Invisalign Maker Gets FDA Warning Letter for Failing to Report Allergic Reactions

By December 10, 2010 April 18th, 2019 Defective Medical Device litigation

If you watch television or browse the Internet, you’ve probably seen advertisements for Invisalign, a product that claims to straighten teeth invisibly and without braces. So I was very interested, as a defective medical device attorney, to see that the product’s manufacturer is in trouble with the U.S. Food and Drug Administration for failing to report potentially life-threatening allergic reactions. Makers of drugs and medical devices are required by law to report “adverse events” to the FDA, meaning injuries or illness to people who used the product correctly. As the San Jose Mercury-News reported Dec. 2, an FDA warning letter sent Nov. 18 faulted Align Technologies for failing to do this. The company must provide more information to the FDA or face fines and other penalties.
Invisalign uses a clear plastic casing to “train” teeth straight. That material apparently has caused an allergic reaction in at least three users, which in some cases led to hospitalization. However, the FDA said Align Technologies failed to report these, even though some cases date back as far as 2007 and could lead to serious injury or death. The FDA’s warning letter cited at least three cases of patients with swollen and irritated lips, swollen lymph nodes, burning sensations on the tongue, sore throat and mouth ulcers. One patient received steroids to treat an unspecified reaction. In all cases, Align failed to report the problem within 30 days as required by law. The letter also faulted the company for not responding with documentation adequate to show it’s taking corrective action. Align said it had responded.
As a pharmaceutical liability attorney, I wonder how many more of these Invisalign allergic reaction cases are out there but have not been reported. If Align has not been meeting its legal requirement to disclose allergic reactions, it’s hard to know whether this is a widespread problem or a few isolated incidents. However, the company says 1.3 million people have used devices in the Invisalign family. Even if 5 percent of those people had any kind of reaction, that would still be 65,000 people hurt by Invisalign. To make matters worse, Align has known since at least 2007 that its product can cause life-threatening allergic reactions, but failed in its duty to warn customers and the FDA. That failure to warn makes the company liable for any legal actions filed by people who were hurt by Invisalign products that they trusted — but that the company knew could send them to the hospital.


Manufacturers of medical devices and medications are just like other makers of consumer products — in that they have a legal obligation to make sure their products are safe. If they fail to do that or warn patients about the risk, people who are hurt have the right to hold them legally and financially responsible for the results. Carey, Danis & Lowe represents clients who were sickened or injured by defective medical products, including medical devices as well as prescription and over-the-counter medicines. Based in St. Louis, our defective medical device lawyers represent people around the United States who are pursuing individual claims or joining a class action that brings together many people hurt by the same defendant. In these claims, patients can recover all of the medical costs caused by the defective product, lost income and other financial losses, as well as financial compensation for their illness or injury, pain and any permanent disability or death.
If you’ve been hurt by a defective medical device or a manufacturer’s knowing failure to warn you about risks, don’t wait to contact Carey, Danis & Lowe for help. To set up a free consultation, send us a message through our website or call 1-877-678-3400.