I consent to sharing of information with my GP where necessary.

BACKGROUND

AQUALYX 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

AQUALYX 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. AQUALYX 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 AQUALYSIS treatment, AQUALYX 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. AQUALYSIS is intended for patients with localised adipose tissue not responding to diet or increased physical excersise. AQUALYSIS 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 AQUALYSIS are permanent, however the procedure takes time to reach its full effect. Patients that have undergone follow-up examinations seven years after therapy stillshow a relevant diminution of fat tissue in the treated areas. AQUALYX is a medical device that is generally not reimbursable by government or private health care insurers. The patient must bear all expenses.

THERAPY

AQUALYSIS 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. AQUALYX is injected directly into the fat tissue. Administration of anaesthesia is usually not required. To date not one single incidence 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 AQUALYSIS.

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 rigidity or lumps within the tissue, denting of the treated area due to irregular reduction of fat cells, dizziness immediately after the procedure for around 2 hours (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, bronchial asthma, symptoms of shock, hyperpigmentationif the treatment areas are exposed to the sun immediately afterwards (hyperpigmentation may last up to several months). To date there have been no recorded cases of permanent redness or hyperpigmentation.

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 AQUALYX 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 AQUALYX, treatments using laser, cryolipolysis or radio-frequencytherapy 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 AQUALYSIS using AQUALYX. 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 healthcare professional.

Patient Instructions:

Aqualyx

Before treatment:

• Avoid aspirin, vitamin E, St. John's wort and other dietary supplements including ginkgo, evening primrose oil, garlic, feverfew and ginseng
  for 2 weeks.
• Avoid ibuprofen and alcohol for 2 days
• If possible, come to your appointment with a cleanly washed face.

General injection related complications:

• Pain
• Bruising
• Redness
• Swelling
• Tenderness
• Headache
• Infection
• Numbness
• Anxiety

Most will resolve in a few hours or a few days.

After treatment:

• Do not massage the treated areas on the day of treatment
• Avoid lying down for 4 hours immediately after treatment
• Avoid applying heat to the treated area on the day of treatment
• Avoid activities that cause facial flushing on the day of treatment, including consuming alcohol, hot tub or sauna use, exercising and
  tanning
• Gently apply a cool compress or wrapped ice pack to the treated areas for 15 minutes every few hours as needed to reduce discomfort,
  swelling, or bruising up to a few days after treatment. If bruising occurs, it typically resolves within 7-10 days
• After treatment, oral consumption and/or topical application of Arnica Montana may help to reduce bruising and swelling
• Botulinum toxin treatment effects take about 1-2 weeks to fully develop and last approximately 2.5-4 months
• Anti-wrinkle top up included within 4 weeks/28 days of treatment, book online at www.freshfaced.com or phone 01415528898.
• If 2-4 weeks after treatment you feel that you need a correction or want to buy another syringe of filler, please book online at
  www.freshfaced.com or phone 0141 552 8898.
• If you have any problems or concerns following treatment please phone 0141 552 8898.

Patient Covid-19 Screening

* A new, continuous cough means coughing for longer than an hour, or
three or more coughing episodes in 24 hours. If the patient usually has a
cough, it may be worse than usual.

If you have answered YES to any of the above, you should not attend the practice.

If you have recovered from COVID-19, or completed a period of self-isolation, you are able to attend the practice.

A person is considered to have recovered from COVID-19 infection when
they meet all of the following criteria:
• It has been at least 7 days since the onset of the COVID-19 symptoms;
• They no longer have a high temperature.
N.B. A cough may persist for several weeks in some people, even though the coronavirus infection has cleared. The loss of, or change in, sense of smell or taste may also linger. According to the CMO letter (18 May 2020) a person with a persistent cough and/or loss of sense of smell or taste but no other symptoms does not need to continue to self-isolate for more than 7 days. 

I hereby declare that the information provided is complete and accurate. I fully understand that any false information can put the healthcare workers attending to me at a higher risk of contracting COVID-19 disease. I fully agree to follow all the instructions regarding precautionary steps by the treating clinician and staff at the clinic.
I am visiting the clinic with full knowledge that we are going through a COVID-19 global pandemic.
There is always a risk of contracting this virus when I am visiting a place during this pandemic.
There is a possible risk of getting this virus by visiting any place during this pandemic. I have been fully explained the content of this declaration form in a language that I can understand.
I hereby absolve the treating clinician and the team members of Royston Dental Practice / freshfaced of any criminal or medicolegal liability arising due to my visit to the clinic. I hereby give my consent for this.