Yesterday I received a response from the Therapeutic Goods Administration’s Device Support Team in response to my Medical Device Incident Report regarding the failure of my Vivos mRNA Appliance and the fact that it tipped my teeth.
The Therapeutic Goods Administration’s (TGA) Database of Adverse Event Notifications (DAEN) – medical devices lists adverse events, such as failures and damage caused by medical devices in Australia. It is compiled from reports made by manufacturers, suppliers and end customers. Since the Vivos mRNA Appliance is used to treat obstructive sleep apnea, it is considered a medical device and is subject to regulation by the TGA.
I reported that the Vivos mRNA Appliance tipped my teeth using the Users Medical Device Incident Report. The Australian Register of Therapeutic Goods (ARTG) number for the Vivos mRNA Appliance is 389679 and my Device Incident Report (DIR) number is 81170. My report should be accessible in the DAEN – medical devices search using there two numbers after 13th November 2022, but in the meantime the TGA’s response states that:
- “The TGA is aware of this type of adverse event and is monitoring the situation.”
- “Reports not investigated are used for monitoring and trending analysis.”
- “In this instance, no further investigation of the reported event will occur.”
The only information about the event in the response is a redacted version of the information I supplied in my event report, so it appears that the TGA haven’t contacted the company or my provider for more information.
This highlights the importance of all users whose treatment with the DNA or mRNA Appliance fails and/or causes them harm to submit an adverse event report with their local medical device regulator. Regulators have limited resources to investigate reports and tend to prioritise those with high severity and lots of instances. The more reports they receive, the greater the chance that they will take action. Regulators have the power to prevent the importation and sale of medical devices that are not safe and effective, and clearly the Vivos mRNA Appliance was neither safe nor effective in my case.
If you have been treated with a Vivos appliance or a DNA Appliance from their predecessor BioModelling Solutions, Inc and had an adverse outcome such as tipping teeth or a failure to generate the expected growth, it is important to report this to your local regulatory agency so that they see sufficient events to warrant an investigation into the safety and efficacy of the appliance. While it is your provider’s legal obligation to do this, it may not be their top priority. I recommend doing it yourself to ensure that it happens.
Here are links to medical device regulators where you can submit your consumer reports:
Australia (TGA): Submit Report. ARTG #389679. Background Information.
US (FDA): Submit Report. Background Information.
Canada (Health Canada): Submit Report. Background Information.
If you’re located in another country and know the links to submit adverse event reports to your local regulatory agency, please and let me know so I can add them to the list above.
I also recommend joining the Vivos DNA/mRNA Appliance Failed Cases Facebook group if you want to connect with other people whose treatment failed for support in regulatory reporting, seeking refunds, correcting damage done by the appliance, moving forward with other treatments, etc.
16 Comments
Marci · September 20, 2023 at 4:06 AM
Hi Graham, I hope it’s okay that I included your web posts on my blog about my journey with VIVOS sleep apnea device. I didn’t end up with teeth tipping, but not the results I was hoping for either. It was an expensive experiment to say the least!
Here’s the post on my “sleep deprived me” blog referring to your experience… https://sleepdeprivedme.home.blog/2023/09/19/another-persons-perspective/
I am interested in the Facebook group as well…
Graham Stoney · September 20, 2023 at 7:58 AM
Sorry to hear you didn’t get the result you were going for either Marci. Thanks for the link.
Erik · November 17, 2022 at 10:12 AM
It’s been a while since you last posted regarding your CFS, just wondering how you’re doing in that area…
Hope all is well..
Cheers
Graham Stoney · December 16, 2022 at 9:28 AM
I’m doing OK-ish thanks Erik. I still feel a bit like a zombie but I’m convinced it’s due to the sleep apnea and possibly poor daytime breathing, so I’m exploring maxillomandibular advancement surgery to address it. Hopefully that will enable me to ditch my CPAP machine. How are you doing?
James · October 5, 2022 at 1:43 AM
Graham. I had a similar experience about 4 months into treatment. I was expanding the device around the same amount of time. But was noticing it was a lot tighter after each adjustment. Almost “forcing” it in my mouth. After a couple months I started biting my back jaw alot! My dentist at the time did tell me my teeth were getting tilted out. And that I was expanding the device too fast. So they recommended that I not adjust the device for 6 weeks, but wear keep wearing it. Then instead of the recommended adjustment, I started to just go with how loose or tight it was before adjusting the expander. It took a couple or few months but eventually the titled teeth got corrected.
Im not sure if I just caught it in time. And you might be all done with the mouth piece, and your tilt might be much farther along. But it’s worth mentioning that maybe you need to wear the mouth piece for a couple months without expanding it. This might correct the issue.
Claudia · October 1, 2022 at 11:21 AM
Thank you for your answer Graham. While texting you my phone freezed and for some reason changed my name for yours. Hope you are doing good and thank you again.
Claudia · September 29, 2022 at 3:54 PM
Hi Graham, I was voting for you to have a good outcome about the mrna appliance. I contacted you few months ago about possible aesthetic changes on your face while wearing it which were none at the time. Now that you are done and excluding the negative outcome u sadly had to go through, I was wondering if you did see any positive changes aesthetically. Hope you are doing great and on the right path to your healing. Thank you.
Graham Stoney · December 16, 2022 at 9:49 AM
No, I didn’t see any aesthetic changes. Only teeth tipping which isn’t obvious visually to others.
Clark · August 26, 2022 at 6:28 PM
Thanks for the link, will fill it out soon
Meanwhile, join the discord for your MMA planning
https://www.reddit.com/r/UARSnew/
If Lydia Lim offers you a 8mm net and called it counter clockwise rotation and yet the advancement looks linear, you probably want some further advice from our cult members
Graham Stoney · August 27, 2022 at 10:14 PM
Thanks Clark. I’ve subscribed to the reddit board; do you know the invite link to the discord server?
Clark · August 29, 2022 at 9:30 AM
The admin has a closed door policy where a PSG is required for admission because the cult leader indulge in esoteric rules, here is a one time link for your use, please say hi upon arrival so we know its the right person
https://discord.gg/82Wm8jbt
Graham Stoney · August 29, 2022 at 9:48 AM
Thanks Clark. Unfortunately Discord says “Invite Invalid”. Discord support say the invite may have expired. How would I get a permanent invite link? Alternatively, I think I’ve tried to join the UARS discord before but I think the admin banned me because I was pursuing Vivos treatment. It could also be a shared IP issue. Discord support asked me to ask the server admins to revoke all bans in their server settings > bans menu. Is there any chance you could ask the admin to unban me now I’ve repented please?
Graham · September 29, 2022 at 3:52 PM
Hi Graham, I was voting for you to have a good outcome about the mrna appliance. I contacted you few months ago about the aesthetic changes you saw on your face while wearing it which were none at the time. Now that you are done and excluding the negative outcome u sadly had to go through, I was wondering if you did see any positive changes aesthetically. Hope you are doing great and on the right path to your healing. Thank you.
Graham Stoney · September 29, 2022 at 4:14 PM
I haven’t noticed any positive aesthetic outcomes. All I really notice is that I bite my cheeks often now due to my molars being flared.
Graham Stoney · December 16, 2022 at 10:07 AM
Hi Clark. What is the name of the Discord server you recommended for planning MMA? I’d like to see if there is some other way to join. Thanks, Graham
Janet · August 23, 2022 at 10:05 PM
I’m sorry this happened to you. Thank you for faithfully detailing your experience with this appliance over all this time. It’s been a huge help for those of us who’ve considered using it.