A controversial new skin treatment that uses a needle-studded roller is being done in medical clinics and spas in Canada, even though it’s against the law to sell them in this country.
Microneedling involves the use of a roller - resembling a meat tenderizer - to penetrate the upper layers of the skin, creating tiny wounds or channels in the skin. It’s supposed to increase the effectiveness and penetration of the skin-care products and helps boost collagen. Think aerating your lawn, then fertilizing it.
The beauty procedure, which appears to be growing in popularity world wide, has many raving about diminished wrinkles, acne scars and stretch marks. Celebrity fans reportedly include Hollywood stars Jennifer Aniston and Angelina Jolie.
Kim Hartsman, owner of Beautex.com, which recently imported rollers from Asia to sell to Canadian estheticians and doctors, was stunned to learn from the Toronto Star that distributing dermal rollers is illegal. She believed the rollers, which are approved in the U.S and in Europe, were considered cosmetic devices.
“It’s puzzling and frustrating, because we are the last in the world to get (rollers),” says Hartman. The owner of the Thornhill-based training center and wholesale supplier of beauty products says she was especially surprised to learn of the prohibition because microneedling is less invasive than tattooing or permanent makeup, which penetrates deeper into the dermis.
But according to Health Canada, dermal rollers make health claims about what their products do, so that places them in the same class as a medical device requiring a licensing. They have not been approved for sale in Canada. Manufacturers of the rollers make health claims about what their products do, so that places them in the same class as a medical device requiring a license, says spokesperson Olivia Caron. “As Health Canada has not licensed any of these products there should be none being sold,” she says.
Health Canada issued one license in 2009 for dermal roller by a company called Prollenium Medical Technologies. That license was cancelled in 2010 and the roller was recalled because of “lack of assurance of sterility.” Since then, no other applications have been received for dermal rollers.
“There are risks to Canadians associated with the use of dermal rollers” says Caron. They included infection because of device contamination during use, or due to contaminated skin care products applied during or following the procedure, and risk of disease transmission if shared.
The Hong Kong Consumer Council issued a warning Aug. 15 about the so-called Microneedle Therapy System. Since December 2007 the council has received at least 43 complaints with more than 10 of itching, redness, dryness, peeling, pain, rash and worsened acne. Most complaints were treated in beauty salons but, in some cases rollers were purchased by internet, from doctors and at beauty stores, according to a council spokesperson.
If the roller is shared, not properly used or not adequately disinfected, it can worsen skin conditions and result in swelling, scaring and infection. Dermatologists warn that viruses such as HIV, hepatitis B and hepatitis C can be transmitted through shared devices that aren’t properly disinfected.
“In the wrong hands it can be very dangerous,” says dermatologist Dr. Lisa. Kellett of Toronto’s skin care clinic DLK on Avenue, who has seen first-hand the results of microneedling gone wrong. Women have come to her with active infections on their faces from microneedling treatments done at home, in the spas and at beauty salons. Each week, she says one or two patients ask her to rescue their skin.
“I’ve seen track marks and scaring from infections,” says Kellett, who refuses to do the procedure in her clinic. “When you’re dealing with something that can potentially be scaring, that’s permanent, it’s very upsetting for patients. They’re very distraught.” Some woman develop cellulitis, an infection in the lower level of the skin that is treated with antibiotics. Usually the affected area is red, warm and tender and a person may develop fever and chills.
“Either the procedure wasn’t done properly, there was something wrong with the device or an infection occurred…The problem is there are so many steps where something can go wrong.”
Another concern, say critics of the procedure, is that the rollers, which can easily be bought on websites such as Ebay, are popping up in beauty salons used by estheticians or beauticians who aren’t trained to handle complications should they arise. However, neither the Consumers Council of Canada nor Health Canada have received complaints about the rollers, also called dermarollers.
While the federal heath department has the power to seize the rollers or issue a public warning, it will not do so until it has received a formal complaint. Only then is an investigation launched. However under Ontario legislation it’s not illegal for a doctor to use an unlicensed medical device.
Some doctors offer microneedling for about $100 to $200 per session. There is a one time fee of between $150 and $180 for the roller. Hartsman hasn’t stopped selling the rollers and will only do so after speaking with Health Canada. “I’m going to continue selling them because I have not been told not to. I’m going to contact Health Canada to see what process I have to go through.” She hopes Health Canada gets around to licensing the rollers while imposing some guidelines on their sale.
A blanket ban does the public a disservice and may push some distributors underground, she says.
Hartsman would like to see rollers with shorter needles (.2mm and .3 mm) designated cosmetic devices, which would make them available for home use. Medium length needles (.5mm and 1mm) should be reserved for use by trained estheticians, and needles longer then 1.5 mm should be restricted for use by doctors, she believes.
“That’s a much more logical way to handle the situation,” she says. “And we would follow those guidelines and nothing would be hidden away. I really believe people will hide them in their cupboards and drawers when the health department comes in. And that will be a shame.”