symptoms.An additional sign that she had was pain which she attributed to myrbetriq.It was vaginal pain which a bowel movement can trigger.It was pretty uncomfortable and sometimes made it difficult for her to sit.She stopped myrbetriq about ten days ago, but the pain persisted.The physician explained to the patient that her overactive bladder symptoms and postvoid dribbling could be due to the sling that may be too tight.If that was the problem, loosening the sling will often relieve those symptoms.There was a risk, however, of recurrent stress incontinence.It did not sound like she was having significant stress incontinence now.Concerning the pain that she was having, the physician told her that she was a bit more uncertain as to its cause, and it was difficult for the physician to make a diagnosis without examining her.The physician told her he thought it was unlikely related to myrbetriq.She discussed possibly treating that vaginal discomfort with estrogen cream; the physician said it was a good idea.It was also possible that it could positively impact her other symptoms.The physician suggested that due to her degree of bother, they considered urodynamic testing to make a more specific diagnosis.She was not averse to doing that but would like to give estrogen cream a trial 1st.Since she was coming from a long distance, they decided on the following regimen: the patient will use vaginal estrogen daily for two weeks, followed by twice weekly.After six weeks, if there is no significant improvement, she will come to ucla for a physical examination and video urodynamics.On (b)(6) 2021, the patient did not improve using vaginal estrogen and was scheduled to come to ucla for uds but could not make it and canceled her appointment.Speaking with her today, she has been having increasing vaginal pain - a stabbing sensation that she feels was related to the sling.She had persistent frequency, urgency, and occasional (2 times) high-volume uui.The physician explained to the patient that he was concerned about obstruction from her sling.In addition, the sling may be responsible for pain.She wanted to work towards sling removal if appropriate.They decided she would come to ucla for an exam, cystoscopy (to rule out erosion), vuds, and possible sling revision or removal the following day.They spoke about the pros and cons of revision versus complete removal, and they would make that decision before surgery.In the meantime, she was in severe pain and had a superimposed uti.The physician gave her a limited supply of oxycodone for her acute pain (12 tabs).She was on nitrofurantoin.They will schedule the above.The patient was satisfied with the plan.On (b)(6) 2021, the patient was seen and examined for an annual examination to discuss the problems with her procedure on (b)(6) 2020 (sling, cystoscopy).The patient reported that she was experiencing continuing pain.It wasn't easy to sit, walk, wipe, and sleep.The patient would like to have it removed.She was also requesting a referral in arizona.The patient was also experiencing depression and was previously taking sertraline, which was ineffective.She stopped taking it alone and would like to try a new medication now.On (b)(6) 2022, the patient was seen and examined for a possible urinary tract infection (uti) due to a mesh sling that will be removed soon.The patient was last treated with antibiotics six months ago.She stated that she was treated with azo one month ago without antibiotics.Frequency and burning are ongoing due to bladder mesh.The patient also complained of fatigue and frequent and painful urination.Upon examination, the patient also experienced lower back pain.As part of the physician's plan, the patient was started with nitrofurantoin monohyd macro capsule, 100 mg, one capsule with food, orally, bid, five day(s), 10 capsules for uti.For her lower back pain, the patient was prescribed gabapentin capsule, 300 mg, one capsule, orally, once a day, 30 days (s) 30.The patient's urinalysis result revealed the following: protein: 100 mg/ dl.Ketones: negative.Leukocytes: large.Nitrates: positive.Ph: 6.5.Spec gravity: 1.030.Glucose: negative.Blood: moderate.Bilirubin: negative.Urobili: 0.2 e.U /dl.The patient was expected for a follow-up in two to three days or as needed if symptoms did not improve.On (b)(6) 2022, the patient was seen and examined for severe recurrent major depression without psychotic features (hcc) - stable.The patient was not on sertraline and would not like to be on medication.The patient took this medication for two months, and she felt the medication did not help.She did not follow up to increase her dose.The patient was agreeable to monitoring and would notify the physician if she felt she needed more help.The patient was instructed to return in about four weeks (around (b)(6) 2022), or if symptoms worsen or fail to improve, for a lab review.On (b)(6) 2022, the patient sent correspondence to her physician requesting a prescription to calm her down.The patient stated, "very small and nonsense things trigger me, and i get pissed off.I haven't had one good night's sleep for over a year.I am surprised by how well i can physically function during the day, but my mental health is seriously messed up.I am physically shaking; i feel my heart is going to jump out of my chest.I cannot stand this." her physician responded that he needed to see her for a visit or a video visit to discuss her symptoms.The patient agreed and moved forward with the appointment.On (b)(6) 2022, the patient was seen and examined for follow-up and lab review.In the physician's assessment, the patient is experiencing a chronic or worsening feeling of sadness, chronic or worsening nervousness, severe recurrent major depression without psychotic features (hcc) - chronic/worsening, and chronic or worsening anxiety.The patient was counseled at length regarding the back box warning for the increased incidence of suicide among people starting antidepressants and the need to continue therapy for at least a year if successful in reducing the chance of recurrence.They also discussed the full effects of antidepressants felt by 6-8 weeks of therapy.The patient verbally affirmed that she would stop the medication and contact the physician immediately if she began to feel physically or mentally unwell.The patient also acknowledged that if she has been taking the medication for over a month and decides to stop, the dose should be slowly tapered and not stopped immediately.The patient was also provided the information for support services.The patient was instructed to return in about four weeks (around (b)(6) 2022), or if symptoms worsen or fail to improve, for depression and anxiety.On (b)(6) 2022, the patient sent a communication requesting a possible hospital admission for thorough testing due to pain.The patient verbalized, "the mesh is causing me so much pain i am bent while walking; my back is all messed up, and constant pain and flare-ups do not go away.I also have arthritis in my legs, knees, hands, fingers, and ankles.My entire body hurts.I am tired of living in constant pain.".

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date when patient first sought consult post procedure due to pain, discomfort and vaginal discharge.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).(b)(6) health center.Block h6: patient code e2311 captures the reportable event of discomfort.Patient code e2330 captures the reportable event of pain.Patient code e1705 captures the reportable event of burning sensation.Patient code e0402 captures the reportable event of hypersensitivity/allergic reaction.Patient code e020201 captures the reportable event of anxiety.Patient code e1301 captures the reportable event of dysuria.Patient code e1309 captures the reportable event of urinary retention.Patient code e1310 captures the reportable event of urinary tract infection.Patient code e1401 captures the reportable event of abnormal vaginal discharge.Patient code e2326 captures the reportable event of inflammation.Patient code e0122 captures the reportable event of movement disorder.Patient code e020202 captures the reportable event of depression.Patient code e0206 captures the reportable event of unspecified mental, emotional or behavioural problem.Impact code f2303 captures the reportable event of medication required.Impact code f2203 captures the reportable event of imaging required.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

• Brand Name: ADVANTAGE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 17386380
• MDR Text Key: 319661136
• Report Number: 3005099803-2023-04005
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female