FDA Adverse Event Injury Summary report: N

MENTOR

MDR report key: 2163607 · Received July 11, 2011

Report

Report Number
MW5021330
Event Type
Injury
Date Received
July 11, 2011
Date of Event
October 29, 2007
Report Date
July 11, 2011
Manufacturer
MENTOR
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I'M WRITING MY STORY TO THE FDA. THIS IS ABOUT MY BREAST SILICONE IMPLANTS THAT HAVE BEEN BLEEDING OUT FOR 7 OR MORE YEARS. I STARTED TO CONTINUALLY TO BE SICK WITH SYMPTOMS LIKE: LOW GRADE FEVERS 99.6 TO 100.8 (ALL THE TIME), FATIGUE, SWOLLEN LYMPH NODES, FLU-LIKE SYMPTOMS, NIGHT SWEATS, INSOMNIA, BACKACHES, WEIGHT LOSS, WEIGHT GAIN, BONES HURTING, CANKER SORES IN MY MOUTH FOR 4 MONTHS AND ON AND OFF FOR 2 YEARS, LARGE SUB LINGUAL TONSILS, COUGHING, WEAKNESS, SHORTNESS OF BREATH, CHEST PAINS, PAIN DEEP IN THE BONES, MEMORY LOSS. UNTIL (B)(6) 2007, WHEN MY BLOOD PRESSURE WENT UP AND I STARTED GETTING CHEST PAINS, THEN I SAW MY CARDIOLOGIST. HE RAN ALL THE TESTS, ECHO, THALLIUM TREADMILL AND BP MONITOR WITH BLOOD TESTS. ALL THE TESTS CAME BACK NEGATIVE EXCEPT FOR MY CRP, IT WAS 20.6. THIS HAD MY CARDIOLOGIST CONCERNED. HE ASKED THAT I RETURNED IN 2 MONTHS FOR A REPEAT TEST TO SEE IF IT WAS STILL HIGH 20.1. IN (B)(6), THE TEST WAS REPEATED WITH THE SAME RESULT 20.1. SENT ME FOR A CHEST CT SCAN. CAME BACK ABNORMAL AGAIN. MY CT SHOWED MANY SPOTS WITH INFILTRATES IN BOTH LUNGS AND PATCHY SPOTS WITH ABNORMAL LYMPH NODES. HE REFERRED ME TO A PULMONOLOGIST; SHE SAID I NEED A LYMPH NODE BIOPSY IN MY AXILLARY'S NODES, WANTED TO R/O LYMPHOMA. SHE HAD MORE BLOOD TEST DONE AND MY CPR WAS UP TO 43 AND SED RATE WAS UP, WBC WAS UP, BLOOD WORK IS STARTING TO COME BACK ABNORMAL. SHE REFERRED ME TO A GENERAL SURGEON TO PERFORM THE BIOPSY AND THE BIOPSY CAME BACK SHOWING SILICONE IN THE LYMPH NODES AND ALSO IN MY MEDIA-STERNUM FROM THE LAST BIOPSY. THE DOCTORS ARE NOW SAYING THIS HAS BEEN LEAKING INTO SYSTEM SLOWLY SINCE BEFORE 2004 AND MY AUTOIMMUNE SYSTEM HAS BEEN FIGHTING, WHICH IS WHY I HAVE BEEN SO SICK. WELL, THE 1ST SURGERY WAS ON (B)(6) 2007. THE INCISIONS ARE ABOUT 3IN ON BOTH SIDE OF MY PELVIC AREA. THIS SURGERY WILL BE DIVIDING THE INFERIOR EPIGASTRIC BLOOD VESSELS, TRAINING THE TRAM TISSUES TO RELY ON THE SUPERIOR EPIGASTRIC SYSTEM. THIS STEP IS NOT REQUIRED FOR SUCCESSFUL PEDICLE TRAM RECONSTRUCTION BUT CAN IMPROVE BLOOD SUPPLY TO THE FLAP. SO-CALLED DELAY PROCEDURES MAY EFFECTIVELY ELIMINATE THE POSSIBILITY OF PERFORMING MICROSURGERY ("SUPERCHARGING") IF THE PEDICLE FLAP HAS ANY ARTERIAL OR VENOUS INSUFFICIENCY PROBLEMS, SINCE THE VESSELS DIVIDED IN THE "DELAY" CANNOT BE USED. IT IS INFECTING MY LUNGS AND IMMUNE SYSTEM AND OTHER MAJOR ORGANS. IN ALL I HAD A MINIMUM OF 13 MAJOR SURGERIES WHICH INCLUDE MORE RECONSTRUCTIVE SURGERY AND WOUND CARE, DEVELOP NECROSIS FROM THE SURGERY, ALL THE SILICONE COULD NOT BE REMOVED. I HAD DONE A LOT OF RESEARCH AND THERE IS VERY LITTLE ABOUT MY CONDITION AND SILICONE ILLNESS. BOTH THE SURGEON AND PLASTIC SURGEON HAVE SAID THIS IS A VERY RARE CONDITION. ON (B)(6) 2007, BILATERAL PEDICLES TRAM FLAP WITH THE REMOVAL OF SILICONE IMPLANTS. BOTH IMPLANTS WERE RUPTURED