The FDA Is Warning Against the Use of These At-Home Lip-Plumping Devices
Even if someone somehow manages to procure a pure, legitimate HA filler, getting it into the pen opens another 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 adds 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 issue 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 folks, barring healthcare workers, aren’t familiar with the intricacies of sterile technique, “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 regulate hyaluron pens?
Serving as an example of what can feasibly be done to protect the public from self-harm, the Canadian health authorities issued a public safety warning on these pens in 2019, says Dr. Beleznay, who tells us that the sale of hyaluron pens is also restricted in Europe. Beyond warning citizens of the dangers involved, Health Canada requested that importers, distributors, and manufacturers of hyaluron pens “stop selling these devices, in addition to asking all companies involved to recall the devices on the market,” according to the agency’s safety alert.
When we asked Simson if the U.S. FDA was taking steps to remove these devices from the market or to prohibit manufacturers from marketing them for cosmetic 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 hard to imagine the hyaluron pen ever gaining FDA clearance, considering the litany of risks outlined by our medical experts and the current absence of data on the DIY devices. “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 points out.
While optimistically awaiting hyaluron-pen legislation here in the U.S., we at Allure implore you to heed our experts’ warnings and not succumb to social media’s latest bad idea.
Additional reporting by Marci Robin.
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