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Invisalign Invisible Braces Linked to Reports of Serious Allergic Reactions

  • Written by: Staff Writers
  • 75 Comments

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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75 comments

  1. MARTIN Reply

    My Dentist recommended Invisalign for TMJ my results have negative My bite has not been corrected and have been in severe pain

  2. maria Reply

    I posted a comment at 19th july 2016 about my nightmare with invisalign retainers. I had also a hard time getting an innofensive report about the symptoms I had when using the product. Finally I was given hypoalergenic retainers in the 5th of December.I falled immediatly in bed with flu ( coincidence) and at the second week my face was a furnace of skin rashes , swoolen eyes, itchy neck and fever.Conclusion: The hypoallergenic retainers are also heavily toxic.

  3. Jamie Reply

    I began Invisalign last year. About three weeks in my mouth and throat started to burn. I contacted my dentist and he assured me be had never heard of this before. I asked him if possible allergic reactions have been reported he said no. My mouth continued to get worse, then I got what seemed like the flu, migraines, foggy thinking, blurred vision, fatigue, stomach issues, lymphoids swollen and my hair started to fall out. All of these symptoms are still happening. I have contacted Invisalign and they said they will change the trays to the hypoallergenic trays well it’s still happening. I have been on antibiotic after antibiotic, mouth wash and even got referred to an oral surgeon. The only time it gets better is when I do not weare my Invisalign. I spent a lot of time, money and illness on this. I’m so close to being done but I can’t deal with feeling this way. I’m a single mom with two special needs children. I don’t want to feel this way I want my life back.

  4. Jeanette Reply

    I haven’t had Invisalign yet, but my dentist is encouraging me to get…and I’m doing my research on teeth, jaw, and joints…I need to straighten my teeth because they are shifting and they are interfering with my joints, ie locked hip, and effecting my walk. So…wow I’m really glad I came into this website, now I’m at a conundrum…

    Anyways, I ran into this website online: Ask for an “Aligner 0” to go back to “normal” for those having physicial issue with the change in teeth position…You can read it here. https://www.realself.com/forum/invisalign-the-worst-mistake-my-life

  5. LESLIE Reply

    Shortly after beginning to use Invisalign, I got a rash around my mouth which has now spread to a few other areas of my face, including under my right eye and on the outside edge of one nostril. Thinking it might be an allergy to the plastic, I asked my dentist to get an ingredient list for the product. Approximately two months into wearing the Invisalign trays, my hair started falling out. Related? Today I went to my allergy doctor who said I was allergic to the Invisalign trays.

  6. Sandra Reply

    I got first trays March 2016. Didn’t have much trouble, that I was aware was caused by the trays. I had been having headaches and neck spasms before the trays. After the trays the headaches became migraines, debilitating to say the least. At about tray 16 I noticed I was developing a rash around my mouth, in the corners and under the lower lip. Thought it was from the dry winter air. Tried everything to clear it up. I could feel the rash start burning. Did not equate it with the trays. It would go away partially and then I would feel the burning and know immediately that I would have a bright red semi-circle around my mouth. My tongue also started hurting and was irritated. It hurt even drinking water. The headaches were still persistent, and I was starting to loose my appetite as food tasted bad and it was increasingly difficult to chew, I developed stomach problems, a cough and dry heaves as a result. To top off all that, my dentist was never present when the trays were handed to me in the office and my attachments were never checked. I was on set 24 of 35 when I started complaining about the fit of the trays. At set 29 the dentist’s tech actually looked at my teeth and said that the alignment was off and took more impressions. When I went in to pick the next set up I was told that some of the attachments had been improperly placed and I needed some more attachments and would have to wear another 24 sets of trays. I, too, have sensitivities to the weirdest stuff and it got worse when I started this treatment. Never connected the two. Although I did have a bit of a reaction in the beginning just thought I was overreacting. But I did have bouts of facial hives, which I put down to stress and would take massive doses of Benadryl to counteract them. This seemed to work to alleviate the pain and anxiety that it caused to an extent, but I still did not equate the signs and symptoms with the trays. I did notice that as I went through the trays that they were getting dirty looking and discolored sooner and sooner. I started soaking them in Hydrogen peroxide after reading that 30 minutes or more would help clean the trays. When I had the tech take the impressions she said I would have to wear the current set, number 29 for another 3 weeks, which turned into 6 weeks by the time they received the new set of 24. I was concerned at that point about the bacteria and was soaking the trays every day. If the dental practice had been taking care of me properly some of this may have been avoided, but now after reading the stories of suffering and pain at this and several other sites, that I will not be going on with the treatment. It was a foolish idea I suppose to think that a medical professional would have my best interests at heart. The treatment cost $5,175, which I am of course still paying on. 🙁 Hopefully the dentist will give me some sort of refund and remove the attachments. Am going in tomorrow. Wish me luck.

  7. Teresa Reply

    I didn’t have a reaction for a couple of months but now my mouth feels like I rinsed with acid. Skin peeling off lips and even bled. Invisaligns screwed up my natural bite too. Thank God I have a great dentist. Lost a lot of sleep and caused me some major distress. Ortho didn’t disclose upfront how grueling it would be or the risk. Didn’t find out until I was to deep in to back out. Warning!!! False information about how easy and quick it is. Hope I haven’t compromised my health.

  8. Dawn Reply

    I just began the retainer treatment and it is obvious I have an allergic reaction to the plastic ones they offer. I now wasted a lot of time and money for me teeth to end up crooked again because back in the day they made all metal with gold retainers which my orthodontist says he cannot make.

  9. Heather Reply

    anaphylaxis from Invisalign – I had anaphalaxis reaction to the polyurethane and carcinogenic toxic isocyanate that makes up the tray material! I couldn’t breath! no one told me this could kill me! My throat swelled up, tight, heart racing, faint. It was horrible! I was scared! I was not warned this could happen! I went to the Invisalign website and it says they are non toxic..but that’s a lie. Im 39 and never had breathing problems in my life! why are these toxic ingretients not listed on the website? why wasn’t I told? The trays are taken out, no refund given on the trays, just more medical bills from the hospital visit. its beyond me that they would use this stuff in the mouth. Saying something is FDA approved doesn’t mean they went through product testing. I found reports on MAUDE (complaints reported to the FDA) showing MANY other people had been sent to the hospital because of difficulty breathing, sore throat, throat closing, dry mouth as well! For the billions Invisalign has made in profit they should offer organic materials. For example, use edible plastic made from seaweed. Its clear and can last 2 weeks before degrading. I know better than to put chemicals in my mouth. Especially cancer causing ones. This is probably why Invisalign makes it near impossible to find out what the trays are made of. Additionally, I read reports as far back as 2010 that the FDA warned Invisalign that the aligners were causing serious reactions in users. Ill never put that plastic back in my mouth ever again. Ill live with crooked teeth.

  10. carol Reply

    After 3 weeks of using Invisalign my voice changed. It has got a lot worse (I sound like a deaf person speaks). I can’t pronounce certain letters and I get out of breath when I speak. In addition I have had breathing and swallowing difficulties. I started the treatment in May 2018. I have since found out that there are life-threatening side effects to Invisalign! Had I known this I would not have taken the chance, and tried alternative orthodontic treatment (or none at all). As I haven’t had swelling or anaphylaxis I have continued with the treatment but I am now considering stopping it.

  11. Sarah Reply

    I started Invisalign and my TMJ pain got very severe with the 1st tray the pressure was awful- I was told I would have some pain so tried to push through – I looked up online and asked the Dentist- after trying muscle relaxers and pain meds my face neck and jaw pain got worse and the pressure in my sinuses was really painful then my nose started bleeding and cracked inside In several areas – I have a large scabs come out everyday now
    I had to stop treatment after 1 week and now 5 days later no relief from the TMJ pain
    Still on muscle relaxers and pain medicine
    They are removing the attachments Friday
    I feel like they should’ve looked into this further before letting me purchase the invisaline as I answered the questionnaire as having TMJ Even though I was not having any symptoms prior to starting

  12. kerry Reply

    Started invisalign a few months ago. First 2 weeks seemed OK but within a few days of tray #2 I began to have ulcers in my mouth. I have had this issue in the past but nothing like this! I noticed the tray itself has sharp edges that cut the underside of my tongue. I stopped using the appliance thinking I would heal and then try again. The “buttons” that are placed on my teeth are also cutting into my oral mucosa. I’m going on around 5-6 weeks of constant outbreaks of excruciating ulcers, swollen lips. I am horribly fatigued just from dealing with the pain. Every time I start to heal from one outbreak another starts. I have had up to 4 ulcers in every part of my mouth and tongue at the same time (unprecedented). I seem to also have a gum infection in one area that I manged wuite well before with daily flossing etc. I have had swollen lymph nodes which I assumed was my immune system trying to deal with the overwhelming tissue damage, but now I have laryngitis (never had it in my life and I am 61). I am normally a very healthy athletic woman with lots of stress management skills but this is really upsetting. I see the dentist tomorrow, and I am pretty much DONE. Especially after reading all of this. I guess crooked teeth are part of my destiny. Of corse I have already paid 5000$!

  13. Marie Reply

    My daughter just spent 3 days back and forth to the ER for Epi shots, steroids, iv’s and other antihistamines due to Invisalign. The dentist never spoke of any possible side effects/reactions to this product. If she was not able to get to the ER those 3 times in 3 days, I could be reporting a fatality. Do not take any meds. medical devices without finding out any potential reactions. I thank God she is ok but her 4 young children and husband are also a wreck looking at what could have been a fatal outcome.

