MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC INVISALIGN; ALIGNER, SEQUENTIAL

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Sensitivity of Teeth (2427); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/07/2020

Event Type  Injury  

Event Description

I started using invisalign and was not able to sleep with it.During day time i will be totally fine.At night time, it will cause severe burning in mouth few hours into the sleep.My dentist keep telling me it needs time for mouth to get used to it but it wasn't getting any better.I went onto 3rd tray when i started to research on my own and discovered burning mouth syndrome is a thing it is caused by invisalign.At this point we stopped invisalign treatment but permanent damage had occurred and my teeth which were originally perfect, now had gaps and bite alignment had functionally messed up.I couldn't even talk properly as my top and lower front teeth would sometime collide which was terrible.Now a year has passed and my bite is still far from perfect (functionally), although there is progress but really slow and i still have teeth pains regularly, as an engineer myself who works in medical device company (independent), i know medical devices are required to do risk analysis to show what can go wrong and how to mitigate and prevent it.As i learned the hard way with invisalign, it turns out allergic reactions can take place with invisalign which puts patient in terrible state because they make permanent changes in teeth already like filing teeth and literally creating gaps between teeth (i don't understand why and they don't tell us this up front).A reasonable solution is that invisalign offer patients to try a tray for a week or two without moving their teeth (until patient is comfortable to sleep with them and doesn't report any issues).This will ensure that they trays don't cause unknown allergic reactions.The fact they don't do that is incredibly irresponsible and seems to be driven by profits.Because from what i have seen, even dentists don't know about these allergic reactions (in my case) and they don't understand how to respond to them.I am shocked how this business is conducted in such irresponsible manner putting well being of patients at serious risks.I am wondering, they don't do risk analysis? they don't even tell patients or doctors the risks? how come these risks are never told to patients like me before hand? where are the fault lines in this business when the patient don't get the right info about real risks? i understand that fda has issued burning mouth syndrome warning with invisalign way back somewhere around 2011 but the reality is that these allergic reactions with invisalign vary so much and much more complex.Most doctors don't know how to deal with them like in my case and the result is that patients like me suffer with health, emotionally and even financially.I urge fda to impose heavy fines on invisalign and mandate them to offer what i would call zero tray, a tray that a patient can wear as a trial without moving teeth for at least a week so they know it doesn't cause any adverse reactions.If there was an adverse reaction, they can simply abandon it without paying any health penalty and misaligning their teeth.In my case because my teeth were moved unto 3rd tray and then i had no choice but stop the treatment, it left my bite in the middle of no where misaligned.This is an extremely serious risk.I am still suffering.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC
• MDR Report Key: 11506813
• MDR Text Key: 240739383
• Report Number: MW5100053
• Device Sequence Number: 1
• Product Code: NXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR
• Patient Weight: 82