Description of Event or Problem · 1
INVISALIGN PLASTIC BRACES - I BEGAN USING THE PRODUCT ON (B)(6) 2016. IMMEDIATELY, MY TONGUE HAD BURNING/TINGLING SENSATIONS WHERE EVER MY MOUTH OR TONGUE CAME INTO CONTACT WITH THE PLASTIC ALIGNERS. ADDITIONALLY, MY TONGUE GOT SORES AND ABRASIONS FROM SHARP EDGES OF THE INVISALIGNERS. EVER SINCE APRIL, I ERRONEOUSLY ASSUMED AT THE SORENESS/BURNING OF MY TONGUE WERE DUE TO THE SHARP EDGES CAUSING DERMABRASIONS TO MY MOUTH AND TONGUE. THIS WAS EVIDENT EVEN AFTER I BEGAN USING AN EMERY BOARD TO FILE THE SHARP EDGES ON THE ALIGNERS AND/OR EVEN WHEN I WORE ORTHODONTIC WAX TO COVER THE ALIGNER EDGES. ON (B)(6) 2016, I DISCOVERED ONLINE A 2010 FDA LETTER TO INVISALIGN REGARDING A PATIENT'S BURNING TONGUE SENSATION WHEN WEARING INVISALIGNERS. I BELIEVE THIS PROBLEM IS VERY WIDE-SPREAD AND I AM A VICTIM OF THIS ADVERSE REACTION WHICH HAS GOTTEN WORSE OVER THE MONTHS I'VE WORN INVISALIGN. ADDITIONALLY, I DISCOVERED COMPLAINTS ONLINE FROM 2012, WHERE PATIENTS HAD SEVERE MOUTH SORENESS AND ALLERGIC REACTIONS. INVISALIGN CUSTOMER SERVICE ADMITTED TO ME THEY HAD A PROBLEM WITH THEIR DISINFECTANT BUT DISCONTINUED USING IT IN 2012. THEY WOULD NOT TELL ME WHAT THEIR CURRENT DISINFECTANT IS NOR WOULD THEY PROVIDE ME WITH A PRODUCT SAFETY DATA SHEET SO I COULD KNOW WHAT INGREDIENTS WERE IN THE PLASTIC ALIGNERS. THEY MERELY TOLD ME THE ALIGNERS ARE MADE OF MEDICAL GRADE PLASTIC AND I SHOULD GET THE PRODUCT SHEET FROM MY ORTHODONTIST. ON (B)(6) 2016, I MET WITH MY ORTHODONTIST AND RELAYED THE INFORMATION ABOVE TO HER. SHE SAID SHE WAS NOT IN POSSESSION OF INVISALIGNER'S PRODUCT INGREDIENT/SAFETY SHEET EITHER. ALSO ON (B)(6), I NOTICED THAT WHEN I HAD THE INVISALIGNERS OUT FOR 60 MINUTES FOR LUNCH, MY TONGUE NO LONGER HAD THE BURNING/TINGLY SENSATION, BUT WH(B)(4)EN I RE-INSERTED THE ALIGNERS, MY TONGUE VERY QUICKLY GOT THOSE SENSATIONS AND BECAME RED ON THE TIP AND ALONG IT'S EDGES. THIS HAS OCCURRED WITH THE NEWEST ALIGNER (#20) AND I CAN SAFELY CONCLUDE THAT THIS BURNING/ALLERGIC REACTION HAS BEEN GOING ON SINCE I BEGAN INVISALIGNERS ON (B)(6) 2016. THE ONLY RELIEF I HAVE IS WHEN MY ALIGNERS ARE OUT OF MY MOUTH FOR 2 HOURS TO EAT MY MEALS EACH DAY. THE REMAINING 22 HOURS/DAY I AM NOW HOLDING MY TONGUE AGAINST THE ROOF OF MY MOUTH TO KEEP IT AWAY FROM THE PLASTIC OF THE ALIGNERS, BUT THIS IS A HIGHLY ABNORMAL WAY TO MAINTAIN MY MOUTH/TONGUE. TODAY, I CAME UPON THE ONLY RESEARCH PAPER DONE SO FAR ON ADVERSE REACTIONS WITH INVISALIGNER PRODUCTS. (B)(4).