Invisalign, Plastic Retainer Allergy Blog Post

[bbsadmin]

From the DentaKit.com blog:

Do Invisalign and Other Plastic Aligners and Retainers Cause Allergy or Illness?

Do plastic or acrylic Invisalign aligners and other types of plastic retainers make people sick? Some readers at ArchWired.com's Metal Mouth Message Board seem to think so. For more than four years, members across the country have reported getting symptoms that include sore throats, upper respiratory symptoms, fatigue, nausea, headaches, and swollen glands -- allegedly from their plastic aligners or retainers.

There is no official clinical evidence that these products contain substances that are harmful or potentially allergic. There have been no official reports or investigations into the matter. According to an article in the San Jose, CA Mercury News, in November 2010, the FDA issued a warning letter to Align technologies, stating that it could face federal fines or other penalties because it hasn't disclosed enough information about patients who suffered serious side effects after using the product. In the article, Align CEO Thomas Prescott said in an interview that he knows of only "a small handful of what appeared to be potentially allergic reactions" to the product. Nonetheless, he said, "we take this very seriously." Align Technologies provided the agency with information it hopes will resolve the matter.

Nevertheless, several ArchWired.com readers claim that they developed symptoms of illness shortly after starting Invisalign treatment, or wearing similar clear plastic retainers made by other companies.

According to Align Technologies' website, Invisalign aligners do not contain Bisphenol-A or phthalate plasticizers. Quoting the company's product FAQ, "These aligners are made with USP Class VI medical-grade, high molecular weight, polyurethane resins. Tests have been conducted to determine the biocompatibility of these materials, and show that they are biocompatible and pass all applicable regulatory requirements and thresholds for human wear in the mouth. Of course, as with any medical device, you should consult with your health professional about your aligner or retainer treatment and any applicable risks of use."

Align Technologies goes on to state, "Invisalign aligners are classified as Class II medical devices by the FDA, and Align Technology, Inc., received the necessary 510K clearance from the FDA to be able to sell and market the Invisalign system in 1998."

This doesn't mean that your aligner or retainer is beyond reproach. It's possible that there is some sort of allergy or sensitivity that the manufacturers and the FDA don't know enough about. It's also possible that some of these illnesses occur because people aren't keeping their aligners or retainers clean enough, resulting in an overgrowth of bacteria on the appliances.

If you think that your aligners or retainers are causing illness, there are several things you can do:

* If you feel that you are having a life-threatening reaction, call 911 or go to your nearest Emergency Room.

* Tell your dentist, orthodontist, and/or medical doctor (but apparently many dentists haven't heard of such side effects)

* Make sure you keep your aligner or retainer free of bacteria by using a germ-killing retainer cleaning product, such as Retainer Brite, SonicBrite, or DentaSoak. If you're not sure what product to use, or how to kill the bacteria with home remedies, ask your orthodontist. Above all, you want to ensure that your aligner is continually free of bacterial buildup by cleaning it properly every single day. Also make sure that your hands are clean when touching your aligners or touching your mouth.

* If you keep your retainer or aligner in a case, be sure to keep the case clean, as well. If your case smells bad, that means it has an overgrowth of bacteria.

* If symptoms persist, contact Align Technologies (for Invisalign) or the manufacturer of any other type of retainer you wear, and report the problem. You may also want to contact the Federal Food and Drug Administration (FDA) to make a formal report.

* Share you concerns on ArchWired.com's message board, or other dental message boards.

* Finally, if the symptoms persist, and you truly believe that your orthodontic treatment is making you ill, consider ceasing your treatment (at least for a while to see if you improve) or getting a different type of retainer or traditional braces instead.

Here are a few links to posts made on the ArchWired.com Metal Mouth Message Board about illness allegedly resulting from plastic aligners and retainers:

viewtopic.php?f=19&t=13809
viewtopic.php?f=19&t=37813
viewtopic.php?f=19&t=27737
viewtopic.php?f=19&t=38531

Here are a few other links from other websites concerning this issue:

http://en.allexperts.com/q/Dentistry-96 ... ctions.htm
http://en.allexperts.com/q/Dentistry-96 ... ctions.htm
http://escoforum.wordpress.com/2011/01/ ... materials/
http://allergy.hyperboards.com/index.ph ... c_id=17416
http://www.bracesreview.com/forums/invi ... trays.html

[curlew]

Looking through the links at the end of your post, there is a recent comment in the thread on this blog: Allergic reactions to Invisalign materials | Electronic Study Club for Orthodontics

Here: January 10, 2011 at 12:56 pm

This comment indicates that Invasalign can if it chooses to produce "Hypo-Allergenic" aligners, but says this is not advertised by Invasalign (even to dental practioners?) and required a specific inquiry, with written evidence, following an adverse reaction with one of his clients.

The obvious question is: why aren't the various companies (not just Invasalign) who design and supply these type of aligners, not using hypo-allergenic materials in the first place, for all of their products - all of their clients?

It seems clear that Invasalign has researched a hypo-allergenic alternative, and can supply it if prompted, but will only offer this option after the fact of an adverse reaction, when pressed by a dental practitioner.

Given the distress an adverse reaction may cause to an individual, this way round of doing things is entirely unjustified, in my opinion. I assume there are cost implications involved, but it's hard to imagine these costs are insuperable, as the alternative is already researched, and exists - it is just not being rolled out as a standard product.

[DrJasonKTam]

I've been trying to find an answer for this board. In particular, this post about "hypoallergic" aligners is something new to me also. I have heard of a different method of processing/packaging the aligners from one doctor, but again, heard nothing from the company until now.

I emailed my rep to get more info. He sent this upwards and got this response:

We do not offer any “hypo-allergic” aligners made with a different material. Dr. Tam may be talking about “test aligners”, that are made with the same material than regular aligners but go through a slightly different disinfection process.

Let me know if you have any other questions about this. The information the doctor shared on the blog might be inaccurate…whether he was told something or misunderstood what he was told, I’m not sure…but we do not make aligners with different materials.

I do not want to discount the possibility of allergy, but it has been a very low incidence amongst over 1.5 million patients to date. Of note, all of the documented cases of allergy are with individuals who are very sensitive to other things as well. I do not have information regarding this process or what may make this different. I will try to find out what the difference is.