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Invisalign Invisible Braces Linked to Reports of Serious Allergic Reactions

  • Written by: Staff Writers
  • 58 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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58 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.

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