MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTRL

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

Patient Problems Foreign Body Reaction (1868); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Anxiety (2328); Fibrosis (3167); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2020

Event Type  Injury  

Event Description

It was reported that a patient underwent a bladder sling procedure on (b)(6) 2020 and the mesh was implanted.It was reported that the patient experienced difficulties from the onset after surgery.It was reported that the patient suffered from multiple utis, urine retention, and painful urination.It was also reported that the patient had significant groin and leg pain, and never felt healthy again.It was reported that the patient was constantly tired and sick, and could not engage in life activities that had previously been a part of the patient's life.It was reported that the patient sought treatment from the doctor and a specialist.It was reported that the patient had the sling removed on (b)(6) 2020 and although the patient is still healing, the patient's health has improved significantly.It was also reported that the patient will likely experience worse incontinence issues than what was experienced prior to the implant surgery.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned maude report #: mw5103488.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3936241 and product code tvtrl.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the reason for this surgical procedure? please provide the date of surgery.When did the issue begin? what is the date and name of the procedure performed to correct your condition? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/22/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: what was the reason for this surgical procedure? please provide the date of surgery.When did the issue begin? what is the date and name of the procedure performed to correct your condition? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.Additional information received via email from the patient: what was the reason for this surgical procedure? to prevent leakage.Please provide the date of surgery.(b)(6) 2020.When did the issue begin? i have been fighting frequent urination since 1993 what is the date and name of the procedure performed to correct your condition? (b)(6) 2020 - bladder sling.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.Additional information provided in patient operative report details as follows: date: (b)(6) 2021.Visit type: office visit ¿ gyn.This is a 47-year-old female presents for mesh problems.History of present illness: mesh problems: the symptoms began 4 months ago and generally lasts 4 months.The symptoms are reported as being severe.The symptoms occur daily.The location is vagina.Aggravating factors include not sure.Relieving factors include not sure.She states the symptoms are acute and are of new onset.Patient underwent surgery in (b)(6) 2020 -tvt exact placed for stress incontinence.Patient reports pelvic pain, more on the left.She also reports shooting pains down both legs.The patient is unable to be intimate due to pain.Patient also reports stabbing and poking sensation/pain in the vagina, patient also reports some urgency, frequency, dysuria, and nocturia x 2.Nulliparous.No hysterectomy.Gynecologic history: patient has not had a hysterectomy.Obstetric history: gravidity: 0.Parity: term: 0, pre-term: 0.Past systemic history: medical history (detailed).Surgical history/management (detailed).Appendectomy ¿ 1990.Pelvic sling ¿ 2020.Reconstructed ear drum ¿ 1997.Medications (active prior to today) medication name : methenamine hippurate 1 gram tablet, augmentin 500 mg-125 mg tablet, colace 100 mg capsule, estrace 0.01% (0.1 mg/gram) vaginal cream.Allergies: ciprofloxacin ¿ reaction: racing heart; sleeplessness.Sulfamethoxazole ¿ reaction: racing heart; sleeplessness.Trimethoprim ¿ reaction: racing heart; sleeplessness.Medication name: bactrim.Smoking status: never smoker.Tobacco/vaping exposure there is passive smoke exposure.Alcohol there is a history of alcohol use.Consumed rarely.Review of systems: gi ¿ abdominal pain.Gu - dysuria, nocturia (frequency: 2x), urge incontinence, urgency, urinary frequency.Psych ¿ anxiety.Ms ¿ joint pain.Allergic/immuno - seasonal allergies.Reproductive ¿ dyspareunia.Vital signs bp 103/65 mm/hg, pulse 83 /min., pulse 18 resp/min, height ¿ 5 ft.4.5 in./163.83 cm, weight ¿ 142 lb/64.41 kg, bmi ¿ 24 kg/m2.Detail type: description assessment: other mechanical complication of other prosthetic devices, implants and grafts of genital tract, initial encounter.Patient plan: surgery has been offered for removal of the previous tvt exact sling mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy as well as removal of the mesh from the abdominal wall and the abdominal paravaginal space.The patient was extensively counseled that even with removal of her mesh that she may continue to have pain and there is no guarantee that she will be pain free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which include but are not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.Assessment: pelvic and perineal pain.Medications (start date- (b)(6) 2021): augmentin 500, colace 100 mg, estrace 0.01%, methenamine hippurate 1 gram tablet.No scopette used due to pain.No stress sitting or standing.I went over with the patient the difference between stress and urgency.Patient states she has both.She states her urgency has gotten much worse since the sl1ng.I went over with the patient dietary changes to help decrease her symptoms.Voiding diary showed 20 voids in a 24-hour period.Retention on uroflow and pressure flow.Patient unable to void around caths.Caths were removed and the patient was able to go 37mls with a post void residual of 135mls.Date of surgery: (b)(6) 2021 08:29 am.Surgeon: (b)(6) md.Preoperative diagnosis: vaginal pain, pelvic pain, left and right groin pain and pain with coitus.Postoperative diagnosis: same plus urinary stricture.Procedure: tvt exact sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, removal of abdominal mesh.Anesthesia: general via laryngeal tube.Estimated blood loss: 100 ml.Drains: foley to gravity.Specimens: tvt exact mesh.Complications: none.Procedure in detail: the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in a modified dorsal lithotomy position, prepped and draped in the usual manner for vaginal surgery.This was a very difficult surgery due to the scarring from previous surgery as well as the left and right sling arms being in the obturator muscles and the sling was deeper on the left in the urethral wall.Foley catheter was inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal wall and an incision was made directly into the- anterior vaginal wall for the full extent of the- anterior vaginal wall.The previous sling was identified superficial in the vaginal wall on the left and deep at the urethra on the left and freed from the scar tissue.The mesh was incised in the midline and dissected as far as lateral as possible.The dissection was carried to the contralateral side, the paravaginal space was opened.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The sling on the right was freed from the underlying urethral wall and dissected from the obturator muscle and laterally into the retropubic space as far as possible.The paravaginal space was opened bilaterally for exposure, and the sling mesh was held with a clamp.The sling on the left was freed from the underlying vaginal wall and dissected laterally into the left obturator muscle but was deep.The paravaginal space was opened bilaterally for exposure, and the sling mesh was held with a clamp.Our attention was directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free exposing the rectus muscles.The mesh was feed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection completely freed the right sling arm.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The left sling arm was identified and also freed from the fascia and rectus muscles.Traction of the arm elevated the bladder wall.The mesh was followed as it entered the left obturator internus muscle and dissected free.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The fascia was closed with interrupted sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19 f drain was placed in the subcutaneous space.Skin edges were reapproximated with staples.Hemostasis was excellent.The anterior vaginal wall was closed with running suture of#2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The needle, sponge, and instrument counts were correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.(b)(6) md.Lab services: final diagnosis: mesh removal - mild chronic inflammation, fibrosis and foreign body giant cell reaction to polarizable foreign material, consistent with mesh.Gross description: the surface of the mesh has adherent pink fibrous tissue.Operative procedure 1: mesh removal.2: urethrolysis.3: abdominal paravaginal defect repair.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12651616
• MDR Text Key: 282958382
• Report Number: 2210968-2021-09823
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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: 01/31/2021
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3936241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White