If you have read this blog ever – literally any blog post here – you have seen me lament on about the frustrations of “Cosmetic Surgeons” masquerading as Plastic Surgeons.
The general public may not be aware that the two are not synonymous with each other (in fact, any Doctor can call themselves a Cosmetic Surgeon). This has led to OB/Gyns performing breast augmentations and Derms performing blepharoplasties with their patients none the wiser to their lack of specialized training. Residing in south Florida doesn’t help the situation as we are home to scam and scandal in cosmetic medicine. Remember when USA Today published this piece in April?
And just when I thought it could not possibly get any more questionable in this field I love so much, I am scrolling through Instagram Stories and see this sponsored headline “Need-less Filler – Inject your lips – no pain, no needle! Only $350”.
Surely, I think, this must be some bizarre spa lip exfoliation-suction treatment nonsense. I click the link – Hyaluron Pen Needle-less Injections. AT.A.LASH.BAR. What?!
This needle-less injector, also known as a jet injector, has been around for years, used to inject diabetics with insulin. The skin is pierced by the high power jet of the pen and the medication is then administered versus a traditional injection made with a needle.
You are probably thinking “no needles, cheaper than other filler treatments on the market, can’t be too dangerous as my nail tech is offering it – how can this be bad?”
These are not FDA approved. There are no current FDA Marketing Applications for a Hyaluronic Acid injector. There is, however, an FDA Guidance Document available on general use needle-less injectors (like the ones used for diabetics and certain vaccines) regulating them as a Class II Medical Device. This means that the product manufacturer cannot legally sell or market these devices for unapproved or off-label use. This also applies to the purchaser of the product, in this case, the provider.
This means, whatever device is being used on you is not a medical device. It is some generic garbage sold on Amazon or AliBaba or some other non-medical supply company.
Also – the fillers this device claims to inject is said to be similar to Restylane or Juvederm – Hyaluronic Acid. This is a prescription medication that must be purchased and legally administered by a licensed medical provider which, your lash girl is not. So, what are they injecting you with? Your guess is as good as mine but it most definitely is not regulated and likely came from China.
Canada has issued a safety alert regarding these devices as there have been reports of misuse causing hematomas, abscesses and inflammatory skin conditions. Add to the list a potential bacterial or fungal infection due to contamination during filling and the potential cross contamination of transmittable disease from one patient to the next as your spa staff does not have the same OSHA training or knowledge on preventing these issues as a medical professional would.
The Texas Medical Board also just issued at least one compliance letter on this device.
If I am scaring you then I am doing my job.
The takeaway? This is a medical device administering medication that should only be performed by a medical professional. Shame on the manufacturers of these devices for marketing their seminars and training to cosmetologists and shame on these cosmetologists for not staying in their lane and sticking to what they are (legally) allowed to do.
