PALATAL EXPANDER

Description of Event or Problem

I AM A 62-YEAR-OLD MALE WHO RECEIVED ORTHODONTIC TREATMENT FROM (B)(6), DOCTOR OF DENTAL SURGERY FROM (B)(6) 2017 TO (B)(6) 2020. DR. (B)(6) USED A PALATAL EXPANDER FOR ABOUT A YEAR WITH THE INTENTION OF MOVING MY TEETH TO EXPAND MY PALATE TO CREATE MORE BREATHING SPACE IN MY MOUTH TO REDUCE BREATHING ISSUES WHEN I SLEEP. UNFORTUNATELY, THE PALATAL EXPANDER AND MOVEMENT OF MY TEETH RESULTED IN SEVERE SIDE EFFECTS, INCLUDING ROOT RESORPTION THAT KILLED THE ROOTS OF MY FRONT 8 TEETH. THAT NECESSITATED TREATMENT FROM A PERIODONTIST AND PROSTHODONTIST THAT REQUIRED THE EXTRACTION OF THOSE 8 TEETH PLUS 6 DENTAL IMPLANTS AND THE INSTALLATION OF AN IMPLANT BRIDGE. IT'S BEEN A 2.5 YEAR PROCESS TO MITIGATE THE NEGATIVE EFFECTS OF THE PALATAL EXPANDER TREATMENT. I'VE HAD TO WEAR TEMPORARY FALSE TEETH (AN ESSIX TRAY) DURING MUCH OF THE TREATMENT PERIOD, AND IT HAS COST ME ABOUT (B)(6) ON TOP OF THE ORIGINAL ORTHODONTIC COSTS PAID TO (B)(6). I HAVE SINCE BECOME AWARE OF REPORTS THAT THE FDA IS INVESTIGATING THE USE OF PALATAL EXPANDERS IN ADULTS, WHICH HAVE NOT BEEN CLEARED OR APPROVED BY THE FDA. SOME REPORTS EXPLAIN THAT PALATAL EXPANDERS CAN BE USED SAFELY AND SUCCESSFULLY IN CHILDREN - WHOSE UPPER JAWBONES TYPICALLY AREN'T DONE GROWING UNTIL THEIR LATE TEENS - BUT NOT FOR ADULTS WHOSE JAWS HAVE ALREADY FUSED. SOME OF THOSE REFERENCES ARE: HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/SAFETY-COMMUNICATIONS/EVALUATION-SAFETY-CONCERNS-CERTAIN-DENTAL-DEVICES-USED-ADULTS-FDA-SAFETY-COMMUNICATION. HTTPS://WWW.FIERCEBIOTECH.COM/MEDTECH/FDA-BEGINS-INVESTIGATION-UNAUTHORIZED-DENTAL-DEVICE-SPARKED-LEAST-20-LAWSUITS. HTTPS://WWW.ABOUTLAWSUITS.COM/AGGA-LAWSUIT/COMPLICATIONS-AGGA-APPLIANCE-FDA-EVALUATION/ IF YOU HAVE ANY QUESTIONS OR IF I CAN ASSIST YOUR INVESTIGATION, I'D BE HAPPY TO SPEAK WITH YOU (B)(6).