Is Botox safe?
Botox can be considered an extremely safe product if administered competently by a qualified physician. The application of Botox in cosmetics has been thoroughly tested for both short-term and long-term effects and officially approved.
What to look out for with Botox
Botulinum toxin, or Botox colloquially, is a registered drug and has been used in the medical field for many years. Regardless, we recommend that you do your own homework when choosing a clinic and doctor where you want to have the treatment performed.
- Make sure your doctor is BIG registered, a member of NVCG and preferably also Cosmetic Physician KNMG.
- It is extremely important that the Botulinum toxin brand meets the essential requirements of the European Directive and has a CE mark. Ask your doctor about this.
- Ideally, the Botox brand also possesses the U.S. Food and Drug Administration Certificate (FDA). FDA certification requirements are more stringent than the European CE mark.
Bart Biermans and Mirthe van der Putten prepare Botox
Applications Botox in different specialties
In medicine, Botulinum toxin, in addition to cosmetics, has been used in various specialties for many years. Among others:
- Neurology uses Botox to counter certain spasms
- Urology for bladder problems
- Dermatology for hyperhidrosis (excessive sweating)
In medical treatment with Botox, the dosage is often much higher than in cosmetic Botox treatment.
Different brands of Botox in the Netherlands
In the Netherlands there are a number of Botulinum toxin products, under different brand names, on the market with the active ingredient Botulinum toxin. The well-known brands frequently used in the Netherlands are:
- Botox®
- Azzalure®
- Bocouture®
The above brands all have the same effect, which is to temporarily interrupt the connection between the muscle and the nerve. As a result, the muscle and nerve can no longer communicate with each other and the muscles relax.
In the aesthetic world, it was seen that temporarily shutting down 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 Botox®, Azzalure® and Bocouture® brands have the CE mark. This means that these marks meet the essential requirements of the European Directive.
Botulinum toxin is not considered a medical device under EU law. Therefore, the medical device directive does not apply. However, Botox falls under drug legislation, which states that products cannot be marketed unless they are approved on the basis of their quality, safety and efficacy. Botox has been authorized as a drug in the EU since 1994.
IGZ monitors safety of Botox
The IGZ watches over the safety of medicines and thus monitors manufacturers, importers and wholesalers operating in this field. The advertising that drug manufacturers make for their products is an increasingly more important focus for the IGZ.
Botox or rather Botulinum toxin is a drug that locally slackens the muscle. Since Botox is not a medical device is but a registered drug, the IGZ can monitor it through the instruments of the Medicines Act. The IGZ will also take action on reports of medical devices coming onto the market without CE markings or with falsified CE markings.
Have Botox administered only by BIG registered physician
Although Botox is a safe product, it is very important that it be administered competently by a physician. Botox is an officially registered drug therefore it should only be used by a doctor.
By law, anyone who has completed the study of Medicine, and is therefore a physician, may administer the drug Botox. To ensure that the quality of our health care is and remains high, the BIG Act was accepted by the first chamber in 1993. The purpose of this law, in addition to providing quality care, is to protect patients from incompetent and negligent actions of healthcare providers.
An injection of Botox can be administered by any doctor, but whether that doctor is actually competent and experienced enough is questionable.
The objective of this quality law consists of two key points:
- Monitoring and promoting the quality of professional practice, and
- Protecting patients from incompetent and careless actions by individual health care professionals.
So it is very important to verify that the doctor who is going to treat you with Botox is trained to do so. Always check that the doctor is registered in the BIG register. A BIG registration clarifies a health care provider’s competence. You can also see if any disciplinary action has been taken, such as a suspension
Member of the NVCG
In addition to being registered in the BIG registry, a doctor can register with the Dutch Cosmetic Medicine Association (NVCG). This is a government-recognized scientific association for cosmetic medicine and aims to improve the quality and education of medical cosmetic treatments.
Cosmetic physician KNMG
Since any doctor is allowed by law to administer Botox, training has arisen to actually receive the title Cosmetic Physician KNMG. These doctors demonstrate many years of experience with injectables such as Botox. A Cosmetic Physician KNMG is inspected and must meet standards.
The training takes several years and is a combination of practice and theory. Having completed the training, it can be assumed that the doctor has built up sufficient records, has enough theoretical knowledge AND has enough practical experience.
Summary
In short, Botox is a safe drug in both medical and cosmetic fields, provided you are treated by a knowledgeable and experienced doctor. Preferably a physician who is registered in the BIG register, is a member of the NVCG and carries the official title Cosmetic Physician KNMG. Finally, always make sure you are treated with a brand of Botox that has both a European CE mark and a U.S. FDA mark. Remain constantly critical when deciding to undergo Botox treatment!
Literature list 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
- Health Care Inspectorate, Cosmetic Sector Surveillance Plan, 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-uitvoere
- https://nvcg.nl/#:~:%20Cosmetische%,%20te%.
- https://www.knmg.nl/
The Body Clinic
The Body Clinic has been a leading clinic in injectables in the Netherlands for 15 years. We specialize in Botox and Filler treatments, skin improvement and skin rejuvenation and as best tested by the Consumer Association and with a 9.0 and 2,100 reviews the best rated clinic on Kliniekervaringen.nl. Our doctors have been working at The Body Clinic as cosmetic doctors for 15 years. The doctors at The Body Clinic are BIG registered, members of NVCG and cosmetic doctor KNMG.
