Radiesse® Dermal Filler Consent Form

Product/Treatment Information:

Radiesse® dermal filler consists of tiny, smooth calcium hydroxylapatite (CaHA) microspheres suspended in a sodium carboxymethylcellulose gel carrier. To make the treatment more comfortable, Radiesse also contains an anaesthetic called Lidocaine.

Upon injection, Radiesse initially acts as a filler. It is easily malleable, can be used to shape and contour large areas of the face, and provides an immediate one-to-one correction. Once injected, Radiesse begins the process we refer to as neocollagenesis, stimulating the steady, ongoing growth of the body’s collagen. Over the first 2-3 months, the gel carrier is resorbed into the body, and the remaining Calcium hydroxylapatite acts as tissue scaffolding alongside your natural collagen.

The effects of Radiesse dermal filler will generally last between 9 - 18 months. However, no guarantee can be given for its duration as the product can be affected by internal and external influences, including medical conditions, medications, smoking and sun exposure. Very rarely, Radiesse is resorbed within weeks, and it is impossible to know if this will happen. No refunds will be given in these circumstances, but we will do all we can to assist you.

Repeating the treatment each 9-12 months is advised to maintain the desired result. 

Treatment

A topical anaesthetic cream is applied for 30 minutes before your treatment for greater comfort during the procedure.

Your treatment will involve a series of injections of Radiesse dermal filler into the facial tissues, which usually takes 30 - 60 minutes to complete.

The treatment results will be visible immediately. However, this should not be seen as your final result, as some skin tissue swelling may add to the filling effect. The final treatment result will be best seen 14 days after treatment when any residual swelling or bruising should have subsided. Very rarely can there be little or no effect and further treatment with Radiesse dermal filler may be required at additional cost?

Aftercare

Immediately following your procedure, it is normal for there to be slight redness and some swelling around the treated areas. These signs generally subside within 48 hours. The treated area will feel slightly tender to 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 with 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 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 discolouration, particularly skin that appears mottled white, blue and/or grey, should be reported to the clinic immediately. This may require an emergency review from your practitioner.

PLEASE NOTE: Should you experience difficulty breathing or swallowing following treatment with Radiesse, 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 one month after your treatment. It is important to attend this follow-up appointment 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 soft-tissue augmentation and volume replacement treatments exist, including permanent or non-permanent hyaluronic acid dermal fillers. We do not provide permanent dermal fillers at Lumiere Medispa because of the increased risks of infection and granulomas. Aside from these treatments, additional options for correcting lines and wrinkles exist, including facial creams, Botulinum Toxin Type A, chemical peels, and microneedling and may be discussed with your practitioner.

Contraindications:

You cannot have Radiesse if:

  • You are under 18 years of age.

  • You have a known hypersensitivity to Calcium Hydroxylapatite, Sodium Carboxymethylcellulose, 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 swelling and may experience bruising for several days. You should plan your treatment and social/work diary around this and allow at least two weeks between treatment and the event.

  • You suffer from recurrent episodes of herpes simplex (cold sores) infections near the intended treatment area. Radiesse 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 therapy used 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:

  • Non-Dissolvable Material. Radiesse, unlike hyaluronic acid dermal filler, cannot be dissolved with hyaluronidase. Instead, it will naturally break down over time but may take up to 2 years to be fully resorbed into the body. If you experience any of the below complications, we may not fully resolve them because we cannot remove the Radiesse material once injected. You may require surgery to remove the Radiesse material in rare and serious complications. If you feel uncomfortable with this risk, you may wish to discuss an alternative treatment, such as hyaluronic acid dermal filler, that can be dissolved in emergencies.

  • 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.

  • Little to no effect. Shorter or longer duration of effect. Radiesse is generally a successful treatment for volume replacement and the biostimulation of the localised collagen matrix. However, sometimes, there may be little to no effect, or the effect may be shorter or longer than 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 Radiesse, there is a risk that you may dislike its effect or feel that your treatment result is asymmetric. If this should occur, it is essential to speak with your practitioner, as corrective treatment may be possible.

  • 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 typically, such as using over-the-counter cold sore medication; however, we advise that you please get in touch with your practitioner as soon as possible.

  • Infection. As with any procedure that involves a break to the skin’s surface, an injection of Radiesse 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 Radiesse 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.

  • Hypersensitivity/allergy. Most medications carry a potential risk of allergic reactions. Allergic reactions could occur with Radiesse 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 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 the Radiesse material. This can happen weeks or months following the procedure, presenting as facial swelling and discomfort, requiring medical intervention from your practitioner. 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 but 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, Radiesse 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 very rare medical emergency, and your practitioner is trained to deal with this, but due to the non-dissolvable nature of Radiesse, 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 Radiesse treatment, as known and unknown side effects and complications are 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 Radiesse treatment.

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

Risks and complications

You have discussed the potential risks and benefits of Radiesse 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 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 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 a Radiesse 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 severe 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 with your practitioner to your satisfaction. You consent to receive Radiesse dermal filler 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.