Advisory - Dr. pen microneedling devices are not authorized for sale and may pose health risks

OTTAWA, ON, Dec. 16, 2021 /CNW/ -

Summary

Example of an outside label for a Dr. pen Auto Microneedle System (CNW Group/Health Canada)

Example of pen, cartridges and charger for a Dr. pen Auto Microneedle System (CNW Group/Health Canada)

• Product: Dr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions. Sold in various colours and styles.
• Issue: These devices are not authorized and may pose health risks.
• What to do: Do not use these unauthorized medical devices. Consult your healthcare professional if you have used them, or have had them used on you, and you have health concerns.

Issue
Health Canada has received a number of complaints regarding the importation, sale and use of unauthorized Dr. pen microneedling pens and cartridges in Canada, including reports from local public health units. These devices have been found for sale online, at salons and spas, and by beauty academies in conjunction with aesthetic training programs. They are often advertised for at-home use, but may also be used as part of aesthetic services provided at salons and spas.

In Canada, microneedling pens and cartridges require a medical device licence from Health Canada to be sold. Health Canada assesses the devices for their safety, quality and effectiveness before issuing medical device licences to authorize their sale. It is illegal to advertise for sale, import for sale, or sell medical devices in Canada without appropriate licensing under the Medical Devices Regulations.

The safety and effectiveness of unlicensed devices have not been assessed by Health Canada. They may present a higher risk to Canadians as some may be low quality, may not work, or may be unsafe. Dr. pen microneedling pens and cartridges are not licensed by Health Canada.

In addition, to date, no microneedling devices have been authorized for at-home use, where there are higher health risks associated with inappropriate use, contamination, and infection. Health Canada has authorized microneedling devices for professional use only, to treat or improve the appearance of skin (e.g., scars, wrinkles and deep facial lines, cellulite and stretch marks).

The devices have many small needles, tips, or pins on the surface, which are repeatedly inserted into and removed from the skin. The known risks associated with microneedling devices include short-term or potentially permanent changes to skin. Common reported issues include dryness, rough skin, redness, itching, bruising, bleeding or crusting. Serious adverse events include infection, cross-contamination, pigmentation changes (patches of darker or lighter skin), reactivation of herpes cold sores, and swollen lymph nodes. 

There may be additional risks for individuals who have clotting or bleeding disorders, a compromised immune system, uncontrolled diabetes, active skin infection, rash, scars (i.e., a history of keloid scars), warts, birthmarks or moles in the area to be treated, darker skin types, are pregnant of breast feeding, have allergies to either stainless steel or topical anesthetics, are on certain medications (such as anticoagulants), or who are receiving certain treatments for a malignancy (cancer). It is recommended that individuals seeking microneedling treatment, only seek treatment from an experienced professional who can answer all of their questions about the benefits and risks for their individual circumstances in order to make an informed decision regarding their treatment.  

What you should do

• Do not use or buy unauthorized Dr. pen microneedling pens and cartridges or receive services at spas or from estheticians using these devices.
• Consult your healthcare professional if you have used these products, or have had them used on you, and you have health concerns.
• Only seek microneedling treatment from an experienced professional, as they can assess the benefits and risks of microneedling treatment for your individual health circumstances.
• Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).
• Report adverse effects or complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.

What is Health Canada doing? 
Health Canada continues to follow up with companies (manufacturers, importers, distributors, and retailers) selling unauthorized microneedling devices and to take action on complaints received by the Department. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of these devices into Canada.

Related links

• Safe medical devices in Canada
• Buying medical devices from the internet
• Medical Devices Active Licence Listing (MDALL)
• Health Canada reminds that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spas (March 27, 2019)
• Plasma pens are not authorized in Canada and may pose health risks (November 26, 2018)
• Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks (September 13, 2019)

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]