Profhilo Consent Form

Product

Profhilo is a sterile hyaluronic acid gel consisting of non-animal, non-cross-linked hyaluronic acid that is injected into the skin for the biomodulation of lax skin tissues and skin hydration. Hyaluronic acid is a naturally occurring sugar found in the human body. The role of hyaluronic acid in the skin is to deliver nutrients, hydrate the skin by holding water within the skin, and act as a cushioning agent. The effects of hyaluronic acid within Profhilo will generally last between 4-6 months, however no guarantee can be given for its duration as the product can be affected by internal and external influences, including some medical conditions, medications, smoking and sun exposure.

Treatment

A topical anaesthetic cream can be applied for 30 minutes before your treatment if you are nervous or needle-phobic. If you feel you will need a topical anaesthetic in addition to this, it is advised that you arrange to see your practitioner 30 minutes before the actual treatment for maximum effect and greater comfort during the procedure.

You can also request that Lidocaine be added to the Profhilo syringe to help with the stinging sensation associated with Profhilo delivery. Please be aware that this will increase your risk of bruising and swelling. If you would like this added, please discuss it with your practitioner.

If this is your first Profhilo treatment, you will require two to three treatments spaced four weeks apart for best results. After this, you will need to maintain your result with a single treatment every four months.

Your treatment will involve a series of injections of Profhilo hyaluronic acid into the superficial skin tissues. Once your photos have been taken and your consent forms have been read and signed, it will usually take up to 15 minutes to complete.

Following the treatment with Profhilo, you will have small bumps present within the skin where the hyaluronic acid material has been placed. These bumps will go away over 24hrs. Very rarely, these can take longer to dissipate, particularly in thin-skinned individuals.

Results - The results are not seen immediately. You will start to see an improvement gradually around 7-14 days after your first treatment, with accumulative results forming one month after your second treatment.

Aftercare

Immediately following your procedure, slight redness and mild swelling around the treated areas are normal. These signs generally subside within 48 hours. The treated area will feel slightly tender to the touch or with extreme facial expression. If bruising occurs, it will typically resolve over 5-10 days. Applying Arnica gel or bruise creams may help for a quicker recovery.

Should you experience any unexpected side effects or any that concern you, please get in touch with the clinic on 01844 278362 as soon as possible. If it is outside of clinic hours and you require urgent advice, please call the out-of-hours number detailed in your aftercare email.

What to do after treatment

Do sleep with a few extra pillows at night for the first 1-2 days. This will help to minimise morning swelling.

Take extra care when cleansing and applying products to the treated area for the first 48 hours.

What NOT to do after treatment

DO NOT touch or wear make-up in the treated areas for 12 hours.

Avoid strenuous or excessive exercise and swimming for 24 hours

Do not massage or manipulate the treated areas, and avoid facial treatments and massage for

two weeks.

Avoid extended sun and UV exposure (including sun beds) and temperatures below 0 degrees for two weeks.

Avoid heat treatments such as sauna and steam for two weeks.

What to watch out for after treatment

Severe pain or increasing swelling is NOT normal and should be reported to the clinic immediately.

A rash or skin discolouration should be reported to the clinic immediately.

PLEASE NOTE: Should you experience difficulty breathing or swallowing following treatment with Profhilo, you must attend to your local hospital emergency department and contact your practitioner.

Occasionally, you may require further treatment to obtain the desired results. You will have been offered a follow-up appointment for one month after completing your course of treatment. It is important that you attend this follow-up appointment following your first course of Profhilo so that the final result can be assessed. Any additional treatment that is required will incur an additional charge and will be discussed with you before any treatment is given.

Alternative Treatments

Other treatments for skin rejuvenation are available and may be discussed with your practitioner at any time. If you feel that the risks and side effects associated with Profhilo are not acceptable to you, you should consider discussing an alternative treatment with your practitioner or not treating it at all.

Contraindications:

You cannot have Profhilo if:

You are under 18 years of age.

You have a known hypersensitivity to hyaluronic acid or lidocaine.

You have an active infection or inflammation near the intended treatment area.

You think you could be pregnant, are pregnant, or are lactating or breastfeeding. There are no adequate and well-controlled studies of Profhilo in pregnant or nursing women, therefore safety cannot be guaranteed.

Cautions:

You need to tell your aesthetic practitioner if:

You have an upcoming important event. You will have visible skin bumps for 24-48 hours and may experience bruising. You should plan your treatment and social/work diary around this.

