FDA Warns Maker of Invisalign 'Invisible Braces'

FDA Warns Maker of Invisalign 'Invisible Braces'

FDA Warns Maker of Invisalign 'Invisible Braces'

Invisalign Maker Warned

The U.S. Food and Drug Administration says the maker of Invisalign "invisible braces" that realign teethdidn't fully disclose cases of severe allergic reactions suffered by some patients, including oral ulcers and swollen lips and gums, theSan Jose Mercury News reports. . The agency learned of the alleged problems in July while inspecting Align Technology, Inc. In a warning letter sent to the company on Nov. 18,2010, the FDA said Align Technology hadn't spelled out what it would do to correct course, though the company said it told the FDA about "the actions Align has completed and plans to complete" to comply with federal reporting procedures. In 2007, a patient reported "swollen, irritated, and sore" lips and gums. Other similar incidents have required hospitalization. In May, another patient reported "a burning tongue sensation, sore throat,ulcerations in the mouth, and swollen lymph nodes," according to the FDA. Align's CEO told theSan Jose Mercury News that there have only been a "small handful" of allergic reactions to its product, used by 1.3 million people.

While Invisalign is among the more popular inconspicuous ways to realign teeth, there are a couple other options.

Braces look all grown up

With an expanding array of "invisible" orthodontichardware, fixing flawed teeth has become more appealing than ever,U.S. News's Lindsay Lyon wrote in 2008. In fact, adults are increasingly opting to do so: About 1 in 5 orthodonticpatientsis 18 or older, the American Association of Orthodontists estimates, up by a third in the past decade. "The [options] are becoming more aesthetic and less conspicuous," says Raymond George Sr., president-elect of the AAO. "That is an incentive" for both adults and teens. Aesthetics are not cheap, though. Expect to spend $3,000 to $8,000, he says, for any of the following treatments.

Lingual braces. Attaching to the backs of teeth, not the fronts, these braces are discreet. They are also kinder to the lips and cheeks than forward-facing braces, but they may instead irritate the tongue.

Tooth-colored brackets. Even traditional braces are becoming more unnoticeable thanks to brackets that visually blend in. Made of ceramic or plastic, they make the "metal mouth" look a thing of the past. But the new brackets can be more brittlenot to mention pricierthan the metallic kind, George says, and may be prone to fractures, requiring replacement.

The nation's orthodontists can offer you a lot of information on braces. A whole lot. Perhaps no surprise: They're all for them.

Here's somemyth busting facts about braces from the American Assn. of Orthodontists, including this gem:"Myth:Signals from braces link to the Internet to download songs onto an iPod.Fact: This is not possible right now." We can't wait.

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