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FDA issues warning to Invisalign maker

from San Jose Mercury News

A San Jose, Calif., company that makes a device used to realign teeth has been warned 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. Align Technology, which touts its Invisalign system to reposition teeth, recently disclosed that it received the warning letter from the Food and Drug Administration on Nov. 18 and that it since has provided the agency with information it hopes will resolve the matter. Calling Invisalign "a wonderful product" that has been used by more than 1.3 million patients, 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." more

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