Description of Event or Problem · 1
COMPLAINANT, (B)(6) FEMALE REPORT LOSING TOTAL VISION IN RIGHT EYE AFTER ARTEFILL DERMAL FILLER ADMINISTERED TO REMOVE FACIAL AND NECK WRINKLES. ON (B)(6) 2013, COMPLAINANT WENT TO DR (B)(6) COSMETIC SURGEON AND HAD "CROW'S FEET" WRINKLES ON RIGHT EYE AND WRINKLES ON NECK LINE REMOVED. COMPLAINANT WENT IN FOR PROCEDURE AT 9 AM, REGAINED CONSCIOUSNESS AT 1 PM AND DISCOVERED NO VISION IN RIGHT EYE. DOCTOR EXAMINED PT AND WHEN SHE RESPONDED COULD ONLY SEE BLACK, HE BECAME VERY ALARMED AND IMMEDIATELY REFERRED HER TO DR (B)(6), RETINA VITREOUS MEDICAL ASSOCIATES, A RETINA SPECIALIST. (B)(6) SAW PT AND IMMEDIATELY CALLED PRODUCT MANUFACTURER, SUNEVA MEDICAL. DOCTOR WAS TOLD FILLER CONTAINED POLYMETHYLMETHACRYLATE (PMMA) MICROSPHERES (SYNTHETIC MATERIAL) AND COULD NOT BE DISSOLVED. THE DRUG APPARENTLY ENTERED BLOOD STREAM AND CAUSED AN EMBOLISM. SAME DAY COMPLAINANT SENT TO DR (B)(6) FOR HYPERBARIC MEDICINE WHERE SHE SPENT THE NEXT 3 HOURS IN A HYPERBARIC CHAMBER TO RELIEVE EYE PRESSURE. WHEN COMPLAINANT LEFT THE CENTER, HER VISION FIELD CHANGED FROM BLACK TO DARK GREEN, A PRELIMINARY SIGN OF IMPROVEMENT. FOLLOWING MORNING VISION RETURNED TO BLACK. COMPLAINANT RETURNED TO DR (B)(6) FOR MORE HYPERBARIC TREATMENTS FOR NEXT SEVEN DAYS. COMPLAINANT VERY DISTRAUGHT AND WENT TO UCLA ER FOR HELP. SHE WAS TOLD TO CONTINUE WITH THE HYPERBARIC TREATMENTS BUT NOTHING COULD BE DONE AT THE MEDICAL CENTER. ON OR ABOUT (B)(6) 2013, COMPLAINANT CONTRACTED AN EAR INFECTION CAUSED BY THE CHAMBER PRESSURE. DR (B)(6) REMOVED FLUID FROM PT'S EAR AND CONTINUED TO MONITOR COMPLAINANT'S CONDITION. ON (B)(6) 2013, COMPLAINANT SAW DR (B)(6), RETINA SPECIALIST FOR A SECOND OPINION AND WAS TOLD EYE HAD SUFFERED PERMANENT DAMAGE. ACCORDING TO THE DOCTOR, THE NEEDLE WAS INADVERTENTLY PLACED IN WRONG SITE WHERE THE DRUG MIGRATED THROUGH THE BLOOD TRIBUTARIES TO AN ARTERY THUS CAUSING THE EMBOLISM. ON (B)(6) 2013, COMPLAINANT SAW DR (B)(6), CHIEF OF THE RETINA DIVISION. APPARENTLY DR (B)(6) WAS NOT SUPPORTIVE AND REFUSED TO DISCUSS COMPLAINANT'S CASE: INSTEAD REFERRED HER TO HIS COLLEAGUE DR (B)(6), AN OCULAR PLASTIC SURGEON AT THE INSTITUTE. COMPLAINANT'S BLINDNESS IN RIGHT EYE APPEARED TO BE PERMANENT. COMPLAINANT'S INITIAL CONSULT AND TEST FOR SKIN REACTION IN EARLY (B)(6) NEGATIVE. NO DISCUSSION TRANSPIRED REGARDING USE OF ARTEFIL FILLER ON ANY AREA OTHER THAN NASOLABIAL FOLDS. COMPLAINANT FOUND THAT ARTEFILL WAS APPROVED BY THE FDA FOR USE ONLY FOR THE NASOLABIAL FOLDS, NOT ABOVE THE "SMILE LINE" I.E., NEAR THE EYES. IT IS, HOWEVER, EXTENSIVELY USED OFF LABEL BY PHYSICIANS IN OTHER FACIAL AREAS. REVIEW OF COMPANY WEBSITE SHOWS SIMPLE ONE-SENTENCE STATEMENT FOR USE BUT NO EXPLANATION OR DESCRIPTIVE INFORMATION OR WARNING FOR USE IN OTHER AREAS. COMPLAINANT SEARCHED AND FOUND 160 CASES IN 2008 INVOLVING ADVERSE REACTIONS. PROVIDER NAME: (B)(6).