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Patients report side effects after popular cosmetic procedure to dissolve facial fillers with unregulated 'off-label' drug

Re-emerging from Melbourne's marathon lockdown, Agnés* decided to dabble in cosmetic injectables as "a bit of a pick-me-up".

It was a decision she didn't think much of at the time, so when the dermal lip filler didn't look quite as she hoped, she decided to have it removed in an increasingly common procedure known as dissolving.

After having 30 units of a popular drug called hyaluronidase injected into her lips and jaw, Agnés woke with "bone-crushing pain".

She said she presented to emergency concerned she could be having a stroke.

"I felt very sickly, there was a sense of, almost like I had been poisoned by something," she said from the lounge room of her Queensland home.

"I had very dilated pupils, I had a very fast heart rate.

"There was that deep sense, that innate, intuitive sense that something was not right about what I had received."

Told she might be having a reaction to the anaesthetic, Agnés returned home from hospital feeling uneasy.

In the days and weeks that followed, the 33-year-old, who said she had enjoyed otherwise good health, noticed rapid changes in her body amid escalating pain.

Medical records show she had dry eyes, blurred vision, slurred speech, chest pain and problems with the ligaments in her jaw, but the cause of it all was not clear. 

A lack of research has meant doctors have been unable to say with certainty if hyaluronidase is behind the adverse outcomes.

Now the filmmaker lives with a long list of systemic ailments she believes were triggered by the dissolving agent, including permanent nerve damage, degraded connective tissues throughout her body and a mystery autoimmune issue doctors have been unable to diagnose.

The drug Agnés was injected with has long been used in eye surgeries and other medical procedures to break down connective tissues and help spread anaesthetic by making skin cell tissues more permeable.

But its use in cosmetic procedures has not been approved by Australia's Therapeutic Goods Administration (TGA) and other global regulatory health bodies, meaning it is used "off label".

The TGA said "off label" means that how the drug is used is left up to doctors' discretion, despite there being no rigorous testing on its safety.

As a result, the widely used drug remains unregulated in Australia's booming cosmetic surgery industry.

A lack of clear industry guidelines on the drug's best use around the world has also meant patients have been injected with different types and amounts of the enzyme.

'Skin coming off my bones like a rag'

Cosmetic injectable patient in Russia describes skin sagged "like a rag"

While some patients experience no adverse side effects, the Australasian College of Cosmetic Surgery and Medicine said it's seen a direct increase in patients reporting complications ranging from mild to severe after the dissolving procedure.

Without certainty on the full extent of the drug's impacts, patients such as Agnés have reported being "medically gaslit" by doctors and left in medical limbo by an industry they say places profits over patient safety.

Patients reported changes across their entire body after dissolver injections

She said the issue is compounded by a lack of informed consent, with some doctors providing little to no warning of the risks or complications involved with dissolving treatments. 

"When you actually look into what this product is and what this enzyme does, it's actually catalytic and it is [designed to] break something down," Agnés said.

"And that is the best way to describe what it feels like – like slowly being corroded, being broken down by something."

Victorian woman Tina* said she was "still paying the price" after having 6 milligrams of hyaluronidase injected into her cheeks and temples to dissolve facial fillers seven years ago.

"I look in the mirror and I can see myself ageing rapidly. My mother just turned 70 and we look pretty much the same," the 48-year-old said.

"I used to walk into a room and people would take notice, now I put my head down and hide, I even quit my job.

"It's all about money making – it takes half an hour to inject someone and make a couple of grand out of it, easy cash."

'You're still pretty, go home'

Agnés said she has been unable to work for two years as she battles chronic illness, "incredible fatigue" and suicidal thoughts.

She said the worst part of her ordeal was the "overt medical gaslighting" she experienced from countless doctors she sought help from over the years.

On one trip to emergency at a Melbourne hospital, Agnés said a doctor told her: "You're still pretty, go home and get some sleep."

She said doctors dismissed her illness as dysmorphia, which left her isolated and cut off from family support systems.

"I was told point blank, that it's not possible. I was told that it must be something else that's just happened to happen around the same time," she said.

"It was so cruel and so callous … to suggest it wasn't real. It was a way of saying a woman is experiencing some kind of hysteria, instead of doctors just saying 'we simply don't know'.

"Medical gaslighting doesn't only destroy and break down the person that it's being done to. It seeps out and poisons and fractures the support system that that person has."

A Facebook group with more than 4,500 members has provided a platform for members to share their experiences of filler and dissolver damage, and the subsequent psychological impact.

London social worker Hazel* volunteers her time offering emotional support to more than 200 of the group's members living in "shock and fear".

"There are hundreds of people feeling suicidal and sadly some who have taken their lives," she said.

"The shame and fear of being judged leads to people often suffering in isolation."

