Maker of Invisalign Out of Line, According to FDA
Posted on Friday, December 10th, 2010
We’ve seen the problem with pharmaceutical drugs: Seeking maximum profits, drug companies aggressively market their pills, touting their alleged wonders and glossing their risks. Then reports of serious “side effects” start coming in, and the drug companies go into crisis management mode.
Other industries play similar games. According to a report in the San Jose Mercury News Align Technologies – maker of the widely promoted Invisalign teeth straightening system – was warned by FDA to clean up its act. The company is facing “federal fines or other penalties because it hasn’t disclosed enough information about patients who suffered serious side effects after using the product.”
FDA officials in San Francisco…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.”
That a corporation would pursue profit over safety, sadly, isn’t really news. But the story does offer reminders of a couple of important lessons:
- No treatment – whether drug or device, conventional or holistic, necessary or purely cosmetic – is completely without risks.
- Dental materials placed in your mouth can affect your health for better or worse.
This is why biocompatibility is such a big concern in our office – especially so when it comes to restoring teeth. Whether we’re replacing toxic mercury amalgam fillings or placing new restorations on damaged or decayed teeth, we want to be sure that what we place is safe, that it won’t cause an allergic reaction or other complication. In cases where a person’s health is poor due to chronic illness – especially where dental factors may have been involved in the development of that illness – we make a point of testing for biocompatibility prior to beginning the work.
We believe this extra step is worth the extra time and small increase in cost: It’s a way of guarding against greater, more expensive-to-treat problems down the road.