FDA Adverse Event
Injury
Summary report: N
ALLERGAN SALINE IMPLANTS
MDR report key: 8970735
·
Received September 5, 2019
Report
- Report Number
- MW5089603
- Event Type
- Injury
- Date Received
- September 5, 2019
- Date of Event
- March 22, 2011
- Report Date
- September 4, 2019
- Manufacturer
- ALLERGAN
- Product Code
- FWM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I GOT BREAST IMPLANTS IN 2007. STARTED TO LOWER MY T CELLS IN 2011. IN 2015 I WAS HOSPITALIZED. FOUND OUT THAT I HAD GRAVES. I HAVE ALL THE BII SYMPTOMS. RECENTLY HAD MY IMPLANTS REMOVED. I'M HEALED. THEY NEED TO STOP IMPLANTING WOMEN. WE DID A POLL AND FOUND OUT THAT 70% OF WOMEN HAVE NOT REPORTED BREAST IMPLANT ILLNESS. PLUS THE 350K+ COMPLAINS HIDDEN FROM THE FDA. LET'S STOP MAKING WOMEN SICK; 80% OF THEM HAVE A THYROID ISSUE. BREAST IMPLANTS SUPPRESS THE IMMUNE SYSTEM. YOUR BODY CONSTANTLY FIGHTS TO SURVIVE. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761577 | ALLERGAN SALINE IMPLANTS | PROSTHESIS, BREAST, INFLATABLE, SALINE FILLED | FWM | ALLERGAN | |||
| 761578 | ALLERGAN SALINE IMPLANTS | PROSTHESIS, BREAST, INFLATABLE, SALINE FILLED | FWM | ALLERGAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization| R| S |