MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON, INC. GYNECARE TVT EXACT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number TVTRL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)

Event Date 12/09/2020

Event Type  Injury  

Event Description

I had a bladder sling implant surgery on (b)(6) 2020 by dr.(b)(6).The sling used was the johnson & johnson gynecare tvt exact.I experienced difficulties from the onset after surgery.I suffered from multiple utis, urine retention, and painful urination.In addition, i had significant groin and leg pain, and just never felt healthy again.I was constantly tired and sick and could not engage in life activities that had previously been a part of my life.I sought treatment from dr.(b)(6) who insisted that what i was experiencing was not from the sling.I, therefore, had to find a seek treatment elsewhere as i knew the issues i was suffering were related to the sling.I had to travel to (b)(6) to seek treatment from a specialist who was willing and able to do a complete removal.I had the sling removed on (b)(6) 2021 and although still healing, my health has improved significantly.I will likely not know what i will be facing going forward until my body has completely healed from the removal surgery.However, it is likely that i will experience worse incontinence issues than i did prior to the implant surgery.Although i questioned the use of the mesh before the implant surgery, i was told the amount being implanted was a small amount, about half of the tip of my pinky, and was also advised that the issues with the mesh only involve those who have the hernia repair surgery.Neither of these statements was accurate.I had to pay a significant amount of money for both surgeries and for travel.Fda safety report id# (b)(4).

• Brand Name: GYNECARE TVT EXACT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): JOHNSON & JOHNSON / ETHICON, INC.
• MDR Report Key: 12365779
• MDR Text Key: 268485938
• Report Number: MW5103488
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3936241
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 68