Filler pens: Does needle-free filler equal no risk?
No-needle “injector” devices are increasingly being used in the UK for aesthetic procedures, including mesotherapy and dermal fillers.
The pen-like devices have become particularly popular among the non-medical community as an alternative to traditional methods using needles or cannulas because of the purported absence of pain, side effects or complications for the patient.
However, without any clinical evidence to support these claims and gradually emerging indications to the contrary, it’s a murky area that needs unpacking to protect patient safety.
Emerging technology
Jet injection devices have long been used to deliver drugs into the body without the use of needles, most commonly with insulin for diabetics. But over the past year or so the technology has emerged in the aesthetics and beauty industries as an alternative to injectable product delivery, with applications including anti-wrinkle treatments, dermal fillers, mesotherapy, fat dissolving and PRP. Most of the unbranded pen devices on the market are composed of a disposable sterile cartridge inside a casing activated by a spring-push mechanism. Product is delivered into the skin mechanically using high air pressure, but the majority of devices don’t carry specifications in terms of depth or dimensions of the entry point created by the jet.
Needle-free pens appear to be an attractive option to beauty therapists who acknowledge they don’t have the skills required to administer traditional injectables or who don’t want to inject, because they believe that needle-free options provide a safer alternative. Several training providers describe needle-free treatments for dermal filler as “pain and complication-free”, with one website stating: “The hyaluronic acid only reaches the papillary layer of the dermis making this a safe treatment with no risk of occlusion as well as no sharp tips to puncture blood vessels [sic].”
Another, which offers one-day courses with certification to treat clients immediately on completion, describes the treatment as “largely pain-free and bruise-free”. However, increasing anecdotal evidence suggests otherwise. National accredited practitioner register Save Face had received 67 complaints relating to no-needle filler procedures so far this year. “Patients get told that if they’re scared of needles this is a pain-free option to get plumper lips. Actually, from the experiences of people we’ve heard from, it’s not. It’s very painful and the results are very unpredictable,” says Ashton Collins, co-director of Save Face.
Growing concerns
Meanwhile, Scotland-based Frances-Turner Traill, clinical director of FTT Skin Clinics and consultant cosmetic nurse for the Confidence Cosmetic team at the Nuffield Hospital in Glasgow, recently dealt with the first vascular occlusion as a result of a lip filler treatment using a needle-free device that Aesthetic Medicine is aware of.
The severe case was referred into Turner-Traill’s clinic as an emergency 12 hours after a lip treatment caused by a needle-free injector pen. In her opinion, the devices bring their own new set of potential complications. “ The extrusion force is higher than that of a healthcare professional using a needle. There’s no skill, no artistry and no respect to anatomy using pens over needles or cannulas,” she says.
Collins agrees: “The molecules [of HA filler] are really too large to penetrate the skin in that way, and what happens is the product gets distributed very unevenly. We’ve had patients come to us with product having dispersed with the air pressure so that it ends up sitting outside the lip border. With a needle or a cannula you can be very targeted with where you put the product, but with this it’s very unpredictable. “
Other potential issues stem from the type of filler being implanted. Many no-needle filler training providers advertise that students will work with highly viscous, cross-linked volumising HA fillers, with the product often placed superficially, potentially leading to complications such as granulomas. A case reported by The Sun Online in August of this year involved a patient left with severe lumps and bruising immediately after treatment using a needle-free pen with Dermalax Plus with Lidocaine, available from Filler World. Other training providers don’t give any details of the product students will be taught to use in their online blurb, or indicate that they will be given advice on how to choose a suitable product for the intended treatment area.
“We’ve issued notices to our members to say that this isn’t as straightforward as hyalasing standard lip filler [in the case of a complication], and because the product used varies so much – in one case a girl had been ‘injected’ with topical hyaluronic face serum – you really just have no way of knowing what’s been used… there are no patient records and, with these fillers there are often no batch numbers or anything to trace back what people have been injected with, so for practitioners to be correcting these sorts of things can be quite high risk,” explains Collins.
MANAGING COMPLICATIONS
If a patient presents with a complication from needle-free lip filler, Turner-Traill shares the following advice: “You may be treating a vascular occlusion compromised with haematoma and a significant spread of product due to the high-pressure delivery. Check intra-orally too to assess area of compromise or occlusion and impending necrosis.
“The vascular occlusion with compromise presenting may be more significant than you have dealt with previously and subsequent treatment therefore will be too. Check that although capillary refill time may be returning, it is useful to measure against an unaffected area before, during and after treatment.
“Ensure you have clinical pathways in place such as hyperbaric oxygen therapy and plastic surgery support on standby.”
Beneficial applications
This all isn’t to say that needle-free injection devices are dangerous across the board or that they don’t have any place in the safe practice of medical aesthetics. Dr Martyn King, chair of the Aesthetic Complications Expert Group and owner of Cosmedic Skin Clinic in Staffordshire, trialled the Med Jet device from Smart Group in clinic. He says: “I found it very, very good for doing mesotherapy and PRP and, though I didn’t use it in this way, I think it would be very good at doing hyperhidrosis. Because of the pain you get with injecting hands and feet in particular, I think Med Jet would treat those areas quite well.”
The Med Jet device uses a low-pressure delivery system and creates an aperture six times smaller than a 30-gauge needle. It can be used for intradermal, subcutaneous and intramuscular delivery. King continues: “I mostly used it for PRP on the scalp which is quite a painful procedure, but I didn’t get bruising or bleeding. Rather than injecting with a needle, which would mean injecting more volume in less places, more because of the pain than anything else, with Med Jet, you can do a lot more injections in quite a quick space of time and inject a little bit less, so you could actually cover quite a large area with just a little injection.”
However, when it comes to filler, King advises to steer clear of volumising products and thinks more complications will begin to emerge. “I think what we’ll start to see is a lot of people with small lumps and papules below the skin. The trouble is that while fillers do get broken down naturally in the skin, if you inject too superficially they can last for years, because naturally produced hyaluronidase is in much lower quantities in the superficial layers of the skin.”
Calls for more research
Until more research is done into the performance and effects of needle-free filler delivery, it’s somewhat of a waiting game for enough anecdotal evidence to slow the uptake of patients accessing these treatments dangerously. “The JCCP is aware of the increasing use of injection-free filler pens and the anecdotal evidence of complications,” says Andrew Rankin, nurse prescriber and JCCP trustee. “Of course, there is a difference between no evidence of risk and evidence of no risk. In the absence of evidence, we would consider the use of these devices would be at Level 7.”
He points to a safety alert from the Canadian government advising Canadians that “needle-free dermal filler devices that are promoted for cosmetic skin treatments – such as reducing wrinkles and increasing lip volume – may pose health risks.” It also states that none of the devices have been authorised for sale in Canada and that potential side effects include hematomas, abscesses from a bacterial infection, spreading of transmissible diseases due to cross-contamination if proper sterilisation isn’t observed, and damage to the blood vessels due to excessive pressure or operator error.
BCAM board member Uliana Gout agrees that very little evidence exists on the topic in medical aesthetics, and that research needs expanding as a priority. “‘Transdermal delivery of actives is an exciting and pioneering arena in aesthetic medicine with regard to skin quality improvement and even stimulation of the underlying structure,” she says. “An example is the evolution of needle-free injector pens; which are proving an interesting new development for practitioners. As always it is essential to assess the evidence-base behind each innovation to ensure optimisation of safety and efficacy.
“Namely, care should be taken with cross-linked fillers injected into the skin and below with regard to ensuring no intravascular risk is associated with a blind injection mode. Managing and assessing depth of injection is essential for patient satisfaction and safety.”
