FDA Adverse Event
Injury
Summary report: N
MENTOR MEMORYGEL BREAST IMPLANT
MDR report key: 8115558
·
Received November 28, 2018
Report
- Report Number
- MW5081705
- Event Type
- Injury
- Date Received
- November 28, 2018
- Date of Event
- January 1, 2017
- Report Date
- November 27, 2018
- Manufacturer
- MENTOR TEXAS, LP
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I RECEIVED BREAST IMPLANTS (MENTOR SILICONE MEMORY GEL) (B)(6) 2016. SOON AFTER MY IMPLANTS SURGERY I STARTED TO GET RASHES ON MY BODY. THEY STARTED UNDER BREAST AND TRAILED DOWN MY STOMACH. I HAVE PROGRESSIVELY GOTTEN WORSE AND NOW HAVE SPOT OVER MANY PARTS OF MY BODY THAT APPEAR TO BE ACTING LIKE PSORIASIS ( DIAGNOSED BY DERMATOLOGIST WITH PSORIASIFORM DERMATITIS). I AM ALSO LOSING HAIR AND HAVING JOINT PAIN AND STIFFNESS ISSUES. I ALSO LOST A BABY OF (B)(6) 2017 DUE TO UNKNOWN REASONS. I¿VE HAD AN ONSET OF THIS BAD HEALTH SINCE THE IMPLANTS WERE PLACED. I¿M VERY CONCERNED THAT THE IMPLANTS CAUSING THESE ISSUES. I HAVE REQUESTED A SAMPLE OF THE IMPLANT AND HAVE AN ALLERGIST TO SEE IF WE CAN DETERMINE IF THERE IS AN ALLERGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 950456 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS BREAST, INFLATABLE, INTERNAL SILICONE GEL-FILLED | FTR | MENTOR TEXAS, LP | 350-4754BC | ||
| 950457 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS BREAST, INFLATABLE, INTERNAL SILICONE GEL-FILLED | FTR | MENTOR TEXAS, LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Disability |