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

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

Patient Problems Erosion (1750); Incontinence (1928); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 12/12/2022

Event Type  Injury  

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.Citation: urogynecology, (2022); 28 (xx): page 862¿871.Doi: 10.1097/spv.0000000000001249.

Event Description

Title: assessment of adverse events in a matched cohort of women undergoing concurrent midurethral sling at the time of minimally invasive benign gynecologic surgery.The aim of this retrospective matched cohort study was to compare postoperative complication rates between women undergoing midurethral sling (mus) placement at the time of benign gynecologic surgery and those undergoing mus alone.Between january 2010 through december 2020, a total of 38 women (with mean age of 51 years) who had undergoneconcurrent minimally invasive benign g ynecologic surgery and mus placement for sui were included in the study.Types of slings used during the study period included retropubic (gynecare tvt exclusively) and transobturator (american medical systems monarc, coloplast aris, gynecare tvt-o).Retropubic mus technique included the bottom-to-top technique, whereas transobturator mus technique included the in-to-out and out-to-in techniques.The following events cannot be ruled out as complaints: patient information: retropubic (gynecare tvt).> minimally invasive gynecologic surgery (migs) with concurrent mus.-(n=4) urinary retention postoperative before discharge; -(n=3) clavien-dindo scale, grade 1 postoperative before discharge; -(n=3) voiding dysfunction; -(n=5) urinary incontinence; -(n=4) uti; -(n=2) clavien-dindo scale- grade 1 30 days postoperative; -(n=6) clavien-dindo scale- grade 2 30 days postoperative; -(n=2) readmission; -(n=4) vaginal mesh exposure; -(n=1) de novo pelvic pain; -(n=10) stress incontinence; -(n=1) reoperation for sui; -(n=4) de novo urgerncy incontinence; -(n=5) sling lysis or excisioon; *no treatment mentioned for this group.> mid-urethral sling (mus) only.-(n=18) urinary retention postoperative before discharge; -(n=21) clavien-dindo scale, grade 1 postoperative before discharge; -(n=21) clavien-dindo scale, grade 2 postoperative before disc; -(n=3) urinary retention 30 days postoperative; -(n=10) voiding dysfunction; -(n=24) urinary incontinence; -(n=7) uti; -(n=9) clavien-dindo scale- grade 2 30 days postoperative; -(n=3) vaginal mesh exposure; -(n=2) de novo dyspareunia; -(n=3) de novo pelvic pain; -(n=6) nerve injury; -(n=38) stress incontinence; -(n=3) reoperation for sui; -(n=12) de novo urgerncy incontinence; -(n=4) sling lysis or excisioon; *no treatment mentioned for this group.In conclusion, midurethral sling placement at the time of minimally invasive benign gynecologic surgery is safe but is associated with a higher incidence of postoperative hospital resource utilization and sling mesh extrusion, and a need for revision.

• Brand Name: TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
• 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: 18885074
• MDR Text Key: 337420179
• Report Number: 2210968-2024-02873
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 02/20/2024
• Initial Date FDA Received: 03/12/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female