  14. Suzanne Reply

    I had invisalign for 9 months and had severe allergic reactions that my dentist said was impossible to react a month out. Almost died. Went to hospital 3 times, told doctors they basically laughed it off.Five years later now an autoimmune disease as my body couldn’t deal with 9 months of hives, facial swelling, itch that was so bad.

  15. Jill Reply

    I was a healthy person prior to my use of invisalign. When I began use I came down with an upper respiratory illness, cough and sinus issues. My mouth was cut by the trays and I would have to saw the trays down and apply wax. My mouth was bleeding and sore. My dentist worked with me to continue.
    Before long I became sullen, pale and my hair became very thin and brittle. Even my skin became tough and I had terrible nausea and abdominal pain. I proceeded to have an elevated lipase and was hospitalized for pancreatitis. I was a healthy, normal weight full time working woman prior to this. I live a no alcohol healthy lifestyle. I ended up having my gall bladder removed but continued to have pancreatitis.
    When I realized I was either allergic to or being poisoned by the plastic trays in my mouth I removed them immediately one night when my heart was beating so slowly I thought I would die.
    I had a small intestine biopsy which showed unexplained allergic reaction. When allergy tested at a later date I am not allergic to anything else.
    My health is compromised to this day and I continue to have abdominal pain and nausea but my color is improved and my hair has recovered and my skin. I wish my dentist had known to have me stop use when I became so gravely ill.

  16. Rose Reply

    I’ve had Invisaligns for 9 months. When I began I was completely healthy and competing in dance competitions. 3 months into the Invisaligns, I start getting tired, itchy skin, hair loss, sore throat, no more strength to do my dance competitions, muscle soreness, diarrhea. I went to several doctors and it took 6 months to find that it is the thyroid/autoimmune disease. I did some googling and found other people saying it is a side effect of the Invisaligns.

  17. Karen Reply

    I wore Invisalign several years ago. I wore all of the different trays that were given to me each time for the changes to be made. I finally had to stop because I felt like my left side of my mouth ( gum line) was always hurting. Told my dentist & he didn’t say much. Went to an oral surgeon , who looked at my mouth & gums & said I don’t see a thing wrong. On to a periodontist who again said I see nothing wrong. So after many years now Ive been suffering with a constant burning on the left side. Had I known that Invisalign could have caused this I would have immediately stopped wearing the trays. Now what to do??

  18. Sonia Reply

    I developed post nasal drip, allergies and rapid heart beats due to Invisalign. I always sound like I have a soar throat. After I developing all these symptoms I looked online and realized others have too.

  19. Regrets Reply

    Don’t do it, prioritise your physical health over beauty
    I am 18 trays into my treatment of invisalign. I had dizzy spells ever since i started wearing it but i ignored it cause it wasnt too bad. Until now. My dizzyness and headaches is so crippling its hard to get out of bed, and i cannot concentrate on my homework because of my dizzy spells. It feels like a rock is shoved into my brain, i always feel groggy. I am speaking to my dentist about stopping treatment. I have seen the doctors but they have never heard of this before, and the dizzy medication they gave me does not help. Please reconsider if you are going to do invsialign. There are side effects they do not warn you about.

  20. Becky Reply

    I had been wearing invisalign for a few months when I started experiencing dizziness, blurred vision, facial neuralgia type pain, burning in my mouth, hands and feet. I did not connect invisalign to these symptoms at first but noticed when I took the trays out for the few days the symptoms would subside. I have seen physicians to rule out other causes of these symptoms and all tests are negative. I have had these out for approximately 2 months and most of the symptoms have subsided but I still have some residual symptoms such as burning sensations in my hands and feet. My dentist and I have contacted the company but they are not responding to my telephone call or email.

  21. Taracha Reply

    I started my Invisalign in March of 2019. I was to start on tray twelve this past Tuesday. Four months ago I started having issues where I felt dizzy sporadically. I do not wear daily glasses but my vision started to get gradually off. I can see but I have to focus manually. It is as if my brain doesn’t automatically tell my eyes to focus.

    Within the last month I have started to lose my sense of smell on some things. Then I started to have a foul smell in my nose that just comes randomly. It is as if it is inside. I even go as far as take a shower to clear my airways, and wash my hair when I smell it. It is still there. It smells like spoiled turkey or slight rot. I had sores in my mouth in the previous month, then sore tongue followed. I had a sore throat and constant runny nose. My orthodontist told me none of my symptoms were related to the invisalign. He advised they are safe. He never mentioned any hypo allergenic version. When I told him my sense of smell seems directly connected sense they are in my mouth. He damn near laughed it off as if it couldn’t possibly be true.

