Invisalign Invisible Braces Linked to Reports of Serious Allergic Reactions

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By: Staff Writers | Published: December 8th, 2010

Federal investigators have issued a warning to the makers of Invisalign for a failure to notify the FDA about potential problems with their invisible braces, which have reportedly caused some users to suffer extreme allergic reactions. 

The FDA Invisalign “invisible braces” warning letter was issued last month and accuses Align Technology, Inc. of failing to pass on adverse event reports to the agency in a timely manner. Some of the complaints, which include incidents of severe allergic reactions that have required hospitalization in some cases, date back to November 2007, but were not reported to the FDA as required by law.

According to the warning letter, allergic reactions to Invisalign braces reported by users include swollen and irritated lips, sore throats, a burning sensation on the tongue, ulcerations in the mouth and swollen lymph nodes. In some instances Invisalign side effects led consumers to stop using the braces.

Federal regulations require medical device and drug companies who receive consumer complaints regarding potential side effects of their products to forward those adverse event reports on to FDA within 30 calendar days of receiving them or otherwise becoming aware of the incident.

In a response to the letter, Align Technology said in a press release that it was attempting to fully comply with the FDA’s concerns, that they are turning over all copies of documentation requested by the agency and that they want to resolve the issue “with minimal impact on the company.”

Align Technology claims that the Invisalign system has been used by more than 1.3 million people since it received FDA approval in 1998. The product line includes Invisalign, Invisalign Teen, Invisalign Assist, Invisalign Express and Vivera Retainers. It was not clear from the warning letter which Invisalign products were associated with the reported problems and which were not.

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There Are 11 Comments So Far • (Add Your Comments)

  1. Afer using Invisalign for two years, in December 2010, the first incident, I awoke to severely swollen lips and face. I had chapped lips, cracked and bleeding mouth corners, a burning, tinling sensation of the tongue. This condition continues today with the addition of the inside of my mouth and gums are bleeding and so inflamed and I do not want to brush my teeth or rinse. My skin itches. This condition has continued with lessening and worsening until today.
    I went to an allergist and was tested for food allergies. Negative. I have gone to two other doctors. I have restricted my diet, kept food intake logs. I am frustrated and fell horrible.
    The last doctor has suggested I no longer use the aligners. This is day 3 and the condition seems to be lessening however I have been told by the doctors that it could take a month for all symptoms to disappear.
    Why was I or my dentist not notified by Invisalign that this condition could occur? How did they get FDA approval?

    In December 2010 I received my first mailed-directly-to-me replacement aligners from Invisalign via Mexico. Then my nighmare began.

  2. I’m sorry that you didn’t yank those suckers out of your mouth at the first sign of trouble. That’s what I did when I began to cough inexplicably. I asked myself, “what is different that could be causing this cough?” The only difference was the Invisalign plates. I immediately discontinued use. I showed my ortho the many complaints about this product, he contacted the company and they replaced the trays with their hypoallergenic version which gives me no trouble. I would go to acupuncture or a naturopath or someone who can help strengthen your immune system as soon as possible. Good Luck.

  3. Hi Beverly, i had been using invisalign since Nov 2011. In December i had the most awful cold and flu like symptoms with a hacking cough. I was ill continuously for the next 5 months with excruciating headaches, coughing and a feeling of fluid on my chest. I went to the docs 3 times (i just thought i had a recurring cold). I was prescribed a course of antibiotics which i took reluctantly as i had not taken them for years as i prefer to let my own immunity fight a cold. But i was so rough that i needed something. I know that normally within a day or so, you start to feel better with antibiotics – but as directed I took the whole course. I was no better. I could not exercise and was short of breath performing activities that would normally be a breeze. The final straw came this spring when i attempted a bike ride with my husband. I believe i had what can only be described as an asthma attack. Eventually I took my aligners out for 48hours at one point and realised there was an improvement. I have since returned to the dentist with my issue. He tells me that this has occurred in only 0.1% of circumstances. My health has improved dramatically in the 2 months that i have not worn the aligners. I am now wearing a standard retainer. My dentist now tells me the only option is fixed braces. This is not an option or me as I want invisible ones as per the value proposition sold by Invisalign. He tells me that Invisalign dont do hypoallergenic versions. So, Beverly I am keen to know how you managed to get the hypoallergenic versions. Can you let me know.

  4. Karen,
    I had the same symptoms as you can they couldn’t figure out what was wrong with me. They thought I had cancer bc I had swollen lymph nodes all over my body some the size of a golf ball. I had extreme fatigue to the point I couldn’t go to work or get out of bed so then they thought it was mono but it wasn’t. I spent 2 yrs going to doctors- hematologist, ent, rheumatologist, cat scans,X-rays and they all showed nothing. I felt no one believed me anymore. On top of it all I then started suffering with extreme gastrointestinal issues. I had refused to go to more specialists bc I just couldn’t deal with it. I heard from a friend whose brother is going through the same exact thing as me and she called me to tell me it happened as soon as he began Invisalign. I almost fainted and then realized that my symptoms were at that time as well. I’m so upset that there’s no documentation about this so I called my dentist today and he says he’s never heard of this at all and he didn’t offer me any hypoallergenic options bc he said this reaction was not possible. I showed him all of this info and he doesn’t believe me… Very interesting. I’m contacting the FDA and will get to the bottom of this bc no one should ever go thorough what we all did. I spent months on diff. medications, had to be put on steroids bc my throat was closing and thought out all theses treatments nothing worked.

