Invisalign® Braces Lawsuit

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Attention Invisalign® Users: FDA Warning to Manufacturer

November 17, 2010 – A recent FDA inspection of the firm that manufactures the Invisalign® orthopedic system found several violations of law including (but not limited to) the following:

Failure to submit reports of individual adverse events no later than 30 calendar days after the day the company received information that reasonably suggests that an Invisalign device may have caused or contributed to a death or serious injury.

Failure to submit reports of individual adverse events no later than 30 calendar days after the day the company received information that reasonably suggests that an Invisalign device has malfunctioned and this device or a similar device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.
The letter goes on to cite specific examples of these violations:

  • Complaint Identification Number (b)(4), received on November 2, 2007, documents a patient experienced “swollen, irritated and sore lips and additionally her gingival is also swollen”. You have evidence from complaints received and filed as MDRs prior to this event that similar incidents required hospitalization. You also have documentation that the patient discontinued the use of the device to avoid further risk of further adverse events.
  • Complaint Identification Number (b)(4), received on May 11, 2010, documents that a patient experienced a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes. Based on previous events documented by Align Technology, Inc., your firm has knowledge that this device would be likely to cause or contribute to a death or serious injury if the event were to recur.

The FDA concludes the letter by stating that failure on the part of the company to correct these violations could lead to regulatory action including (but not limited to) seizure, injunction, and/or civil money penalties.

Official FDA Warning Letter

If you would like more detailed information about this warning letter, please visit the FDA website.

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