Facial Sculpting

Aqualyx Patient Content Form


BACKGROUND

AQUALYXTM was developed by the renowned aesthetic surgeon Prof. Pasquale Motolese in 2002 and has been used for many years in different countries of the European Community and abroad. The manufacturer Marllor states sales of two million vials in two years. No major side effects occurred and the treatment was well-tolerated and successful.

FORMULATION

AQUALYXTM is an injectable, hydrous, micro-gelantuous solution, which is biocompatible and biodegradable. It causes the dissolution of fat cells, after which the body then expels the released fatty acids naturally. AQUALYXTM is a complex containing detergent from the desoxycholate family that has been physically modified in order to reduce the biological half-life and the sugar-based slow release system results in minimal side effects. The ingredients are an polymer from 3, 6-Anhydro-L-Galactose and D-Galactose, buffer systems, sodium salt of (3α, 5α, 12α) – 3, 12-dihydroxy-5-cholan-24-acid, water for injection purposes and sodium chloride.

During intralipotherapy AQUALYXTM is injected directly into the subcutaneous fat tissue using very thin, sharp cannulas. Within the following weeks the treated fat cells are gradually dissolved. The metabolism in the treated area is increased. Intralipotherapy is intended for patients with localised adipose tissue not responding to diet or increased physical excersise. Intralipotherapy is not intended for weight loss, it is used to improve and alter the contour of the body. Results can not be compared to a liposuction, as that is an operative method of fat reduction where large amounts of fat are permanently removed from the body. The results of intralipotherapy are permanent, however the procedure takes time to reach its full effect. Patients that have undergone follow-up examinations seven years after therapy stil show a relevant diminution of fat tissure in the treated areas. Intralipotherapy is an aesthetic-medicinal treatment that is generally not reimbursable by government or private health care insurers. The patient must bear all expenses.

THERAPY

Intralipotherapy can be used as a means of moderate reduction of fat tissue as well as a treatment against benign adipoma for patients that do not want to undergo surgery. AQUALYXTM is injected directly into the fat tissue. Administration of anaesthesia is usually not required. To date not one single phenomenon of overdose or toxication has been recorded. Intervals between treatments should amount to three to four weeks. The amount of treatments can vary between two and eight sittings according to the characteristics of the treated area. In support of the therapy a localised ultrasound treatment can be administered directly after injection. However ultrasound treatment is not the decisive factor in the process of the desired fat reduction. As with all aesthetic medicinal therapies there is no guarantee for a fully successful treatment. A minimum of two treatments will be required. About 1% of treated patients have experienced nil to minimal effects after intralipotherapy.

I have been informed about the following points concerning my intended intralipotherapy:

ABSOLUTE CONTRAINDICATIONS:

I am of legal age

I am pregnant

I am breastfeeding

I am a diabetic with vascular diseases (microangiopathy)

RELATIVE CONTRAINDICATIONS:

I suffer from the following diseases:

Autoimmune disease (e.g. scleroderma)

Severe hepatic diseases

Acute infections and chron. infection risk

Severe adipositas (adipositas per magna BMI > 30)

Hypersensitivity against ingredients

Severe kidney disease

Allergies

Blood coagulation disease

Disturbed menstruation

Furthermore I have been informed about the following adverse effects:

General risks: injection therapy may result in permanent damage of nervous tissue and nerves, as well as inflammatory reactions and infections that may result in irreversible scarring.

Expected adverse effects: swelling and hyperthermia of injected area, haematoma, pressure sensitivity, moderate pain and itching within the treated area.

Possible adverse effects: redness of the skin that may become permanent, permanent punctual rigidification or lumps within the tissue, denting of the treated area due to irregular reduction of fat cells, vegitative disorder, as well as temporary debility of the circulatory system (please be sure to hydrate by drinking a sufficient amount of water), increased sweating, nausea, diarrhoea (uncommon), intracyclic menstrual bleeding (women), allergic reactions (very uncommon) such as nettle rash, asthma bronchiale, symptoms of shock, hyperpigmentation (may last up to several months).

I have been informed about alternative therapies such as dietary measures, increased physical exercise or operative correction (e.g. liposuction). I am not considering any of these options.

Clinical control:

A clinical control will be carried out after completing all arranged treatments and after passing the appointed time intervals.

I have read this informed consent and certify that I understand its contents in full. I have been informed that I must not apply any kind of cosmetics onto the treated area within the first twelve hours following the treatment with AQUALYXTM and that immediate exposure to heat sources during the following days are to be avoided (e.g. sunlight, UV-radiation, sauna). I am aware of the fact that after therapy with AQUALYXTM treatments using laser, kyrolipolysis or radio-frequency-therapy must not be administered. Furthermore, I should abstain from particularly demanding physical exercise for seven days.

I have been given a copy of this consent form. My consent and authorisation for this procedure is strictly voluntary. By signing this informed consent form, I grant authority to my physician to perform intralipotherapy using AQUALYXTM and to administer an additional ultrasound treatment as may be deemed necessary or advisable in the diagnosis and treatment of my condition. The nature and purpose of this procedure, with possible alternative methods of treatment as well as complications, have been fully explained to my satisfaction. No guarantee has been given by anyone as to the results that may be obtained by this treatment.

I have had enough time to consider the information from my physician and feel that I am sufficiently advised to consent to this procedure.

I hereby give my consent to this procedure and have been asked to sign this form after my discussion with the physician.

Area of treatment:

Place, Date

The medical fee shall be payed on the same day prior to each treatment. The fee per treatment is as agreed upon:

 

Leave this empty:

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Signed by Nina Bal
Signed On: 11th January 2020

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Document name: Aqualyx Patient Content Form
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5th November 2019 12:42 pm BSTAqualyx Patient Content Form Uploaded by Nina Bal - info@facialsculpting.co.uk IP 51.179.98.227