This is an informed consent form that has been prepared to help inform you of the potential benefits and risks of Profhilo. It is important that you read this information carefully and discuss fully with your practitioner before proceeding with treatment.

It is also important that you take as much time as you need to consider the treatment carefully, weighing up all your options before reaching an informed decision. It is essential that you are aware of your right to have a second opinion and you are encouraged to ask any questions that come to mind throughout the entirety of the process.

Profhilo is a skin bioremodeller consisting of high concentration hyaluronic acid. It works by stimulating skin collagen and elastin production as well as promoting increased skin hydration. Profhilo is administered in small amounts by intradermal injection using very fine needles and aims to boost, tighten, hydrate and lift your skin. Profhilo is used to treat tired, aged, lax and dehydrated skin as well as for fine lines and wrinkles. Profhilo is commonly used for skin rejuvenation on the face but can also be used on the neck and hands. Profhilo is not the treatment of choice for deep lines and scars or to add volume, it is not a dermal filler and will not produce the same results as these. You will be offered a topical anaesthetic cream before injection of Profhilo to help reduce discomfort during the procedure.

Profhilo is injected on two treatment sessions 4 weeks apart, to maintain results a further 2 treatment course is recommended every 6 months. After initial treatment you can expect to see results gradually over a period of 4-6 weeks. Results should last 6 months on average but they can last for longer or shorter time periods. I am aware that results vary between clients and results are dependent on many individual factors. I am aware that there is no guarantee that I will achieve desired results and that more than one treatment course may to be needed to achieve or maintain desired results.

As with any procedure there are potential risks and complications associated with Profhilo. You must be aware of the following possible risks before proceeding. You must fully discuss any questions with your practitioner.

Common complications:

These include pain, bleeding and bruising at the time of injection. After injection, the area may feel tender but should not be actively painful. If you experience significant pain following Profhilo then you must contact your practitioner as soon as possible for review. Bruising is dependent on several factors, most of the time bruising is mild but occasionally can be more significant. Bruising can take up to 2 weeks to fully resolve but should be much improved after 1 week. More uncommonly severe bruising can lead to haematoma formation, a collection of clotted blood. In this case the swollen collection of blood will need at least 2 weeks to resolve naturally and your practitioner will give you the appropriate after care advice. Your skin may appear red and swollen after Profhilo injection, this is usually mild and should improve after a couple of days, but it can last up to 14 days in some cases.

Uncommon complications include:

Skin infection (cellulitis) which presents as hot, red, shiny skin and you may also be generally unwell. In the case of suspected infection following Profhilo, you should contact your practitioner but also seek medical assessment as soon as possible as you will likely need antibiotics. Occasionally infection can form a swollen collection called an abscess. In this case you again must seek urgent medical attention. If you suffer from cold sores (a herpes virus infection of the lip) these can sometimes be reactivated following injections. Occasionally people can develop an unwanted inflammatory reaction to Profhilo and this can lead to nodule formation called granuloma. These often present as a delayed complication several months after the treatment. Several treatment options are available for granuloma formation and you may require medical assessment. Sometimes people can faint or feel faint with injections, you must tell your practitioner as soon as possible if you feel unwell during the treatment.

Rare complications include:

Allergic reaction to Profhilo, including anaphylactic reaction which would require emergency medical assistance and transfer to hospital. Rarely Profhilo can be injected into an artery blocking the flow of blood to the tissue being treated. This is known as vascular occlusion, if untreated it is serious because it can lead to death of tissue (necrosis) which may require reconstructive surgery to correct. In the rare event of vascular occlusion, it would be treated with emergency injections of a dissolving drug called Hyaluronidase. This is an enzyme that removes the hyaluronic acid occluding the blood vessel and can usually fully reverse the vascular occlusion leading to no long-term harmful effects. Your practitioner will be trained in how to use Hyaluronidase in an emergency, however if treatment with Hyaluronidase is not successful then you would require urgent medical assessment or assessment by a doctor who is a specialist in aesthetic medicine.

I have been advised of the relevant information associated with this treatment and I confirm that I fully understand this advice. This includes advice about:

- the aims/motivations for having the procedure and the desired outcome
- the risks inherent in the procedure
- the risks inherent in refusing the procedure
- the risks specific to me
- the expected benefits of the treatment
- the potential disadvantages of the treatment
- alternative procedures and their pros and cons - including the option of no treatment at all
- any uncertainties about and the likelihood of success of the procedure
- any follow-up treatment that may be required

I understand that I have the right to discontinue treatment at any time.

 I agree to and authorise the taking of clinical photographs and videos. I understand that these clinical photographs and videos will form part of and will be kept with my confidential medical records.

I understand this is an elective procedure and I hereby voluntarily consent to treatment with dermal fillers for facial rejuvenation, lip enhancement, establish proper lip and smile lines, and replacing facial volume.  The procedure has been fully explained to me. I also understand that any treatment performed is between me and the doctor/healthcare provider who is treating me and I will direct all post-treatment questions or concerns to the treating clinician. I have read the above and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and I understand that no guarantees are implied as to the outcome of the procedure. I also certify that if I have any changes in my medical history I will notify the doctor/healthcare professional who treated me immediately. I also state that I read and write in English.

I am the treating Aesthetic Nurse.  I discussed the above risks, benefits, and alternatives with the patient. The patient had an opportunity to have all questions answered and was offered a copy of this informed consent.  The patient has been told to contact my office should they have any questions or concerns after this treatment procedure.

I certify that I have read the above consent and that I fully understand it. I have been given ample opportunity for discussion and all my questions have been answered to my satisfaction. No new information has become available that affects my decision to have the treatment or my decision to consent. I hereby consent to this procedure. This constitutes the full disclosure and supersedes any previous verbal or written disclosures.