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); Fatigue (1849); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2010

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: the new england journal of medicine.Please see article attached.Events related to tvt-obturator captured via 2210968-2021-03942.

Event Description

Title: midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.This study aimed to compare outcomes with retropubic and transobturator midurethral slings at 12 months in women with stress incontinence.A total of 597 women (n=298 retropubic sling group ; n= 299 transobturator sling group) were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment.The retropubic sling used was the tension-free vaginal tape (gynecare); one of two transobturator slings was used; tension-free vaginal tape obturator (gynecare), which is placed starting inside the vagina and coming out through the obturator foramen (¿in-to-out¿) or the monarc (american medical system), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina (¿out-to-in¿).The predetermined equivalence margin was ±12 percentage points.Reported complications in the retropubic sling group included serious adverse event (n=41), wound related event (n=9), mesh exposure (n=8), mesh erosion (n=1), urethral perforation (n=1), bladder perforation (n=15), vaginal epithelial perforation (n=6), recurrent cystitis (n=1), posoperative bleeding (n=1), voiding dysfunction (n=18), neurologic symptoms (n=13), surgical-site infection (n=2), genitourinary event (n=40), vascular or hematologic event (n=18),numbness (n=8), weakness (n=7), self-reported pain =6 wk after procedure (n=7) and persistent urge incontinence (n=36).Reported complications in the transobturator sling group included serious adverse event (n=19), wound related event (n=10), mesh exposure (n=4), mesh erosion (n=1), surgical-site infection (n=4), granulation tissue (n=1), vaginal epithelial perforation (n=13), pulmonary embolus (n=1), urothelial abrasion (n=1), genitourinary event (n=24), vascular or hematologic event (n=7), numbness (n=9), weakness (n=22), voiding dysfunction (n=4), self-reported pain =6 wk after procedure (n=6), new urge incontinence (n=1) and persistent urge incontinence (n=30).The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturatorsling group (3.0 percentage-point difference; 95% confidence interval [ci], -3.6 to 9.6).The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% ci, -1.6 to 14.3).The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (p = 0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (p = 0.01).There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.In conclusion, the 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence.Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence.

• 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; neucahtel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11740193
• MDR Text Key: 255423806
• Report Number: 2210968-2021-03941
• 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: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• 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