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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2014

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.Citations: jeong sj, lee hs, lee jk, jeong jw, lee sc, et al.(2014) the long-term influence of body mass index on the success rate of mid- urethral sling surgery among women with stress urinary incontinence or stress-predominant mixed incontinence: comparisons between retropubic and transobturator approaches.Plos one 9(11): e113517.Doi:10.1371/journal.Pone.0113517.No additional information available.If further details are received at a later date a supplemental medwatch will be sent.Adverse events associated with tension free vaginal tape device reported via mw # 2210968-2021-05100.Adverse events associated with tension free vaginal tape - obturator device reported via mw # 2210968-2021-05101.

Event Description

It was reported in a journal article with title: the long-term influence of body mass index on the success rate of mid-urethral sling surgery among women with stress urinary incontinence or stress-predominant mixed incontinence: comparisons between retropubic and trans-obturator approaches.The purpose of this study was to compare the effects of bmi on the long-term outcomes of mid-urethral sling surgery between subjects with retropubic and trans-obturator approaches in korean women who were followed-up for >36 months after surgery.From october 2003 to december 2008 total of 243 women, 74 (30.5%) were normal weight, 124 (51.0%) overweight, and 45 (18.5%) obese according to the bmi assignment.There were no women in underweight category.Seventy-four (30.5%) women received surgery via the retropubic approach and 169 (69.5%) did via the trans-obturator approach.Most of surgeries were performed under spinal anesthesia.However, general or local anesthesia was used in some cases according to comorbidity of patient or to preference of patient.Spinal (regional) anesthesia was used in 84.6% women, general anesthesia (including monitored anesthetic care) in 12.8%, and local anesthesia in 2.6%.Types of anesthesia were not different according to the type of surgery (approach) or severity of bmi.All patients showed urine leakage during valsalva maneuver on urodynamic study.Surgery was performed based on the standard technique described by ulmsten et al with some modifications.Tvt (gynecare, ethicon) or sparc sling (american medical system, minneapolis, usa) was used in the retropubic procedure, and tvt-o (gynecare, ethicon), monarc (american medical system, minneapolis, usa), or smesh (woorhi medical, namyangju, korea) was used in the trans-obturator procedure.Follow-up consisted of physical exam, completion of validated symptom questionnaire, 3-day frequency-volume chart (if necessary), stress test, and urine flow with measurement of pvr.Patients were followed up at 1, 3, 9, 15 months after surgery and yearly thereafter.Intraoperative and postoperative complications were examined.Reported complications included postoperative wound infection (n=3), urinary retention (n=11), pain on operative site (n=5), de novo urgency (n=10) and mesh erosion (n=2).Intraoperative bladder injury (n=3) and transfusion (n=2).In conclusion bmi was not independently associated with failures in either approach.Higher success rates in women with lower bmi in the trans-obturator approach were attributed to the lower percent of preoperative mui in those with lower bmi.

• 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
• MDR Report Key: 11912729
• MDR Text Key: 265800320
• Report Number: 2210968-2021-05101
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K033568
• 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: 05/04/2021

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: 05/04/2021
• 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
• Patient Outcome(s): Required Intervention