MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US ,LLC COLOPLAST RESTORELLE MESH MESH, SURGICAL, POLYMERIC

Catalog Number 501440

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: COLOPLAST RESTORELLE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COLOPLAST MANUFACTURING US ,LLC
• MDR Report Key: 8545599
• MDR Text Key: 143217228
• Report Number: MW5086103
• Device Sequence Number: 2
• Product Code: FTL
• 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

• Date FDA Received: 04/23/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 501440
• Device LOT Number: 5716491
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 04/23/2019 Patient Sequence Number: 1