    In addition to all this, I have not been keeping track of things well. I am usually great with keeping track of things and order. But the last month I notice I have something like a brain fog. I don’t smoke. I don’t do any drunks. I barely drink twice a month.

    I workout and eat right. I have never felt this in 40 years. I feel completely off. I have been to my General practitioner, the Nurse practitioner, the gyno, and the Optometrist. They all have no idea why I am feeling like this.

    This entire ordeal is mimicking the Roundup cases that surface in the most recent news. For years the people were subject to what was told to be “safe” for them but look how that ended. I took those aligners out asap when I found this yesterday.
    I am taking all this back to my Orthos office and demanding some refund. I would rather have a small gap than a damaged neuro system. I mean WTH. Why wouldn’t this be apart of the normal warning conversation… oh wait, I didn’t get any warning information. And I DID ask about side affects.

    I will see what happens as I leave these off and let you all know. This is detrimental and needs to be addressed.

  22. Terri Reply

    By my email you will realize that I work in a health related field. I wore invisalign for two years and was very compliant. I asked before wearing them if there was any estrogenic material in the plastic. I was an 11 year survivor of Breast Cancer and I am careful about the amount of estrogenics in plastic. I was assured that there was not any. I had small issues but I was referred to Mayo for an MRI for unrelated issues and they saw a large shadow. After being an 11 year survivor to a low stage cancer, my lymph nodes in my neck are 91-100 percent (hghest range) estrogen. I am now battling metastatic Breast Cancer. Because of where my tumors are in my neck, near my thyroid, I asked pulmonologist is these inflamed nodes were in a pathway for something I would have had in my mouth. His answer was it is a perfect pathway and that was when they just thought I had swollen nodes. If I had not been a survivor they would not have done a biopsy of the nodes and found that they are estrogen based cancer. This is simply to raise awareness, and not to raise fear. Invisalign is made of MDI polyeurothane plastic and in 2007 the World Health Association said use of this plastic should never be discussed for oral use. Also, one study we found showed that MDI polyeurothane caused bronchial tumors and collapsed lungs in rats. I am writing this from Mayo where I am for more testing. I was diagnosed last year at this time. For me, it is not worth the risk.

  23. Marsha Reply

    I’ve been using Invisalign for 8 months. I was so excited to finally have a an overbite and just make my smile look nicer. I’m probably older than most who get these liners but I couldn’t afford braces when I was younger. I went to a highly recommended orthodontist and he showed me on his high end machine what my teeth look like and what it will look like after I get theses liners. I was ready to start. The first week of using the liner I felt nauseous and very tired but I attributed that to the saliva buildup I was experiencing and nothing more. As the months progressed I developed a horrible coughing which gave me terrible headaches and I felt weak and tired. I was coughing so hard I broke a blood vessel in my eye. I thought I was just sick. I went to visit my daughter in NJ for ten days. While there I was having terrible symptoms like pneumonia or flu so I went to an urgent care center and I was given flu medication even though the swab didn’t show that I had the flu. I didn’t get better and somehow managed to fly home so I could go to my GP who said I probably have pneumonia and he gave me cough medication which I’m still taking and will stop in a few days. I also took Mucinex and Tylenol. My husband has been very worried about my health so he did some investigating online and found others with my symptoms. All of which were wearing Invisalign. I sent an email to my orthodontist and he replied back to me saying that in all his 19 years of practice only 3-4 people have had a reaction and it usually occurs at the very beginning of using the liners and he’d notice if I was allergic. He suggested I stop wearing the liners for 2-3 days to see if I felt better and to call him. Well I did take the liners out yesterday and I woke up this morning without the horrific coughing. I slept well last night. I can’t tell you how much better I fell this morning. My GP set up an appointment a few weeks ago for me to see a pulmonologist about my coughing which I’m going to this morning. I’d like to know what materials are used to make the Invisalign liners. That’s going to be my next question to my orthodontist. I hope that the plastic isn’t harmful to my health long term.

  24. Rose Reply

    I am currently on tray 8 of Invisalign, and my teeth are looking very nice. But, unlike most others on this site, I am not having tongue, lip, mouth issues. What I am having, however, is gastric issues, lethargy, and headaches. I have had multiple doctor appointments, X-rays, supplements, Gas X, upcoming gastroenterologist appointment, etc. I have had heartburn perhaps 3 or 4 times in my entire life, so gastric issues are foreign to me. I look as if I am 4 months pregnant (I’m 65), and am so uncomfortable by the end of the day, I have to wear sweats. The timing is such that I can possibly associate it with the use of the trays, and will stop wearing them beginning today. I am making an appointment with my orthodontist in going forward. I have little faith that he will agree with my assumption of issues with the Invisaligns but feel confident, after reading others experiences, I have gotten to the crux of my gastric problems.

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