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.
Health Canada continues to receive complaints of plasma pen sales and spa services. Health Canada is also aware that some beauty academies are selling the unauthorized devices to esthetician trainees once they have completed their training.
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:
- skin punctures with the needle tip;
- excessive skin burns caused by overuse or prolonged use;
- burns to the eye; or
- burn complications such as scarring and infection.
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
- Avoid buying or using unauthorized plasma pens, or receiving services at spas and by estheticians using these devices (or any other devices promoted as plasma pens).
- Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).
- 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.
- Plasma pens are not authorized in Canada and may pose health risks (November 26, 2018, Information Update)
- Risks of shopping online
- Buying medical devices from the Internet
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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SOURCE Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709