Consent and consultation form for patients treated with Aqualyx

AQUAL Y,)(TM 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 Marl/or states sales of two million vials in two years. No major side effects occurred and the treatment was well-tolerated and successful. FORMULATION: AOUAL YX™ is an injectable, hydrous, micro-gelatinous solution, which is biocompatible and biodegradable. It causes the dissolution of fat cells, after which the body then expels the released fatty acids naturally. AOUAL YX™ 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 a polymer from 3, 6-Anhydro-L-Galactose and D-Galactose, buffer systems, a sodium salt of (3a, 5a, 12a) - 3, 12-dihydroxy-5-cholan-24-acid, water for injection purposes, and sodium chloride. During intralipotherapy AOUAL YX™ 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. lntralipotherapy is intended for patients with localised adipose tissue not responding to diet or increased physical exercise. lntralipotherapy is not intended for weight loss, it is used to improve and alter the contour of the body. Results can not be compared to 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 still show a relevant diminution of fat tissue in the treated areas. lntralipotherapy is an aesthetic-medicinal treatment that is generally not reimbursable by government or private health care insurers. The patient must bear all expenses. THERAPY: lntralipotherapy 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. AOUAL YX™ is injected directly into the fat tissue. Administration of anesthesia is usually not required. To date, not one single phenomenon of overdose or intoxication has been recorded. Intervals between treatments should amount to three to four weeks. The number of treatments can vary between two and eight sittings according to the characteristics of the treated area. In support of the therapy, localised ultrasound treatment can be administered directly after injection. However, ultrasound treatment is not a 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.