  5. Like some of you, the first symptom I had was a horribly dry mouth I could not relieve. I felt perhaps there was some type of residue on the braces so soaked them in Retainer Brite. The dry mouth continued so I tried soaking in a solution of vinegar and warm water. Nothing seemed to change. Over months the dry mouth became less of a problem but I developed a cough. At first I thought it was environmental allergies but the cough continued on to the point that I visited my primary care physician. She gave me all the prescription medications which have cured any cough in the past. The cough continued. We went on a short vacation and one night I forgot to wear the Invisaligns. Magically, within less than 24 hours, my cough was gone. Because I already have two autoimmune diseases, I don\’t want to risk putting whatever chemicals there are in the Invisaligns in my body any longer. I\’m very disappointed my dentist didn\’t warn me in advance about all the possible side effects.

  6. Hey Guys,

    Thanks for all the messages above, now I know my invisalign might be the root cause for my severe allergic reactions. I tried braces first however I had ulcers, then I tired Invisalign, initially it was good and I thanked GOD that I have some fix for my teeth. however I was always getting ulcers in my mouth etc and it was manageable. but since 1 week my cold, sneezing and runny nose is so bad, I am totally exhausted, I was scared that I had asthma. very scared to see bleed in my nose some times. few hours back I removed it. let me see for few days if it can fix the issue. BTW I see that someone said they have hypo allergic ones, if it is there, could you please let me know.

  7. I tried the Invisaligns for about five months. Almost immediately, I started having asthma-type problems, a sore throat, and had swollen lymph nodes in my neck. I always felt like I was walking through a smoky room (I have never smoked in my life.) My doctor ran several tests, and my eosinophils (sp?) were elevated. I stopped using the aligners at that time (almost five months ago), and my eosinophils returned to normal. However, my body is still reacting. I still have the “smoky room” feeling in my throat and esophagus, and asthma problems. (I have had exercise-induced asthma in the past, but it always went away when I was in good shape (which I’m in now).) My swollen lymph nodes gradually returned to normal, but it took several months.

  8. I haven’t wore my invisalign in a while so I clean them and I put them back in. Then I felt like my breathing went shallow like slow. Then my chest felt like I had an elephant sittimg on my chest. Pretty scary feeling. And the thing is the invisalign never madse me feel like this. And I don’t have an allergies.

  9. I started invisalign almost 2 years ago. On day two of my first tray I had a sore throat/ear pain/swollen neck lymph nodes. These symptoms re-occurred about 5-6 times in the following months, and my lymph nodes started getting bigger. I’m not an allergic person and never had asthma, so I didn’t even think about the connection with the trays. I thought I was getting run down by work/stress, and under advice of my doc I got tested for HIV/lymphoma/glandular fever etc – all negative. I decided to stop worrying about this until I changed my tray one day and got 4 mouth ulcers and the symptoms again with crazy swollen painful neck and jaw lymph nodes, and that’s when I realized that it was the invisalign causing these problems. I spoke to my otho and he brushed it off saying it was impossible as he never heard of it. So I continued the treatment for another 6 months- at which point one of my neck lymph nodes got to the size of a walnut, and excruciatingly painful. I have recently stopped invisalign as I though this was really affecting my health – my teeth feel very uncomfortable without the retainers as they have been moved for over a year and now cannot settle… my lymph nodes are less painful but still big, and I suspect will be so for a few months at least… what a complete and utter nightmare- I wish I had never embarked in this treatment or was advised correctly as soon as I started having these problems!!! Glad I am not alone, though…

  10. I used Invisalign trays around 2003-2004 and have been using the Vivera retainers since completion during the night. The beginning of June this year, the soft tissues in my mouth (mostly my upper and lower lip) maintained a gradual swelling over the course of almost two weeks. Along with the swelling, I experienced a burning sensation on my tounge as well as on my lips. I saw my allergist, my pcp and a GI. So far, everything has checked out fine. I was suggested to stop use of my trays and was placed on a 5 day treatment of Prednisone, though the swelling was still unexplained. My symptoms resolved after two weeks of the irritation without the use of the trays.

    After nearly a week without the irritation, my teeth grinding prompted me to use the tray again (unaware at this time the tray had caused the issue). The following day, the tissues in my lower mouth began a tingling sensation and presumed to enlarge again! Though not as bad as the initial reaction, it is so frustrating. It has been two days and nights without the retainer and the swelling and irritation has maintained. I have an appointment with my dentist this Friday and have placed a call to my allergist again.

    I am almost certain that the trays have caused this reaction now. What if anything can be done about this? SO frustrating.

  11. I am so glad I made this connection and searched this after a sleepless night from a mysterious allergic reaction. I started invisalign 2 days ago. Yesterday, I started getting irritated areas on my tongue and swollen lymphs. But days end…my tongue had swollen and I was getting itchy all over. Calling my ortho 1st thing and getting a refund. Thanks to all for your posts.

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