FDA Invisalign Warning Of Side Effects To Patients

FDA Invisalign Warning Of Side Effects To Patients

By: Bill Waters
Staff Writer
Published: Dec 4, 2021

FDA Invisalign Warning

The FDA has sent out a warning to patients who use Invisalign. The warning concerns side effects when using Invisalign, according to the FDA. The company makes a device used to realign teeth without the need for braces.

Invisalign has been warned that it could face federal fines and other penalites. The FDA claims it hasn't disclosed enough information regarding patients who suffered serious side effects after using the product. Align Technology confirmed Tuesday that it received the warning letter from the Food and Drug Administration on Nov. 18.

The company said it provided the agency with information it hopes will resolve the matter. 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."

The product has been used by more than a million patients. After being inspected by the FDA this summer, the company sent the agency a response to its concerns Nov. 8. However, the response may have crossed the mail with the warning letter, according to General Counsel Roger George.

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