MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Micturition Urgency (1871); Unspecified Infection (1930); Nausea (1970); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Tract Infection (2120); Vomiting (2144); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 05/03/2016

Event Type  Injury  

Event Description

This manufacturer report pertains to the first of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-00678 for the associated device.It was reported to boston scientific corporation that an uphold lite and advantage system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, erosion, erosion of the bladder mesh into the bladder, infections, revision surgeries, scarring and loss of enjoyment of life.Moreover, the patient claims to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product: physical pain and mental anguish sustained in the past; physical pain and mental anguish, that in reasonable probability, patient will sustain in the future.Physical impairment sustained in the past; physical impairment that, in reasonable probability, patient will sustain in the future medical care expensed incurred in the past; and medical care expenses that, in reasonable probability, patient will occur in the future.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) united states.The following imdrf patient code capture the reportable event of: e1405 - dyspareunia.E2006 - erosion.E1715 - vaginal scarring.E2330 - chronic pain.E1906 - infections.E0206 - loss of enjoyment if life and mental anguish sustained in the past.The following imdrf impact code capture the reportable event of: f1905 - revision surgeries.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-00678 for the associated device.It was reported to boston scientific corporation that an uphold lite and advantage system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, erosion, erosion of the bladder mesh into the bladder, infections, revision surgeries, scarring and loss of enjoyment of life.Moreover, the patient claims to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product: physical pain and mental anguish sustained in the past; physical pain and mental anguish, that in reasonable probability, patient will sustain in the future.Physical impairment sustained in the past; physical impairment that, in reasonable probability, patient will sustain in the future medical care expensed incurred in the past; and medical care expenses that, in reasonable probability, patient will occur in the future.Additional information received on april 11, 2023: the patient underwent a vaginal vault suspension with uphold graft, transvaginal tape implantation, and cystoscopy procedure on (b)(6) 2016, to address vaginal vault prolapse and genuine stress urinary incontinence.The patient had a complete vaginal vault prolapse and a hypermobile urethra, which was discovered during the course of surgery.However, no complications were reported during the procedure.A cystoscopy was performed, and there was no evidence of bladder injury or perforation.

Manufacturer Narrative

Block h2: additional information blocks a2 (date of birth) and b5 (narrative) has been updated based on the additional information received on april 11, 2023.Correction: block d7a (sud reprocessed and reused) has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e1405 - dyspareunia.E2006 - erosion.E1715 - vaginal scarring.E2330 - chronic pain.E1906 - infections.E0206 - loss of enjoyment if life and mental anguish sustained in the past.The following imdrf impact code capture the reportable event of: f1905 - revision surgeries.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-00678 for the associated device.It was reported to boston scientific corporation that an uphold lite and advantage system device were implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient claims to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, erosion, erosion of the bladder mesh into the bladder, infections, revision surgeries, scarring, and loss of enjoyment of life.Moreover, the patient claims to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product: *physical pain and mental anguish sustained in the past; *physical pain and mental anguish, that in reasonable probability, patient will sustain in the future.*physical impairment sustained in the past; *physical impairment that, in reasonable probability, patient will sustain in the future *medical care expensed incurred in the past; and *medical care expenses that, in reasonable probability, patient will occur in the future.Additional information received on april 11, 2023: the patient underwent a vaginal vault suspension with uphold graft, transvaginal tape implantation, and cystoscopy procedure on may 3, 2016, to address vaginal vault prolapse and genuine stress urinary incontinence.The patient had a complete vaginal vault prolapse and a hypermobile urethra, which was discovered during the course of surgery.However, no complications were reported during the procedure.A cystoscopy was performed, and there was no evidence of bladder injury or perforation.Additional information received on september 12, 2023: on (b)(6) 2016, the patient had an abdominal sacrocolpopexy and cystoscopy.During the procedure, it was found that there was a diverticulum on the dome of the bladder, but both ureteral ostia showed adequate urine egress.No bladder injury was detected, and the patient tolerated the procedure well and was in stable condition when brought to the recovery room.The patient visited a clinic on (b)(6) 2022, complaining of urinary incontinence.During the patient's vaginal exam, a small area of mesh or permanent stitch was observed at the left apex.This area was tender on palpation with a q-tip.Although no definite erosion was detected, it is likely that there was a small exposure.Review of systems: genitourinary: the patient was positive for difficulty urinating, dyspareunia, dysuria, frequency, and urgency.Physical exam: genitourinary: the patient presented with vaginal tenderness, bilateral inguinal rashes, mesh exposure, anterior, posterior, and apical prolapse, and mild vaginal atrophy.Assessment/plan: *mixed urinary incontinence - according to the patient, this issue began in (b)(6) 2021 without any previous problems.The patient underwent two repairs for pelvic floor reconstruction using mesh in the past.The patient has been taking oxybutynin for the previous month but reported that it had not been effective.The physician discussed various treatment options, including pelvic floor therapy, medications, botulinum toxin injections, and sacral neuromodulation.Moreover, the patient does report urinary tract infections and potentially dysuria during her visit.The doctor will start by treating the patient's dysuria and send a urine sample for culture testing.If antibiotics don't alleviate her urgency and urgency incontinence due to an overactive bladder, the patient may require a cystourethroscopy to check for mesh erosion in the bladder, as she already has erosion in the vagina.Only after these steps will any further treatment be considered for her overactive bladder.*vaginal mesh exposure - according to the doctor, the patient would likely benefit from vaginal estrogen cream.However, she has a history of cervical cancer for which she had a hysterectomy 18 years ago.*stress urinary incontinence - the doctor discussed the options, including expectant management, pelvic floor muscle rehabilitation, pessary, and mid-urethral sling.*pelvic organ prolapse - the doctor discussed treatment options, including expectant management, pessary use, physical therapy, and surgery.*dysuria - the patient underwent a urinalysis during her visit, which revealed a trace of blood and large leukocytes.The patient will be empirically treated with bactrim.The treatment will likely be held off on any further workup for overactive bladder until the potential resolution of symptoms with further antibiotics.*dyspareunia and vaginal atrophy - the patient experienced discomfort during intercourse and was tender during the examination.This could be due to the mesh, mesh exposure, or significant vaginal atrophy.The doctor suggested resolving this issue with vaginal estrogen cream.However, the patient's history of cervical cancer required a pap smear, which was conducted during the visit.If the results of the pap smear are negative, the patient may proceed with vaginal estrogen cream therapy.On (b)(6) 2022, the patient underwent a cystourethroscopy due to urinary urgency, urinary frequency, urge incontinence, and a history of multiple pelvic surgeries with mesh and current vaginal mesh erosion.The findings of the procedure are as follows: *urethra: normal without strictures and without scarring.*bladder: a large bladder stone was seen in the supratrigonal left portion of the inferior bladder.This was not attached to anything as it was able to be moved with a jet of water from the cystoscope.On further inspection, directly behind the intratrigonal ridge was an area of blue mesh seen that was not coming through the bladder but was able to be seen through the transitional epithelium.On closer inspection, another small stone was seen that was unable to be mobilized with a jet of water and likely stuck to a piece of mesh that had eroded through the posterior bladder.*ureteral orifice(s) were/were seen bilateral.Ureteral orifice(s) were in the normal location, and bilateral ureteral orifices were effluxing clear urine.On (b)(6) 2022, the patient reported a sensation of "something dropping." she leaked with cough, sneezes, etc.She had urgency, frequency, and leaking with urgency.She has to urinate five times in the morning prior to work.This had been going on for four months prior to procedure.She had tried overactive bladder meds for this before (having taken oxybutynin for the month prior).She utilized pads (6-7 a day) and voided every 15 min.She cannot always empty her bladder well.Moreover, the patient stated feeling well but endorsed anxiety about the upcoming procedure.She denied fever, chills, nausea, vomiting, or recent sick contacts.Physical exam: vaginal tenderness and mesh exposure are present.Vaginal exam comments - a small area of mesh/permanent stitch was seen at the left apex.This area was tender on palpation with a q-tip.No definitive erosion was noted, but it was likely a small exposure.Assessment/plan: bladder mesh erosion.The mesh could be seen through the transitional epithelium, but there is a small bladder stone that is nonmobile, likely an area of mesh erosion.A large bladder stone is seen in the bladder on cystoscopy.They discussed options in the clinic, and the patient elected for surgery.The doctor discussed with the patient that this would likely be a large surgery where the bladder must be opened to get the mesh out.In addition, the patient underwent a cystourethroscopy with placement and subsequent removal of bilateral ureteral stents, exploratory laparotomy, removal of prostatic vaginal graft, cystotomy with removal of bladder calculus and complicated closure of cystostomy, and cystoscopy.Upon cystoscopy, bladder stones, as well as eroded mesh, were seen in the mid trigone above the injured trigonal ridge.On exam under anesthesia, no mesh erosion was palpated or seen.Within the abdomen, the uterus and ovaries are surgically absent.Extensive adhesions from the omentum to the left pelvic sidewall anterior left abdominal wall were noted.Additionally, it was seen that the sacrocolpopexy mesh was no longer providing any tension to the vagina.The mesh was dissected until was completely excised.It was noted that all bladder stones identified were removed, including the stone attached to the mesh.When no further mesh was present, the incisions were closed, and a leak test was performed successfully.The patient tolerated the procedure well and was taken to the recovery room in a stable position.On (b)(6) 2022, the patient presented to the emergency department for abdominal pain and persistent nausea and vomiting.The patient alleged feeling fatigued since the surgery, and started having persistent nausea and vomiting.She also had multiple intermittent episodes of loose stool and diarrhea since then.She denied any fever, hematochezia, melena or sick contacts.Review of systems: genitourinary - positive for abdominal pain, diarrhea, nausea and vomiting.Physical exam: abdominal - there was an abdominal tenderness.There was no guarding or rebound.Comments - diffuse abdominal tenderness to palpation.The abdominal incision appears clean and well-healing without any erythema or purulence.

Manufacturer Narrative

Blocks b5 (narrative), b7 (other relevant history) and h6 (patient codes and impact codes) has been updated based on the additional information received on september 12, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 3, 2016, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1405 - dyspareunia.E2006 - erosion and vaginal mesh exposure.E1715 - vaginal scarring.E2330 - chronic pain.E1906 - infections.E0206 - loss of enjoyment if life and mental anguish sustained in the past.E1310 - urinary tract infections.E2015 - vaginal atrophy.E2328 - large bladder stone.E2330 - pain.E020201 - anxiety.E1301 - dysuria.The following imdrf impact codes capture the reportable event of: f1905 - device revision surgery.F2302 - the patient was given a prescription for bactrim and vaginal estrogen.F1901 - multiple pelvic surgeries.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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: 16378021
• MDR Text Key: 309554641
• Report Number: 3005099803-2023-00676
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 60 YR
• Patient Sex: Female