Patients are demanding greater regulation of the cosmetic facial filler industry as they report devastating injuries, pain and side-effects after undergoing a common reversal procedure.
Guardian Australia has spoken to more than a dozen women who say they have suffered side-effects as a result of being injected with an enzyme called hyaluronidase and claim they have since been “medically gaslit” by practitioners in the booming cosmetic injectables industry.
Hyaluronidase, or hyalase, is used in eye surgeries and other medical procedures to break down connective tissue and make the tissue between cells more permeable, allowing injected substances to spread and absorb more rapidly.
But its increased use by Australian cosmetic injection clinics to remove dermal fillers has some experts concerned, amid reports of some patients experiencing burning pain, facial drooping and increased skin laxity, as well a lack of informed consent.
Elke*, 33, was living in Melbourne and building her career as a film-maker when she decided to get filler in her lips coming out of lockdown in 2020.
“We’re going to have this fabulous summer and why not feel even more fabulous?” she remembers thinking.
Visiting family a short time later, she decided she wanted to get rid of it, so she sought out a practice to dissolve the filler. She says this procedure was marketed as routine and nobody warned her of associated risks.
But Elke quickly noticed changes to the way her face looked beyond her lips, including drooping in some areas, and claims she has experienced extreme pain that’s come and gone repeatedly since.
“It was almost immediate that I had a drop on [one] side,” she said.
“This was when my life changed forever really, about two weeks in. I had what could only be described as bone-crushing, soul-crushing pain, like someone had my head in a vice and I was sweating and sweating.”
Since then Elke says her skin has sagged and drooped and she feels like it is affecting her whole body almost two years on. Due to the severity of her symptoms, she has relocated to Queensland to be closer to family and says she is unable to work.
Dr Daniel Ezra, a London-based plastic surgeon, has been investigating the use of hyaluronidase via a small study of about 150 people and said about 20% of participants reported adverse changes, including discoloration and hollowing of the face.
“My view on it is that there’s definitely a real thing,” Ezra said.
“It’s difficult to believe a whole lot of people are just imagining something simultaneous all over the world.
“You cannot make any conclusions based on one study, which is relatively small, but it hopefully will have raised enough questions that people will start to look at this and start to ask the right questions.”
Injectable treatments were excluded from the recently released scathing independent review into cosmetic surgery in Australia, commissioned by the Australian Health Practitioner Regulation Agency (Ahpra) late last year after media reports revealed serious problems in the sector.
Cosmetic injections require a valid prescription from an authorised prescriber such as a doctor, dentist or nurse practitioner, and the prescriber is supposed to consult with the patient and explain possible side-effects before anything is injected.
The Therapeutic Goods Administration (TGA), the drugs regulator, recommends patients check that both the prescriber and injector are “appropriately qualified” and registered with Ahpra.
Sydney woman Hannah* says she feels like her face has never fully recovered after she had tear-trough fillers dissolved in mid 2019, having gotten them for her wedding the year before.
She says her face became sunken and hollowed after the injection, especially on the side the injector told her she would “flood” with hyaluronidase.
After raising concerns in the weeks following the injection, Hannah was told it was “normal to feel deflated afterwards” but that the enzyme could not have affected her natural tissues.
In 2020 she spent $10,000 on a facial fat grafts and a blepharoplasty to repair some of the damage but says there have still been long-term changes.
She says it felt like “all the bits in [my face] came apart and they never really joined back together again”.
Surgeon calls for education on hyaluronidase
Dr Naveen Somia, a Sydney surgeon and past president of the Australasian Society of Aesthetic Plastic Surgeons, said hyaluronidase was “very effective” at removing cosmetic filler but carried “a real risk of pretty bad reactions” and he used it only when necessary.
Somia believes that the enzyme would target and destroy some naturally occurring hyaluronic acid in the face, not just the hyaluronic acid filler.
“It’s reasonable to assume that if it is targeting hyaluronic acid, it does not discriminate between normal hyaluronic acid and the hyaluronic acid in filler,” he said, noting he believed the body should eventually replace the lost volume.
Somia said Australian regulators should assess the product for use as a filler dissolver so it could be properly regulated.
The substance commonly comes in a powdered form before it is reconstituted into an injectable liquid by mixing it with either water, saline solution or an anaesthetic.
There are no official Australian guidelines for what those ratios should be for optimal outcomes, nor what the enzyme should be mixed with.
“There should be more awareness among practitioners as to how to use it,” Somia said.
In a statement, the TGA said it would welcome an application for the product’s regulated use in cosmetic procedures.
“However we cannot compel any company to make such an application to the TGA,” a spokesperson said.
According to the TGA, there have been 27 adverse event reports for products containing hyaluronidase, most commonly for allergic-type reactions, including anaphylaxis over the past 10 years.
In a statement, the Ahpra said it was not aware of any significant issues with the enzyme’s use and encouraged “anyone thinking of having a cosmetic procedure done to get informed to make a safe choice”.
“We would expect practitioners to inform their patients about the treatments and any risks of side-effects in accordance with guidance outlined by the TGA,” an Ahpra spokesperson said.
*Names have been changed upon request
