Invisalign in the News - Did anyone see this?

[Gabria13]

FDA issues warning to Invisalign maker

Braces Maker Invisalign Issued FDA Warning

Align to Resolve Warning Letter Issue

FDA issues warning to San Jose tooth-alignment company


Was wondering what everyone's thoughts were on this. For the record, I am about to begin my 5th set of trays (U: 5/16, L: 5/23) and have experienced no unusual problems.

[MCOMarkhamOrthodontist]

This warning does not have to do with the Invisalign product nor does it blame Invisalign for any health issues that may have occurred. In fact, there is still no current evidence that aligners cause any adverse health reactions.

The warning is due to the reporting of such problems and the timing of it as per the policies of the FDA. The full warning letter can be seen on the FDA website here:

http://www.fda.gov/ICECI/EnforcementAct ... 234578.htm

[Chi-town]

Thanks for posting. Happy to see the FDA is doing something about it. My regular doctor gave me prescription anti allergy medication for my dry cough, I wonder if it is related to Invisalign. I am happy with Invisalign treatment in terms of teeth movement (more than 12 months on it), I want responses to my bad painful mouth sores and respiratory issues. If they are connected to Invisalign, I want to know, and I want my doctor and my ortho to know. When I asked ortho about Invisalign allergies, he said nobody ever complained (now we learn Invisalign was not disseminating the info). All corporations must be socially responsible (especially health-related businesses). I am sad Invisalign did not take side-effects seriously before receiving an FDA warning.

[mommamorin]

Dr. Tam, I know you are very "close" to the powers that be at Align Tech so you may not be able to answer this question, but what ARE the trays actually made of? I had the dry cough that Chi-town refers to as well as Weeyn in the UK and a couple others of us who were on this board in 2008. I also have been diagnosed with asthma as well since wearing Invisalign not having any problems before with my breathing and im 53! I did call Align Tech about this issue in early 2009 and they refused to help me with my questions and referred me to my provider. My provider had no clue and his rep from Aligh Tech did not either. Come to think of it as i am typing, my DIL has had Invisalign for a year now and has been getting recurrent migraines. hmmm. i have not read the article but will do so now. thanks

[mommamorin]

the link you posted now says "page not found"

[mommamorin]

This warning does not have to do with the Invisalign product nor does it blame Invisalign for any health issues that may have occurred. In fact, there is still no current evidence that aligners cause any adverse health reactions.

The warning is due to the reporting of such problems and the timing of it as per the policies of the FDA. The full warning letter can be seen on the FDA website here:

http://www.fda.gov/ICECI/EnforcementAct ... 234578.htm

Although Invisalign has been out there for quite a few years now, the process has become highly popular only in the past couple of years. Who knows what ramifications on health this product may have. It will be years before it is truly known.
I am not bashing Align Tech, but I do think they should be more forthcoming with their clients.

[MCOMarkhamOrthodontist]

The article with the FDA letter was originally published in the San Jose Mercury. This letter from the FDA is regarding a request for additional documentation with regards to how patient complaints are handled. It is a standard letter. Align actually had an interview with the reporter who obviously focussed on the few number of incident Medical Device Reporting filings out of more than 1.3 million patients treated. As far as I can interpret, none of these incidents actually confirmed that it was the aligners that actually caused this issue. I'm not a materials engineer, so I cannot discuss all of the components on the Material Safety Data Sheet, but I would be happy to post this for the forum if anyone would find it useful.

The safety and health of my patients and all of those in treatment is of paramount importance. On a personal note, having treated hundreds of patients with Invisalign, and having undergone treatment myself, and now using Vivera, I haven't experienced any of the issues that I have seen on the forums. If I do find out more information, I will let the board know.