Patient-oriented information · Knowledge base

Safety and accompanying effects of a botulinum toxin treatment

Botulinum toxin type A — colloquially also called a “Botox treatment” — has been used in medicine for decades and is among the extensively studied active substances in aesthetic medicine. Prerequisites for safe application are a medical indication, a thorough personal patient briefing and proper professional execution.

This page provides a factual overview of the regulatory framework, the duty to inform and possible accompanying effects of a treatment with botulinum toxin type A at the private practice of Dr. med. Thomas Ackermann (Herzogenaurach, Erlangen-Nuremberg region).

Regulatory framework

Is botulinum toxin a prescription-only medicine in Germany?

Yes — botulinum toxin type A is a prescription-only medicine in Germany; the legal basis is the German Medicinal Products Act (AMG) and the Prescription Ordinance (AMVV). Preparations are regulated by the Federal Institute for Drugs and Medical Devices (BfArM) or, at European level, by the European Medicines Agency (EMA). Marketing, storage and use are subject to the legal requirements of pharmaceutical law.

Prescription only

Application exclusively by medical doctors. Application by non-medical personnel is not permitted in Germany. Prerequisites are medical indication, anatomical expertise and the ability to assess possible accompanying effects.

Duty to inform · §630e BGB

What you may expect before every treatment

Before every medical treatment — including before an aesthetic treatment — there is a statutory duty to inform the patient. It includes:

  • Discussion of the procedureApproach, expected effect, duration of effect.
  • Possible accompanying effectsCommunication of individual risks based on personal history.
  • AlternativesReference to alternative treatment options.
  • Pre-existing conditions and medicationDiscussion of relevant pre-existing conditions, regular medication and individual circumstances.
  • Written documentationDocumentation of the briefing.
In this practice

The patient briefing takes place personally and without time pressure — as the basis for a deliberate, informed decision.

Indication

Not every wish is an indication

A treatment with botulinum toxin type A is only considered when a medical indication exists. The indication is established individually on the basis of the history and a proper muscle analysis.

An indication-appropriate and individually dosed treatment is oriented toward preserving natural proportions and a balanced facial expression — not toward a maximum effect.

The medical approach follows the principle of a rather restrained, adjustable dosing. Follow-up reviews are an integral part of the treatment concept.

Contraindications

When a treatment is not considered

Known contraindications

  • HypersensitivityKnown hypersensitivity to ingredients of the preparation used.
  • Pregnancy and breastfeedingNo treatment is performed during this phase.
  • Neuromuscular conditionsConditions that affect neuromuscular transmission.
  • Acute infections or inflammationIn the planned treatment area.

Further individual contraindications are recorded in the personal medical consultation.

Accompanying effects

Possible reactions — what is common, what is rare

As with any medical procedure, accompanying effects are possible. The following overview categorises reactions by frequency and does not replace the individual patient briefing.

Common, usually self-limiting reactions

  • Local reactions at the injection siteMild redness, swelling, small haematomas.
  • Transient feelings of pressure or tensionUsually subside within hours to a few days.
  • Occasional headachesPossible in the first hours to days after the treatment.

Rarer reactions

  • Asymmetric effectReadily adjustable during the follow-up review.
  • Transient impairment of adjacent muscle groupsFor example eyelid droop — self-limiting.
  • Allergic reactionsTo ingredients of the preparation.

A complete individual briefing on frequency, course and possible measures takes place in the personal medical consultation (§630e BGB).

Important to know

The effect of botulinum toxin type A is fully reversible. It wears off over several months without further treatment. No pharmacological or psychological dependence develops.

Practice philosophy · Harmony of Aesthetics

Safety and naturalness belong together

At the private practice of Dr. med. Thomas Ackermann, aesthetic treatments are understood as medical procedures — with everything that belongs to that: thorough history-taking, personal briefing, written documentation, professional execution and follow-up review.

The anaesthesiological training includes the precise pharmacological application into defined anatomical structures — experience that benefits the botulinum toxin treatment methodologically.

Practitioner choice

What patients can pay attention to

  • Specialist qualificationDocumented treatment experience.
  • Thorough patient briefingPersonal and without time pressure.
  • Written documentationBriefing pursuant to §630e BGB.
  • Practice infrastructure and hygiene standardsProper facilities and materials.
  • Follow-up review and adjustmentA scheduled follow-up appointment.
Further reading

Related content

Note: This information does not replace the personal medical briefing pursuant to §630e BGB. Specific indication, effect, dosage and possible risks of a treatment can only be discussed in the individual consultation with the treating physician.

This page serves factual information and does not constitute advertising within the meaning of the HWG (German Therapeutic Products Advertising Act).