AND BLEEDING OUT, MORE ON THE LEFT THEN ON THE RIGHT SIDE. BUT THE PLASTIC SURGEON -PS- SAID THESE HAVE BEEN LEAKING FOR A LONG TIME. THE PS CLEANED ALL THE AREA WHILE NOT TO DISTURB THE BLOOD VESSEL FOR THE TRAM FLAPS. THE PS USED THE SKIN OF THE BREASTS FROM WHERE HE REMOVED THE IMPLANTS AND TRANSPLANTED THE FLAPS BILATERALLY TO KEEP ME THE SAME SIZE AND SYMMETRICALLY. THE ABDOMEN REPAIR "TUMMY TUCK". THERE HAS BEEN SOME BRUISING AROUND THE "NEW PLACEMENT" OF THE BELLY BUTTON AND ABDOMEN AROUND THERE. THE PS USED MESH FOR MY ABDOMEN INSTEAD OF ALLODERM, BECAUSE THE MESH WAS STRONGER. I CAN FEEL THAT MESH WHEN I WALK. I WAS IN SURGERY FOR 8 1/2 HOURS AND SUFFERED RESPIRATORY FAILURE WITH PULMONARY EDEMA WITHIN THE FIRST 24 HOURS. I WAS MOVED TO THE FLOOR AND DEVELOPED PNEUMONIA IN THE RIGHT LOWER LOBE. I SWEAR, I WAS NOT GOING TO MAKE IT BASED ON BREATHING. ANTIBIOTICS PUSH AND LASIX PUSH AND PLENTY OF RESPIRATORY THERAPY, WHEN I GOT HOME I HAD EXTRA EQUIPMENT OXYGEN, WALKER, AND HOSPITAL BED. I WAS ON A LOT OF ANTIBIOTICS AND PAIN PILLS. I WENT TO THE DOCTOR AND IT LOOKS LIKE I'M GOING TO BE ADMITTED BACK INTO THE HOSPITAL ON (B)(6) 2008 FOR MORE SURGERY FOR A WOUND THAT DEVELOPED IN THE ABDOMEN. THE SURGERY IS FOR DEBRIDEMENT OF THE WOUND THAT IS NOT HEALING AND PLACING A WOUND VAC ON IT. THE DOCTOR WILL HAVE TO REDO 8 INCHES OF THE INCISION. I WILL BE IN THE HOSPITAL FOR 2-3 DAYS; I WILL HAVE TO PRAY MORE. THE SURGERY IS SUPPOSED TO TAKE 1 TO 1 1/2 HOUR; WITH THE COMPLICATIONS OF MY LUNGS THAT TIME SHOULDN'T BE TOO BAD. I WAS AFRAID OF DEVELOPING INFECTION, (B)(6). THEN 6 WEEKS OF THE WOUND VAC ON MY ABDOMEN. I DID DEVELOP (B)(6) AND WAS HOSPITALIZE FOR 4 MONTHS IN 2008. I HAVE STARTED TO SEE THE TRANSPLANTATION TEAM TO HAVE A POSSIBLE LUNG REMOVED BEFORE I RUN OUT OF TIME. BOTH LUNGS ARE FILLED WITH SILICONE, AS WELL AS MY KIDNEYS, AND MY GASTROINTESTINAL TRACT. MY PULMONARY DOCTOR I HAVE HAS BEEN WITH ME FOR 4 YEARS, AND SHE HAS SEEN ME GET WORSE THROUGH ON-GOING TESTS AND YEARS. WITH THE LUNG BIOPSIES (B)(6) 2011, SHOWING SILICONE THROUGHOUT MY LUNGS, SHE THEN SAW MY LAST PFTS AND IT WAS WORSE BY 80% SINCE (B)(6) 2011, AND MY O2 LEVEL IS AT 7 LITERS NOW. IT HAS GONE UP BY 3 LITERS SINCE (B)(6) 2010. SO CURRENTLY, I AM GOING THROUGH THE PRE-TESTING FOR LUNG TRANSPLANTS TO SEE IF I QUALIFY FOR THE TRANSPLANTS. SO I HAVE TO GO THROUGH A LOT OF TESTING TO SEE IF MY BODY CAN HANDLE THE TRANSPLANTS. ONLY MY DOCTOR UNDERSTANDS EVERYTHING ABOUT WHAT IMPLANTS CAN DO TO YOU. SHE HAS SEEN ME GO THROUGH IT A LOT. WHEN MY IMPLANTS WERE REMOVED IN 2007, THE DOCTOR HAD TO LEAVE THE OUTER PART IN BECAUSE MY TISSUE WAS ALREADY TAKEN OVER. MY IMPLANTS HAD BEEN LEAKING UP TO 7 YEARS PER THE TIMELINE OF ALL THE ISSUE WITH MY HEALTH PER MY DOCTORS. I HOPE THE LUNG TRANSPLANTS WILL BE APPROVE TO PLACE ME ON THE ORGAN TRANSPLANT LIST. SILICONE IMPLANTS SHOULD NOT BE AVAILABLE UNTIL MORE AND NEW UPDATED RESEARCH IS DONE. PLEASE, I BEG YOU TO LISTEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MENTOR BREAST IMPLANTS FTR MENTOR MENTOR

Patients

Seq Age Sex Outcome Treatment
1 51 YR Hospitalization| L| R