Description of Event or Problem · 1
SEVERE COBALT AND CHROMIUM; IN 2005 I WAS PART OF A CLINICAL TEST STUDY AT (B)(6) HOSPITAL TEAM LED BY (B)(6), MD. I RECEIVED 3 PRODISC L AT L2-3, L3-4, AND L4-5 DURING AN ANTERIOR APPROACH. I WAS FOLLOWED UNTIL THE PRODISC WAS APPROVED IN 2006 FOR USE AT 1 LEVEL. I DO NOT REMEMBER THE DATE AND ALL OF MY MEDICAL RECORDS HAVE BEEN PURGED FROM THEN. AS TIME WENT ON, MY BACK PAIN INCREASED, I DEVELOPED SCOLIOSIS AND COBALT AND CHROMIUM TOXICITY. I HAD AN ARTIFICIAL RIGHT HIP IN 2011 THAT WAS REPLACED IN 2019 BECAUSE I HAD IMPINGEMENT AND HIGH COBALT AND CHROMIUM LEVELS AND ILLNESSES RELATED TO TOXICITY SUCH AS MEMORY LOSS, HYPOTHYROIDISM, HAIR LOSS, DEPRESSION, SEVERE DIARRHEA, ETC. MY LEVELS KEPT INCREASING AFTER THE HIP WAS REPLACED SO ATTENTION WAS TURNED TO MY BACK. I WAS IN EXTREME PAIN, THE DISCS WERE LODGED IN MY SPINAL CANAL, HAD SCOLIOSIS AND WAS SICK FROM THE TOXINS. NO ONE WOULD REMOVE THEM BECAUSE THEY SAID THE MORTALITY RATE WAS TOO HIGH. EVERY DR WANTED TO FUSE THE DISCS IN PLACE AND HOPE FOR THE BEST WITH TOXICITY BUT I WANTED THEM REMOVED BECAUSE OF THE LONG TERM EFFECTS OF TOXICITY, THEY WERE REMOVED AT THE (B)(6) CLINIC ON (B)(6) 2020, AND REPLACED WITH 3 ALIFS. MY TOXICITY LEVELS ARE FINALLY GOING DOWN. I AM STILL IN SEVERE PAIN, ALMOST DIED DURING THE SURGERY, LOST 7 LITERS OF BLOOD, ICU FOR DAYS. NO ONE KNOWS THE LONG TERM TOXICITY EFFECTS OF THE PRODISC. I HAVE BLURRY VISION, HYPOTHYROIDISM, DEPRESSION, HAIR LOSS, MEMORY LOSS AND AM BEING FOLLOWED BY A CARDIOLOGIST, ENDOCRINOLOGIST, VISION SPECIALIST. I AM STILL IN SEVERE BACK PAIN, HAVE BLOOD CLOT AND SCAR TISSUE FORMING AROUND MY BOWELS FROM THIS SURGERY. I TRIED TO ATTACH THE BLOOD RESULTS BUT I CAN'T FIGURE OUT HOW. THEY SHOW THAT THE COBALT AND CHROMIUM TOXICITY WERE CAUSED BY MY 3 PRODISCS. THEY WERE RISING FOR YEARS AND FINALLY AFTER MY DISCS WERE REMOVED, THE TOXICITY LEVELS DROPPED. UNFORTUNATELY, THAT WILL NOT FIX DAMAGE ALREADY DONE TO MY BODY. FDA SAFETY REPORT ID # (B)(4).