Invisalign® Involved In FDA Scandal

Invisalign® are a multinational brand specializing in their very own system of orthodontic aligners, bearing their name. They make “invisible” aligners, made of see through plastic that are all the rage in adult orthodontry for two reasons; one is of course the fact that they are more aesthetically pleasing, and they are removable (as all aligners are), making them the ideal orthodontic tool of choice for adult tooth alignment. But recently they got into some trouble with the FDA.

Troubles With The FDA

The problems that they experienced were related to their lack of reporting. Apparently, after your product is verified safe for use or consumption by the FDA (the Food and Drug Administration in the USA), you have to report if side effects or complications during the use of your product occur. This happens when for instance your clients or patients report a problem to you, or ask you for help regarding a complication or a side effect, something that Invisalign® has failed to do. The FDA has noted this, and is threatening the company, which is a terrible PR curse, and will undoubtedly result in them losing clientele.

The reported cases were quite mild by FDA standards. There was a case in 2007 of a patient reporting that they had swollen lips and mouth and had some irritation of the periodontal tissue and mucus membranes in their mouth. The other case was a little bit more severe. It occurred in 2010 and ended up with the patient in need of hospitalization. The patient complained of allergic reactions, a burning sensation in the tongue and ulceration of the mouth as well as swelling of the lymph nodes. Pretty scary stuff from an orthodontic appliance.

Implications

This does not imply that the treatment or the aligners themselves are somehow not fase. They are safe, they are perfectly good to use, it is just that some people may experience allergic reactions to the materials used in producing the aligners. The real problem is that the company has failed to report these incidents, and has failed to comply with the FDA altogether. This failure to report may very well be a result of a lack of interest on the companies part, or may be as bad as sheer neglect and uncaring, but it may very well be due to an administrative error as well. Either way, this incident does not paint a pretty picture about the folks up on top who are in charge of the Invisalign® label.      

image: 1.