FDA Adverse Event Injury Summary report: N

NATRELLE SILICONE IMPLANT

MDR report key: 7697783 · Received July 17, 2018

Report

Report Number
MW5078465
Event Type
Injury
Date Received
July 17, 2018
Date of Event
February 27, 2015
Report Date
July 13, 2018
Manufacturer
ALLERGAN
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2015, I HAD SILICONE IMPLANTS PLACED; 3 MONTHS LATER I WAS DIAGNOSED WITH THRUSH. IN THE 3 YEARS SINCE THAT SURGERY, I'VE HAD RECURRING INFECTIONS, AND A STRAIN OF CANDIDA FOUND IN THE (B)(6) /CANCER PTS WHICH I DO NOT HAVE. I LOST 30 LBS OVER 3 YEARS. HAD SEVERE THROAT, NECK AND BACK PAIN, PROBLEMS BREATHING. MY VOCAL CORDS WERE INFLAMED. I HAD NIGHT SWEATS, FATIGUE, HAIR LOSS, SKIN SORES, IMPAIRED COGNITIVE FUNCTION AND SPEECH PROBLEMS, MUSCLE WEAKNESS. I SAW MANY SPECIALIST, OBGYN, ENT, ALLERGIST, BREAST SPECIALIST, INTERNIST, IMMUNOLOGIST, CHIROPRACTORS AND ALMOST THERAPY. EVERYTHING I ATE WOULD GO STRAIGHT THROUGH ME. I SUFFERED FOR YEARS WITH NO ANSWERS UNTIL I BEGAN RESEARCHING BREAST IMPLANT ILLNESS. THE IMPLANTS WERE SLOWLY POISONING ME. NO MATTER WHAT I DID I CONTINUED TO GET MORE SICK. I HAD BAKER GRADE 4 CAPSULES HAT HAD ADHERED TO MY CONNECTIVE TISSUES, MUSCLE AND RIBS. I HAD EXPLANT ON (B)(6) 2018. THROUGHOUT MY JOURNEY, ALL THE DRS, LABS, MRI, ULTRASOUND ALL WAS NORMAL WITH THE EXCEPTION OF REOCCURRING FUNGAL INFECTIONS AND MAST CELLS FOUND FROM IMMUNOLOGIST. SINCE EXPLANT MOST SYMPTOMS HAVE RESOLVED AND I AM ONLY 6 WEEKS POST OP. I SUSPECT AS I CONTINUE TO HEAL MY HEALTH, WILL CONTINUE TO IMPROVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
538816 NATRELLE SILICONE IMPLANT NATRELLE SILICONE IMPLANT FTR ALLERGAN
538817 NATRELLE SILICONE IMPLANT NATRELLE SILICONE IMPLANT FTR ALLERGAN

Patients

Seq Age Sex Outcome Treatment
1 38 YR Hospitalization| O| S