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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.  if further details are received at a later date a supplemental medwatch will be sent.  event related to tension free vaginal tape reported via mw #2210968-2021-02036.Event related to tension free vaginal tape obturator reported via mw #2210968-2021-02037.Event related to tension free vaginal tape abbrevo reported via mw #2210968-2021-02039.Event related to tension free vaginal tape exact reported via mw #2210968-2021-02040.

Event Description

It was reported in a journal article with title: 7- year old clinical experience of treating women¿s urinary incontinence using suburethral slings.Efficiency assessment of the usage of suburethral slings in the treatment of stress and mixed urinary incontinence and frequency of postoperative complications in near and long-term postoperative period.In the period of 7 years (from march 2005 to december 2012), 467 female patients (middle age: 57± 3.2 years old) have been operated on the urinary incontinence.Suburethral slings installed were: tvt in 4 patients in 2005y; tvt-obturator in 18 patients in 2005y, 27 patients in 2006y, 33 patients in 2007y, 48 patients in 2008, 50 patients in 2009y, 45 patients in 2010y, 65 patients in 2011y, 53 patients in 2012y; tvt-secur in 3 patients in 2006y, 5 patients in 2007y, 26 patients in 2008y, 9 patients in 2009y, 5 patients in 2010y, 9 patients in 2011y, and 9 patients in 2012y; tvt-abrrevo in 10 patients in 2011y and 20 patients in 2012y; tvt-exact in 2 patients in 2012y.Postoperative complications in 2005y included erosion of the vaginal wall (n-?) in which a local anti-inflammatory therapy was done with subsequent appointment of estrogen-containing candles; 3 patients had to be operated on the excision of part of the implant with the closure of the defective mucous, which subsequently led to the complete healing of the erosion in the term of up to 2 months postoperative complications in 2006y included erosion of the vaginal wall (n-?) in which a local anti-inflammatory therapy was done with subsequent appointment of estrogen-containing candles; 3 patients had to be operated on the excision of part of the implant with the closure of the defective mucous, which subsequently led to the complete healing of the erosion in the term of up to 2 months, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, relapse of stress urinary incontinence (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints postoperative complications in 2007y included urinary retention (in early postoperative period) residual urine (more than 20 ml) (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, erosion of the vaginal wall (n-?) in which a local anti-inflammatory therapy was done with subsequent appointment of estrogen-containing candles; 3 patients had to be operated on the excision of part of the implant with the closure of the defective mucous, which subsequently led to the complete healing of the erosion in the term of up to 2 months, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, postoperative complications in 2008y included urinary retention (in early postoperative period) residual urine (more than 20 ml) (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, relapse of stress urinary incontinence (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints postoperative complications in 2009y included urinary retention (in early postoperative period) residual urine (more than 20 ml) (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, relapse of stress urinary incontinence (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints postoperative complications in 2010y included erosion of the vaginal wall (n-?) in which a local anti-inflammatory therapy was done with subsequent appointment of estrogen-containing candles; 3 patients had to be operated on the excision of part of the implant with the closure of the defective mucous, which subsequently led to the complete healing of the erosion in the term of up to 2 months, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints,relapse of stress urinary incontinence (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints postoperative complications in 2011y included urinary retention (in early postoperative period) residual urine (more than 20 ml) (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, erosion of the vaginal wall (n-?) in which a local anti-inflammatory therapy was done with subsequent appointment of estrogen-containing candles; 3 patients had to be operated on the excision of part of the implant with the closure of the defective mucous, which subsequently led to the complete healing of the erosion in the term of up to 2 months, detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints, relapse of stress urinary incontinence (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints postoperative complications in 2012y included detruzo overactivity de novo (n-?) in which an appointment of adequate long drug therapy made it possible to eliminate all the patients¿ complaints the overall success rate of urinary incontinence correction by using suburethral slings is 98,3%.The frequency of postoperative complications is from 1,1 to 5,6% in their complex clinical and instrumental assessment.Rate of complications depends on the type of urinary incontinence identified in the preoperative examination.To identify the component of mixed urinary incontinence which significantly reduces the efficiency of sling surgery the patients should have standardized examination in the preoperative stage, including keeping a diary of urination and urodinamic evaluation.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11427427
• MDR Text Key: 247132570
• Report Number: 2210968-2021-02038
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K052401
• 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: 02/05/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention