Description of Event or Problem · 1
HAD DOUBLE MASTECTOMY DUE TO STAGE 3 BREAST CANCER. HAD NATRELLE 133 EXPANDERS IN FOR APPROX 10 MONTHS WHILE UNDERWENT CHEMO AND RADIATION. ON (B)(6) 2013 ALLERGAN 410 TEARDROP "GUMMY BEAR" TEXTURED IMPLANTS PLACED. PS RECOMMENDED BECAUSE HE SAID THE TEXTURE WOULD HELP THEM STAY IN PLACE BETTER THAN SMOOTH. FOR 3 YEARS AND 7 MONTHS, I HAD CONTINUAL PAIN IN MY AFFECTED BREAST (RIGHT) WHICH RADIATED DOWN MY ARM. OFTEN WOULD EXPERIENCE SHARP STABBING PAIN IN MY CHEST WHICH HAD IT BEEN MY LEFT SIDE. I WOULD HAVE CONTACTED MY DR BELIEVING I WAS HAVING A HEART ATTACK. SWELLING OFF AND ON THAT WOULD EXACERBATE LYMPHOMA IN MY RIGHT ARM AS WELL. EXTREME DISCOMFORT WEARING BRAS AND BY MID AFTERNOON I WOULD SWELL WEARING THEM. BRAS BECAME SO UNBEARABLE I QUIT WEARING DUE TO INCREASED SWELLING, PAIN AND I ACTUALLY RUINED 4 BRAS BECAUSE THE IMPLANTS WERE SO HARD THEY BENT THE UNDERWIRE. I WASN'T WEARING CHEAP BRAS. BOUGHT (B)(6) BRAS RECOMMEND BY MY PS. HE SAID I NEEDED THE UNDERWIRE TO SUPPORT THE IMPLANTS. THE IMPLANT WOULD TURN 180 DEGREES IN MY CHEST AND I HAD TO SEE MY PS EVERY 4-8 WEEKS SO THAT HE COULD MANIPULATE IT BACK INTO PLACE. HE REQUESTED MY HUSBAND DO THAT DAILY. MY HUSBAND COULDN'T BEAR TO DO IT BECAUSE IT WAS SO PAINFUL, WHEN MY PS MANIPULATED IT BROUGHT TEARS TO MY EYES. SO MY PS TOLD ME TO MASSAGE 2-3 TIMES DAILY AND CONTINUALLY TRY TO TURN IT TO KEEP IT IN PLACE. I UNDERWENT FAT GRAFTING (LIPOSUCTIONED FROM MY STOMACH) TO TRY TO LOOSEN THE SKIN. WHEN I WOKE, MY PS TOLD ME HAD SEVERE CAPSULAR CONTRACTURE SO HAD TO REMOVE THE IMPLANT CLEAN OUT SCAR TISSUE AND REINSERT. I ALSO HAD EXTREME LIMITED RANGE OF MOTION IN MY RIGHT ARM AND WAS UNABLE TO LIFT MY ARM ABOVE MY SHOULDER FOR THOSE 3 PLUS YEARS. FINALLY, HAVING ENOUGH OF THE CONSTANT PAIN, SWELLING AND UNBEARABLE ITCHING, I REQUESTED TO HAVE THEM REMOVED. ON (B)(6) 2016 UNDERWENT SURGERY TO REMOVE AND REPLACE. SURGERY LASTED LONGER THAN PLANNED AND WHEN I WOKE UP, HE TOLD ME HE DID A SECOND FAT GRAFTING AS WELL. HE TOLD ME "LOOKED WORSE IN THERE THAN I EXPECTED." I LEARNED THAT THE IMPLANTS NOR ANY TISSUE REMOVED WERE NOT SENT TO PATHOLOGY. NO PICTURES WERE TAKEN AND MY PS' OFFICE HAS REFUSED TO RELEASE MY MEDICAL RECORDS TO ME OR MY PRIMARY DOC. I CURRENT HAVE SMOOTH IMPLANTS. IN (B)(6) 2018 UNDERWENT BRAIN MRI AND CT OF THE CHEST, PELVIS AND ABDOMEN TO RULE OUT CANCER RECURRENCE DUE TO HEADACHES, LIGHTHEADEDNESS, DIZZINESS, LOSS OF BALANCE, MEMORY LOSS, LOSS OF CONCENTRATION, BRAIN FOG, SEVERE MUSCLE AND JOINT PAIN, EXTREME BODY STIFFNESS ESPECIALLY WHEN WAKING UP OR SITTING FOR LONG PERIODS OF TIME, TINGLING AND NUMBNESS IN EXTREMITIES, SWELLING IN MY FACE, HANDS AND FEET, DIFFICULTY SWALLOWING AND WAKING UP IN THE NIGHT, UNABLE TO BREATH / CATCH MY BREATH, HIGH BLOOD PRESSURE, SLOW WOUND HEALING, AND EXTREME FATIGUE. CONTINUE TO SEE MY PRIMARY AND ONCOLOGIST TO MANAGE SYMPTOMS WITH NO REAL ANSWERS AS TO THE CAUSE. FDA SAFETY REPORT ID# (B)(4).