Name & Surname
Date of birth
Are you pregnant? yesno
Are you breastfeeding? yesno
Have you recently been treated with another dermal filler on your face? yesno
If yes, please specify
Have you even been treated with a permanent implant? yesno
Have you undergone laser skin resurfacing or received a peel in the past 6 weeks? yesno
Do you suffer from facial herpes simplex? yesno
Do you have any active skin conditions, i.e. acne or psoriasis? yesno
Do you have or have you ever had any form of skin cancer? yesno
Have you previously experienced a hypersensitivity to any of the PLURYAL products? yesno
Have you ever experienced sensitivity to lidocaine (anesthetic)? yesno
Have you received Roaccutane treatment in the past 12 months? yesno
Do you suffer from any know allergies? yesno
Do you have a history of anaphylactic shock (severe allergic reactions)? yesno
Are you taking aspirin, steroids or anticoagulants? yesno
Are you currently taking any other medication? yesno
Do you suffer from any of the following conditions: angina, epilepsy, diabetes, HIV positive, hepatitis, auto-immune diseases or depression? yesno
Have you recently undergone a surgery? yesno
Are you currently undergoing dental surgery? yesno
Do you suffer from low blood pressure or have a history of fainting? yesno
Have you recently been exposed to sun or sun beds? yesno
If the answer to one of the above questions is “YES”, the practitioner may decide that you are not suitable for treatment
PATIENT CONSENT FORM FOR TREATMENT WITH PLURYAL PRODUCTS
Pluryal products* are sterile, biodegradable, viscoelastic, clear, transparent, isotonic and homogenized injectable gel implant. The device consists of non-animal sodium hyaluronate, obtained from Streptococcus equi bacteria.
The products have obtained the EC certification and are approved for use in all European Union countries as well as countries where they have been registered.
Pluryal products are injected into the skin to:
• Replenish the loss of hyaluronic acid due to ageing, to improve hydration, tone and elasticity of the skin and to act as a filler for small lines such as crow’s feet, smile lines or smoke lines surrounding the mouth; in this case the treatment is performed in 3 sessions, at 3 weeks-intervals;
• Correct lines, wrinkles and folds in the face, to remodel lips as well as cheeks and facial contours. They can be also used to correct facial cutaneous traumatic depressions or to treat facial lipoatrophy, debilitating scars or morphological asymmetry.
My treating practitioner has explained how and when the Pluryal products* are used.
I have been given the opportunity to ask questions and have received satisfactory answers to my questions. I have particularly understood that certain reactions are common after the injections of Pluryal products* or similar medical devices and these reactions include:
• For Pluryal Booster: bleeding during and after injection, edema, erythema without swelling that resolves within one week or in extreme cases after up to 2 months, hypersensitivity to sodium hyaluronate, hematoma, indurations or nodules at the injection site, inflammation that may coincide with itching and pressure sensitivity for up to a week after the injection, pain during injection, papules, swelling of tear troughs, transient pain or discolouration at the injection site.
• For Pluryal Classic / Pluryal Volume: abscess, angioedema, bacterial infections, beading/lumpiness, bleeding, bruising, burning, discoloration (dispigmentation), discomfort, edema, erythema, firmness, granulomas, hematoma, herpes reactivation, hypersensitivity, implant-site mass, implant visibility, induration, inflammation, irritation, itching, livedoid pattern after accidental arterial embolization, malar edema, migration, necrosis due to vascular compromise, nodules (inflammatory and non-inflammatory), numbness, pain, paresthesia, puncture marks, redness, retinal artery occlusion, scar sarcoidosis, scleromyxedema (generalized), swelling, telangiectasia, tenderness, vasculitis, vasospasm, vasovagal reaction during injection, vision loss due to retinal artery occlusion.
Other than the temporary side effects, I have been informed that a poor effect or weak filling effect if Pluryal products are injected incorrectly into the dermis.
My treating practitioner has also informed me that, depending on the treated area and injection technique, effects from the Pluryal fillers treatment can last 9 months in the skin and around 6 months in the lips, but this period may vary according to cases, either longer or shorter.
Effects of the Pluryal Booster treatment will last between 4 to 6 months, if I follow the initial regimen, which consists of having 3 treatments at 3 weeks interval. I have responded to questions related to my medical history with honesty. I have also received the “Post-treatment Recommendations” as well as information about its contents. I understand the importance of following the advice indicated in the “Post-treatment Recommendations” form.
I hereby consent to treatment with Pluryal products*.
1. Pluryal Booster
2. Pluryal Classic / Classic Lidocaine
3. Pluryal Volume / Volume Lidocaine
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Signed by Nina Bal
Signed On: 8th January 2020
If you have questions about the contents of this document, you can email the document owner.
Document Name: Pluryal Injectables
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