PennWell Dental Community
The following article was posted recently in the DentaKit.com blog:
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: