The importance of clearance by the US Food and Drug Administration (FDA) for devices like Bellus’ SkinPen® has spread to the United Kingdom.
The UK has taken note on the seriousness of using safe devices to perform microneedling treatments, and many medical directors believe that it is the correct decision. Even though the regulatory requirements can differ, the potential health risks associated with microneedling remain the same.
The FDA has updated its definition of microneedling devices to a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use, and the Administration believes this change will enhance patients’ access to innovative devices.
So what does this mean for your practice?
No matter where your practice is located, the health risks associated with the use of a microneedling device shouldn’t be ignored but they can be prevented.
It’s important to make sure your practice uses only FDA-cleared devices. By using SkinPen, the first FDA-cleared microneedling device, you can be sure to protect your patients’ health, as well as your risk of liability.1