Consent and consultation form for patients treated with Profhilo
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.
About Profhilo
Profhilo® consists of one of the highest concentrations of hyaluronic acid (HA) available in any aesthetic product. Hyaluronic acid is a naturally occurring substance, which is a major component of our skin and has a function in wound repair, hydration, and cell to cell communication. One of the main characteristics of hyaluronic acid is that it effectively binds water like a sponge. Profhilo® has been around since 2015, so it is a relatively new treatment, but has a low risk of complications. It comprises of a combination of high and low molecular weight hyaluronic acid (64mg of hyaluronic acid in a 2ml pre-filled syringe, 32mg of high molecular weight HA and 32mg of low molecular weight HA). Unlike most HA products that are cross-linked using chemical agents, Profhilo® is thermally stabilised. The thermal stabilisation process changes the character and behaviour of the HA and allows it to have a longer lasting effect. As there are no chemical cross-linking agents, Profhilo® contains pure hyaluronic acid.
Possible Side- Effects
Hyaluronic acid is a natural substance found in the skin and the substance itself is safe when it has been purchased from a reputable pharmacy or supplier. Counterfeit products carry a higher risk of adverse events, so it is important to seek a practitioner who can demonstrate the source of the product.
Profhilo® is composed of a highly pure grade of hyaluronic acid and with the absence of any additives, it is extremely biocompatible and has fewer documented adverse effects than traditional hyaluronic acid fillers.
Side-effects may be more likely due to the following factors:
Patient factors: Condition of the skin, age, certain medical conditions, certain medications.
Practitioner factors: Training, years of experience, number of procedures performed.
Premises factors: Suitability of the premises.
Profhilo® has very few complications, however no treatment is without risk and these should be discussed during your consultation.
Possible adverse effects include:
Pain: You may experience some minor tenderness or discomfort post-treatment. If you do have more pain than expected, it is important to contact your treating practitioner immediately as this may indicate a complication, such as a vascular occlusion.
Redness: This is normal and usually resolves quickly. If the treatment area becomes red a few days after treatment, particularly if heat is also present, this may indicate an infection and you need to contact your practitioner straight away.
Swelling: Some swelling or oedema is normal after treatment and may be worse the following morning after the procedure. However, persistent swelling should be reported to your practitioner as there may be treatment to help relieve this.
Bruising: As the procedure involves injections in the skin, bruising is a common finding. This can be anything from a small mark on the skin to extensive bruising which extends beyond the area treated and can take up to two weeks to resolve. Rarely, bruising can lead to permanent staining of the skin.
Infection: Your treatment should be conducted in an appropriate clinical environment, your practitioner should adhere to infection control protocols and you should receive appropriate aftercare advice to lessen this risk. Infection often develops as a warm, red, swollen area over the area that has been injected a few days after your treatment. If this occurs, make sure you contact your practitioner for a review as soon as possible.
Tyndall Effect: Rarely, hyaluronic acid may remain visible beneath the skin as a bluish or grey hue. Remedial treatment may be required to deal with this, and you should book a review appointment with your treating practitioner.
Herpes (Cold sores): Treatment around the lip area can exacerbate an outbreak of herpes, which may be worse than a normal outbreak and may require treatment from your practitioner. The ACE Group World recommends that preventative medication may be required for certain treatments in people who are prone to cold sores. It is important that this is discussed as part of your medical history.
Lumps: Following treatment, it is normal to have visible lumps at the injection sites. These dissipate over the next few hours but may be present for up to 48 hours and may be worse the morning after treatment. If you develop a lump several weeks or months after treatment, it is recommended to arrange a face to face review with your treating practitioner. Lumps may appear as soft swellings or as hard nodules. They sometimes occur following an acute illness, such as a dental or sinus infection, or with exposure to excessive sunlight.
Vascular Occlusion: This is a rare, but serious, complication from dermal filler injections. In this situation, your blood supply may have been compromised by filler that has caused a blockage or obstruction of normal blood flow. If this is not correctly managed, the skin and tissue supplied by the blood vessel does not receive sufficient oxygen and can result in tissue loss, scarring and secondary infection. A vascular occlusion will normally cause severe pain, an irregular change in colour of the area treated and poor capillary refill (a test performed by your practitioner to see if the blood supply has been compromised). It will often appear immediately during treatment or soon afterwards and once this has been identified, your practitioner should have the necessary products at hand to effectively manage this.
Blindness: This is an extremely rare and devastating complication that can occur with dermal filler treatments. There are certain areas of the face that pose a higher risk if they are injected, although it can occur from any facial dermal filler procedure. This should be discussed during your consultation with your practitioner, because if blindness occurs, it is likely to be permanent.
Stroke: Another extremely rare, but documented complication of dermal fillers.
If you develop any unexpected side-effects after treatment, it is important to contact your practitioner for a review as soon as possible, as they may be able to offer some corrective treatment. Although your practitioner may contact you by telephone or video call initially or you may send your own photographs, this is no substitute for a face to face review to provide an accurate diagnosis.
Are There Contraindications for Injectable Treatments Like Profhilo?
You may not be suitable for treatment if any of the following apply:
Treatment cannot be performed if pregnant or breast-feeding and is not recommended if you are actively trying to get pregnant or undergoing IVF.
If you suffer from keloid scarring or have active skin conditions, such as acne or psoriasis.
If you have certain medical conditions, such as diabetes, rheumatoid arthritis, autoimmune conditions, blood clotting disorders, cancer, immunosuppression (either medical or drug-related).
If you are suffering from any skin infection in or near the treatment area, including cold sores.
If you are suffering from any other infection, including dental, throat, ear, chest, or sinus infections.
If you are unwell, including coughs and colds, on the day of treatment.
If you are taking any medicines which affect bleeding, such as aspirin or warfarin.
If you have had Roaccutane® or isotretinoin in the past 6 months.
Certain allergies, including bee sting allergy.
Recent facial surgery or other dermal fillers in the same area.
Permanent implants, such as silicone implants in the face or pins and plates
Injection treatments are not performed on individuals under 18
If you have any questions or concerns, please raise these with your practitioner before your treatment.