Hazel said there was "little to no specialised support" for cosmetic patients who were adversely affected by procedures.

"The industry is very quick to take our money, but hugely reluctant to invest any money in our emotional, psychological or physical wellbeing when things go wrong.

"Instead, people are ignored and dismissed."

Adverse effects 'unmasked'

London-based ocular plastic surgeon Dr Daniel Ezra said he has conducted the largest study of the dissolving agent's impacts, which found 20 per cent of 150 patients experienced adverse effects.

"It's very concerning. It's a very significant proportion," Dr Ezra said of the results, which he said were expected to be published in a medical journal in coming months.

"The narrative surrounding fillers has always been that it's a natural substance and it goes in and can be removed without any adverse outcome – and that's clearly not the case.

"There are a small number of patients who will find they end up in a much worse position after the filler dissolver than they ever were.

"It's not good enough to simply say, 'Well, it's completely harmless, we dissolve the filler and nothing will happen and if you've got a problem, then it's all psychological in origin' – which seems to be happening."

Dr Ezra said while hyaluronidase had been used in eye surgeries for decades with no major reported problems, there was "something particular" about its use to reverse cosmetic fillers that was "different and seems to manifest problems".

He said he believed the filler could be causing the atrophy of connective tissues that was only "unmasked" when it was dissolved.

An unregulated, unpredictable drug

The drug's safety has proved to be a point of contention in the industry, with views differing among doctors and surgeons.

For specialist plastic surgeon and former president of the Australian Society of Plastic Surgeons, Dr Naveen Somia, the enzyme is "like CPR for the skin" — essential to an injector's "resuscitation toolkit".

For Ben Talei, a facial plastic surgeon in Beverly Hills, dissolver is used on his patients as a last resort and with a stern warning of its unpredictable nature.

"[Hyaluronidase breaks down fillers] unpredictably in some people, more so than others, and the reason why, nobody knows for certain," he said.

Dr Talei said the enzyme can also dissolve the naturally occurring hydrating substance in skin, known as hyaluronic acid, and for some patients, it may never regenerate.

He said an inflammatory response, "incited by gel [fillers] turning into a syrup, spreading, pissing off your face a little and then igniting something in someone's body that's very sensitive certainly can [happen]".

"Those are the things that nobody can give you a name for and nobody can say exactly what's happening," he said.

"The biggest problem we have is that doctors don't fully understand the appearance of these things and they end up chasing it with more dissolver."

A booming billion-dollar industry

Every year, half a million Australians are estimated to spend $1 billion on cosmetic surgery procedures alone – clocking more per capita than the US.

As people emerged from the COVID pandemic, the industry began experiencing a phenomenon known as the "filter effect", where patients sought facial surgeries and procedures that resembled a social media filter.

The pursuit of high cheek bones and plumped-up pouts has fuelled a boom in fillers that resulted in patients being "over injected", according to Australasian College of Cosmetic Surgery and Medicine (ACCSM) medical dean Ronald Feiner.

Dr Feiner said "ill-informed" practitioners were regularly over-injecting fillers and then using "excessive" amounts of hyaluronidase that has resulted in "grotesque outcomes" and "diminished" skin quality in some cases.

ACCSM said the increase in "poor outcomes" from hyaluronidase was due to a rise in "poorly trained injectors" and "inappropriate product selection and product placement".

Dr Feiner said he had fielded calls from injectors who did not know how to prepare or administer the drug, despite also hearing practitioners "naively" describe hyaluronidase as their "most go-to injectable". 

To date, the TGA has received 72 "adverse event reports" for hyaluronidase from cosmetic and eye surgery patients, including pain and anaphylaxis.

The Australian Health Practitioners Regulatory Association (AHRA) commissioned an independent review of the cosmetic surgery industry in the wake of a Four Corners expose that highlighted the lack of regulation in the industry.

While all 16 recommendations are being implemented, the review failed to include injectable treatments, such as fillers and dissolvers due to a decision to focus on "more invasive" surgeries that carry a "higher risk".

"We continue to monitor the cosmetic injectables area and will undertake further regulatory work where this is needed to keep the public safe," AHPRA said in a statement.

More research on injectables needed

Dr Ezra said the biggest roadblock to understanding the true effect of the enzyme was a lack of research and funding, with clinical trials costly and difficult to finance.

Pharmaceutical companies have little incentive to fund drug safety research, given it is already being widely used off label.

"It's important that we keep an open mind about these things. And the real way that we can determine this is to collect data and perform these research studies," Dr Ezra said.

"We need to listen to them [patients] and take them seriously."

For Agnés, her future remains unclear, with every day a struggle.

"All I have to do today is make it to tomorrow – my whole body is rotting," she said.

Until then, Agnés said Australia's cosmetics industry desperately needs "accountability, regulatory change and informed consent".

*Names have been changed to protect identity

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