Description of Event or Problem · 0
I AM WRITING WITH AN ALLEGATION ABOUT A DENTAL DEVICE CALLED THE ANTERIOR GROWTH GUIDANCE APPLIANCE (AGGA) AND CONTROLLED ARCH BRACES (CAB). I SUFFERED INJURIES FROM THIS TREATMENT, WHICH ARE THE SUBJECT OF A PRODUCT LIABILITY LAWSUIT IN FEDERAL COURT IN WHICH I AM A PLAINTIFF. CBS NEWS AND KAISER HEALTH NEWS ENGAGED IN A JOINT INVESTIGATION ON THIS APPLIANCE, IN WHICH THE REPORTERS COULD NOT FIND ANY FDA APPROVAL FOR THE AGGA APPLIANCE (HTTPS://WWW.CBSNEWS.COM/NEWS/AGGA-DENTAL-DEVICE-LAWSUITS-TEETH-DAMAGE/). FROM 2018-2020, I WAS TREATED WITH THE AGGA APPLIANCE AND WITH CONTROLLED ARCH BRACES (CAB). MY PROVIDER WAS A GENERAL DENTIST IN (B)(6) WHO WAS TRAINED BY THE (B)(6). MY PROVIDER ATTAINED A TREATMENT PLAN AND RADIOLOGY REPORT FROM DR. (B)(6)'S (B)(6) CORPORATION, VIA ITS SUBSIDIARY, (B)(6) INSTITUTE. THE APPLIANCE WAS PRESENTED AS A TREATMENT FOR SLEEP DISORDERS SUCH AS OBSTRUCTIVE SLEEP APNEA AND UPPER AIRWAY RESISTANCE SYNDROME. IT WAS ALSO SUPPOSED TO GROW MY MAXILLA (UPPER JAW) FORWARDS. THE APPLIANCE DID NOT GROW MY UPPER JAW OR IMPROVE MY OBSTRUCTIVE SLEEP APNEA. MY INJURIES INCLUDE ROOT RESORPTION, GUM RECESSION, DAMAGE TO THE ALVEOLAR BONE, PAIN, AND A POSTERIOR OPEN BITE MAKING IT IMPOSSIBLE TO CHEW NORMALLY. MORE INFORMATION CAN BE FOUND IN MY LEGAL COMPLAINT (B)(4). THE COMPLAINT CAN BE FOUND AT THIS LINK: (B)(4). I CALL ON THE FDA TO INVESTIGATE THE AGGA APPLIANCE, TO REMOVE IT AND ALL SYNONYMOUS DEVICES FROM THE MARKET, AND TO PUNISH ANY PARTY WHO HAS VIOLATED THE LAW THROUGH THE MARKETING AND SALE OF THIS DEVICE. I UNDERSTAND THAT THE FDA IS ALREADY LOOKING IN TO THE AGGA APPLIANCE. I WILL ADDITIONALLY NOTE TO THE FDA THAT THE SECOND PHASE OF AGGA TREATMENT (CONTROLLED ARCH BRACES) IS ALSO HARMFUL. CONTROLLED ARCH BRACES SEEK TO EXPAND THE DENTAL ARCHES, BUT PREVIOUS RESEARCH ON EXPANSION ORTHODONTICS HAS SHOWN THAT IT CAN CAUSE ALVEOLAR BONE LOSS, WHICH WAS SHOWN IN A DIFFERENT PRODUCT CALLED "DAMON BRACES" (HTTPS://PUBMED.NCBI.NLM.NIH.GOV/29911904/). AFTER AGGA PUSHES THE FRONT TEETH FORWARD, CREATING LARGE GAPS, CONTROLLED ARCH BRACES CLOSES THOSE GAPS WITH BRACES AND POWERCHAIN ELASTICS. THE RESULT IS THAT THE TEETH ARE SEE-SAWED FORWARDS AND BACKWARDS, MOVING LARGE DISTANCES. DR. (B)(6) HAS CREATED A VIDEO SHOWING AGGA CASES IN WHICH THE TEETH HAVE SUFFERED A "ROUND TRIP," CAUSING DAMAGE: YOUTUBE.COM/WATCH?V=XWQKI1LDW7G. CONTROLLED ARCH BRACES ALSO INVOLVES A FRLA APPLIANCE, A FIXED APPLIANCE WHICH CONNECTS TO THE MAXILLARY FIRST MOLARS AND IS MARKETED AS A PALATE EXPANDER IN ADULTS. THE FRLA APPLIANCE FLARES THE FIRST MOLARS OUTWARDS. FRLAS MAY BE USED ON THE MANDIBLE ALSO DURING AGGA. ANOTHER HARMFUL ASPECT OF AGGA TREATMENT IS THAT MOLAR PADS ARE PLACED TO OPEN UP THE BITE AND ALLOW THE MANDIBLE TO COME FORWARD. THE PADS ARE ALSO MARKETED AS A TREATMENT FOR TEMPOROMANDIBULAR JOINT DISORDER, SIMILAR TO SPLINTS. THESE MOLAR PADS CAN BE AS HIGH AS 5MM OR MORE. OVER TIME, THE FORCE OF THE MOLAR PADS CAUSES THE MOLARS TO INTRUDE DOWN INTO THE ALVEOLAR BONE. THIS CAUSES A POSTERIOR OPEN BITE WHICH IS DIFFICULT TO CLOSE WITH ORTHODONTICS. THE AGGA APPLIANCE, FRLA APPLIANCE, CONTROLLED ARCH BRACES, AND MOLAR PADS ARE ALL USED TOGETHER IN THE SAME TREATMENT, BASED ON A PSEUDOSCIENTIFIC PHILOSOPHY THAT PLACES LARGE FORCES ON TEETH AND RECKLESSLY DISREGARDS THE HEALTH OF THE ROOTS, ALVEOLAR BONE, AND OCCLUSION. IN ADDITION TO INVESTIGATING THE AGGA APPLIANCE, THE FDA COULD ALSO INVESTIGATE CONTROLLED ARCH BRACES, THE FRLA APPLIANCE, AND THE USE OF TALL MOLAR PADS. I HAVE INCLUDED PHOTOS OF THE AGGA APPLIANCE IN MY MOUTH, AND ALSO CONTROLLED ARCH BRACES, THE FRLA, AND THE MOLAR PADS. THANK YOU FOR YOUR CONSIDERATION. SINCERELY, (B)(6).