Has Invisalign advertising “crossed the line”?

One goal of my blog is to challenge the claims and assertions of companies and their paid clinical salespeople. I hope that by bringing attention to unethical advertising practices, I can influence some companies to change their ways.

Though I strive to be successful in this aim, at times, I feel as though I am losing the battle.

I am concerned about the latest campaign by Invisalign and their introduction of the Invisalign Palatal Expander (IPE). This is part of their attempts to develop appliances used in Phase I interceptive treatment of children. 

The IPE is a single piece of plastic that fits on the palatal surface of the upper arch along with some buccal tooth coverage. The patient changes the appliance daily, and the sequential appliances gradually increase the width of the arch. However, due to their design, they must only have limited contact with the teeth. This means that the IPE is likely to have a similar mode of action to a simple removable split plate with a mid-line screw. As a result, they are likely to achieve mostly tipping movements, and it is unlikely that they would achieve skeletal expansion as we do with RME and its variants. This is something that anyone with basic orthodontic knowledge would realize.

What do Invisalign suggest?

The latest advertisements state the following:

• The expander is less painful than traditional palatal expanders
• Clinically proven to be safe and effective
• A revolutionary new design with no metal screw
• One hundred per cent of surveyed Invisalign-trained orthodontists agree that the IPE reduces anxiety in patients compared to traditional expanders.

They have mentioned some references in the fine print on their website. However, these references only state that “the data is available with Align Technology”. It is noteworthy that the claim about reducing anxiety is based on a survey of only 10 orthodontists who have treated at least one patient with IPE. This cannot be considered as a scientifically sound evaluation.

The claim that I was most concerned about was.

“The IPE system is the only FDA-cleared removable palatal expander that’s just as effective as traditional expanders”.  

Let’s break down that statement. The FDA grants clearance to appliances that are similar to other appliances currently in use. Therefore, since this appliance is similar to removable expansion plates, there shouldn’t be any clearance issues. Additionally, there is currently no data available on its effectiveness.

In another advertisement, Invisalign compares IPE to RME and suggests that RME is medieval.  Here is a screenshot. You will see that they state

“traditional palatal expanders work by inserting a tiny key and cranking the appliance wider every day. The process is difficult and stressful for kids and adults”.

This advertising style also concerns me because it suggests that orthodontists who use RME, the standard care, are outdated. This is not good.

What do the KOLs say?

Shortly after the start of the advertising, the KOLs were pretty quiet. However, recently, they have started to appear on orthodontic social media. Most of these posts show poorly documented expansion case reports. These do not persuade me that IPE is effective or superior to other methods, such as RME.

Have Invisalign crossed the line?

There are two issues regarding Invisalign’s advertising. Firstly, they make claims without providing supporting data. This may be wrong because the evidence is not subjected to external scrutiny.

While they emphasize FDA clearance, it is important to note that this is only because the appliance is similar to other expanders. Furthermore, despite what their advertising states, there is no published evidence to suggest that this appliance is any better or different than a removable expander. Additionally, it is worth noting that patient cooperation is crucial for Invisalign Palatal Expander, which is less of an issue with fixed expanders.

Secondly, it is rather strange to claim that fixed appliance screw expansion is a “medieval” method, implying that conventional orthodontic treatment is not as advanced as the new Invisalign treatment. This claim is unfair and only creates a divide between specialists.

After writing the post, I learned that Invisalign withdrew its “medieval advertising” after pressure from the Canadian Association of Orthodontists. Invisalign admitted their mistake, which is the appropriate course of action for an incorrect claim.

Final comments

Invisalign have, yet again, made claims about their appliances that are not supported by research. You may remember the promotion of the Mandibular Advancement Appliance. It is odd that such a successful company takes this step, as it is unnecessary.

Unfortunately, the specialist associations have not yet asked them to withdraw these advertisements. It is high time for the major specialist societies to step up and speak out. Ethical orthodontists cannot do this by themselves.