FDA Adverse Event Injury Summary report: N

TEXTURED SALINE IMPLANT

MDR report key: 6876133 · Received September 18, 2017

Report

Report Number
MW5072215
Event Type
Injury
Date Received
September 18, 2017
Date of Event
May 1, 1993
Report Date
September 17, 2017
Manufacturer
UNK
Product Code
FWM
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2013 I BEGAN HAVING EXTREME FATIGUE, JOINT PAIN, INSOMNIA, CONSTANT FEELING OF FIGHT OR FLIGHT, ANXIETY, NOISE SENSITIVITY (A DOORBELL WOULD SEND ME INTO AN ADRENALINE RUSH), LIGHT SENSITIVITY, TINGLING IN EXTREMITIES. I WOULDN'T BE ABLE TO DRIVE IN A CAR BECAUSE I THOUGHT EVERY CAR PASSING WAS GOING TO HIT US. I HAVE NO FAMILY HISTORY OF MENTAL ILLNESS, BUT WAS LOSING MY MIND. I WENT TO DOCTOR AFTER DOCTOR AND MY LABS WOULD COME BACK NORMAL. THE ONLY THING THAT WAS FOUND WAS A GOITER ON MY THYROID. I HAD A (B)(6) AND A (B)(6) AT THE TIME AND I COULD NOT FUNCTION AS A MOTHER SO WE HIRED A FULL TIME NANNY. I HAD GIVEN UP ON DOCTORS, BUT MY FAMILY INSISTED I GO TO (B)(6). SINCE THE ONLY THING THAT HAD BEEN FOUND WAS A GOITER THAT WAS WHAT GOT ME IN. I MET WITH THE ENDOCRINOLOGIST AND TOLD HIM MY SYMPTOMS AND HE HAD ME MEET WITH THE PSYCHIATRIST. THE PSYCHIATRIST GAVE ME SLEEPING TECHNIQUES. AFTER MONTHS OF GOING TO MAINSTREAM DOCTORS I GAVE UP AND WENT TO INTEGRATIVE AND HOLISTIC DOCTORS. I TESTED POSITIVE FOR HEAVY METALS, LIVER, KIDNEY, THYROID, AND ADRENAL. I DID FIND SOME RELIEF THROUGH SLOW DETOX FROM HEAVY METALS, AND OTHER SUPPLEMENTS. IN THE PAST YEAR, THOUGH, THINGS STARTED GETTING WORSE AGAIN. I WAS NOT ABLE TO FOCUS TO READ MY CHILDREN'S HOMEWORK. I HAD VISION DISTURBANCES, EXTREME INSOMNIA, DEBILITATING FATIGUE, AND ONCE AGAIN I WAS NOT FUNCTIONING ENOUGH TO HAVE CLOSE TO A NORMAL LIFE. THROUGH A FRIEND AND THEN MY OWN RESEARCH I FOUND OUT THAT BREAST IMPLANTS CAN CAUSE ALL OF THE SYMPTOMS I WAS HAVING. MY BREAST IMPLANTS WERE 24 YEARS OLD AND I HAD BEEN SICK FOR 4. I WENT TO A DOCTOR IN (B)(6) THAT DOES EN-BLOC THAT REMOVES THAT IMPLANT AND CAPSULE. I HAD TO GO TO AN INTERNAL MEDICINE DOCTOR TO HAVE PRE-OP TESTS PERFORMED. I ADMITTED TO THE INTERNAL MEDICINE DOCTOR MY 4 YEARS OF ILL HEALTH AND HE SAID HE WANTED TO DO SOME TESTING. I TOLD HIM THAT I FIRST WANTED TO GET THE IMPLANTS OUT, THAT SOME THINGS CLEAR UP AFTER EXPLANT. I HAD MY IMPLANTS REMOVED ON (B)(6) 2017. I HAVE FOUND A GREAT DEAL OF RELIEF ALREADY. I COULD HAVE NEVER WRITTEN TO EVEN MAKE A COMPLAINT 3 WEEKS AGO. I WAS NOT THE FIRST PERSON WHO HAD GONE TO THIS M.D. WITH SIMILAR COMPLAINTS AND NEEDING PRE-OP TESTS DONE FOR EXPLANT. SILICONE AND SALINE BREAST IMPLANTS ARE MAKING SOME WOMEN VERY SICK. THE CHASE TO GET THEIR LIFE BACK IS COSTING INSURANCE COMPANIES A LOT OF MONEY. THE IMPLANTS ARE ALSO CAUSING THESE WOMEN SUFFERING AND LEADING THEM TO BE UNPRODUCTIVE U.S. CITIZENS. CHILDREN ARE BEING LEFT UN-PARENTED. MANY WOMEN ARE GOING PUBLIC, AS I WILL BE, TO WARN WOMEN. I HAVE ALREADY THROUGH SOCIAL MEDIA TOLD MY STORY. WHAT ARE YOU GOING TO DO ABOUT THIS PROBLEM?

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
651402 TEXTURED SALINE IMPLANT TEXTURED SALINE IMPLANT FWM UNK
651403 TEXTURED SALINE IMPLANT TEXTURED SALINE IMPLANT FWM UNK

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R| S