Sunday, December 5, 2010

The FDA and Invisalign

The recent activity between the FDA and Align Technology is concerning. Seems the makers of Invisalign have been neglecting to report side effects reported to them by patients and dental professionals. This is an FDA requirement for makers of medical devices.

This was a concern of mine going in...I have sensitivities to many chemicals, and Invisalign aligners are essentially plastic gadgets you leave in your mouth nearly full time for a year or more. I also read that the aligners are sprayed with a disinfectant before leaving the factory; the disinfectant could also cause reactions.

What should we all be doing about it? First, keep an eye out for side effects like swelling, sore throats, itching lips or gums. Keep you orthodontist in the loop, and don't be afraid to report to the company or FDA. I also take the precaution of thoroughly cleaning fresh aligners before inserting them. This means soaking in Dentasoak (which I love [unpaid endorsement]) for 15 minutes, then brushing with a toothbrush and a little low abrasive toothpaste, then a good rinsing in warm water. Seems to take away the "plasticy" taste and odor of new aligners.

No comments:

Post a Comment