Invisalign maker gets FDA warning on side effects

December 2, 2010

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SAN JOSE, Calif.—The Food and Drug Administration has issued a warning to a company that makes a popular teeth straightener about its failure to report information about patient side effects.

Align Technology Inc., which makes the Invisalign system, disclosed this week that it received a Nov. 18 warning letter from the FDA following an inspection this summer.

The letter accused the San Jose, Calif., company of failing to comply with federal requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.

Align Technology's general counsel, Roger George, says the company replied to the FDA on Nov. 22 and is working to resolve the issues.

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