FDA Adverse Event Injury Summary report: N

BREAST IMPLANTS

MDR report key: 7938539 · Received October 4, 2018

Report

Report Number
MW5080373
Event Type
Injury
Date Received
October 4, 2018
Date of Event
October 3, 2014
Report Date
October 2, 2018
Manufacturer
ALLERGAN INC.
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS WONDERING IF YOU EVER HEARD OF BREAST IMPLANT ILLNESS AS MANY WOMEN SUFFER FROM WHAT IS CALLED BREAST IMPLANT ILLNESS WITH MANY ISSUES THAT RANGE AS MY ISSUES CONSIST OF THE FOLLOWING EXTREME FATIGUE, BRAIN FOG, BAD MEMORY LOSS, LOSS OF CONCENTRATION, BODY PAIN INCLUDING MY JOINTS, ANXIETY, SEVERE DEPRESSION, NECK PAIN, EXTREME WEIGHT GAIN AT TIME OF IMPLANTS. I WEIGHED (B)(6), (B)(6) 2014 INCLUDING I HAVE THE LAP BAND AND HAD IT SINCE 2017. AS THE MONTHS WENT ON AFTER MY IMPLANTS MY WEIGHT INCREASED (B)(6) 2014. I WEIGHED (B)(6) BY (B)(6) 2014; (B)(6) BY (B)(6) 2015; I WEIGHED (B)(6), (B)(6) 2015; ON (B)(6) 2016, (B)(6), ON (B)(6) 2016, (B)(6) ON (B)(6) 2016, (B)(6), AND YESTERDAY (B)(6) 2016 - (B)(6). I AM (B)(6) AND JUST TURNED (B)(6). I HAVE BEEN SUFFERING SINCE I WAS (B)(6) AS I STARTED ON A DETOX AND PROBIOTICS AND AN ANTI-INFLAMMATORY PILL CALLED CURCUMIN 40 MG, CURAMED, FISH OIL AND TRIKATU. I AM ALSO ON A NON-GMO, GLUTEN, WHEAT AND DIARY DIET AND EATING ALL NON-INFLAMMATORY FOODS AS THIS HAS BEEN ONLY A WEEK AND THE INFLAMMATION IS FINALLY GONE DOWN A LITTLE. ON WITH MY LIST OF NON-EXPLAINED HEALTH ISSUES, MY VISION HAS CHANGED SO MUCH. THE GLASSES I JUST GOT 5 MONTHS AGO I CAN¿T SEE OUT OF, INSOMNIA, HAIR LOSS, DRY SKIN, NO LIBIDO AT ALL, BODY ACHES BAD, DIZZINESS, MIGRAINES, CONSTANTLY COLD, SHAKING ATTACKS, DARK CIRCLES UNDER MY EYES, DRY MOUTH, REALLY BAD SHARP SHOOTING BREAST PAINS, PAIN IN RIB CAGE AND ARMPIT AREA. HOT SHOWERS MAKE ME VOMIT INSTANTLY. RINGING IN MY EARS, HANDS TINGLE AND GO NUMB, BRUISING EVERYWHERE, TEETH AND GUM PAIN, PUFFY FACE AND NECK; DIFFICULTY SWALLOWING, POST NASAL DRIP, REFLEX, NAUSEA, WATER RETENTION, EXCESS PUFFINESS IN FEET AND IN HANDS, EARS FEEL FULL, PAIN BEHIND LEFT EAR ALL THE TIME. ADRENAL FATIGUE, HYPOTHYROIDISM, CHAPPED LIPS, CONSTIPATION, ACNE, SENSITIVE TO BRAS, CLOTHING AND SEIZURES. ALL ARE A PART OF WHAT IS CALLED BREAST IMPLANT ILLNESS AS MY BODY IS REJECTING AS THE SILICONE IS LEAKING OR SWEATING INTO MY BODY AND BLOODSTREAM CAUSING ALL OF THIS. THE IMPLANTS ARE POISONING ME AND MY BODY AS I CAN¿T FUNCTION, IT¿S UNEXPLAINABLE. AS TOXINS ARE BEING RELEASED INTO MY BODY. I CAN¿T TAKE AN OUNCE OF WEIGHT OFF AND AM UNDETECTABLE BY DOCTORS AS I HAVE HAD EVERY TEST ON EARTH DONE. I¿VE SEEN SEVERAL DOCTORS AND SPECIALIST AND BEING MISDIAGNOSED HAVING CHEMO AND IT WASN'T NEEDED. NOW (B)(6) HAD ALSO HAD THIS AND DID IT JUST RECENTLY IN (B)(6). EXPLANTED HER IMPLANTS AS SHE STATED THEY WERE KILLING HER SLOWLY. WHY HASN'T THIS BEEN QUESTIONED OR LOOKED INTO? AS (B)(6) HAS REPORTED, (B)(6) STORY SO HAS (B)(6) MAGAZINE, (B)(6), (B)(6), (B)(6) AND (B)(6), AND THE FDA OR GOVERNMENT IS NOT LOOKING INTO THIS AS THOUSANDS OF WOMEN ARE DEALING WITH THIS ON A DAILY BASIS. BEDRIDDEN, CAN'T GET UP OR MOVE NOT TO BE ABLE TO FUNCTION AT (B)(6) AND I HAVE A (B)(6). IT IS SO HARD FOR ME TO HANDLE AS I USED TO GET UP AT 3:30 AM AND WORKOUT. PLEASE WE NEED YOUR HELP. AS MOST WOMEN ARE UNAWARE OF THIS AND ARE TOLD THEY HAVE SOMETHING ELSE AND GETTING TREATED FOR IT AND NOT GETTING ANY BETTER. BUT ONCE THE IMPLANTS ARE REMOVED AND YOU GO THROUGH SOME DETOX THE SYMPTOMS, GO AWAY AND YOU REGAIN YOUR LIFE BACK. PLEASE, I JUST WANT ME BACK FOR MY DAUGHTER AND MYSELF. PLEASE HELP ME, MY LIFE IS ON THE LINE. I HAD SURGERY (B)(6) 2017. I HAD SEVERE ISSUES STILL AND I WILL FOR LIFE. I¿M NOW (B)(6) AND MY DAUGHTER IS 17 IN HER SENIOR YEAR AND I CAN'T HAVE A NORMAL LIFE WITH MY DAUGHTER. I CAN'T DO DAY TO DAY THINGS LIKE GO TO THE GYM, TAKE HER TO THE DOCTORS, DENTIST, ORTHODONTIST AND I¿M TAKING CARE OF MY (B)(6) FATHER WHO NOW HAS DEMENTIA ON TOP OF COLON AND BLADDER CANCER. THIS IS NOT WHAT A (B)(6) PERSON SHOULD FEEL LIKE BEDRIDDEN AND STILL DEPRESSED. I DON'T WANT MY DAUGHTER TO SEE ME LIKE THIS AND HER THINKING THIS IS NORMAL. IT IS NOT AT ALL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
773886 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN INC. 10
773887 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN, INC. 10

Patients

Seq Age Sex Outcome Treatment
1 42 YR Hospitalization| L| O| R| S