Costhetics has news you can’t afford to ignore.
Because of the lack of information concerning the details of its production and its safety for consumer use, a popular microneedling device has been removed from the Australian Register of Therapeutic Goods (ARTG). The latest generation of Dermapen may no longer be imported, manufactured, or exported by its sponsor according to the TGA.
Don’t despair. The Dermapen ban doesn’t have to spoil your Christmas. Microneedling is still an outstanding collagen induction therapy to help you get ready for holiday selfies. When administered by a well-trained professional using a properly manufactured piece of equipment, microneedling delivers well-documented benefits to skin. The problem, you see, is the device, not the treatment. For this reason, it is vital for professionals to immediately discontinue microneedling with the Dermapen handpiece. Consumers must be alert and ready to just say no when offered a treatment with this device by a non-compliant provider.
We’ve Got Your Number Dermapen
Last August, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) banned the use of Dermapen 3, Dermapen 3 needle tips, and the Dermapen Cryo device.
In November Dermapen 4 was banned in Australia. To ensure you’re not exposed to any dangerous Dermapen or other health device, Costhetics recommends you entrust your care to a trained, experienced professional only.
Costhetics salutes the Therapeutic Goods Administration for its ongoing work to protect consumers. If you’d like to know more about how the TGA assesses a product for certification, please keep reading.
Certifiably Safe
For a device to legitimately make medical claims in Australia such as “reduces scaring” (as opposed to “reduces the appearances of scarring”), it must firstly obtain clearance from the TGA and hold an ARTG certificate which is publicly available on the TGA’s online searchable register. Devices are listed on the ARTG according to their risk classification. Lower risk classification devices require less evidence of safety and efficacy, while higher risk classification items are held to a higher standard.
Microneedling devices are generally considered safe but are still classified as medical devices as their tiny needles break the skin’s protective barrier. This controlled injury causes sudden changes to the skin’s structure and can be a breeding ground for cross contamination of blood. The risk is exacerbated by the length of the needle being used. “At any depth, even a 0.2mm puncture can cause inflammatory responses that lead to problems,” reports Naked Chemist journalist Samantha Miller. “Not only that, but you are effectively injecting active serums at a depth where serums are not meant to go.”
Safety First: Know the Source
Some are dismissive of the TGA exclusion of the Dermapen device, calling it nothing more than a small “paperwork problem.” It is a paperwork problem, but far from a small one. There is no paper trail to show where and how the device is made, suggesting that it may be made (all or in part) outside of Australia and not subject to the rigorous manufacturing requirements our country enforces.
The growth of a global beauty industry has been positive in so many wonderful ways, but it has also created an opportunity for bad actors to cut corners and offer sub-standard goods in search of profits. They avoid prosecution by simply relaunching under another name. This is where the story gets murky when it comes to Dermapen. It was discovered that the device had been relisted incorrectly with the TGA as a class 1 device, under a different sponsor name. Additionally, the newly listed device was offered under a misleading generic name rather than masked its Dermapen pedigree.
Every consumer should be diligent in knowing where products or devices are made before agreeing to their use. (We should note that this problem is not exclusive to the beauty industry. In the United States, legislators are calling for a crackdown on dangerous over-the-counter drugs sold at bargain stores that can “make people sick,” reports NBC News.)