MAUDE Adverse Event Report: J&J/ ETHICON INC J&J EXACT MESH SLING; MESH SURGICAL SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE

Catalog Number TVTRL

Device Problem Positioning Problem (3009)

Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119)

Event Date 03/16/2018

Event Type  Injury  

Event Description

Doctor (urogyn) in (b)(6) said i needed to have a hysterectomy, sacrocolpopexy with mesh and mid-urethral sling.My one and only complaint was a bulge in anterior compartment which didn't hurt.I also didn't have sui.Doctor insisted i have the above major surgery to correct the problem.I continually asked about the dangers of mesh.His answer was this is the new mesh, if i use vaginal estrogen i won't have any problems.After surgery (b)(6), i had to go to the er when my bladder locked up due to the j&j mid -urethral sling.Urge incontinence was terrible after the implant.I had to have sacrocolpopexy mesh (coloplast restorelle) removed after 9 months due to pain in vagina and i had pain that was in my upper vagina and rectum.I believed that was due to healing.But on (b)(6) 2018 i had to go to the er because my bladder locked up.This continued to happen if i didn't go to the bathroom often.I went in for my post op check in (b)(6).Doctor said "my vagina looked so good no one would ever know i had children".I was cleared to have intercourse.I tried several days later and it was excruciating.I couldn't have penetrating intercourse.I went to see my ob/gyn about the problem.They gave me estrogen and said vagina was very tight.Even after the estrogen, i couldn't have sex.The pain in my vagina had become like a mini jackhammer beating in me.My rectal pain was terrible if i would stand for too long.I started looking for a doctor to remove the mesh.No doctor in (b)(6) can do a complete mesh removal, so i looked out of state.I visited a doctor in (b)(6) first.Second opinion in (b)(6).Both doctors said i was having some kind of an adverse reaction to the mesh.I decided to have it removed in (b)(6).This was on (b)(6) 2018.It was a 9 hour surgery and 3 day hospital stay.I can send all my records from surgeries.

• Brand Name: J&J EXACT MESH SLING
• Type of Device: MESH SURGICAL SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): J&J/ ETHICON INC
• MDR Report Key: 8545599
• MDR Text Key: 143217228
• Report Number: MW5086103
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 04/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: TVTRL
• Device Lot Number: 3930630
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 57