The world’s leading cosmetic surgeons will this week discuss reported side-effects of an enzyme used to dissolve facial fillers, after dozens of patients revealed complications to Guardian Australia.
Earlier this month, the Guardian spoke to more than a dozen patients who claimed to have suffered serious pain and side-effects after being injected with an enzyme called hyaluronidase to fix medical or aesthetic issues arising from prior cosmetic injections.
More than 25 additional readers responded to the article to say they too had suffered complications.
One woman said she had been a fit and healthy 40-year-old before being injected but now claimed to be “so sick that I’m no longer able to work”. She said her skin sagged and she had suffered burning pain.
Another said she ended up in hospital with an allergic reaction and had not given informed consent. “I was also expecting a simple routine procedure and was unaware of the risks,” she said.
The Sydney surgeon Dr Tim Papadopoulos said he was taking the claims seriously and would raise the matter at the International Society of Aesthetic Plastic Surgeons (Isaps) conference in Turkey taking place this week.
“If it’s something that’s out there, we should be aware of it,” Papadopoulos said.
He said it was a challenging issue because they were “very, very rare cases that we’re seeing”.
“I’m very open to the suggestion that there are these rare side-effects,” Papadopoulos said.
“We just don’t have enough information and so anybody who’s doing some studies on this to find out and collect this data would be doing everyone a favour. It’s very, very important.”
Hyaluronidase is used in surgeries to break down connective tissue and make the tissue between cells more permeable, allowing injected substances to spread and absorb more rapidly. However, some patients have reported burning pains, facial drooping and skin changes.
The London-based reconstructive and plastic surgeon William Townley believes there is a “genuine” phenomenon even through he cannot explain it and wants to see researchers investigate the claims.
“It is mostly thus far an anecdotal problem and it’s hard to determine what the science or the mechanism might be behind people experiencing this phenomenon,” he said.
He said that in very rare circumstances there were issues “in areas that are distant or not adjacent to where the hyaluronidase has been injected”.
“It’s not a completely isolated event and therefore it merits consideration,” he said.
The Therapeutic Goods Administration has previously stated it would welcome an application for the product’s regulated use in cosmetic procedures but could not compel any companies to do so.
The enzyme, which is commonly used in ocular surgery, is currently used by cosmetic injectors “off-label” – meaning it is used for purposes other than those it was originally approved for.
The agency reported there had been 27 adverse event reports for products containing hyaluronidase, most commonly for allergic-type reactions, including anaphylaxis over the past 10 years.
The Melbourne dermatologist Prof Greg Goodman said there was “no money” in bringing the dissolving enzyme’s use on label, which would require expensive trials.
“This agent is unregulated, it’s grandfathered in. It’s in nobody’s interest, especially the company who would have to do the application [to] TGA, to apply for it,” he said.
“It’s in nobody’s commercial interest to go through all the studies, phase one, phase two, phase three, phase four, probably cost $1.1bn to actually get a new indication for a drug. It’s not reality, it’s just not going to happen.”
He said he did not believe the enzyme “destroys people’s own tissues” and found the claims “unbelievable”.
“I’m not concerned that people are finessing or changing people’s overfilled areas. I am concerned that people are being overfilled,” he said.
“We’re lucky enough to have something that can remove it.”
Amid calls for greater regulation of the industry that has boomed in recent years, Goodman said there was no point because he could not see how it would be enforced.
“I don’t like the idea of disenfranchising people and I don’t like the idea of saying no, this person can inject that or that person can inject this because you take away people’s livelihoods,” he said.
“You can regulate but how do you police that? Nobody’s got the armamentarium to run around 4,000 injectors and say, ‘You’re doing the right thing, you’re not doing the right thing’. It sounds good but I don’t think it’s a workable situation.”
