Description of Event or Problem · 1
MY FORMER ORTHODONTIST, (B)(6) DDS OF (B)(6) PRESCRIBED INVISALIGN ALIGNERS TO COSMETICALLY STRAIGHTEN MY TEETH. IT IS THIS MEDICAL DEVICE AND MY ADVERSE EVENT TO THE DEVICE TO WHICH I AM COMPLAINING. AFTER MORE THAN TWO YEARS OF INVISALIGN TREATMENT, MY TEETH WERE NOT STRAIGHTEN AND MY JAW JOINTS HAD BECAME VERY PAINFUL. DR. (B)(6) ATTRIBUTED THE FAILURE OF THE INVISALIGN SYSTEM TO MY OWN LACK OF DILIGENCE IN THE DAILY APPLICATION OF THE PRODUCT. SEVERAL YEARS AFTER I STOPPED USING THE INVISALIGN ALIGNERS, MY TEETH LOOKED WORSE THAN BEFORE THE INVISALIGN TREATMENT AND MY JAW JOINTS WERE PAINFUL AND CONTINUOUSLY FALLING OUT OF JOINT; THEREFORE, I VISITED FIVE DENTISTS/ORTHODONTISTS/MAXILLOFACIAL SURGEONS/RADIOLOGIST IN (B)(6) AREA. THEY ALL EVALUATED MY DENTAL AND JAW CONDITION AND DETERMINED THAT MY DENTAL AND JAW JOINT CONDITION IS SO SEVERE THAT I REQUIRE MAJOR SURGERY TO ATTEMPT TO REPAIR AND/OR MY JAW AND DENTAL PROBLEMS. NEITHER I OR MY PHYSICIANS WERE ABLE TO GET MY MEDICAL RECORDS FROM DR. (B)(6) AND/OR ALIGN TECHNOLOGY INC. EVENTUALLY, DR. (B)(6) SPOKE ONLY WITH MY CURRENT TREATING ORTHODONTIST, DR. (B)(6), AND PROVIDED HIM WITH ONLY FOUR X-RAY IMAGES. MY FORMER DENTIST IN (B)(6) PROVIDED ME WITH A COPY OF A PRE-TREATMENT ONE PAGE LETTER FROM DR. (B)(6) TO HIM. THE FOUR IMAGES AND THE SINGLE PAGE LETTER ARE MY ONLY REMAINING RECORDS FROM MY INVISALIGN TREATMENT PLAN. THE FOUR IMAGES AND THE CONTENT OF THE LETTER CLEARLY INDICATE THE SERIOUSNESS OF MY DEGENERATIVE JAW JOINTS AND A SEVERE DENTAL PROBLEM. AGAIN, THESE ARE THE ONLY RECORDS THAT (B)(6) AND/OR ALIGN TECHNOLOGY WOULD PROVIDE AND THEY ARE CONCEALED FROM ME FOR SIX YEARS. DURING TWO YEARS OF RECENT WIRE AND BRACKET ORTHODONTIA TREATMENT UNDER DR. (B)(6) , I LEARNED THAT ALIGN TECHNOLOGY HAS BEEN REPRIMANDED BY THE FDA FOR NON-DISCLOSURE OF ADVERSE REACTION REPORTS. I ALSO LEARNED THAT A CLASS ACTION LAWSUIT WAS BROUGHT BY THE ALIGN LICENSED PRESCRIBERS AGAINST ALIGN TECHNOLOGY FOR UNFAIR TRADE PRACTICES; THEREFORE, BECAUSE OF THE ADVERSE NATURE OF BOTH CASES I DETERMINED THAT THERE MIGHT BE INFORMATION THAT COULD HELP ME AND/OR MY PHYSICIANS BETTER EVALUATE MY CONDITION. UNDER THE FOIA I REQUESTED AND RECEIVED ALIGN TECHNOLOGY¿S 510K DURING (B)(6) 2011 AND IT WAS THEN THAT I FIRST LEARNED THAT THERE HAD BEEN CONTRAINDICATIONS.