FDA Invisalign Warning: Do You Use Invisalign? Hear What The FDA Has To Say

Filed in Uncategorized by on December 4, 2010 0 Comments

Invisalign has become a popular choice for those people who want straighter teeth without showing off a mouthful of metal and rubber bands. In case you aren’t familiar with Invisalign, the braces are made by the company Align Technology Inc., and are clear plastic molds which are worn over your teeth to straighten them. However, the Food and Drug Administration has recently issued a warning to the invisalign company and the public needs to be made aware of what the FDA Invisalign warning regards.

The FDA issued a warning to the Invisalign company on November 18 following an inspection of the company over the summer. It turns out that Align Technology Inc. has failed to report information about patients’ side effects of wearing the Invisalign braces.

Patients have complained of serious side effects which include allergic reactions to the braces. Some people who wear Invisalign have suffered swollen lips and mouth ulcers.

Align Technology’s Roger George, general counsel, says the company responded to the letter on November 22 and assures people they are working to resolving the issues.

Of course, not everyone who wears the Invisalign braces has suffered from these allergic reactions, but it still remains the company’s duty to report any and all side effects. Perhaps Align Technology was worried if word spread about the side effects they might lose business on the product, though that is not an excuse for failing to disclose all information – particularly when it comes to a medical product worn in people’s mouths.

Which do you think is worse business for the company? The fact that some people have suffered from allergic reactions from wearing Invisalign or that they failed to disclose information and the FDA issued them a warning?

 

Photo Credit: Christian Science Monitor

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