Description of Event or Problem · 0
CONSUMER COMPLAINT AGAINST INVISALIGN I AM AN INVISALIGN USER. I AM ALSO AN EXECUTIVE WITH A MEDICAL DEVICE COMPANY. I HAVE HELD EXECUTIVE-LEVEL MARKETING, SALES, AND STRATEGY ROLES AT COMPANIES SUCH AS ABBOTT, EDWARDS, AND TERUMO. I BELIEVE INVISALIGN IS ENGAGED IN FALSE AND MISLEADING CONSUMER CLAIMS AND ADVERTISING. I ALSO BELIEVE THE COMPANY'S EFFICACY DATA IS INCONSISTENT WITH FDA STANDARDS. A BYPRODUCT, I THINK, OF THE COMPANY MAKING INVISALIGN PRODUCTS AVAILABLE TO GENERAL DENTISTS WHO LACK THE TECHNICAL TRAINING TO CLINICAL ADVICE TREATMENT. I STARTED MY INVISALIGN JOURNEY IN 2022. UPON THE INITIAL SCAN OF MY TEETH, I WAS TOLD I WOULD NEED TO WEAR THE "RETAINERS" FOR 16 WEEKS. OVER 1.5 YEARS PAST AND I WAS STILL GETTING WHAT THE COMPANY CALLS "REFINEMENTS." I WAS RELIGIOUS ABOUT WEARING THE PRODUCTS. NOW, TWO YEARS OUT (AND AFTER WEARING THE NIGHTTIME RETAINERS DAILY) MY TEETH ARE NEARLY BACK TO THE PRE-ALIGNER STATE. I BELIEVE THE COMPANY KNOWS THAT THEY "BAIT AND SWITCH" USERS INTO THINKING THAT THE EXPERIENCE WILL BE SHORT AND SWEET. BUT AS I SPOKE TO THE STAFF AT MY DENTIST OFFICE, I AM TOLD THIS IS A NORMAL DYNAMIC. THE COMPANY SAYS "X WEEKS,' AND THE REALITY IS MORE LIKE "X TO THE THIRD OR FOURTH POWER." YES, IT WAS NOT A GOOD USE OF MY $(B)(6). BUT MORE THAN THAT, I THINK THE COMPANY MUST KNOW THAT Y% OF THEIR CUSTOMERS EXPERIENCE THE INITIAL PROGNOSIS. I ALSO BELIEVE THERE IS SOMETHING UNLAWFUL ABOUT THE MODEL. I MADE THE MISTAKE OF GOING TO MY LOCAL DENTIST, WITH HIS PROUD "SILVER LEVEL INVISALIGN IMPLANTER" PLAQUE PROMINENTLY DISPLAYED (BY THE WAY, THIS IS A MARKET-DEVELOPMENT/BUSINESS-DEVELOPMENT TOOL, NOT A PATIENT EDUCATION ELEMENT AND SOMETHING THE FDA SHOULD LEAN-IN ON). HE OFFERED ZERO TECHNICAL GUIDANCE. AND THAT MEANS THAT THE PRESCRIPTION OF THE PRODUCT ITSELF IS REMOTE AND SOFTWARE-BASED. THEY SCAN, SEND THE DATA TO A PROGRAM THAT REALLY DOESN'T WORK, AND THE LOCAL, LIGHTLY TRAINED DENTIST SIMPLY INPUTS DATA. THE DENTIST IS THERE TO PLACE/GLUE ANCHORS. THAT IS IT. I SUSPECT THE EXPERIENCE IS VERY DIFFERENT IN AN ORTHODONTIST OFFICE WHERE THERE IS MORE CLINICAL DEPTH. I AM CERTAIN THAT THE BUSINESS MODEL DRIVES A LOT OF REPEAT BUSINESS BECAUSE THE RESULTS TO NOT LAST. I COME FROM THE WORLD OF HEART VALVES, TAVR, AND MITRACLIP WHERE POOR EFFICACY RESULTS IN PATIENT DEATHS. I ASK THE FDA TO INVESTIGATE INVISALIGN ACROSS THREE AREAS: 1. FALSE AND MISLEADING CLAIMS RELATING TO THE INITIAL/ESTIMATED PATIENT JOURNEY (CONVENIENCE, COST, ETC.) 2. FALSE AND MISLEADING CLAIMS REGARDING CLINICAL DURABILITY 3. EXTENDING THE CLINICAL GUIDANCE TOO FAR (GENERAL DENTISTRY VS. ORTHODONTICS).