Informed consent in aesthetic medicine is not simply a form that the patient signs at reception. It is a process of providing information prior to treatment, which Law 41/2002 on patient autonomy requires to be set out in writing for invasive procedures and for those that carry a risk of adverse health effects. Botulinum toxin injections, dermal fillers, thread lifts, medium- and deep-layer chemical peels, and laser treatments all fall squarely within this category. This guide outlines what the document must contain, how to provide information to ensure the consent is valid, and what errors recur time and again in complaints.
What the law says
Law 41/2002 stipulates that consent shall generally be given verbally, but must be given in writing in the case of surgical interventions, invasive diagnostic and therapeutic procedures and, in general, procedures involving risks or disadvantages with a significant and foreseeable negative impact on the patient’s health. The information must be truthful, comprehensible and appropriate to the patient’s needs, and must include the purpose and nature of the procedure, its risks and its consequences. In cosmetic medicine, where treatment is not carried out to meet a therapeutic need, the courts require a more comprehensive level of information, including information on rare risks.
What the document should contain
- Details of the healthcare facility (including its healthcare registration number), the doctor in charge and the patient.
- Description of the treatment in plain language: what is done, using which product or device, and on which area.
- Expected outcome and limitations: what the treatment can and cannot achieve, and that the result is not guaranteed.
- Common risks (haematoma, oedema, pain, temporary asymmetry) and serious but rare risks (vascular occlusion, necrosis, blindness following dermal fillers; ptosis following botulinum toxin treatment; infection; hypersensitivity reactions; nodules).
- Alternatives, including the option of not seeking treatment.
- Contraindications and the patient’s declaration regarding medical history, allergies, medication, pregnancy or breastfeeding.
- Pre- and post-treatment care, and warning signs, including instructions on when to seek urgent medical attention.
- Product used: name, batch number and quantity, recorded after treatment.
- Consent for clinical photographs and, separately, for their use for teaching or promotional purposes.
- Cost of the treatment and any necessary touch-ups.
- The right to withdraw consent at any time.
- Date and signatures of the patient and the doctor, with a copy provided to the patient.
One document per treatment, not a generic one
A consent form «for aesthetic medicine treatments» that covers everything tells you nothing. Prepare a specific form for botulinum toxin, another for hyaluronic acid fillers, another for thread lifts, another for biostimulators, and another for each technology. Each has its own specific risks. When you combine treatments in a single session, ensure you sign the documents for each one.
How to provide information to ensure that consent is valid
- Well in advance. The patient must be able to read, ask questions and think things through. It is good practice to provide the document at the first consultation and have it signed on the day of treatment.
- Verbally, as well as in writing. Note in the medical record that the information was provided verbally and what it concerned.
- In a language the patient understands; if not, with an interpreter or a translated document.
- No sales pressure during the event itself: ensure that the signing does not coincide with a time-limited offer.
- Assessing the patient’s capacity. In the case of minors and people with limited capacity, the legal rules on consent by proxy apply.
Common mistakes in claims
- A document that is signed but undated, does not identify the doctor, or does not include a copy for the patient.
- Serious risks that have been omitted on the grounds that they are «very rare». Case law on compensatory medicine requires that such risks be disclosed.
- The product and batch are not registered, which makes it impossible to trace the cause of a reaction.
- Photographs taken without written authorisation, or generic authorisation used for advertising purposes.
- Consent signed by a nurse or at reception without the doctor’s involvement.
- Templates downloaded from the internet, not adapted to the treatment or the centre.
Clinical history and preservation
Consent forms part of the medical record, which must be retained for at least the periods specified by national legislation and that of your autonomous community. Keep it alongside the patient history, the examination findings, the photographs and the product record. If you work in a rented practice, set out in writing who is responsible for safeguarding the documentation and in what capacity.
Ready-to-use models
On Medars, the downloads centre includes informed consent forms for each treatment and other legal reference documents, available to all members, including those on the Basic membership tier. Basic is free for life and is activated once your professional registration has been verified; no card is required. Request access or find out what each level includes at memberships.
Related guides
- Malpractice insurance for aesthetic medicine: what it should cover
- Software for cosmetic medicine clinics: what it should include
- Advertising in aesthetic medicine: what the regulations permit and what they prohibit
- Botulinum toxin training for doctors: what a reputable course should include
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