Braces Maker Align Technology Warned By FDA On Side Effect Issues

By on Dec 4, 2010 in Health, Lifestyle Comments
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Braces maker Align Technology Inc., a popular company that makes the Invisalign system, received a warning from Food and Drug Administration (FDA), international reports said.

The letter was received by the company on Tuesday saying that Align Technology Inc. failed to report enough information about serious side effects of the product to its patients.

According to reports, there are some patients who complained about allergic reactions while using the invisible braces, which was cited in the warning letter.

Align CEO Thomas Prescott said in an interview that Invisalign is used by more than 1.3 million patients and that he knows only “a small handful of what appeared to be potentially allergic reactions” to the product. Nonetheless, he said, “we take this very seriously.”

Meanwhile, Roger George, Align Technology‘s general counsel said that the company is now working to resolve the issues. On November 22, 2010, Align Technology replied to the warning letter with copies of documents requested by the FDA.

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