INFORMED CONSENT FOR TREATMENT WITH SCULPTRA

Sculptra is reconstituted by the physician and injected into the skin to correct skin depressions, such as creases, wrinkles, folds, scars, and for skin aging.


My physician has explained to me how and when Sculptra is used.


I have been given the opportunity to ask questions and have received satisfactory answers to my questions. In particular, I have received information on when treatment with Sculptra should not take place and have also been informed of the precautions, warnings for use with this product, and adverse events related to the injection.


These reactions include bruising, itching, pain, temporary bleeding, redness, or swelling in the treatment area and usually resolve within a few days or a week. More serious adverse events have been reported in some cases, but they are rare. Reported reactions include papules/nodules, swelling/edema, pain, granuloma, symptoms of visual disturbance, infection/abscess, mass/induration paresthesia and facial nerve paralysis, erythema, inflammation, ecchymosis/hematoma, discoloration, deformity, scarring/atrophy, hypersensitivity, pruritus, rash, muscle disorders, and ischemia/necrosis.



In some cases, nodules may form at the injection site within a few weeks or with a later onset, from several months to more than a year after injection. These nodules are occasionally associated with inflammation or discoloration.


In some cases, nodules have been reported to resolve spontaneously or following treatment, but they may have a longer duration or may require surgical excision. Rare isolated cases of vision abnormalities, including blindness, have been reported after the injection of Sculptra in the temple area, periorbital areas, or cheek.


My physician has also informed me that a topical anesthetic cream can be used to alleviate pain. I have received information on when and which topical anesthetics will be used and information on the contraindications, warnings/precautions for use of these products, and potential side effects.



My physician has also informed me that, depending on the area treated and the injection technique, the effects of Sculptra treatment may last up to 25 months, but this period may vary. Follow-up treatment may help maintain the desired correction.


I have answered honestly the questions related to any hypersensitivity to anesthetic agents, to Sculptra, to all its components, and to my medical history.


I have informed my physician of all my previous aesthetic treatments, including injections, surgeries, chemical peels, etc.


I have read and understood the above and consent to the treatment with Sculptra.

Patient consent
Please answer the following questions completely so your doctor can assess any risks during your consultation. If you have any questions, please don't hesitate to ask your doctor.

GENERAL INFORMATION ON THE PROCESSING OF PERSONAL DATA
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.

IN FAITH



Clinica Milano – Skin Lab ®

I agree to be legally bound by this consent
and the Electronic Signature Terms of Use.