Is Botox safe?
Botox can be considered an extremely safe product, provided it is expertly administered by a qualified physician. The application of Botox in the cosmetic sector has been thoroughly tested for both short-term and long-term effects and is officially approved.
What to look out for with Botox
Botulinum toxin, or Botox as it's commonly known, is a registered medicine and has been used in the medical world for many years. Nevertheless, we advise you to do your own research when choosing a clinic and doctor to perform your treatment.
- Ensure your doctor is BIG registered, a member of the NVCG, and preferably also a Cosmetic Physician KNMG.
- It is extremely important that the brand of Botulinum toxin meets the essential requirements of the European Directive and is provided with a CE mark. Ask your doctor about this.
- Ideally, the Botox brand also possesses the American FDA certificate (Food and Drug Administration Certificate). The requirements for the FDA certificate are stricter than the European CE mark.
Bart Biermans and Mirthe van der Putten preparing Botox
Applications of Botox in various specialisms
In medicine, Botulinum toxin, in addition to the cosmetic sector, has been used for many years in various specialisms. Among others:
- Neurology uses Botox to counteract certain spasms
- Urology for bladder problems
- Dermatology for hyperhidrosis (excessive sweating)
In a medical treatment with Botox, the dosage is often much higher than in a cosmetic Botox treatment.
Different Botox Brands in the Netherlands
In the Netherlands, there are a number of Botulinum toxin products, under various brand names, on the market containing the active substance Botulinum toxin. The well-known brands frequently used in the Netherlands are:
- Botox®
- Azzalure®
- Bocouture®
The above brands all have the same effect: they temporarily interrupt the connection between the muscle and the nerve. This prevents the muscle and nerve from communicating with each other, relaxing the muscles. In the aesthetic world, it was observed that temporarily pausing the connection between the muscle and the nerve can have a positive effect on reducing facial lines, such as wrinkles or frown lines.
Botox and CE Mark
The brands Botox®, Azzalure®, and Bocouture® have the CE mark. This means that these brands comply with the essential requirements of the European Directive. According to EU legislation, Botulinum toxin is not considered a medical device. Therefore, the directive concerning medical devices does not apply. However, Botox falls under the legislation on medicinal products, which stipulates that products may not be placed on the market unless they have been approved based on their quality, safety, and efficacy. Botox has been approved as a medicinal product in the EU since 1994.
IGZ monitors Botox safety
The IGZ monitors the safety of medicines and thus inspects manufacturers, importers, and wholesalers active in this field. The advertising that pharmaceutical manufacturers create for their products is an increasingly important point of attention for the IGZ. Botox, or rather Botulinum toxin, is a substance that locally relaxes the muscle. Since Botox is not a medical device but a registered medicine, the IGZ can monitor this through the instruments of the Medicines Act. Furthermore, the IGZ will take measures in case of reports about medical devices being placed on the market without CE marking or with falsified CE markings.
Botox should only be administered by a BIG registered doctor
Although Botox is a safe product, it is very important that it is expertly administered by a doctor. Botox is an officially registered medicine, and therefore, it may only be used by a doctor. According to the law, anyone who has completed medical studies and is therefore a doctor may administer the medicine Botox. To ensure that the quality of our healthcare remains high, the BIG Act was accepted by the Dutch parliament in 1993. The purpose of this law is, in addition to providing quality care, to protect patients against incompetent and careless actions by healthcare providers.
A Botox injection can be administered by any doctor, but whether this doctor is actually competent and experienced enough is the question. The objective of this quality law consists of two key points:
- Monitoring and promoting the quality of professional practice, and
- Protecting the patient against incompetent and careless actions by professionals in individual healthcare.
It is therefore very important to verify whether the doctor who will treat you with Botox has been trained for it. Always check if the doctor is registered in the BIG register. A BIG registration provides clarity about the authority of a healthcare provider. You can also see if a disciplinary measure, such as a suspension, has been imposed.
Member of the NVCG
In addition to being registered in the BIG register, a doctor can register with the Dutch Association of Cosmetic Medicine (NVCG). This is a government-recognized scientific association for cosmetic medicine, aiming to improve the quality and information of medical cosmetic treatments.
Cosmetic Physician KNMG
Since every doctor is legally allowed to administer Botox, a training program has been established to actually obtain the title of Cosmetic Physician KNMG. These doctors demonstrate many years of experience with injectables such as Botox. A Cosmetic Physician KNMG is audited and must meet the standards. The training lasts several years and is a combination of practice and theory. After completing the training, it can be assumed that the doctor has built up sufficient case files, possesses enough theoretical knowledge, and has enough practical experience.
In Summary
In short, Botox is a safe medicine in both the medical and cosmetic sectors, provided you are treated by an expert and experienced doctor. Preferably a doctor who is registered in the BIG register, is a member of the NVCG, and holds the official title of Cosmetic Physician KNMG. Finally, always ensure that you are treated with a Botox brand that has both a European CE mark and an American FDA certificate. Remain critical when deciding to undergo a Botox treatment!
References and Sources
- Youn, S. W., Seo, K. I., Yoo, J. Y., Park, K. C., & Eun, H. C. (2002). A clinical study of facial wrinkles affected by facial expression muscles treated with botulinum toxin(Botox®). Korean Journal of Dermatology, 40(4), 386-392.
- https://www.europarl.europa.eu/doceo/document//E-8-2016-004829-ASW_NL.html
- Inspectie voor gezondheidszorg, Toezichtplan Cosmetische Sector, 2014
- https://wetten.overheid.nl/BWBR0007648/2021-01-01
- https://www.rijksoverheid.nl/onderwerpen/cosmetische-ingrepen/vraag-en-antwoord/mag-mijn-behandelaar-de-cosmetische-ingreep-uitvoeren
- https://nvcg.nl/#:~:text=De%20Nederlandse%20Vereniging%20Cosmetische%20Geneeskunde,medische%20cosmetische%20behandelingen%20te%20verbeteren.
- https://www.knmg.nl/
The Body Clinic
The Body Clinic has been a leading clinic for injectables in the Netherlands for 15 years. We specialize in Botox and Filler treatments, skin improvement and rejuvenation, and have been rated best by the Consumers' Association and are the highest-rated clinic on Kliniekervaringen.nl with a 9.0 and 2,100 reviews. Our doctors have been working at The Body Clinic as cosmetic physicians for 15 years. The doctors at The Body Clinic are BIG registered, NVCG members, and Cosmetic Physicians KNMG.
After studying Medicine at the University of Leuven (2015), Hugo further specialized in plastic surgery in the hospitals of Apeldoorn and Nijmegen. Cosmetic surgery, in particular, caught his attention – he is especially drawn to goal-oriented and practical action. Hugo has extensive experience with injectable treatments (more than 5,000 treatments) and specializes in upper eyelid correction (more than 1,500 operations). **Fresh and natural – without it being noticeable** "The combination of minor surgery and injectable treatments makes cosmetic medicine a wonderful profession where small procedures can make someone feel fresh and revitalized again. I listen to my clients' wishes but always maintain an overview of the overall picture – so that the face remains balanced. Because it's not about perfecting one zone, but about creating harmony throughout the entire face. Together we look at how we can achieve the most natural refreshment possible without it being obvious. My goal? That you look fresh without your surroundings realizing a treatment has taken place. That, for me, is the sign of a successful treatment." **Background & specialization** With his background in plastic surgery and his specialization in cosmetic procedures, Hugo combines surgical precision with an artistic eye for balance and harmony. His experience of more than 5,000 injectable treatments and 1,500 upper eyelid corrections makes him a versatile specialist within cosmetic medicine.
