FDA Adverse Event Injury Summary report: N

GEL BREAST IMPLANTS

MDR report key: 19172741 · Received April 24, 2024

Report

Report Number
MW5154152
Event Type
Injury
Date Received
April 24, 2024
Date of Event
May 7, 1999
Report Date
April 19, 2024
Manufacturer
MENTOR WORLDWIDE
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 1999, I WAS IMPLANTED WITH MENTOR BREAST IMPLANTS SILICONE GEL BY DR. (B)(6) PLASTIC SURGEON, (B)(6). A PERSONAL FRIEND I TRUSTED TO DO THIS PROCEDURE WELL. I WAS NOT TRIAGED OR EXPLAINED ANYTHING. DR. (B)(6) IMPLANTED SILICONE GEL IMPLANTS REPLACING MY PREVIOUS SALINE IMPLANTS. I WAS JUST TOLD MENTOR SILICONE GEL ARE FAR BETTER AND WILL GIVE YOU A MUCH BETTER RESULT. NO SIZE WAS DISCUSSED, I WAS TOLD TO LEAVE THE SIZE UP TO HIM ONCE I WAS PUT UNDER HE HAD DIFFERENT SIZES HE WOULD JUDGE TO WHAT LOOKED BEST FOR MY FRAME. I WOKE UP TO 450CC MAKING ME A LARGE D, I'M 5'3 FT AND 110 LBS. LOTS OF CHANGES BEGAN TO OCCUR TO MY HEALTH NOT KNOWING THE ROOT CAUSE. I'M AN ATHLETIC THAT LIVE AN EXTREMELY HEALTHY LIFESTYLE WITH NEVER ANY HISTORY OF ILLNESSES, SICKNESS, SUBSTANCES USED, ALCOHOL, SMOKING OR ANY KIND OR ANY NEGATIVES THAT WOULD IMPACT MY HEALTH. AS TIME PROGRESSED WITH HAVING THESE DEVICES IN ME MY HEALTH BEGAN DECLINING. PAIN IN MY BACK AND NECK WAS CONSTANT, I FAILED TO CONNECT THE DOTS TO THE CONSTANT 24/7 WEIGHTS STRAPPED TO MY CHEST UNABLE TO ESCAPE MY HEALTH EFFECTING MY SKELETAL FRAME WHICH MEANT IT WAS PULLING ON ALL MY CONNECTIVE TISSUE AND PECTORAL MUSCLES THAT CONNECTS TO AND BRANCHING OUT TO MUCH MORE. IT BECAME A DOMINO EFFECT ON MY HEALTH I COULDN'T CONNECT THE DOTS. I DID MY MAMMOGRAMS REQUESTED BY MY OBGYN. TEST NEVER PICKED UP ON CHANGES THAT WAS ONGOING AND OCCURRING TO ME. OVER HEATING SUDDENLY AND FEELING OVERALL SICK WITH DIZZINESS. I COULDN'T MOVE ALL SEEMED STRANGE. THIS ESCALATED TO MORE. JAW, BRAIN FOG, MIGRAINES, GI ISSUES, DIARRHEA, PAIN IN MY GUT ALL ROLLED AND BEGAN. I COULDN'T UNDERSTAND THE SIGNALS MY BODY WAS SENDING ME YET I HAVE ALWAYS BEEN SO PHYSICALLY HEALTHY. THE EXCALATION CONTINUED GETTING SEVERE. TRYING DIFFERENT MEDS GAVE ME C. DIF INFECTION. I HAD TO NOW DEAL WITH SECONDARY MEDICAL URGENTLY. INFLAMMATION WAS SEEN AND PRESENT ON MY CHEST FOR MANY YEARS TOO. THIS INFLAMMATION BEGAN CREEPING UP TO VISUALLY BEING SEEN ON MY NECK. MY MEDICAL BECAME MORE INTENSE IN 2019. SEARCHING FOR ANSWERS WITH THE MANY SPECIALIST SENT TO CONDUCTING THEIR TESTS WHO COULDN'T IDENTIFY MY CONDITION. 