AQUALYX Consent Form
Treatment/Product Information:
AQUALYX is a CE-marked medical device injectable solution that 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 for the reduction of stubborn fat under the chin and on the body. To date, no single incidence of overdose or toxication has been recorded with AQUALYX.
AQUALYSIS is intended for patients with localised adipose tissue that does not respond to diet or increased physical exercise. AQUALYSIS is not intended for weight loss but to improve and alter the body's contour.
Results can not be compared to liposuction, an operative method of fat reduction in which large amounts of fat are permanently removed from the body.
Formulation:
AQUALYX is an injectable, hydrous, micro-gelatinous, biocompatible, and biodegradable solution. It dissolves fat cells, after which the body naturally expels the released fatty acids.
AQUALYX is a solution complex containing detergent from the desoxycholate family that has been physically modified to reduce the biological half-life. 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, sodium salt of (3α, 5α, 12α)—3, 12-dihydroxy-5-cholan-24-acid, water for injection purposes, and sodium chloride. Lidocaine is also added to the solution for local filtration anaesthesia and patient comfort.
Treatment:
AQUALYSIS can be used to moderately reduce fat tissue and treat benign adipoma for patients who do not want to undergo surgery. Local anaesthesia (Lidocaine) is administered to the injection entry point and mixed within the AQUALYX solution.
During AQUALYSIS treatment, AQUALYX is injected directly into the subcutaneous fat tissue. A needle creates a small entry point, and a long cannula is inserted and fanned throughout the fat of the intended treatment area. A cannula is similar to a needle but without the cutting blade at the end, resulting in less bruising.
Within the following weeks, the treated fat cells are gradually dissolved, and the metabolism in the treated area is increased. The results of AQUALYSIS are permanent; however, the procedure takes time to reach its full effect. Patients who have undergone follow-up examinations seven years after therapy still show a relevant diminution of fat tissue in the treated areas. About 1% of treated patients have experienced nil to minimal results after AQUALYSIS.
In support of the therapy, a localised high-intensity focussed ultrasound (HIFU) treatment can be administered directly before injections of AQUALYX. We recommend this combination approach as HIFU will target fat and skin to increase fat destruction and reduce the risk of post-fat reduction skin laxity. 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.
Post Treatment:
Start drinking water straight away. We advise you to maintain a minimum of 2 litres a day to help support the treatment efficacy.
You may feel dizzy or nauseous after treatment. This is usually related to dehydration. Please do not worry. Increase your water intake, and it should settle.
You may notice the injection sites leaking a small amount of serous fluid. This is normal. We will apply a small dressing to each injection site to cover this. You may remove the dressing the following day.
You may notice the treatment area feels numb, itchy and achy. This is a normal response and can last several weeks.
You may also experience redness, swelling and bruising that could take several weeks to reduce. Although this may look alarming, it is a normal process of aqualysis. However, we urge you to contact us with any concerns.
Treatment Intervals:
For most patients, a course of treatments three to four weeks apart will be required. The number of treatments can vary between two and eight sittings according to the characteristics of the treated area. A minimum of two treatments will be required.
Alternative Treatments:
Your practitioner will always advise you of the safest and most effective treatment based on your medical history and assessment. However, you should also consider the option of no treatment at all. Other treatment options are available, such as HIFU fat reduction and surgical fat removal. Please discuss these options with your practitioner if you wish to explore alternative options.
Contraindications:
You cannot have AQUALYX treatments if:
You have a known allergy to AQUALYX or any of the abovementioned ingredients.
You have a BMI over 30.
You have had roaccutane/Isotretinoin medication in the last six months.
You have an active infection or inflammation near the intended treatment area.
You have open wounds in the intended treatment area
You have a history of keloid or raised scarring.
You have uncontrolled diabetes or poor wound healing.
You have blood clotting problems or are taking blood thinning medications.
You are immunosuppressed.
You suffer from an autoimmune disease.
You have severe liver disease.
You have severe kidney disease.
You have had injectable cosmetic treatments in the intended area under two weeks before AQUALYX.
You think you could be pregnant, are pregnant, or are lactating/ breastfeeding.
Cautions:
You need to tell your aesthetic practitioner if:
You suffer from recurrent bouts of herpes simplex infections near the treatment area, as an AQUALYX treatment may encourage an outbreak.
