FDA Adverse Event Injury Summary report: N

MENTOR BREAST IMPLANT

MDR report key: 8342760 · Received February 14, 2019

Report

Report Number
MW5084072
Event Type
Injury
Date Received
February 14, 2019
Date of Event
August 15, 2016
Report Date
February 13, 2019
Manufacturer
MENTOR
Product Code
FTR
UDI-DI
6570713068
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WOKE UP WITH A HEADACHE AND AFTER SEVERAL DAYS OF IT NOT GOING AWAY AND TRYING SEVERAL DIFFERENT OVER THE COUNTER PAIN MEDICATIONS, I REALIZED IT HAD TURNED INTO A MIGRAINE. AFTER TRYING EVERYTHING I COULD THINK OF OVER THE NEXT SEVERAL WEEKS; CUTTING OUT CAFFEINE, ALCOHOL (WHICH I ONLY HAD AN OCCASIONAL GLASS OF WINE), AND CHOCOLATE, I WENT TO THE DR. THEY GAVE ME AN INJECTION AND PAIN MEDS TO RELIEVE THE MIGRAINE, WHICH HAD NOT LET UP AT ALL OVER THE PAST WEEKS. THE PAIN EASED UP AND I WENT HOME AND SLEPT. I WOKE UP THE NEXT MORNING WITH THE SAME MIGRAINE. OVER THE NEXT WEEKS I HAD MY EYES EXAMINED -EVERYTHING CHECKED OUT OK, NO CHANGE. I HAD A CT SCAN-NORMAL. MY DR. REFERRED ME TO A NEUROLOGIST WHO ORDERED A MRI WHICH CAME BACK NORMAL. IN THE MEANTIME I HAVE HAD NO RELIEF FROM THE MIGRAINES, WHICH ACCORDING TO MY NEUROLOGIST IS SWITCHING BACK AND FORTH FROM AN OCULAR MIGRAINE TO A MIGRAINE WITH AURA. MY SYMPTOMS INCLUDED NAUSEA, FLOATING BLACK SPOTS IN MY VISION, SENSITIVITY TO LIGHT, EXCRUCIATING PAIN IN MY HEAD , NECK PAIN , NECK STIFFNESS, AND SOMETIMES VOMITING. I WAS PUT ON TOPAMAX 200MG 2X A DAY, PROPANOL 60 MG A DAY, MY SERTRALINE WAS INCREASED FROM 50 MG TO 100 MG A DAY, MY ANXIETY HAS GOTTEN SO BAD THEY ADDED DULOXETINE 20 MG AM AND PM , MAGNESIUM OXIDE 400 MG A DAY, CAMBIA 50 MG IF NEEDED FOR MIGRAINE ATTACK, BOTOX INJECTION IN THE BACK OF MY HEAD EVERY 4 MONTHS, I HAVE BEEN DIAGNOSED WITH FIBROMYALGIA AND TAKE LYRICA 25 MG 3X A DAY TO HELP WITH THE PAIN FOR THAT, AND TIZANIDINE 2MG UP TO 4 OF THOSE TO HELP ME SLEEP AT NIGHT . NOT TO MENTION I HAD MY THYROID REMOVED 5 YEARS BEFORE HAVING MY BREAST IMPLANTS PUT IN AND NEVER HAD A LEVOTHYROXINE INCREASE UNTIL I STARTED HAVING ALL THESE HEALTH ISSUES AFTER HAVING MY IMPLANTS PUT IN. I HAVE JUST RECENTLY HEARD OF BREAST IMPLANT ILLNESS (BII) AND AM SADDENED THAT I WAS NOT AWARE OF THIS DISEASE BEFORE HAVING MY IMPLANTS PUT IN. I JUST FOUND OUT THAT THE FDA KNEW ABOUT BII IN 2011 THE YEAR BEFORE I HAD MY IMPLANTS PUT IN AND DID NOTHING TO WARN PEOPLE LIKE ME ABOUT IT. I HAVE SO MANY OF THE SYMPTOMS AND HEALTH ISSUES ASSOCIATED WITH BII AND HAD I KNOWN ABOUT THIS DISEASE THE CHOICES I MADE WOULD HAVE BEEN SO MUCH DIFFERENT. MY LIFE HAS BEEN FOREVER CHANGED! I HAVE NO ENERGY, NO DRIVE, AND NO WILL OR DESIRE TO LIVE LIFE! I HURT ALL OF THE TIME AND THE DOCTORS DON¿T UNDERSTAND WHY BUT NOW THERE IS NO DOUBT IN MIND WHY! THESE BREAST IMPLANTS ARE MY SECRET KILLER! THEY ARE DESTROYING MY LIFE FROM THE INSIDE OUT AND THE FDA KNEW ABOUT IT THE WHOLE TIME AND DID NOTHING TO WARN ME ABOUT IT HAVING BREAST IMPLANTS WAS A CHOICE I MADE TO GIVE ME MORE SELF-CONFIDENCE; TO MAKE ME MORE COMFORTABLE IN MY OWN SKIN. NOW I CAN¿T EVEN STAND BEING IN MY OWN SKIN. EVERY SECOND ACHES AND HURTS, I¿M IN CONSTANT PAIN. SOME NIGHT I PRAY I DON¿T EVEN WAKE UP THE NEXT MORNING! THIS NOT ME! I USED TO LOVE LIFE! I HAVE 5 AMAZING, WONDERFUL KIDS; 4 LOVING GRAND KIDS WHO CALL ME GRAMS AND MY HUSBAND WHO IN HIS OWN WORDS CANNOT LIVE WITHOUT ME. SO WHY? WHY WOULD YOU SIT ON THIS INFORMATION AND MAKE SOMEONE LIKE ME SUFFER THROUGH PAIN LIKE THIS FOR NO REASON?? BECAUSE HAD I HAD THIS INFORMATION BEFORE I WOULD HAVE NEVER HAD THE BREAST IMPLANTS PUT IN! MY HUSBAND DIDN¿T EVEN WANT ME TO DO IT BEGIN WITH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
135056 MENTOR BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE SILICONE GEL-FILLED FTR MENTOR 350-2375 6570713 6570713068
135057 MENTOR BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE SILICONE GEL-FILLED FTR MENTOR 6570713070

Patients

Seq Age Sex Outcome Treatment
1 42 YR Disability BOTOX INJECTIONS EVERY 4 MONTHS IN BACK OF HEAD FOR CHRONIC MIGRAINES.| CAMBIA 50 MG FOR MIGRAINE ATTACK| DULOXETINE 20 MG 2X A DAY| LEVOTHYROXINE 188 MCG DAILY| LYRICA 25 MG 3X A DAY| MAGNESIUM OXIDE 400 MG DAILY| MELOXICAM 15 MG DAILY| OTC MEDS: LORATADINE 10 MG| PROPANOLOL 60 MG DAILY| RX MEDS: TOPIMIRATE 200 MG 2X A DAY| SERTRALINE 100 MG DAILY| TIZANADINE 2 MG UP TO 4 AT BEDTIME