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A nurse would insert long sutures under Isabella鈥檚 face. The barbed, wirelike polyester threads would tighten her skin and reduce fine lines, all in less than an hour. For a little more than $2,000, the results would last two years, the recovery would be swift and the threads inside her face would dissolve, Isabella alleges the nurse said.

It did not go as advertised.

Across Canada, medical clinics and spas offer these PDO thread lifts, a popular marketed as a safe, minimally invasive treatment that can be done over a lunch break.

But as they vie for customers on TikTok and Instagram, providers make misleading claims about the quality and effectiveness of the threads they use on patients, while soft-pedalling potential risks, a Star investigation has found.

Unbeknownst to customers, some clinics are inserting PDOs, or Polydioxanone threads, that have never been approved for any kind of use in Canada.

There are some PDO brands that have been vetted and approved by Health Canada for closing wounds, but none of those have been approved for cosmetic thread lifting.

A health-care provider is allowed to use the PDOs approved for wound treatment on patients wanting cosmetic thread lifts, in what鈥檚 known as an of a . But they are not allowed to advertise such uses.

At least two dozen Ontario clinics and med spas promote PDO thread lifts on their websites. Some even go so far to falsely tell prospective customers that their threads are 鈥淗ealth Canada approved鈥� for facial rejuvenation procedures.

鈥淚f the devices are being used off label, then they haven’t been subjected to rigorous testing or the testing hasn’t been evaluated by Health Canada [for that purpose] so nobody knows whether or not those products are effective or safe to use,鈥� drug safety expert Dr. Joel Lexchin said.

鈥楢 surgical procedure鈥�

Doctors and nurses don鈥檛 have to take special PDO thread lift training before inserting the sutures in patients鈥� faces. There is a plethora of one-day or weekend training courses including some that offer the certificate of 鈥渢hread master.鈥�

The Star鈥檚 findings raise questions about whether regulators are properly monitoring the selling and inserting of this popular treatment that published research shows carries the possibility of while only delivering short-term benefits.

鈥淚t is still a surgical procedure,鈥� Dr. Woffles Wu said, a plastic surgeon in Singapore and one of the pioneers of thread lifts.

鈥淵ou could perforate a blood vessel, you could puncture a nerve. There are all kinds of complications that could happen,鈥� he said, adding that thread lifts were originally intended only for plastic surgeons and very qualified dermatologists.

As Isabella lay on a reclining chair inside the Richmond Hill clinic, the nurse used a needle affixed at the end with a tube, or cannula, to push the long, clawed suture into the left side of her face. The thread ran downward, under the skin and parallel to the ear, then into her jowl, recalled Isabella. (She requested her name not be used due to embarrassment over what she says are lasting deformities caused by the procedure.)

Isabella heard a snap as the thread broke into pieces under her skin. The nurse quickly fetched another thread to insert, she said.

The threads stayed inside her face for a couple of months before one of them suddenly popped through her skin.

Rise of the 鈥榣unch-break鈥� lift

Thread lifts first surged in popularity in the early 2000s. At the time, Oprah Winfrey crowned them as a “one-hour lunch-break lift” and a ”.”

Within a few years, however, the procedure鈥檚 lustre dulled after the U.S. Food and Drug Administration (FDA) revoked the clearance of a prominent brand after studies reported complication rates as high as 69 per cent, according to media reports at the time. Patients who had received these permanent threads 鈥� unlike the dissolvable ones, they remain in the skin indefinitely 鈥� experienced intractable pain, infection and threads poking out of the skin.

A 2009 report by doctors in New York state concluded the procedure with permanent sutures provided only limited short-term improvement that may be largely attributed to post-procedural swelling and inflammation and said they couldn鈥檛 justify further use of thread lifts for facial rejuvenation.

Since then, lifts 鈥� especially using dissolvable threads 鈥� have returned as a popular offering in cosmetic clinics and spas.

In Canada, there is only one brand 鈥� Silhouette Instalift made of PLLA (poly-L-lactic acid) 鈥� that has been approved by Health Canada to be used for cosmetic lifts. Many practitioners, however, choose to use PDO threads, which are cheaper and, their proponents say, easier to manoeuvre inside a patient鈥檚 face.

Yet thread lifting with PDOs remains a 鈥渟carcely studied rejuvenation technique,鈥� said Dr. Candelaria Contreras, a Colombian doctor who co-authored a 2023 systematic review of the scientific literature written about PDO thread lifts.

Contreras鈥檚 paper, published in the Journal of Cosmetic Dermatology, found a properly done PDO thread lift can lead to 鈥渟uccessful results鈥� lasting six months, but also warned that there are not enough scientific studies on how to correctly insert the threads.

Despite claims by some Canadian practitioners of a high success rate for PDO thread lifts, there isn’t a consensus on it in the scientific community. Research from South Korea suggests a vast majority of patients report being satisfied with the results of their treatment, while a 2019 study in Aesthetic Surgery Journal suggests its complication rate could be as high as 34 per cent. The complications in that study included thread displacement, infection, and temporary dimpling.