2020 WAS HERE AND I WAS NOW STUCK IN A STORM OF NO HELP YET DEATHLY ILL. I CONTINUE TO PUSH LOOKING FOR HELP DURING IMPOSSIBLE TIMES. I VISIT DR. (B)(6), (B)(6) 2021 ADMITTING HE HAD "PROFANITY" PUTTING SILICONE GEL DEVICES IN MY HEALTH AND WITNESSED MY CONDITION AND FELT MY DEVICES HAD RUPTURED. I GOT NO HELP WITH EXPLANTING FROM DR. (B)(6) WHO WANTED (B)(6) TO EXPLANT DURING A GLOBAL PANDEMIC WHEN ALL WAS CLOSED AND NO WORK WAS HERE. I WAS EXTREMELY SICK. (B)(6) COULDN'T HELP ME IMMEDIATELY DUE TO PANDEMIC AND MY NOW (B)(6) MEDICAL INSURANCE SO THEY INSTEAD SENT ME TO (B)(6). TO GET HELP. I WAS AN EMERGENCY CASE BUT STILL HAD A 3 WEEKS, PUSHING THEIR CANCER PATIENTS ASIDE TO FIT ME IN. I WAS EXPLANTED BY DR. (B)(6) AND 3 OTHER MED STUDENTS AT (B)(6), (B)(6) 2021. NO TIME TO FURTHER DO ADDITIONAL TESTING IT WAS EVIDENT MY BREAST IMPLANTS WERE RUPTURED. UPON OPENING MY CHEST IT WAS A MESS WITH SILICONE GEL EVERYWHERE. MANY CHANGES OF SURGICAL GLOVES TO GET RID OF SILICONE GEL AS BEST THEY COULD. A PRIOR MAMMOGRAM DONE (B)(6) 2021 BY (B)(6) SHOWED MY BREAST IMPLANT WERE FINE AND INTACT, THEY FAILED TO PROPERLY DIAGNOSE ME. A 6 HRS SURGERY TOOK PLACE. THE DEADLY DANGEROUS MENTOR SILICONE GEL BREAST IMPLANTS WERE INDEED RUPTURED BADLY. PLS ALSO NOTE I LATER FOUND OUT AFTER MY SURGERY BY RESEARCHING MY DEVICES I WAS IMPLANTED WITH MENTOR SILICONE GEL DEVICES BANNED BY THE FDA IN 1996 TO 2006. I'M SUFFERING STILL VERY BADLY TODAY WITH UNREPAIRABLE SYMPTOMS, THERE'S NO MEDICAL REMEDY TO CLEAN OUT SILICONE GEL FOR CASES LIKE MINE, I'VE HAD 7 MRIS AT (B)(6) CONFIRMING SILICONE GEL TRACES IN MY CHEST AND LYMPH NODES. THE NEXT STEP NOW IS A FULL MASTECTOMY TO MY BREASTS. "(B)(6)." I'VE HAD A MASSIVE AMOUNT OF TESTING DONE WITH (B)(6) ((B)(6) NP) WORKING UNDER DR. (B)(6) THAT WAS NEVER THERE TO SEE PATIENTS AT URGENT CARE, HE WAS A MATCH DOCTOR FOR (B)(6) TO OPEN DOORS AND OPERATE THE PRACTICE NOW CLOSED 2024. (B)(6) HAS MOVED TO (B)(6) AND OPERATING IN THE SAME WAY AS SHE DID IN (B)(6) UNDER ANOTHER MATCHED DOCTOR. RECORDS HAVE BEEN SENT FROM MAKE YOU WELL FAMILY PRACTICE TO (B)(6) TO DR. (B)(6) MY PCP. ALL OTHER RECORDS DONE ARE WITH (B)(6). OTHER RECORDS ARE WITH (B)(6), ER DEPT DURING PANDEMIC LOOKING FOR HELP. (B)(6). SAME THING. (B)(6) HAS A TON OF TESTS THERE WITH IMAGING LOOKING TO SEE WHY I WAS SO SICK WITH NO SIGNS OF ANYTHING....YET I WAS SO DEATHLY ILL AS IF I WAS POISONED AND MY POOR BODY WAS FIGHTING HARD TO STAY ALIVE. IT'S UNDENIABLE I HAVE BREAST IMPLANT ILLNESS THAT I WILL NEVER RECOVER FROM. I'M BED BOUND FOR THE MOST PART OF MY LIFE WITH THE OCCASION OF GOING TO A GYM TO UTILIZE MATS AND SMALL 3 LBS WEIGHTS MYSELF TO DO PHYSIO ON MY CHEST WHEN MY HEALTH ALLOWS IT. WHEN I DO MY CONDITIONS WORSENS AS MUCH AS I TRY TO GET ON TOP OF THIS HORRIFIC MEDICAL CASE, THE BURN FROM THESE CHEMICALS INSIDE ME BURNS MY AIRWAYS AND SINUS TO A POINT I CANT BREATH. PAIN SHOOTING DOWN MY ARMS AS LYMPH NODES ARE SWOLLEN AND GOD ONLY KNOW WHAT MORE MY CELLS WILL NOW TURN TO. IM ASKING THE FDA THAT BREAST IMPLANTS DEVICES MUST BE BANNED