Plasma pens are not authorized in Canada and may pose health risks

Starting date:
November 26, 2018
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Identification number:
RA-68366

Issue

November 26, 2018
For immediate release

OTTAWA – Health Canada is advising consumers that plasma pens (also known as “fibroblast” devices) promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and removal of moles, skin tags, scars and spots, may pose health risks. Plasma pens are small handheld medical devices that focus electricity on the surface of the skin, which causes a controlled burn and spreads heat throughout the targeted area.

Health Canada has not approved any plasma pen devices for sale in Canada, which means that they have not been evaluated for safety, effectiveness or quality.

Health Canada has been made aware that plasma pens are being used in spas and are also being sold to consumers online and through esthetician training courses.

Possible side effects—even when the device is used properly—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.

If used improperly, 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.

Starting in June 2018, Health Canada contacted a number of companies (importers/distributors and manufacturers) selling unauthorized plasma pens 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 plasma pens. Health Canada has also asked the manufacturers involved to recall any of these devices that have been sold.  

Health Canada is contacting spas and estheticians, and provincial and territorial authorities, to inform them of the medical device licensing requirements and risks associated with the use of plasma pens. The Department is also working with the Canada Border Services Agency to help prevent further importation of unauthorized plasma pens.

Consumers should avoid the use of these unauthorized products at spas and by estheticians.

Consumers can check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL). They can also check Health Canada’s Recalls and Safety Alerts database for advisories on illegal health products that have been found on the Canadian market.

Consumers are encouraged to report complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.

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Health Canada
(613) 957-2983

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(613) 957-2991
1-866 225-0709

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