Health Canada has released a consumer advisory regarding the use of plasma pens, also known as fibroblast devices. Plasma pens are hand-held devices that heat and burn the skin using focused electricity on the skin surface. They are used for cosmetic skin treatments such as eyelid lifts, wrinkle reduction, and removal of moles, skin tags, scars, and spots.
Plasma pens have not been approved for sale in Canada, which means that they have not been evaluated for safety. However, they are being used in personal services settings and sold to consumers online and through esthetician training courses.
It is recommended that consumers avoid the use of plasma pens/fibroblast devices that may be offered at spas, cosmetic clinics, or any other location including private homes.
Possible side effects of this procedure include pain and swelling of the treated area, redness, sagging skin, hyperpigmentation (spots), ultraviolet sensitivity, skin peeling, and skin crusting. These side effects can happen even when the device is used properly. If used improperly, other risks include:
- Skin punctures with the needle tip
- Severe burns caused by overuse or prolonged use
- Burns to the eyes
- Complications from burns such as infection and permanent scarring.
Health Canada has contacted companies who are selling these unauthorized plasma pens to inform them that it is illegal to advertise, import for sale, or sell these devices without the proper approvals and licensing. Health Canada has also contacted spas and estheticians to inform them of the licensing requirements and risks associated with the use of plasma pens.
You can check whether a medical device has been authorized by Health Canada by searching the Health Canada Medical Devices Active Licensing Listing.
For more information about this advisory, please call Health Canada at 1-866-225-0709 or call the Windsor-Essex County Health Unit Environmental Health Department at 519-258-2146 ext. 4475.