MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Unspecified Tissue Injury (4559); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2021

Event Type  Injury  

Event Description

Title: functional outcomes of vaginal surgery for urethral extrusion of mid-urethral tape in women.The study aims to determine the presentation of and immediate and longer-term outcomes of vaginal surgical excision of urethral extrusion of mid-urethral tape.Between 2007 and 2018, 34 women receiving vaginal surgical excision for urethral extrusion of mid-urethral tape were included in the study.Their median age was 53 (range 34¿82) years.The index tape was tvt (ethicon) in 26 patients and tot/tvt-o (ethicon) in 8 patients.Patients underwent either partial or complete removal of mid-urethral tape partial removal was performed through an anterior vaginal approach with identification and division of the mid-urethral tape on one side lateral to the urethra, removal of the mid-urethral tape from within the urethra then dissection of the remaining vaginally accessible mid-urethral tape as far as possible into the retropubic space underneath the ischial rami into the deeper aspect of the obturator fossa (for transobturator mut) and removal of all visible mid-urethral tape.The associated urethral defect(s) are closed with a 5/0 vicryl (ethicon) suture, and a modified martius labial flap pad is interposed to augment the reconstruction, aid healing and permit safe access for any ensuing surgery for recurrent/persistent stress urinary incontinence.The total laparoscopic/vaginal mesh removal was performed though a combined vaginal and laparoscopic approach.An initial anterior midline vaginal wall incision was performed and the tape was dissected free as per vaginal partial surgical excision.The cut ends of both sides of the tape were then passed through the endopelvic fascia into the pelvis to the laparoscopic surgeon and the complete tape removed.A urethral catheter was inserted perioperatively.Patients were discharged with this catheter in situ and returned for peri-catheter urethrogram at 3¿4 weeks post-surgery.Following confirmation of urethral healing, the catheter was removed.All patients had a pericatheter urethrogram at 3 weeks postoperatively and healing was confirmed in all at a median of 3 (range 3¿ 8) weeks following surgery.Reported complications included urethral extrusion of mid-urethral tape (n=34), urethrovaginal fistula (n=3), stone on the extruded mid-urethral tape (n=3), bladder extrusion (n=1), urogenital pain (n=15), recurrent urinary tract infection (n=11), urinary frequency (n=10), urinary urgency (n=10), incomplete emptying (n=9), poor flow (n=9), urgency urinary incontinence (n=5), dyspareunia (n=5), nocturia (n=5), dysuria (n=4) and a superficial labial wound infection (n=1).In conclusion, the outcome of vaginal surgical excision of the mid-urethral tape was cure or improvement of pain in 100% and resolution of poor flow in 89% women.Recurrent/persistent stress urinary incontinence or stress predominant mixed urinary incontinence was present in 82% following removal as compared to 71% women prior to removal.Of the 71% of women electing to have further surgery for recurrent/persistent stress urinary incontinence or stress predominant mixed urinary incontinence, 83% were dry or improved afterwards.

Manufacturer Narrative

(b)(4).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 inc, 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.An attempt has been 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.H6 clinical code: e2402 ¿ stone on the extruded mid-urethral tape, poor flow.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-04126 and 2210968-2024-04128.Citation: international urogynecology journal (2022) 33:2251¿2256; https://doi.Org/10.1007/s00192-021-04774-2.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• 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 ; 9083863534
• MDR Report Key: 19078558
• MDR Text Key: 339809627
• Report Number: 2210968-2024-04127
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female