You suffer from recurrent bouts of herpes simplex (cold sores) infections near the

intended treatment area. Profhilo injections may encourage an outbreak. Patients with a history of cold sores may be given an antiviral three days before treatment.

You are taking blood thinning medications.

You are taking retinoid medications.

You are on immunosuppressive therapy or on therapy to decrease the body's immune response.

You have diabetes.

You suffer from keloid or hypertrophic scarring.

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:

Injection site bruising, pain, swelling, rash, local numbness. These symptoms are usually mild and last less than a week but can last longer. Patients who are using medications that can prolong bleeding, such as aspirin, warfarin, or certain vitamins and supplements, may experience increased bruising or bleeding at the injection site. Swelling can be reduced with a cold compress and by ensuring you sleep with your head elevated for the first night after your treatment. Please remember that localised bumps at the injection site are normal and will usually diffuse within 24 hours but can take longer.

Little to no effect. Shorter or longer duration of effect. Profhilo is generally a successful treatment for the biomodulation of lax skin tissues, however from time to time there may be little to no effect or the effect may be shorter or longer than it is expected. This very rarely occurs, however, should you feel this has happened it is important you speak with your practitioner.

Asymmetry and dissatisfaction with the result. While your practitioner is trained in the successful delivery of Profhilo, there is a risk that you may dislike its effect or feel that your treatment result is asymmetric. If this should occur, it is important to speak with your practitioner, as it may be possible to provide corrective treatment.

Acne-like formations.

Herpes (cold Sores) re-activation. Injection of any kind carries the risk that an outbreak of herpes (fever blisters/cold sores/shingles) may occur in individuals who already carry the herpes virus. You should manage this as you would normally, such as by using over-the- counter cold sore medication; however, we advise that you please contact your practitioner as soon as possible.

Infection. As with any procedure that involves a break to the skin's surface, an injection of Profhilo carries the risk of infection. You should inform your practitioner if swelling, heat and/or discomfort occurs in the treated area for longer than a few days or suddenly occurs weeks or months after the procedure. This may require medical intervention from your practitioner, such as antibiotic therapy.

Nodules and palpable filler material. Very rarely, there is a risk that Profhilo hyaluronic acid material could cause small lumps or bumps, called granulomas, forming under the skin. In most cases, these will be non-visible and disperse in time. Where these bumps are visible, you may need further intervention from your practitioner to dissolve the product and/or a steroid injection.

Hypersensitivity/allergy. Most medications carry a potential risk of allergic reactions. Allergic reactions have been reported with hyaluronic acid and lidocaine (anaesthetic added at request for pain relief), such as anaphylaxis (whole body autoimmune response with oral swelling, airways closing, and difficulty breathing), skin itching, skin swelling, hives, redness, and difficulty breathing. These reactions can occur immediately or days to months later. You should contact your practitioner if you feel unwell or believe you have had an allergic reaction.

In cases of severe allergic reaction (anaphylaxis), you should seek immediate emergency medical care by calling for an ambulance.

Autoimmune responses. Very rarely, when the body has a heightened immune response, such as during illness or excessive sun exposure, it may attack foreign hyaluronic acid. This can happen weeks or months following the procedure, presenting as facial swelling and discomfort and ring medical on from your . Please contact your practitioner should this occur as you may require medications to be prescribed.

Nerve injury. Nerve injury from needle puncture may occur rarely. It will most likely be temporary; however, it could also be permanent. This could result in loss of sensation and/or weakness of local muscles in the area.

Blood vessel blockage. Very rarely, hyaluronic acid can be accidentally injected into, or on top of, a blood vessel. This could block the blood vessel and cause damage to local and/or distant tissue, which could result in localised skin tissue necrosis (cell death) or potentially even a heart attack, stroke or blindness. This is a rare medical emergency; your practitioner is trained to deal with this, but you may also require hospitalisation in extreme cases.

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.

Informed Consent:

This consent form is not meant to include all possible risks associated with a Profhilo 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 a Profhilo treatment.

By signing this consent form, you acknowledge and confirm the following:

Risks and complications

You have discussed Profhilo's potential risks and benefits with your practitioner, and all of your questions have been answered to your satisfaction.

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 only 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

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 a Profhilo 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 a Profhilo treatment under the terms of this consent form and you understand that you have the right not to consent to this treatment and that your consent is voluntary.