Invisalign Maker Failed to Report Side Effects, FDA Says

<"">Clear Invisalign braces, made by Align Technology Inc. in San Jose, California, have been the subject of a number of customer complaints, according to breaking news. Align Technology is also under fire by the U.S. Food and Drug Administration (FDA) for not reporting significant side effects to the agency, said the LA Times.

Customer complaints include allergic reactions, sores, and swelling that, in some cases, said Mercury News, could be life threatening. In response, the FDA issued a warning letter to the invisible braces maker, with additional warnings about potential fines and penalties, saying that Align Technology did not provide the agency with sufficient information about patients who suffered serious side effects as a result of the tooth-aligning product, said Mercury News.

The FDA also indicated that Align Technology could also face a federal injunction or seizure of its assets, wrote Mercury News.

Invisalign boasts an invisible, unobtrusive, individualized approach to teeth alignment.

The FDA letter was dated November 18, said Align Technology, wrote Mercury News.

CEO Thomas Prescott described Invisalign as a “wonderful product” that has been used by over 1.3 million people, quoted Mercury News. Prescott, speaking in an interview, said he was only aware of what he described as “a small handful of what appeared to be potentially allergic reactions” to Invisalign, wrote Mercury News.

Align Technology was inspected by the FDA is summer and sent a response to the FDA on November 8, it said, reported Mercury News. It is possible, according to Align Technology’s general counsel that the Align Technology response and the FDA warning letter crossed in the mail, wrote Mercury News.

Mercury News said that the FDA officials who sent the letter could not be reached for comment, but did note that the letter accused Align Technology of not complying with federal reporting requirements concerning medical devices that are associated with significant injury or death.

The letter went on to describe one patient’s injuries, as far back as 2007, of “swollen, irritated, and sore lips,” quoted Mercury News. The letter pointed out that Align Technology had received complaints earlier that involved similar issues that were significant enough to have “required hospitalization,” reported Mercury News.

The FDA also wrote that in March 2008, a patient complained of “injuries of swelling that could be life-threatening” following Invisalign use, said Mercury News, citing the FDA letter. The FDA also said that, this May, another patient reported “a burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes,” quoted Mercury News.

Align Technology describes the Invisalign device as “a patented proprietary system that uses 3D modeling software and cutting-edge manufacturing technology to provide a clear, removable solution for straightening teeth.”

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