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PROFHILO Consent Form

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.
I understand that several appointments may be necessary to produce optimal results and I will be notified, in advance of each session of treatment, about the location where the next treatment session is going to take place and the identity of who is going to be involved in my care at each stage. I also understand that I will be kept informed of progress and that I can change my mind at any point.
RISKS AND SIDE EFFECTS: 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
CLINICAL PHOTOS AND VIDEOS: 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 have been asked what information I want and would need in order to make an informed decision. I have been given the opportunity to discuss my desired outcome fully in order for me to make an informed decision.
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.
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The following aftercare advice is essential to help reduce the risk of treatment
complications, to improve your comfort/healing and to help achieve the best possible
results from treatment.
Please follow the aftercare advice for Profhilo injections.
• Immediately after Profhilo injections the treatment area may be red, tender or
swollen. The redness and tenderness should improve after 48 hours. Swelling is
often worse on days 2-3 after injection, improved by day 5 and resolved by 2
• For significant swelling contact your practitioner for advice. Swelling may be
reduced by regular cold compress, anti-inflammatory medicines such as
Ibuprofen (after 24 hours, if safe for you to take), antihistamines and sleeping
with your head propped up on 3 pillows to help drainage of fluid overnight.
• Bruising may occur following treatment, bruising will resolve naturally but may
take up to 2 weeks to settle.
• Regular application of Arnica cream may be helpful for bruising.
• Tenderness is normal when the injected area is touched afterwards but active
pain at rest is not normal. If you experience pain, you must contact your
practitioner as soon as possible.
• Avoid any makeup for 24 hours after treatment as this will reduce the risk of
• Drink plenty of water after treatment to keep well hydrated.
• Avoid alcohol and caffeine for 24 hours after treatment.
• Avoid medications such as aspirin or Ibuprofen for 24 hours as they are blood
thinning agents and may worsen bruising (if these medications have been
advised by your GP you must check with your GP before stopping them)
• Avoid supplements such as multivitamins, fish oils, glucosamine and Vitamin B or
Vitamin E, which are blood thinning agents and may exacerbate bruising for 24
hours (if these supplements have been advised by your GP please check with
your GP before stopping them)
• Avoid any excess sun exposure, extremes of hot/cold, saunas, swimming or
strenuous exercise until the redness and swelling has settled.
• A rare complication of Profhilo is vascular occlusion in which a blood vessel is
accidentally blocked with filler. Signs and symptoms include throbbing and
aching pain which can be severe, paleness, a cold feeling to the tissue and
purple streaky mottling tissue changes. If you notice any of these symptoms you
must contact your practitioner as soon as possible, they will guide you through

how to perform a capillary refill test and then assess you fully and advise further
action if required.
• You must seek medical attention and contact your practitioner if you experience
any signs or symptoms of infection after treatment. Infection can present as hot,
red shiny skin, there may be pus formation and you may have a fever or feel
generally unwell.
• You must seek emergency medical attention if you experience any severe allergy
symptoms after treatment. Symptoms may include rash, facial swelling and
breathing difficulties.
• Contact your practitioner as soon as possible if you notice any other unwanted
side effects.
• Your practitioner will advise when further treatment appointments are required. If
you are advised to attend a follow up appointment, please do make every effort to
attend them. You should do this even if you believe that the recovery process is
going well and you cannot see that there are any visible complications.

It is essential that you have read all of the information available. Once you have read and
understood all of the below, please sign the declaration at the bottom of this form. Please
do let your practitioner know if you have any questions or if you do not understand any of
the aftercare instructions provided below.

I confirm that I have read and understood all the information on this Form and that I have
been given the opportunity to ask any questions that have come to mind throughout.

Date / Time