Complications could also include the threads causing the production of scar tissue inside the skin, said Beverly Hills plastic surgeon Dr. Jason Diamond. Though the scar tissue will often go away with time, it may complicate matters if a patient later wants a facelift.

It鈥檚 the reason Diamond said he no longer performs PDO thread lifts.

鈥淢ake no mistake, if someone is in the market for a thread lift, they鈥檙e going to be in the market for a facelift in three, five or 10 years,鈥� Diamond said. 鈥淭hey really are just creating issues with really not much in a way of benefit.鈥�

Amy Snow first noticed 鈥渁 big fuss鈥� about PDO threads in social media posts flaunting the procedure鈥檚 gravity-defying results.

The London, Ont., woman, who was 41 at the time, had lost weight and said her cheeks felt saggy. She booked an appointment.

The procedure lasted close to an hour, Snow said, with threads inserted into her face and neck. Afterwards, she did not see any of the expected effects.

She underwent another treatment weeks later because the nurse told her it would take at least three treatments before she could see any improvement due to 鈥渉eavier cheeks.鈥�

鈥淚 spent over $4,000 on it. And it didn’t even work,鈥� Snow said.

鈥業t鈥檚 kind of top secret鈥�

Kay Arani is known to her more than 100,000 followers on social media as Thread Master Kay.

The Ontario registered nurse routinely posts before-and-after photos of her thread lift customers on Instagram, where she claims PDO threads offer the ability to 鈥渢urn back time in just one procedure.鈥�

聽鈥淣obody can do what I can do. I鈥檓 the best in the country, probably one of the best in North America,鈥� Arani told a journalist posing as a prospective thread lift client.

聽She performs the procedures out of her Oakville home.

Arani says PDO thread lifts are effective and safe if done properly by qualified practitioners. But 鈥渢his is not a one-and-done procedure,鈥� she says. 鈥淚t’s not a facelift 鈥� If you think you’re going to come in, have a thread lift, and then you don’t have to get anything done for two years, you鈥檙e crazy.鈥�

She says the insertion of threads stimulates the body to produce collagen to the area, making the face look temporarily tauter. The threads dissolve, and because they鈥檙e essentially a starch, they鈥檙e 鈥渆asily accepted by the body.鈥�

Arani says she is also an educator who tours North America as 鈥渙ne of the global ambassadors of thread lifting techniques.鈥� Among those she trained, she says, is the nurse practitioner who acts as her supervisor (the College of Nurses of Ontario requires that a clinician has a 鈥渕edical directive鈥� from a physician or nurse practitioner before performing procedures such as thread lifts).

When a Star reporter reached out to Arani posing as a customer, she claimed she used her own brand of PDO threads that were awaiting approval by Health Canada. 鈥淚t鈥檚 kind of top secret,鈥� she said.

When confronted about this claim, she walked it back, saying she does not use unapproved threads on her patients.

Arani has previously drawn scrutiny from Health Canada. In early 2021, following a complaint it received, the regulator determined that Thread Master Kay鈥檚 website violated regulations governing advertising of health products and medical devices by advertising BioSun threads, a brand of PDO threads not approved for any use in Canada.

The original complaint, a copy of which was obtained through Access to Information legislation, alleged Arani used unapproved Biosun brand threads on her clients and trained other doctors and nurses with the unapproved sutures.

As a result of the investigation, Health Canada requested Arani cease any non-compliant advertising. Kay has removed any reference to Biosun from her website. She says the language that was the subject of the complaint was intended not for her Canadian customers but for the international practitioners whom she trains.

In a statement, a lawyer for Arani said his client鈥檚 work as a consultant, educator and thread lifter is 鈥渃ompliant with all regulatory guidelines,鈥� and any 鈥減erceived inconsistencies鈥� in statements she gave reporters 鈥渁re likely due to a misunderstanding of the multi-faceted nature of her professional engagements.鈥�

鈥淥ur client has gone through extensive vetting and scrutiny through the governing bodies and is prepared to clarify these roles and services further to regulatory bodies if required,鈥� the lawyer said.

Unapproved threads appear widespread

The prevalence of unapproved threads in Canada appears to be widespread.

Between 2018 and 2020, Health Canada and Canadian border agents seized three shipments of unapproved PDO threads that were trying to make their way into the Canadian market through Vancouver, Toronto and Edmonton.

The Star has found at least three other providers in Ontario that say they use BioSun threads, even though they鈥檙e not approved in Canada.

A Biosun spokesperson who previously told the Star their products 鈥渄o not ship to Canada鈥� did not respond to questions about how her company鈥檚 products ended up in the Canadian market.

At the Canadian Board of Aesthetic Medicine (CBAM), an organization that provides training on thread lifts and other esthetic treatments, organizers of a thread training course handed out a starter kit of ACCEL PDO threads, unapproved by Health Canada, to trainees who registered for a one-day course.

CBAM did not respond to questions about the unapproved threads.

Jay Santana, CEO of Elite Aesthetics, a Florida-based company that manages brands including ACCEL PDO threads, told the Star the company sponsored the training and gave away unapproved threads to Canadian trainees for the purpose of 鈥渇ostering education.鈥�

The company doesn鈥檛 sell ACCEL threads in Canada, Santana said.聽

However, many unapproved threads are finding their way into the Canadian market as a result of high demand and a lack of options, he said. There is a 鈥渕onopoly鈥� in Canada鈥檚 medical esthetics market in general with only a few big players selling overpriced products, according to Santana.

There are at least 50 clinics in Toronto alone that offer PDO threads, Santana said, noting 鈥渆veryone is buying from somewhere,鈥� including Amazon.

Even when using threads that are approved for a specific use such as wound closure, clinics and spas appear to routinely run afoul of Health Canada鈥檚 rules. The medical device regulator prohibits the advertising of a device for an unapproved use, 鈥渁s this may leave an erroneous impression as to the product鈥檚 merits.鈥�

That hasn鈥檛 stopped dozens of businesses in and around the GTA.

One of those is Etobicoke鈥檚 ML Aesthetics Clinic. Its website said its practitioners who administer PDO threads 鈥渙nly perform safe, Health Canada approved procedures.鈥� The website for REJUUV Medi Spa called PDO threads 鈥渢he first thread lifting system approved by the FDA and Health Canada.鈥�

After the Star asked questions, both spas blamed website administration errors for mistakenly claiming PDO threads were Health Canada approved and subsequently revised their websites. Despite the information on its website, REJUUV told the Star that they do not use PDOs but in fact use the Health Canada-approved PLLA threads.

鈥淢y take home message for all these products, especially in the cosmetic industry, is the information that patients are given is not correct or good enough,鈥� said Dr. Jan Willem Cohen Tervaert, a rheumatologist and professor at the University of Alberta who specializes in diseases that develop after implants.

Dr. Asif Pirani, a cosmetic plastic surgeon at the Toronto Plastic Surgery Center, said he would not use PDO threads off-label as they may involve needles and cannulas that are designed for wound closure but not necessarily tested or suitable for cosmetic thread lifting.

鈥淏ased on the limited data we have in the research body for the risk profile and the limited longevity for me, I don’t think they’re worth it,鈥� Pirani said.

Concerns over insufficient thread lift training

Dr. Neel Bector has increasingly seen a new kind of patient come into his Mississauga clinic, seeking his help to fix issues after receiving PDO threads. 鈥淚 probably see about four or five cases a month, which is pretty high as far as these treatments are concerned.鈥�

Bector, who worked to fix Isabella鈥檚 face after her allegedly botched procedure in Richmond Hill, says PDO threads used off-label for thread lifting may not be as safe as the Health Canada-approved 鈥淪ilhouette鈥� brand of PLLA threads he prefers to inject.

He worries that some practitioners are not properly inserting the sutures 鈥� and there is insufficient training to ensure that this doesn鈥檛 happen.

At Skin Vitality Medical Clinic, a major cosmetic medical services provider in Canada, PDO services are not openly advertised on its websites but when a reporter called posing as a prospective patient, the receptionist said they offer PDO thread lifts using BioSun threads.

It is at Skin Vitality鈥檚 Richmond Hill clinic where Isabella received her PDO treatment. After she felt the thread break off in her face, the procedure continued as the nurse inserted more threads as the pain intensified, she alleges.

By the time she got home, Isabella said she looked 鈥渓ike a monster.鈥�

In the weeks after the procedure, she said she was in so much pain that she went to the emergency room several times. One plastic surgeon suggested a procedure that may remove it but could not guarantee its success.

Then, a couple of months after the procedure, she felt one of the threads move out of place. While out for dinner, a thread poked through her skin and into the side of her mouth. She gently pulled the thread out with her hands at the dinner table in between bites of Chinese food.

The other threads remain in her face, undissolved, she alleges.

Isabella is suing the clinic and the nurse for $3 million, claiming the nurse was incompetent and unqualified and the clinic negligent for inserting unapproved threads into her face. She is also suing Biosun, alleging that the PDO thread maker failed to properly test and distribute its products and failed to ensure its products were safe. The Star had agreed to grant Isabella anonymity prior to the filing of her lawsuit.

In an email statement to the Star, Skin Vitality Medical Clinic denied Isabella鈥檚 allegations and declined to answer specific questions, citing ongoing litigation.

Skin Vitality said its clinics have treated more than one million patients since 1992. Their patients are informed of risks and possible side effects, and must give written consent before treatments.

Biosun has filed a notice of intent to defend. A lawyer for the US-based company said it would be improper to comment as the case is ongoing.

Isabella said there needs to be more oversight of clinics performing thread lifts.

鈥淲hat happened to me I wish would never happen ever again to anyone.鈥