Reply from The Pure Sleep CompanyNov 12, 2020
We're sorry that you have experienced tooth movement, and we take this kind of complaint very seriously. However assuming that you used PureSleep according to our instructions -- and your review indicates that you were certainly trying, it's extremely unlikely that any tooth movement or bite changes were due to PureSleep. Why? We need to start with a little background on how PureSleep works.
Snoring happens when muscles in the jaw, tongue and upper airway relax during sleep, allowing the airway to narrow. As air squeezes through the narrowed opening, it causes the tissue to "flutter" like a flag fluttering in the wind. PureSleep works by holding the jaw forward of its normal position, thereby pulling the associated soft tissue forward, away from the back of the upper airway. This opens the upper airway, allowing more unobstructed breathing.
While PureSleep was the first such device cleared by the FDA to be sold directly to consumers, other similar devices have been available from dentists for over twenty years. All such devices hold the jaw forward by “gripping” the teeth, so some modest pressure on the teeth is unavoidable. Consequently all such products have the potential to cause the user’s teeth to slowly move over time.
However because these changes are very gradual, it’s easy to simply discontinue use at any time if this movement because objectionable. Any such movement will immediately stop and will usually even reverse. However many people actually consider this particular type of tooth movement to be beneficial because it tends to reverse the natural tendency of the upper teeth to flare-out as we get older.
In addition, all such devices have the potential to cause one’s bite to slowly shift if care is not taken to ensure that the jaw returns to its normal position each day. However you said that you "followed the instructions to push [your] jaw back after using the appliance," so that means that each day, it returned to its normal position. Therefore if it returned to its normal position each day, it certainly implies that your bite has not shifted over time. Therefore the problem that you are describing must be tooth movement.
However it normally takes years of use for any such movement to be noticeable. And even though you actually did use PureSleep for years, any changes that it caused could easily be halted by simply discontinuing use, as explained in our instructions. Therefore if you did indeed discontinue use as soon as any tooth movement started to become objectionable, and if ongoing change continued to occur such that orthodontia was needed, it's likely that the ongoing change resulted from the normal, slow process of tooth movement that we all experience as we age. You said, "I never thought I'd need braces in my late 50s," but if you look at the typical Invisalign patient, they're often around your age, and many of them had braces when they were young, but with age, problems developed.
Again, we're sympathetic to your situation, and we can understand that if you started to notice a problem at about the same time you were using PureSleep, it would be easy to conclude that PureSleep must have caused the problem. However it's hard to see how use of PureSleep could have resulted in a need for orthodontia. If as you said, you made sure that your jaw was comfortable in its normal position each day, then there should be minimal bite shift over the years, and if you followed our instructions and discontinued use if your bite started to shift in a problematic way, then it should not have progressed to a point where any type of treatment was needed. Likewise if you followed our instructions and discontinued use of PureSleep if you started to experience tooth movement that was objectionable, it should have precluding any further tooth movement, thereby eliminating any possible need for orthodontia or any other type of treatment.
