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Invisalign 'Invisible Braces' Maker Gets FDA Warning

Adverse Events Not Reported to Agency, FDA Says
By
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.

How Do I Measure Up? Get the Facts Fast!

Number of Days Per Week I Floss

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Only 18.5% of Americans never floss. You are missing out on a simple way to make a big difference in the health of your mouth. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Floss removes food trapped between the teeth and removes the film of bacteria that forms there before it turns to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Try flossing just one tooth to get started.

You are one of 31% of Americans who don't floss daily. You are missing out on a simple way to make a big difference in the health of your mouth. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Aim for 3 more days!

You are one of 31% of Americans who don't floss daily, but you're well on your way to making a positive impact on your teeth and gums. Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Aim for all 7 days!

Only 50.5% of Americans floss daily, and good for you that you are one of them! Regardless of how well you brush, plaque still forms between your teeth and along your gums. Toothbrush bristles alone cannot clean effectively between these tight spaces. Flossing removes up to 80% of the film that hardens to plaque, which can cause inflamed gums (gingivitis), cavities, and tooth loss. Congratulations on your good oral health habit!

SOURCES:

American Dental Association, Healthy People 2010

This tool is intended only for adults 18 and older.

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