You have known allergies or hypersensitivity.
Material Risk (the level of significance you personally apply to the risks, side effects or complications of this treatment within your own circumstances):
As with any medical procedure, this treatment carries the risk of side effects or complications. Discuss these risks with your practitioner to fully comprehend their implications. Consider the risks in relation to your personal circumstances, including your health, lifestyle and career and decide if they are acceptable. If not, discuss alternatives or take more time to decide.
Associated Risks:
Skin erythema (skin redness) is the most common and likely side effect of your treatment with AQUALYX. This is related to the inflammatory process of fat cell destruction. This should subside within a few weeks but can rarely become permanent. To date, there have been no recorded cases of permanent redness.
Swelling of the treatment area. You will likely experience swelling and hardening of the treatment area for several weeks post-AQUALYX treatment. Very rarely, this can become permanently hardened. Initial swelling can be helped with using a cold compress; however, we do not advise anti-inflammatory medications, as this can decrease the overall effect of the treatment.
Bruising welts or numbness. Bruising can occur as a result of AQUALYX treatments and can be extensive. This may last several weeks. You may purchase DMK Red Vein cream to assist in bruise reduction following the treatment.
Pain and discomfort. Although reasonable care and skill are employed to deliver an AQUALYX treatment, you may still experience some injection discomfort. We advise you to inform your practitioner of any discomfort throughout your treatment.
Burning sensation, tingling and/or tenderness. You will also experience tenderness and discomfort at the treatment site area for several weeks following an AQUALYX treatment. This is considered normal; however, you should not be experiencing any severe pain. If you have extreme pain, please contact the clinic immediately.
Allergy and/or anaphylactic shock. As with any medical procedure, there is a risk that you could develop an allergic or anaphylactic shock response to the treatment delivered. This is a very rare occurrence with AQUALYX. Whilst your practitioner is trained to deliver initial emergency treatment, you may be required to attend a local emergency department for further treatment and monitoring. If you experience shortness of breath, swelling of the skin and mucosa, or airway swelling after you have left the clinic, please call 999 for an ambulance. This is an emergency situation that requires immediate medical attention. When it is convenient, please also inform the clinic of the reaction. You should also know that an allergic or anaphylactic shock response could result in disability or death.
Infection. As with any procedure that involves a break to the skin’s surface, there is a risk that an injection of any material could introduce an infection which may require treatment. The side effects of Aqualyx could mask the symptoms of infection, as you are expected to be red, swollen, and tender in the treatment area for at least two weeks. However, please contact your practitioner if you are concerned or are experiencing increasing skin redness, swelling or pain in the treatment area.
Nausea, Vomiting and/or diarrhoea. Rarely have patients reported short-term gastrointestinal effects.
Hyperpigmentation/Hypopigmentation. There is a risk that the inflammatory response to AQUALYX could trigger the skin to develop brown discolouration of the skin (Hyperpigmentation), lighten skin colour, or completely remove skin colour (hypopigmentation) from the treated area. To date, there have been no recorded cases of permanent hyperpigmentation. It is important to avoid the sun or artificial UV exposure on the treatment area following treatment with AQUALYX for a minimum of 2 weeks or if any inflammation is still present.
Dizzyness. AQUALYX will trigger an accumulation of water in the treatment area, an essential AQUALYSIS process. As a result, you may feel dehydrated, dizzy or faint for around 2 hours after an AQUALYX treatment. It is essential that you hydrate regularly before and after an Aqualyx treatment to help reduce this occurrence and improve the overall effect of the treatment. Should you experience any dizziness following an AQUALYX treatment, it is essential that you inform your practitioner and avoid driving or the use of dangerous or heavy machinery until you feel well enough.
Hair reduction. Very rarely, hair follicles within the treatment area may be permanently destroyed.
Nerve inflammation can be temporary or permanent. If a motor nerve has become inflamed, you may experience local muscle weakness. If a sensory nerve has become inflamed, you may experience skin numbness, discomfort, or a burning sensation. This will typically resolve within six weeks but can be permanent.
Intracyclic menstrual bleeding (Women). Following AQUALYX treatment, you may experience menstrual bleeding or a heavy period. The reason for this is unknown. Please contact the clinic if you experience excessive menstrual bleeding following AQUALYX treatment.
