My Invisalign treatment Journey

Thursday, February 17, 2011

Invisalign 'Invisible Braces' Maker Gets FDA Warning Cosmetic Dentistry

Latest Oral Health News

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By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Dec. 3, 2010 -- The FDA says Align Technology Inc., maker of the popular Invisalign "invisible braces," didn't tell the agency about several life-threatening allergic reactions to the product.

The FDA learned of the allegedly unreported events during a July 2010 inspection of the firm. In its warning letter, the FDA says Align Technology failed to tell the agency how it was going to improve its reporting procedures.

In a news release, Align Technology says it did send the FDA the information it requested, but that "our response of November 8, 2010 may have crossed in the mail with the FDA's warning letter." The FDA letter is dated Nov. 17, 2010.

Align Technology is based in San Jose, Calif. Company CEO Thomas Prescott told the San Jose Mercury News that the Invisalign system has been used by more than 1.3 million patients.

Some of those patients appear to suffer serious allergic reactions to the product. The FDA letter describes two complaints:

•On Nov. 2, 2007, a patient reported "swollen, irritated, and sore" lips and gums. Similar incidents previously reported to the FDA required hospitalization of the patient.
•On May 11, 2010, a patient reported "a burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes."
The FDA letter does not imply that the Invisalign device is unsafe, only that Align Technology failed to make the timely reports the agency needs to monitor safety.

SOURCES: FDA warning letter to Align Technology Inc., Nov. 17, 2010.News release, Align Technology Inc.San Jose Mercury News: "FDA Issues Warning to Invisalign Maker."

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Invisalign Treatment update #2♥

Invisalign teen

Let's face it. You've got school, sports, hanging out with friends. So getting metal braces is not at the top of your list of favorite things to do. You want the confidence of a great smile - let Invisalign Teen® get you there, with the virtual invisibility of our clear aligners.
With Invisalign Teen, you could be straightening your teeth without most of your friends even noticing. You don't have to worry about sharp metal wires and brackets irritating your cheeks and gums - especially handy if you play sports. And if you like popcorn or candy, go for it! With its removable aligners, Invisalign Teen lets you pretty much eat whatever you want. Try doing that with braces!

And don't forget about all the pictures you'll be taking—school pictures, prom, team photos or even just snapshots with friends. Since Invisalign aligners are virtually invisible, you can smile confidently while wearing them, or easily take them out for that perfect shot. You won't end up with a lifelong reminder that you were getting your teeth straightened way back when.

While Invisalign Teen works the same way as Invisalign for adults, we've made it even easier for you to track your progress. Each aligner has a Blue Dot Wear Indicator in an inconspicuous location that is designed to fade over a two-week period, letting you know when a new aligner tray needs to be used.

Plus, we know that things can happen, like when you accidentally throw out your aligner with your lunch bag. That's why you get up to six free replacement aligners. Mom will be happy about that

But before you fully decide if Invisalign Teen is the right choice for you, take the Self Assessment, and make sure you discuss your results and how much Invisalign costs thoroughly with your parents. They're the ones who can make this all happen.

Good Luck!!☻

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Monday, February 7, 2011

all about Invisalign treatment

Invisalign treatment -->This is a video explaining everything about Invisalign. Enjoy :]