FDA Adverse Event
Injury
Summary report: N
MENTOR SILICONE GEL BREAST IMPLANTS
MDR report key: 8115213
·
Received November 28, 2018
Report
- Report Number
- MW5081678
- Event Type
- Injury
- Date Received
- November 28, 2018
- Date of Event
- January 1, 2006
- Report Date
- November 27, 2018
- Manufacturer
- MENTOR
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UK
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
SILICONE BREAST IMPLANT - PLEASE BAN THEM. I HAVE LOST OVER A DECADE TO SEVERELY POOR HEALTH AND HAVE NOW REMOVED THEM. PLEASE START LISTENING TO PEOPLE. I CANNOT BELIEVE THEY ARE STILL ALLOWED ON THE MARKET. THERE ARE BEYOND THOUSANDS LIKE ME. WE ARE ALL NOW MAKING IT PUBLIC, SO IT'S TIME TO ACT. IT HAS BEEN TIME TO ACT FOR A VERY LONG TIME. LIVES ARE BEING DESTROYED. I AM CURRENTLY SUICIDAL DUE TO WHAT THIS HAS DONE TO ME, SO I MAY NOT BE AROUND FOR F/U. BUT THERE'S MY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 949475 | MENTOR SILICONE GEL BREAST IMPLANTS | PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL FILLED | FTR | MENTOR | |||
| 949476 | MENTOR SILICONE GEL BREAST IMPLANTS | PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL FILLED | FTR | MENTOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| L| O| S |