France takes the lead in the fight against illegal injections

On Friday May 31, a decree was published in the French Journal Officiel, limiting the purchase and use of intradermal and subcutaneous hyaluronic acid to doctors and dental surgeons.

Extract from the decree

“Section 12
“Devices subject to certain conditions of sale, resale or use


“Art. R. 5211-72. – May only be made available free of charge or against payment to doctors for their professional use and, on their prescription, to their patients:
“1° Injectable medical devices, whatever the method of introduction, including intradermal, containing hyaluronic acid;
“2° Injectable products, regardless of the method of introduction, including intradermal, not having a medical purpose, mentioned in 3 of Annex XVI of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, containing hyaluronic acid.


“Art. R. 5211-73. – The devices mentioned in 1° of article R. 5211-72 may also be made available, under the same conditions, to dental surgeons and their patients.”

Background

The scourge of fake injectors is growing by the day. The number of injections performed by non-physicians is rising sharply. This French decree should inspire other European countries to combat illegal injections, which can endanger the physical integrity of patients.

By banning the purchase of hyaluronic acid syringes or free gifts to anyone other than medical doctors or dental surgeons, this country has created a tool to combat “fake injectors”. France is becoming increasingly aware of this public health problem.

The real effects of this decree

Easier communication and public education

It will be simpler for practitioners, the authorities and everyone else to say that from now on it’s forbidden to buy hyaluronic acid from anyone other than a doctor or dental surgeon.

It’s a simple message that will be understood by as many people as possible, and will make it easier to distinguish between illegal and authorized injectors. It is the responsibility of doctors and dentists to promote this legal framework. Authorized professionals must be exemplary in their practices, and thus guarantee optimal, safe care for their patients.

Delicate implementation

It will be very difficult to monitor the implementation of this decree. In fact, there is a large black market in the resale of hyaluronic acid syringes, and market players are not always very transparent. But it’s a good step and a good message to the general public.

A trust placed in doctors that must be honored

On our side, this reinforces our training obligation and our responsibility towards our patients. By confirming the legal framework in France for the purchase of hyaluronic acid, this obliges authorized professionals to increase their level of training and safety in aesthetic medical procedures. This points directly to the need to train healthcare professionals. At present, aesthetic medicine is not a specialty as such. So there are many ways to train.

Through DUs and DIUs that cover part of the specialty, industry workshops, sponsorship, private training courses of varying quality and completeness, it’s important to choose training courses that are based on scientific publications and a first-rate teaching faculty with a strong reputation.

As a reminder, medical doctors have long been authorized to perform hyaluronic acid injections. However, it is his duty to train himself and to make his training known to insurance companies and to his patients, in the event of conflicts or side effects.

The quality and thoroughness of initial training, both theoretical and practical, will be analyzed. It is therefore the doctor’s responsibility to choose rigorous, comprehensive training accredited by the European Union of Medical Specialists. (UEMS). This is the case of SAMBA training which delivers CME continuing education points through the theoretical and practical phases.

Specialists who need to look at where the problem really lies

This decree demonstrates the authorities’ confidence in the medical profession to provide safe aesthetic procedures. My experience and the reality on the ground show that, sometimes, egos and turf wars get the better of unity in the service of patients and public health. In many countries, doctors from different specialties (dermatologists, plastic surgeons, aesthetic physicians, etc.) engage in petty battles to claim authorship and exclusivity in the practice of aesthetic medicine. From my point of view, this is not the battleground. It must be delivered in the fight against the illegal injectors who corner a colossal share of the aesthetic medicine market. This scourge, which flouts regulations, hygiene, safety, charges and taxation, endangering our patients, must be eradicated.

So it’s high time we spoke with one voice, uniting to raise the quality of our care, improve communication with patients and definitively and permanently extinguish the scourge of “fake injectors ” proliferating in every city in every country in the world. The training program we have created within SAMBA is the only current European example of collaboration between the 3 major specialties that make up aesthetic medicine (plastic surgeons, dermatologists and general practitioners). These 3 specialties are home to the best practitioners in aesthetic medicine. Pooling skills and training together is the only viable way forward.

Don’t be too naive: the next regulatory steps will be more open to nurses or qualified personnel. It’s the law of supply and demand. The doctor will therefore become a supervisor, and it is therefore very important to have a powerful corporation of doctors practicing aesthetic medicine; a corporation that, from now on, agrees on training projects and common training recognition.

In short, doctors of all specialties, train in aesthetic medicine, because it’s a speciality and a set of skills that you can’t acquire in dermatology, plastic surgery or general medicine, and which therefore requires a complete theoretical and practical apprenticeship.

Why should the use of hyaluronic acid be regulated and restricted to authorized and trained healthcare professionals?

Hyaluronic acid injections have been very popular in recent years. However, they present serious risks to the physical integrity of patients if injections are not carried out under safe conditions.

The major and essential complication of hyaluronic acid is arterial embolization. Hyaluronic acid is an occlusive gel. If, during injection, the needle or micro-cannula penetrates the lumen of an artery, the product delivered will embolize the artery.

As soon as downstream tissues are deprived of blood and oxygen, ischemia sets in.

If the right measures are not taken, this ischemia will lead to tissue necrosis which, depending on the location, may result in tissue loss (tip of the nose, lips), deep scarring or even blindness (occlusion of the central retinal artery).

To limit the risks involved, the practitioner must have a thorough understanding of facial anatomy, the path of the arteries and the various layers that make up the face. He must also master his tool, i.e. the syringe fitted with a needle or micro-cannula, and know exactly where he is injecting to limit the risk of intra-arterial injection. In addition, the practitioner must master safety concepts such as maximum quantities not to be exceeded on an injection and warning signs. If, despite all these precautions, the doctor comes across an intra-arterial injection, he or she must be able to detect it. Lastly, he must be able to manage it using the validated and published protocol.

In conclusion

This decree is therefore a good sign for both the general public and healthcare professionals. This is a further step towards the harmonization of practices desired by all those involved in aesthetic medicine. The more training doctors receive, the better they will perform, and the safer and more ethical they will be able to make aesthetic medicine. The next steps are therefore to create communities of doctors who share common knowledge and values.

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