Invisalign Invisible Braces Linked to Reports of Serious Allergic Reactions

  • Written by: Staff Writers

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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  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.

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