Description of Event or Problem · 1
BLINDNESS IN RIGHT EYE, IMMEDIATELY FOLLOWING IMPROPER USE OF A DEFECTIVE PRODUCT, BIOSPHERE EMBOSPHERE. I WAS DIAGNOSED WITH A BRAIN TUMOR (6CM RIGHT FRONTAL MENINGIOMA) ON (B)(6) 2010, BY MRI/CT, AT (B)(6) HOSP, (B)(6). I HAD NOTICED MILD NEUROLOGICAL SYMPTOMS (3 EPISODES OF MILD SCINTILLATIONS OF VISION, EACH LASTING 10 MINUTES); THESE SYMPTOMS ARE MOST OFTEN ASSOCIATED WITH MIGRAINE- OVER THE PRECEDING 4 DAYS. I ENJOYED 20/20 VISION IN BOTH EYES. I AM AN OPTOMETRIST. THE TUMOR WAS SUPERFICIAL I.E. EASY TO ACCESS FOR EXCISION, VIA CRANIOTOMY, BUT HIGHLY-VASCULARIZED. THE NEUROSURGEON, DR (B)(6), ADVISED PRE-SURGICAL EMBOLISM TO REDUCE HEMORRHAGING DURING THE SURGERY, AND ARRANGED A CONSULT WITH AN INTERVENTIONAL RADIOLOGIST, DR (B)(6). I WAS ADVISED BY DR (B)(6) THAT THE PROCEDURE WAS EXTREMELY SAFE, BUT HE MENTIONED THAT THERE ARE REPORTS OF RISKS OF ADVERSE EFFECTS (MENTIONING "STROKE, EVEN DEATH"), BUT HE REASSURED ME THAT ANY ADVERSE EFFECTS WOULDN'T OCCUR UNDER HIS TREATMENT, CITING HIS 40 YR HISTORY OF PERFORMING EMBOLISMS WITHOUT ANY COMPLICATIONS. DR (B)(6) FAILED TO MENTION THE RISK OF INSTANT BLINDNESS, DUE TO EMBOLISM MATERIAL ENTERING THE CIRCULATION OF THE EYE (IATROGENIC CENTRAL RETINAL ARTERY OCCLUSION). OF COURSE, THIS HAPPENED WHILE I WAS ON THE TABLE UNDER HIS CARE, EVEN AS HE WAS ADMINISTERING THE BIOSPHERE EMBOSPHERE PRODUCT IN THE RADIOLOGY SUITE. IN REVIEWING MEDICAL LITERATURE IN THE DAYS FOLLOWING, I DISCOVERED THAT THE RISK OF IATROGENIC BLINDNESS IS NOT UNCOMMON, SOME STUDIES HAVE PLACED THE INCIDENCE OF SUCH ADVERSE AT 2-6%, AND THERE'S MANY REPORTS OF SUCH INCIDENTS GOING UNREPORTED, AND THUS SHOULD'VE BEEN MENTIONED AS A POSSIBLE RISK BY HIM. IN REVIEWING BIOSPHERE'S OWN LITERATURE (E.G. THE PRODUCT INSERTS PROVIDED FOR DOCTORS; I WASN'T GIVEN AN INSERT, AS THE PT), AS OF TODAY, THERE STILL IS NO MENTION OF "BLINDNESS" LISTED ANYWHERE IN THEIR ENTIRE LITERATURE, WHETHER BLINDNESS DUE TO STROKE, OR DUE TO EYE DAMAGE. AS AN EYE DOCTOR, I FULLY UNDERSTAND THAT BLINDNESS DUE TO 'STROKE' (DAMAGE TO THE BRAIN'S OCCIPITAL LOBE, LOCATED IN THE BACK OF THE BRAIN) OCCURS UNDER A DISTINCT AND SEPARATE MECHANISM FROM BLINDNESS DUE TO DAMAGE TO THE EYE (WHICH IS NOT WITHIN THE BRAIN, OBVIOUSLY IN FRONT OF THE HEAD). AS CONVEYED IN THE ANALOGY USED TO EDUCATE PTS, THE EYES IN FRONT ARE LIKE ANTENNAE, WHERE THE BRAIN IS WHERE THE ACTUAL PROCESSING TAKES PLACE WHERE WE "SEE". THESE ARE ENTIRELY DISTINCT MECHANISMS OF DAMAGE THAT LEAD TO BLINDNESS, WITH LOCATIONS OF DAMAGE SEPARATED BY 150 CM -WHICH IN THE WORLD OF NEUROLOGY IS A MILLION MILES. NOT THAT IT MATTERS: AS I STATED, THE RISK OF BLINDNESS, REGARDLESS OF MECHANISM, IS NOT MENTIONED ANYWHERE IN BIOSPHERE'S LIT. I THEREFORE ACCUSE BIOSPHERE FOR FAILING TO WARN THE FDA, DOCTORS, CONSUMERS OF A FAILURE TO DISCLOSE A KNOWN COMPLICATION DIRECTLY ARISING FROM USE OF THEIR PRODUCT (FAILURE TO DISCLOSE A PRODUCT DEFECT). FURTHERMORE, IN REVIEWING MY MEDICAL RECORDS -FOUND IN EMR INTERVENTIONAL RADIOLOGY NOTES-, I FOUND EVIDENCE THAT DR (B)(6) USED EXPIRED EMBOSPHERE MATERIAL (EXP DATE: 02/2010). THIS IS IN VIOLATION OF FDA RULES, AS WELL AS THE BIOSPHERE'S POLICY.