Advisory

News provided by 16 Dec, 2021, 17:57 ET Share this article OTTAWA, ON, Dec. 16,

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16 Dec, 2021, 17:57 ET

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

Summary

IssueHealth 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

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.