OTTAWA, March 27, 2019 /CNW/ - Health Canada is reminding Canadians that plasma pens are not authorized for sale in Canada and that these devices may pose health risks. Health Canada is also underlining that consumers should be wary of spas promoting plasma pen services.
Plasma pens are small handheld medical devices that generate electrical discharges on the surface of the skin, which causes a controlled burn and spreads heat throughout the targeted area. They are promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and the removal of moles, skin tags, scars and spots.
Health Canada has not authorized any plasma pens for sale in Canada, which means that they 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 recently seized seven unauthorized plasma pens from an Eternal Beauty Institute location in Calgary, Alberta (7325 12 Street SE). Using an unauthorized medical device may pose health risks. No evidence has been provided by the manufacturer or reviewed by Health Canada to verify the safety and effectiveness of the device.
Side effects of plasma pen use include pain, swelling of the treated area, redness, sagging skin (particularly in the upper eyelids), hyperpigmentation (spots), ultraviolet (UV) sensitivity, and skin peeling and crusting.
These devices can have additional risks, such as:
The likelihood and severity of side effects increase with the duration, frequency and intensity of treatment.
In addition, Health Canada took action to stop Beauty Biz Academy in North York, Ontario (205, 16 Orfus Road) from promoting a licensed medical device as a plasma pen. The device uses a similar operating principle to a plasma pen, but can generate a greater electrical output so its risks could be even more severe. It is licensed for physician use in a medical and surgical setting, not for cosmetic purposes.
Health Canada first warned about the risks of using unauthorized plasma pens in November 2018. The Department continues to follow up with companies (importers, distributors and manufacturers) selling unauthorized plasma pens and to take action on complaints. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of unauthorized plasma pens.
What you should do
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Également disponible en français
SOURCE Health Canada
Subscribe to our Free Newsletters!