Description of Event or Problem · 1
I AM A HEALTHY FEMALE WHO STARTED USING INVISALIGN IN THE SPRING OF 2010. WITHIN 3 WEEKS OF STARTING INVISALIGN, I STARTED EXPERIENCING SEVERE SORE THROAT THAT MADE ME UNABLE TO SWALLOW. AT THE SAME TIME, I ALSO STARTED HAVING AN EXTREMELY IRRITATED MOUTH AND LESIONS GRADUALLY APPEARED IN MY MOUTH CAUSING BLEEDING GUMS AND SEVERE IRRITATION ON THE INSIDE CHEEKS, SINCE THE TRAYS WERE CREATING FRICTION. MY TONGUE BECAME NOTICEABLY SWOLLEN. WITHIN 3 MONTHS, I STARTED HAVING EAR PAIN, JAW BONE PAIN, EAR PRESSURE, DIFFICULTY SWALLOWING, EAR RINGING, DIZZINESS, NECK SPASMS. IT WAS SUGGESTED TO ME THAT I COULD BE HAVING AN ALLERGIC REACTION TO A PRODUCT THAT WAS APPLIED ON THE TRAYS AND THAT I SHOULD "AIR THEM OUT" AND THOROUGHLY RINSE. I DID SO BUT THE PAIN REMAINED. WITHIN 4 MONTHS, I HAD STARTED HAVING SEVERE MIGRAINES - WHICH I HAVE NEVER HAD PREVIOUSLY, I THEREFORE DECIDED TO CONSULT MY GENERAL PRACTITIONER WHO RAN COMPLETE BLOODWORK, PHYSICAL EXAMINATION AND SUGGESTED THAT INVISALIGN MAY BE CAUSING THESE PROBLEMS SINCE I HAD NO MEDICAL ISSUE WHICH COULD EXPLAIN THESE PROBLEMS. I WAS REFERRED TO THE FOLLOWING SPECIALISTS: ORL, DENTAL SURGEON, DENTIST, PHYSICAL THERAPIST, DID A CT SCAN OF THE NECK AND COUNTLESS PROVIDERS AT A GREAT COST. ALL BELIEVED THAT UNLESS I STOPPED USING INVISALIGN PERMANENTLY, THE PROBLEM WOULD CONTINUE AND POSSIBLY WORSEN. INVISALIGN HAS BEEN STOPPED BUT THE SYMPTOMS, ALTHOUGH REDUCED, CONTINUE DESPITE NOT WEARING THE TRAYS FOR THE PAST FEW MONTHS. THIS DEVICE HAS CAUSED ME GREAT PHYSICAL PAIN, FORCED ME TO TAKE NUMEROUS SICK DAYS AS A RESULT OF THE MIGRAINES, EAR PAIN, NECK SPASMS AND JAW PAIN, HAS COST ME HUNDREDS OF DOLLARS IN COPAY AND MEDICAL/ALTERNATIVE SERVICES NOT COVERED BY MY INSURANCE. IN ADDITION, THE TREATMENT DID NOT MOVE MY TEETH AS PLANNED, DESPITE WEARING IT AS INDICATED - 20 HRS PER DAY - SO I WOULD NEED TO DO ADDITIONAL "REFINEMENT" TREATMENTS, WHICH WOULD ONLY EXACERBATE MY CURRENT PAIN. THIS PRODUCT IS A COMPLETE DISASTER. MY HEALTH WAS FINE BEFORE I STARTED USING THIS PRODUCT. MY ONLY PROBLEM WAS CROWDED TEETH. ALMOST A YEAR LATER, I HAVE THE SAME CROWDED TEETH AND DEBILITATING PAIN - DESPITE FOLLOWING DILIGENTLY THE TREATMENT. PEOPLE SHOULD THINK TWICE BEFORE USING THIS. DOSE OR AMOUNT: 1 TRAY, FREQUENCY: CHANGE AFTER 2 WKS. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CROWDED LOWER TEETH. EVENT ABATED AFTER USE: NO.