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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Incontinence (1928); Unspecified Tissue Injury (4559)

Event Date 06/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: international journal of gynecology and obstetrics (2014); xxx: pages 1-4.Doi: http://dx.Doi.Org/10.1016/j.Ijgo.2014.04.017.No additional information available.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported in a journal article with title: outcomes of minimally invasive sub-urethral slings with and without concomitant pelvic organ prolapse surgery.The aim of this prospective study is to compare subjective changes in urinary symptoms and quality of life 1 year after surgery among patients who underwent minimally invasive sub-urethral sling (mis) surgery for sui with or without concomitant anterior colporrhaphy for pop via the ici-recommended questionnaires.Between november 1, 2002 to june 30, 2010, a total of 294 patients who underwent mis surgery with or without concomitant pop anterior colporrhaphy (irrespective of any other prolapse procedures) were included in the study.The study included all patients with urodynamically proven sui and pop.203 patients (female; mean age = 51.7 ± 10.7 years; bmi = 28.2 ± 5.3) underwent mis surgery alone, and 91 patients (female; mean age = 52.8 ± 11.7 years; bmi = 27.1 ± 3.9) underwent mis coupled with anterior colporrhaphy and/or other compartment pop surgery.Among patients who underwent mis surgery alone, tape was inserted using the standard technique for retropubic tension-free vaginal tape (gynecare tvt; ethicon) or trans-obturator tape from a competitor, and a diagnostic cystoscopy was performed to identify bladder or urethral perforation after the procedure.For patients in the concomitant surgery group, tape was inserted by a separate incision prior to pop surgery.Anterior colporrhaphy was performed by plication of the pubocervical fascia in the midline, and the vaginal skin was sutured with a delayed absorbable suture.A urethral catheter was inserted for continuous drainage in the concomitant group until the next morning, after which the voiding protocol was followed.Reported complications included subjectively not cure (n=?), worse result in iciq-fluts score in the filling domain (n=?), worse result in iciq-fluts score in the voiding domain (n=?), worse result in iciq-fluts score in the incontinence domain (n=?), worse result in iciq-fluts score in the sexual domain (n=?), worse result in iciq-fluts score in the qol domain (n=?), bladder perforation (n=?), vaginal tape exposure (n=?), retropubic hematoma (n=?), and division of tape (n=?).In conclusion, the present study has shown that concomitant surgery for pop and sui can be offered to patients with prolapse and urinary incontinence because it provides a significant improvement in urinary symptoms and quality of life without any increase in complications.As a result, women should be counseled regarding the benefits of concomitant surgery, including the advantage of avoiding a second operation with its attendant morbidity and time for recuperation.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• 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: 11917160
• MDR Text Key: 266848058
• Report Number: 2210968-2021-05144
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1