INFORMED CONSENT FOR MESOTHERAPY TREATMENT

Intradermotherapy or Mesotherapy
Intradermotherapy or Mesotherapy is an injective medical technique that involves the intradermal inoculation of one or more drugs into the specific area targeted for treatment. The purpose is to concentrate the product more effectively, prolong its duration of stay, and thus enhance the action of the specific pharmacological effect.

The drugs used may either have ministerial indication for specific intradermotherapy use or lack such indication. The use of commercially available drugs authorized for a different route of administration can be employed via mesotherapy for the purpose of said treatment under Law 94/98, constituting an "off-label" use. This use can only take place after obtaining the patient's consent, who declares to have been fully informed and to approve this modality, which involves the use of the drug via a different route of administration than that reported in the Ministerial Decree of Commercialization. This use is proposed to the patient exclusively because internationally accredited scientific literature justifies its use and proves its therapeutic effectiveness, and because there are no therapeutic alternatives for the patient of equal efficacy using drugs authorized for the mesotherapeutic route of administration, considering invasiveness, expected outcomes, etc.

CONTRAINDICATIONS AND SIDE EFFECTS
This route of administration may elicit greater reactivity, as well as effects related to the trauma induced by the needle and the pharmacological substances injected, resulting in hematomas (extravasation of blood). Furthermore, the following phenomena may also occur: altered sensitivity, irritation, redness, temperature variation, which generally resolve within a few hours or a few days or weeks, with or without appropriate medical therapy.

I have also been informed that when a drug is administered via any route, including the intradermal or mesotherapeutic route, it is possible for allergic reactions to be triggered, which may manifest as widespread urticarial reactions or systemic effects (respiratory and cardiovascular disturbances) requiring urgent therapeutic measures.

Therefore, I understand that intradermotherapy or mesotherapy may be burdened by complications, which in very rare circumstances could be life-threatening, and exceptionally fatal.

Contraindications to treatment include leukemia, infectious diseases, blood clotting problems, and other specific clinical conditions of the patient evaluated by the physician.

The possibility of complications arising, not necessarily due to the good practice of the operating physician, but related to the drug or device used during administration, as reported in the literature, is possible.

PRE AND POST-TREATMENT INSTRUCTIONS
The procedure may involve risks or complications for reasons not inherent in the doctor's good work. Therefore, no precise guarantees can be given regarding the outcome that can be achieved with this treatment, and particularly regarding the duration of its effectiveness, as many factors can contribute to the premature degradation of the effect induced by the drug.

All pre- and post-treatment instructions for District Intradermotherapy provided by the Physician must be scrupulously followed, as they are fundamental for achieving the outcome. It will be necessary to truthfully declare to the doctor one's state of health, any allergies or intolerances, and any previous medical-aesthetic or surgical treatments performed in the area concerned by the District Intradermotherapy treatment or in the surrounding areas, with specific indication of the product used and the time frame, in order to allow the physician to evaluate any contraindications to the treatment.

Direct exposure to ultraviolet rays (sun exposure, sunlamps) as well as intense heat (very hot showers, saunas, and Turkish baths) or intense cold is absolutely inadvisable for the four weeks following the treatment. Similarly, all traumatic maneuvers (rubbing the treated area, exfoliation, brushing, aesthetic therapies, etc.), and the use of unsuitable detergents or cosmetics that could increase the risk of side effects and alter the therapeutic result, must be avoided.

Furthermore, significant intake of alcoholic beverages and spirits is discouraged for a period of 10-14 days.

As illustrated by your physician, you must be aware of your skin characteristics and the relative specific precautions you must take before and after the treatment.

It is possible that the treatments may need to be repeated to achieve the expected outcome.

For any prolonged or anomalous side effect, as well as for issues related to the outcome, it will be appropriate to contact your physician for a follow-up visit.

ALTERNATIVE PROCEDURES AND TREATMENT AIMS
The Physician has illustrated any alternative procedures available to you, their advantages and disadvantages, risks, and benefits.

The quality of the clinical outcomes of the treatment cannot be assessed a priori, and no precise guarantees can be given regarding the result obtainable with this treatment, as the individual response and conditions can be essential in determining the clinical response of the treated patient.

