FDA issues warning to Invisalign

[dangerdude]

http://www.mercurynews.com/business-hea ... i_16752716

By Steve Johnson
Posted: 12/01/2010 07:33:19 PM PST
Updated: 12/02/2010 05:04:51 AM PST

A San Jose company that makes a device used to realign teeth has been warned it could face federal fines or other penalties because it hasn't disclosed enough information about patients who suffered serious side effects after using the product.

Align Technology, which touts its Invisalign system to reposition teeth, disclosed Tuesday that it received the warning letter from the Food and Drug Administration on Nov. 18 and that it has since provided the agency with information it hopes will resolve the matter.

Calling Invisalign "a wonderful product" that has been used by more than 1.3 million patients, Align CEO Thomas Prescott said in an interview that he knows of only "a small handful of what appeared to be potentially allergic reactions" to the product. Nonetheless, he said, "we take this very seriously."

After being inspected by the FDA this summer, Align sent the agency a response to its concerns Nov. 8, the company said. But that response, which spelled out "the actions Align has completed and plans to complete" to address the agency's concerns, "may have crossed the mail with the FDA's warning letter," General Counsel Roger George said in a statement.

FDA officials in San Francisco who sent the letter could not be reached for comment. But their warning accused the company of failing to comply with federal reporting requirements covering medical devices that contribute to serious injury or death.

One patient complained in November 2007 of "swollen, irritated and sore lips," the letter said, adding that the company had received complaints before that involving similar incidents that "required hospitalization." In March 2008, a patient complained of "injuries of swelling that could be life-threatening" after using the device, the FDA also said. In May of this year, it added, a patient reported "a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes."

In addition to being subject to unspecified fines if it fails to provide the information the FDA has demanded, the agency's letter said Align could face a federal injunction or have its assets seized.

The company, which reported $312 million in sales last year, notes on its website that it won FDA approval to sell its Invisalign appliances in 1998. It describes the product as a clear, removable device that "significantly reduces the aesthetic and other limitations associated with braces" because it lacks metal or ceramic brackets and wires.

[DrJasonKTam]

This warning does not have to do with the Invisalign product nor does it blame Invisalign for any health issues that may have occurred. In fact, there is still no current evidence that aligners cause any adverse health reactions.

The warning is due to the reporting of such problems and the timing of it as per the policies of the FDA. The full warning letter can be seen on the FDA website here:

http://www.fda.gov/ICECI/EnforcementAct ... 234578.htm

[bbsadmin]

But Dr. Tam, there's a pretty large thread on this message board with people reporting upper respiratory problems after starting Invisalign, or wearing aligners or retainers that are made of a similar material. I know that as a medical professional you may think that this is purely "anecdotal," but there must be something to it -- whether it applies to this FDA issue or not.

[DrJasonKTam]

I am not saying that it is impossible that problems may develop, but without properly documented case reports or studies, we cannot say that Invisalign is the cause of it. Posting an article without a proper explanation simply about an FDA warning with Invisalign is misleading.

There are a variety of reasons for problems that individuals may have, but none of these can be currently attributed to the aligners themselves. Poor hydration, sore teeth, stress from new appliances, poor nutrition, unclean aligners, etc are all aspects that can make individuals feel sick. Unfortunately, most doctors, nor the Align website prepare patients properly for the treatment that they are to receive.

Anecdotally, I know of a patient who was hospitalized with aligners (not ours), but this individual had similar problems prior to beginning treatment, and the MD said that he could not say they were due to Invisalign. We have treated hundreds of patients, and none of them has described any of these issues. What I do know is that we rinse the aligners off before using them, and recommend our patients do this as well, since there can be some kind of powder residue on them. I have been told that this is part of the sterilization process, but have been unable to confirm what it actually is.