DUE TO REAL AND SEVERE MEDICAL DAMAGES FROM THESE CHEMICAL BOMBS THAT BLEED FROM DAY ONE OF IMPLANTATION. I LEARNT THEY HOLD APPROXIMATELY 40 TOXIC CHEMICALS WHICH IS HIGHLY POISONOUS TO OUR HEALTH HENCE THE SYMPTOMS I HAVE HAD THAT "DOMINOED" INTO MUCH MORE. MALE DOCTORS DO NOT "(B)(6)" NOR UNDERSTAND HOW SICK I BECAME. A NEW WARNING LABEL WE DON'T SEE TODAY DOES NOT STOP US REGARDLESS FROM BEING POISONED LEADING TO PERMANENT DAMAGES SUCH AS MYSELF NOW. I WAS NEVER GIVEN ANYTHING FOR MY IMPLANTS. I HAVE A CLUSTER OF MEDICAL SYMPTOMS THAT ARE STILL PRESENT DUE TO THE RUPTURED BREAST SILICONE GEL IMPLANT THAT WAS IMPLANTED IN ME (B)(6) 1999 WITH AN EXPLANT IN (B)(6) 2021, WITH STILL THE PRESENCE SILICONE GEL FROM THE RUPTURE. THE CHEMICAL REACTION IN ME IS HORRIFIC IT BURNS MY MOUTH WITH SORE THAT APPEARS WHICH RUNS THROUGHOUT INSIDE ME. THE DAILY PAIN I'M EXPERIENCING IS INTENSE I FEEL LIKE I NO LONGER WANT TO BE HERE LIVING THIS WAY, THE EPI CENTRE IS MY CHEST WHERE RUPTURE TOOK PLACE AND DAMAGED MY HEALTH. MY PECTORAL MUSCLE MAJOR IS STILL DETACHED AND VERY PAINFUL FEELS LIKE MY CHEST IS RIPPING. THE DOMINO EFFECT FROM THE ROOT CAUSE IS NOT PICKED UP BY ALL THE SCIENCE AS MY MAMMOGRAM FROM (B)(6) 2018 STATING ALL WAS FINE YET I WASN'T AT ALL. THE ONGOING PAIN FROM THE DAMAGES INCLUDES CHEST PAIN, NECK MUSCLES SPASMS PAIN FROM THE DYNAMICS CHANGES DUE TO CUTTING INTO MY CHEST MUSCLE TO REMOVE IMPLANT STUCK TO MY CHEST RIB CAGE AND WALLS, GI ISSUES, MIGRAINE, VOMITING, BACK PAIN NECK PAIN FROM FRAME CHANGES, BRAIN FOG, NOT ABLE TO SLEEP, SKELETAL CHANGES PAIN, CHEST TISSUES PAIN, PECTORALIS MAJOR BURN DISCOMFORT WITH PAIN, SINUS BURNS. THIS OUTCOME IS 100% DUE TO BREAST IMPLANT DEVICES ONLY THAT CREATED THIS ILLNESS AND MESS IN MY HEALTH. NONE ARE SAFE AND MUST BE BANNED FROM THE MARKET GLOBALLY. THEY HAVE 100% CREATED MY MEDICAL OUTCOME SEEN VISUALLY BY ALL MY DOCTORS WHO FEEL DEFEATED IN TRYING TO FIND A SOLUTION. DR. (B)(6) I HAVE ALSO SEEN AND KNOWNS MY CASE HE ALSO FEELS DEFEATED BUT OFFERED FAT TRANSFER WHICH ISN'T GOING TO ELIMINATE MY SILICONE GET IN MY CHEST AND LYMPH NODES. A CLUSTER "PROFANITY" THAT HAS NO LABEL IN THE MEDICAL COMMUNITY AND THAT MY STAGE HAS NOT YET REACH CANCER BUT HELP MUST COME BEFORE IT DOES. THIS LEVEL IS A WHOLE NEW LEVEL OF BREAST IMPLANT DAMAGES TO LEAD TO A FULL MASTECTOMY TO INSURE ALL IS REMOVED BUT NOT 100% GUARANTEED IT WILL HELP BECAUSE OF THE INTENSE HEALTH DAMAGES. NO MEDICAL LABEL FOR BII. REF REPORT: MW5154151.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1329159 GEL BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE

Patients

Seq Age Sex Outcome Treatment
1 61 YR Female Hospitalization| S| O| R| L DEGEX| GINGER ROOT| HOMEOPATHIC DROPS| OINTMENTS| SWEDISH BITTERS| TRAZODONE