MAUDE Adverse Event Report: GYNECARE/ETHICON TVT EXACT; MESH

Model Number TVTRL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hair Loss (1877); Incontinence (1928); Itching Sensation (1943); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 12/15/2011

Event Type  Injury  

Event Description

In (b)(6) of 2011, i was implanted with a retro-public sling (gynecare tvt exact, tvtrl, sterile eo lot 3564380.From the very start of implantation of this vaginal sling, i have had side effects.Could not pass urine, went home with a cath, 6 days later, it was removed.Within an hr of arriving home, the severe deep pain in my lower back began.I could not stand up straight, sit, or walk.Crawling was the only was i could get around and continues on and off in spells to date.Once i could lay down, severe pain would radiate down both my legs to my toes.There is no position that i can lay to relieve this pain.The longer i lay the harder it is for me to move my legs at all and still occurs to date.Six weeks after began total incontinence, i am not aware that this will occur, developed lichen sclerosis, loss of hair, itching, unsteady gait, weight gain to pounds, swelling of legs, feet and stomach daily, bladder infections.Over all health now is bad.I am always at the doctors.Loosing control of my bowels when i cough.I was a very physically active woman.Sex is very painful.I can't even stand at the sink and wash all the dishes.

• Brand Name: TVT EXACT
• Type of Device: MESH
• Manufacturer (Section D): GYNECARE/ETHICON
• MDR Report Key: 4068388
• MDR Text Key: 16854651
• Report Number: MW5038083
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/15/2011
• Device Model Number: TVTRL
• Device Lot Number: 3564380
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR