Hyaluron Pen: alternatives following its ban

Hugely popular with women looking for hyaluronic-acid lip treatments, the Hyaluron Pen technique quickly caught the attention of beauty salons. With its many on-paper advantages (no needle, dramatic results for filling wrinkles and plumping the lips, an attractive price), this volumising pen rapidly won over many users — especially younger ones — thanks to how accessible and, in theory, non-invasive it seemed. Yet it ultimately raised questions and concerns among healthcare professionals and the authorities, leading to a ban by the ANSM in March 2021. What were the reasons behind this decision? Is it permanent? And what are the different alternatives for getting fuller lips? Causes, consequences, enforcement… everything you need to know about the ban on the Hyaluron Pen.

What is the Hyaluron Pen?

The Hyaluron Pen was a volumising device shaped like an injector pen that delivered small doses of hyaluronic acid under the skin without using a needle, thanks to a pressure system powered by compressed air. Originally, this type of pressure pen had nothing to do with aesthetics: it derives from the needle-free injectors designed to deliver insulin to people with diabetes, before being repurposed to propel hyaluronic acid into the lips.

An enticing commercial promise

On paper, the companies marketing this technology promised women a non-invasive, less painful solution to reduce wrinkles, improve the appearance of the skin and also increase lip volume. Above all, the commercial promise rested on its ease of use, with the treatment carried out directly in a beauty salon by beauticians who were not necessarily trained, rather than in a medical practice well versed in every safety procedure. Cheaper, easily accessible and in theory minimally invasive, this method of needle-free hyaluronic acid filling quickly seduced many women — particularly the youngest, who wanted to look like their idols — backed by cleverly edited videos on social media.

A technique that is not so painless and a questionable plumping effect

In reality, despite the absence of a needle, propelling hyaluronic acid (HA) into the mucous membrane of the lips with the pen at a speed of 800 km/h is far from painless and atraumatic. Many cases of poor lip reactions were reported, in particular by aesthetic doctors having to « fix » these procedures. They reported, for example, haematomas and necrosis, not to mention the fact that the results were often disappointing for patients. It was also impossible to control the depth and quantity of hyaluronic acid delivered, unlike standard medical procedures.

Unlike medical procedures performed in a practice, which make it possible to precisely target the areas to treat and to harmoniously reshape the lip contour, needle-free hyaluronic acid delivery increased lip volume uniformly, for a result that was unnatural and, above all, only partial. The increase in lip volume was in fact often caused by the trauma of the injection rather than by the action of the product itself.

The Hyaluron Pen finally banned by the health authorities

In France, it is the ANSM (the national agency for the safety of medicines and health products) that is responsible for overseeing the marketing and administration of medicines and medical devices such as the Hyaluron Pen, in order to guarantee patient safety. One of its roles is to collect any adverse effects of a treatment or medicine, in particular through feedback from doctors on the ground.

A practice deemed non-compliant in the absence of certification

Following in the footsteps of Canada in 2019 and Germany a few months earlier, the ANSM ultimately called in a statement on 11 March 2021 for the « suspension of the import, marketing, distribution and advertising of these devices ». To do so, it stated that it was basing its decision on the fact that the two pens in question are non-compliant — that is, they have not undergone an independent certification procedure and cannot be subject to strict control procedures.

Applying the precautionary principle

The ANSM’s decision was therefore based on the precautionary principle, regarding a product that did not meet the certification standards for class IIa medical devices but only a class I self-certification procedure. The health authority therefore considered that the device was likely to present a danger to consumers, in particular risks of haematomas, infection, allergy or even tissue necrosis, even though no side effect had been officially recorded. It was in fact sounding the alarm over the marketing of these products, which were increasingly ending up directly in the hands of consumers, notably because of online sales.

France is, moreover, not alone on this issue. In the United States, the Food and Drug Administration (FDA) explicitly warns against these needle-free injector pens sold for the lips: these devices are not approved and have been linked to cases of serious injury, sometimes with permanent damage to the skin, lips or eyes. French regulations have since been tightened: Decree No. 2024-490 of 29 May 2024 now reserves the sale of injectable hyaluronic acid devices to doctors and dental surgeons, closing the door a little further on these freely available pens.

A ban that is, in theory, temporary

Even though this decision took the form of a suspension, there is in reality very little chance that it will ever be overturned. For that to happen, the manufacturers concerned would have to have their products certified, with audits and clinical studies to back it up — a long, costly and tedious process that therefore has little chance of being undertaken. Beauty professionals who had acquired these pens are now formally prohibited from using them and, if they do, face criminal penalties for administering them illegally.

Safe alternatives for plumping the lips

Despite the ban on the Hyaluron Pen, there are other aesthetic-medicine alternatives — far safer and better controlled — to increase lip volume without major surgery and achieve fuller lips.

Hyaluronic acid injections

The now well-known and well-mastered alternative for plumping the lips is, of course, hyaluronic acid injections performed by a qualified, experienced aesthetic doctor. This method allows precise control over the quantity of hyaluronic acid delivered and reduces the risk of complications.

Superficial HA injections delivered using fine precision cannulas also help to hydrate the lips and give them a glossy appearance. Naturally secreted by the body and therefore biocompatible, this molecule offers the possibility of reshaping the lips without resorting to surgery, while keeping a natural look when the treatment is carried out with care.

The area and depth of the injections vary depending on the result the patient is looking for. Hyaluronic acid injections make it possible to achieve fuller lips for a duration of 6 to 8 months. For a permanent result, however, surgery remains essential.

Lip lipofilling

While hyaluronic acid can add volume to the lips, this product eventually resorbs and its effects are therefore temporary, hence the need to repeat the treatment regularly.

For a permanent result, the only option remains plastic surgery, first and foremost lipofilling. Lip lipofilling, most often performed as part of a facial fat transfer, is a short, relatively minimally invasive surgical procedure.

It consists of harvesting fat cells from the patient themselves, in areas where there is excess fat (knees, buttocks, saddlebags, etc.) in order to reinject them into the lips to reshape them and give them more volume. This is known as autologous fat transfer.

In practice, a small sample of fat is extracted from a chosen area, then undergoes a centrifugation process aimed at purifying it to remove the fibres. It is then reinjected into the lips, but possibly also around the mouth, to fill wrinkles and define a more pronounced lip contour. The result of lip lipofilling is permanent after 3 months. This method nonetheless remains highly unpredictable in terms of results, and hyaluronic acid injections or a lip lift remain the preferred options.

The lip lift

To plump the lips, it is also possible, as part of a facelift, to perform a lip lift by slightly shortening the upper lip to raise the red lip, known as a « lip lift ». The incisions are then concealed inside the nostrils. Here again, the result is permanent after 3 months. It is even possible to combine the lip lift with autologous fat transfer for an even more convincing result.

Botox to reshape the smile

Without adding volume the way hyaluronic acid does, a botulinum toxin injection around the mouth can complement the treatment by relaxing the peri-oral muscles. This technique, sometimes called a « lip flip », slightly everts the upper lip and gently rolls it outward, for a more harmonious smile and a deliberately natural result.

Micro-needling

Micro-needling is an aesthetic-medicine treatment carried out with an electric pen fitted with single-use nano-needles, whose application helps to stimulate the skin’s natural self-healing process. With repeated use on the targeted skin areas (in this case, the lips), this procedure brings about skin regeneration and deep cell renewal through a self-healing process. This is referred to as controlled mechanical micro-injury.

In addition to restarting the production of collagen and elastin, micro-needling also promotes better blood circulation and skin re-oxygenation, helping to restore vigour and radiance to the lips.

Natural solutions for fuller lips without injections

Beyond surgery and aesthetic medicine, there are finally other natural methods to add volume to your lips without injections and make them firmer. While they do not necessarily achieve lips as full as those obtained with aesthetic medicine or plastic surgery, they help achieve more prominent, healthy lips. Among them are:

• lip scrubs to exfoliate dead skin;
• applying a night mask and using a lip balm for better hydration;
• make-up, notably by redrawing the contours with a lip pencil and using a glossy-effect lipstick;
• a plumping lip balm made with active ingredients that temporarily swell the lips;
• facial gymnastics exercises that increase lip volume, in particular the « pout » exercise to stretch the lips as far forward as possible.