Invisalign Invisible Braces Linked to Reports of Serious Allergic Reactions
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.
Comment by linda on 5 March 2011:
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.
Comment by Beverly on 31 March 2011:
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.
Comment by Karen on 3 July 2012:
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.
Comment by Danielle on 1 April 2013:
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.