THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

Invisalign maker gets FDA warning on side effects

December 2, 2010

E-mail this article

Invalid E-mail address
Invalid E-mail address

Sending your article

Your article has been sent.

Text size +

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.

Health search

Find the latest news on:
Or search:
 

@GlobeHealth on Twitter

    waiting for twitterWaiting for twitter.com to feed in the latest...