Atlanta Dental Malpractice Lawyers Warn about Invisalign Allergy Risks
The Food And Drug Administration has found that the maker of the popular Invisalign invisible braces failed to inform the agency about allergic reactions to the product. Some of these allergic reactions were serious enough to be life-threatening.
According to the Food and Drug Administration, it first learned about these allergic reactions this year. The agency has sent the company that manufactures Invisalign, Align Technology, a warning letter, alleging that the company failed to inform the agency about how it was going to enhance its reporting procedures. Align Technology has issued a news release saying that it did, in fact report, these incidences of allergic reactions to the FDA.
The FDA letter describes certain serious symptoms that patients who used the braces suffered:
On November 2, 2007, one patient reported severe gum and lip irritability. The lips and gums became swollen, red, sore and irritable. There were several other such reports that were made to the FDA, and some of these cases were serious enough to require hospitalization of the patient.
As recently as May 11, 2010, there was another report of allergic reactions from using the braces. This patient suffered a burning tongue sensation. The patient also reported soreness in the throat, mouth ulcers as well as swollen lymph nodes.
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