Pursuant to Articles 13 and 14 of EU Regulation No. 2016/679 (the "Regulation") and the provisions of Legislative Decree No. 101/18 (the "Legislative Decree") concerning the protection of natural persons with regard to the processing of personal data, I hereby inform you that the personal data you provide and acquired by Clinica Milano – Skin Lab ® will be processed in compliance with the provisions of the aforementioned Regulation and Legislative Decree. Furthermore, the following is specified:

1. Purpose of processing

The processing of your personal data is solely for the proper performance of aesthetic medicine, prevention, diagnosis, treatment, rehabilitation, or other pharmaceutical and/or specialist services requested by you.

2. Methods of Processing Personal Data

Processing is carried out through operations performed on paper or with the aid of IT tools, or via apps and cloud platforms, and consists of the collection, recording, organization, storage, consultation, processing, modification, selection, extraction, comparison, use, interconnection, blocking, communication, deletion, and destruction of such data. Sometimes, it may be necessary to send data electronically via email, which will be encrypted and password-protected. Processing is carried out by the data controller and by persons expressly authorized by the data controller.

3. Provision of Data and Refusal

The provision of general, sensitive, genetic, and health-related personal data is necessary for the performance of the activities required for prevention, diagnosis, treatment, rehabilitation, or other pharmaceutical and/or specialist services requested by you. Your refusal to provide personal data will make it impossible to perform these activities.

4. Data Disclosure

The personal data collected will not be disclosed. The data will not be shared with third parties, except when necessary and/or required by law and/or for tax compliance. The data will be disclosed only to healthcare personnel at the facility where Clinica Milano – Skin Lab® operates and, where necessary, to physicians, analysis laboratories, medical specialists, hospitals, and consultants—lawyers and/or accountants—used by Clinica Milano – Skin Lab®.


5. Data Retention

Your personal data will be retained for the time strictly necessary for medical care and, in any case, for no longer than ten years. Even when computers are used, appropriate protection measures are adopted to ensure the correct storage and use of data, including by medical practice staff, in compliance with professional secrecy. Professionals and facilities that may have access to such data as a result of the healthcare services provided by Clinica Milano – Skin Lab ® are also required to observe these safeguards.

6. Data Controller

The data controller is Clinica Milano – Skin Lab ®, Via Cerva, 22 – 20122 Milan – SEM s.r.l. | VAT No. 11055590969

7. Rights of the Data Subject

The data subject has the right:

• to request from the data controller access to, rectification or erasure of, or restriction of processing of, personal data, or to object to processing, as well as the right to data portability;
• to receive, in a structured, commonly used, and machine-readable format, the personal data concerning him or her, which he or she has provided to a data controller, and has the right to transmit those data to another data controller without hindrance from the data controller to which the personal data have been provided;
• to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal;
• to lodge a complaint with the Italian Data Protection Authority.

The aforementioned rights may be exercised by written communication sent via certified email to semsrl1@pec.it or by registered mail with return receipt to Via Cerva, 22 – 20122 Milan.

With reference to the images (photos and/or videos) taken and/or filmed by Clinica Milano – Skin Lab ®, which are essential for developing your treatment plan and managing diagnoses and future assessments, you authorize, free of charge and without time limits, also pursuant to Article 10 of the Italian Civil Code and Articles 96 and 97 of Law No. 633 of April 22, 1941 (Copyright Law), the storage in your medical records in paper format or with the aid of IT tools or via apps and platforms that use the Cloud, and the possible publication and/or dissemination of your images in any form on the Clinica Milano – Skin Lab ® website or on its social media profiles such as Instagram or Facebook. I also authorize the storage of these photos and videos in the electronic archives of Clinica Milano – Skin Lab®, confirming that the purpose of such publications is purely for informational and educational purposes regarding the professional activities carried out by Clinica Milano – Skin Lab®. This authorization may be revoked at any time by written notice sent by registered mail or certified email.

The undersigned declares that he or she has read the above information, accepts all of its provisions, and consents to the processing of his or her personal data for the purposes, terms, and conditions set forth above.