Description of Event or Problem · 1
IN (B)(6) 2011, I HAD ESSURE IMPLANTS (LOT 754913) PLACED IN MY FALLOPIAN TUBES BILATERALLY. IN (B)(6) 2011, I BEGAN EXPERIENCING NEUROLOGIC SYMPTOMS CONSISTING OF MODERATE PARESTHESIAS IN BOTH ARMS AND LEGS, DIZZINESS, AND PROBLEMS WITH BALANCE AND COORDINATION. IN (B)(6), I SAW A NEUROLOGIST WHO DIAGNOSED ME WITH A SEVERE VITAMIN B12 DEFICIENCY, WITH SERUM B12 LEVEL OF 150. I WAS IMMEDIATELY PLACED ON DAILY VITAMIN B12 1000 MCG INJECTIONS AND DAILY ORAL VITAMIN B12 1000 MCG SUPPLEMENTS JUST TO MAINTAIN MY SERUM VITAMIN B12 LEVEL WITHIN NORMAL RANGE. IN (B)(6) 2011, I BEGAN EXPERIENCING CONTINUOUS CARDIAC PALPITATIONS AND CHEST PAIN. I SAW A CARDIOLOGIST WHO DIAGNOSED ME WITH PREMATURE ATRIAL CONTRACTIONS, SOMETIMES BIGEMINAL. I WAS MAINTAINED ON A BETA BLOCKER MEDICATION TO CONTROL MY CARDIAC SYMPTOMS. IN (B)(6) 2012, I BEGAN DEVELOPING SPONTANEOUS FEVERS OF 102-103 THAT WOULD LAST SEVERAL DAYS AT A TIME. I DEVELOPED EPISODES OF SPONTANEOUS SWELLING, EXTREME REDNESS AND PAIN IN MY NOSE AND ALTERNATING BETWEEN BOTH OF MY EARS, EACH LASTING WEEK TO 10 DAYS AT A TIME. I SAW A RHEUMATOLOGIST WHO DIAGNOSED ME WITH RELAPSING POLYCHONDRITIS. I CONTINUED TO HAVE INTERMITTENT FEVERS, FATIGUE, JOINT AND MUSCLE PAIN. IN (B)(6) 2013, MY FLARES WERE SO FREQUENT, THEY WERE NOT BEING EFFECTIVELY CONTROLLED WITH PREDNISONE. MY RHEUMATOLOGIST SAID THE NEXT STEP WOULD BE TO PLACE ME ON IMMUNE SYSTEM SUPPRESSANT MEDICATIONS. I ASKED MY RHEUMATOLOGIST IF SHE BELIEVED MY AUTOIMMUNE DISORDER AND OTHER PREVIOUS SYMPTOMS COULD HAVE BEEN CAUSED BY THE IMPLANTATIONS OF MY ESSURE DEVICES, SINCE I HAD NO HEALTH PROBLEMS PRIOR TO THEM BEING IMPLANTED. SHE SAID SHE THOUGHT IT WAS VERY SUSPICIOUS AND REQUIRED FURTHER INVESTIGATION. SHE SAID THE IMPLANTS MAY HAVE CAUSED A SYSTEMIC INFLAMMATORY RESPONSE IN MY BODY, OR I MAY BE REACTING TO THE COMPONENTS THE DEVICE IS MADE OF, SUCH AS THE NICKEL. I WAS NOT TESTED FOR A NICKEL ALLERGY PRIOR TO IMPLANTATION, AS THE FDA DROPPED THAT REQUIREMENT. IN (B)(6) 2014, I VISITED MY GYNECOLOGIST TO DISCUSS MY SYMPTOMS AND REQUEST TO HAVE THE ESSURE IMPLANTS REMOVED. I DID NOT WANT A COMPLETE HYSTERECTOMY, SO HE REFERRED ME TO A SPECIALTY GYNECOLOGIC SURGEON WHO COULD REMOVE ONLY THE ESSURE DEVICES, FALLOPIAN TUBES AND BILATERAL CORNUA OF THE UTERUS. IN (B)(6) 2014, I HAD A PELVIC CT SCAN TO CONFIRM CURRENT PLACEMENT OF BOTH COILS. BOTH COILS HAD MIGRATED DISTALLY IN THE FALLOPIAN TUBES, THE LEFT PRACTICALLY EXITING THE FALLOPIAN TUBE NEAR THE OVARY. ON (B)(6) 2014, I HAD LAPAROSCOPIC PELVIC SURGERY TO PERFORM REMOVAL OF BILATERAL ESSURE COILS, BILATERAL SALPINGECTOMY, AND BILATERAL CORNEAL RESECTION OF THE UTERUS. I AM CONVINCED THAT THE ESSURE DEVICES ARE WHAT HAVE BEEN CAUSING MY HEALTH PROBLEMS AND DECLINE SINCE (B)(6) 2011 WHEN THEY WERE IMPLANTED.