Herpes (cold sores) reactivation. Treatments that stimulate a biological response, such as AQUALYX, carry the risk of an outbreak of herpes (fever blisters/cold sores/shingles), in individuals who already carry the herpes virus. You should manage this as you would normally, such as using over-the-counter cold sore medication. Please contact your practitioner if you experience a severe outbreak following treatment.
Failure to respond. You may not achieve the results desired and discussed during your consultation. About 1% of treated patients have experienced nil to minimal effects after AQUALYX. This is due to the treatment's reliance upon a biological response, which cannot be predicted. If you require additional treatments or an alternative combination of treatments to achieve the desired results, this will be at your own cost.
Uneven skin and body contours. Very rarely, following AQUALYSIS body contouring treatments with AQUALYX, your fat may not break down evenly, resulting in denting, lumps, bumps, uneven body contours and an unsatisfactory permanent result. This is a result of the irregular destruction of the fat cells and cannot be predicted.
If you experience any side effects of concern, please do not hesitate to contact the clinic as soon as possible.
This consent form is not meant to include all possible risks associated with an AQUALYX treatment, as there are both known and unknown side effects and complications associated with any medical treatment. We have written this consent form to ensure you are fully informed of the procedure, the reasons why you may not be able to receive treatment and the known risks of an AQUALYX treatment.
Photographs:
We need to take photos of the treatment area to document the original condition before treatment begins and to monitor results and potential changes throughout the treatment process. These photos will become part of your medical aesthetic treatment record at Lumiere Medispa.
You have the right to refuse consent for these photographs. However, please be aware that without this consent, we will not be able to treat you for medico-legal reasons.
If we wish to use your photos for any other purpose, we will always seek separate written consent from you. You have the right to refuse this additional use of your photos, and it is not mandatory to consent to any other photo usage to receive treatment.
By signing this consent form, you acknowledge and confirm the following:
Risks and complications
You have discussed the potential risks and benefits of an AQUALYX treatment with your practitioner, and your questions have been answered satisfactorily.
You understand that medical attention may be required to resolve any complications associated with your treatment. In most cases, except those in an emergency, you should contact your practitioner for advice/treatment.
Medical History
To the best of your knowledge, you have provided the details of your past medical history and will inform your practitioner if this changes before any future treatments.
You understand that withholding aspects of your medical history could lead to serious physical and mental harm.
Contraindications & Cautions
You are not pregnant or possibly pregnant, lactating or nursing, and you will inform your practitioner if this changes before any future treatments.
Fees & Charges
You understand and agree that all services rendered will be charged directly to you, and you are personally responsible for payment.
You further agree, in the event of non-payment, to bear the cost of collection, court costs and reasonable legal fees, should they be required.
Refunds
Fees charged for treatment are for the delivery of a treatment and the accompanying service, which is inclusive of the following;
-Consultation and assessment
-The provision of information and advice
-The provision of the treatment itself, as described above
-Follow-up appointments and aftercare advice and support as appropriate
Whilst we undertake to provide excellent service, factual, honest, and ethical advice, safe, expert treatment in experienced hands, and the best products, we cannot guarantee your results. We cannot offer refunds if the results achieved fail to meet your expectations. The successful outcome varies by degree, and how long these effects last varies from one individual to another and cannot be guaranteed.
You understand that whilst you have been advised of a probable result, this should not be interpreted as a guarantee.
You will contact your practitioner if you are unsatisfied with your treatment outcomes.
Aftercare
You have verbally discussed the aftercare required following an AQUALYX treatment and have been informed that you will also receive this via email. You understand the importance of following the post-treatment advice and agree to follow it.
You understand that failure to follow this advice could lead to serious physical and mental harm.
Photograph Use Consent:
You understand that receiving treatment at Lumiere Medispa requires photographs to be taken of the treatment area. These photographs may be taken before, during, and after each treatment and will form part of your legal medical record at Lumiere Medispa. By signing below, you freely give your consent for your photos to be used solely for this medico-legal purpose. If we wish to use your photos for any other purpose, we will always seek separate written consent from you, and you have the right to refuse.
Valid Consent
By signing below, you acknowledge that you have read and understood this consent form and have had the opportunity to discuss any questions you have with your practitioner to your satisfaction. You consent to receive an AQUALYX treatment under the terms of this consent form and understand that you have the right not to consent to this treatment and that your consent is voluntary.
