Invisalign Makers Get FDA Warning

Invisalign Maker Gets FDA Warning

A popular alternative to traditional metal braces, the Invisalign brace system appears to be a welcome relief for most dental patients. The system does not have many of the drawbacks of traditional braces, such as the cuts inside of the mouth, food getting caught, the pitting which can occur to the teeth where the traditional braces are attached, and of course the often painful periodic tightening.

However, it appears that the news is not all so good. The FDA recently reported that they sent a warning letter to Align Technology Inc., maker of the Invisalign. In the letter, the FDA sites the company for failing to disclose many life-threatening allergic reactions to the product. The reactions included: “swollen, irritated, and sore” lips and gums. Some of which actually required hospitalization. Also “a burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes.”

While the FDA letter does not go so far as to declare the product unsafe, it did warn the company of its failure to make timely reports of any issues with its use.