MAUDE Adverse Event Report: ETHICON GYNECARE TVT-O

Catalog Number 810081

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Discharge (2225); Discomfort (2330); Numbness (2415); Prolapse (2475); Constipation (3274)

Event Date 06/15/2007

Event Type  Injury  

Event Description

I had a tvt-o implant on (b)(6) 2007 due to bladder prolapse, and it seemed fine for a while.However, in 2010-2011 i began having difficulty emptying my bladder, retention/leaking/incontinence/stress, urinary tract infections, groin pain, hip/buttock, leg numbness, stomach pains, dyspareunia, and constipation.After numerous testing, and being re-diagnosed with bladder prolapse, i had to have a rectocele repair, and a fascia lata sling procedure in (b)(6) 2012.This did not last, and i ended up having to self-cath on a daily basis.I also had to take daily regiments of medications to reduce the urinary tract infection, discomfort, and constipation.This routine lasted until (b)(6) 2015, when i ended up in the hospital, and then i contacted a surgeon for another opinion.In (b)(6) 2015, the fascia lata sling was removed, and the original sling was found to be contracted and adhered to my obturator muscles, bilaterally, and it was in my retropubic space.After the slings removal, the surgeon performed a paravaginal repair, and a laparoscopic burch procedure.To date, i have not had to self-cath.Nor take constipation medication, and my urinary tract infections have gone away.Yet, my legs continue to get weak, my groin area aches constantly, and i only feel pressure with intercourse; no sensation.Rx meds: ibuprofen 800mg for occasional discharge, ice pack / moist heat for discomfort in groin/legs.Otc meds: none.

• Brand Name: GYNECARE TVT-O
• Type of Device: GYNECARE TVT-O
• Manufacturer (Section D): ETHICON
• MDR Report Key: 4921859
• MDR Text Key: 6433857
• Report Number: MW5044247
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2015

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: Other
• Device Catalogue Number: 810081
• Device Lot Number: 3018601
• Other Device ID Number: LCNP15062/A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 77