Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks
- Starting date:
- September 13, 2019
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Important Safety Information
- General Public, Healthcare Professionals
- Identification number:
OTTAWA – Health Canada is advising Canadians that needle-free dermal filler devices that are promoted for cosmetic skin treatments—such as reducing wrinkles and increasing lip volume—may pose health risks. These small handheld medical devices used to deposit hyaluronic acid or other dermal fillers under the skin are also known as hyaluron pens, hyapens, fog injection devices, SERA pens, and nebulizer injector guns.
Health Canada has not authorized any needle-free dermal filler devices for sale in Canada. This means that the devices have not been evaluated for safety, effectiveness or quality. It is illegal to advertise for sale, import for sale, or sell medical devices in Canada without appropriate licensing under the Medical Devices Regulations.
Health Canada is aware that needle-free dermal filler devices are being used in spas and are being sold directly to consumers online and through esthetician training courses.
Potential side effects include:
- Inflammatory skin reactions
- Hematomas (collection of blood outside a blood vessel)
- Abscesses (collection of pus, usually caused by a bacterial infection)
- Staining of skin
If used improperly, these devices may have additional risks, including:
- Bacterial and fungal infection due to contamination during filling
- Spreading of transmissible diseases due to cross-contamination between users
- Damage to skin, eyes or blood vessels due to excessive pressure or operator error
What you should do
- Do not buy or use unauthorized needle-free dermal filler devices, or receive services at spas or from estheticians using these devices.
- Consult your healthcare practitioner if you currently use or have used a needle-free dermal filler device and are concerned about your health.
- Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing.
- Check Health Canada’s Recalls and Safety Alerts database for advisories on illegal health products that have been found on the Canadian market.
- Report complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.
What Health Canada is doing
Since May 2019, Health Canada has contacted a number of companies (importers, distributors, and manufacturers) selling unauthorized needle-free dermal filler devices to inform them that it is illegal to advertise, import for sale, or sell these devices in Canada without appropriate licensing. Health Canada requested that they stop selling these devices in addition to asking all companies involved to recall the devices on the market.
Health Canada continues to contact spas and estheticians, as well as provincial and territorial authorities, to advise them of the medical device licensing requirements and the risks associated with using needle-free dermal filler devices. The Department is also working with the Canada Border Services Agency to help prevent further importation of these unauthorized medical devices.