Even if somebody by some means manages to acquire a pure, professional HA filler, getting it into the pen opens one other can of worms. "[They] require the transfer of filler from its original syringe to an ampoule within the pen," notes Dr. Sundaram. "This is a multi-step process — connect the transferring syringe to a needle, draw up filler, squirt it into the ampoule — and every time it’s done, there is a risk of contamination."
Dr. Sunder provides that "even if this maneuver is performed in a medical setting, the transfer would not be sterile. But this being performed in a person’s home is a set-up for an infection."
Then there's the problem of DIY sterilization. "Each of these pens has removable parts, and the question is, how clean are the actual devices themselves?" Mariwalla says. "The companies are expecting you to inject a material of unknown origin and stability into your skin, with a device that has ridges and parts that are supposed to be cleaned how? With soap and water and dried on the dish rack? Does not seem safe to me."
Since most people, barring healthcare staff, aren't conversant in the intricacies of sterile method, "the likelihood is that patients are going to end up with a non-sterile HA that they're pushing into their skin," Dr. Sundaram says.
What steps are being taken to control hyaluron pens?
Serving for instance of what can feasibly be accomplished to guard the general public from self-harm, the Canadian well being authorities issued a public security warning on these pens in 2019, says Dr. Beleznay, who tells us that the sale of hyaluron pens can be restricted in Europe. Beyond warning residents of the hazards concerned, Health Canada requested that importers, distributors, and producers of hyaluron pens "stop selling these devices, in addition to asking all companies involved to recall the devices on the market," in accordance with the company's security alert.
When we requested Simson if the U.S. FDA was taking steps to take away these units from the market or to ban producers from advertising and marketing them for beauty use, she replied, "As a policy matter, the FDA does not discuss the regulatory status of specific products except with the firms that are responsible for such products. However, to date, no needleless injector has been approved for the injection of hyaluronic acid for aesthetic purposes."
It's laborious to think about the hyaluron pen ever gaining FDA clearance, contemplating the litany of dangers outlined by our medical consultants and the present absence of information on the DIY units. "If anyone wanted to legitimize these pens, we'd have to have controlled studies — head-to-head against needle injection — to [assess] the safety, efficacy, reliability, and short- and long-term consequences," Dr. Sundaram factors out.
While optimistically awaiting hyaluron-pen laws right here within the U.S., we at Allure implore you to heed our consultants' warnings and never succumb to social media's newest dangerous concept.
Additional reporting by Marci Robin.
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