Micro-Sclerotherapy (Leg Thread Vein) Consent Form

Product/Treatment Information:

Micro-sclerotherapy is an injectable treatment for visible thread and spider veins on the legs. A sclerosing agent called Fibrovein is injected into the veins using tiny needles. This substance is irritating to vein walls and causes them to become inflamed or ‘sticky’. In the weeks following treatment, the veins close off and break down. 

Fibrovein micro-sclerotherapy has been performed on millions of people for many years, and its safety is well-established. Of course, that does not mean there are no side effects or risks associated with Fibrovein micro-sclerotherapy. We have included the known risks further down this consent form.

Most patients comment that the procedure is relatively painless, and the main complaint is the initial localised itchiness of the treated areas. This itching is a normal histamine reaction that we expect with this treatment.

Depending upon the number of vascularities on the legs, most patients will experience a 60-80% reduction in thread and spider veins following Fibrovein micro-sclerotherapy. You should expect 2-6 treatments, each spaced eight weeks apart.

At your first appointment, we will provide one pair of full-leg, class 1 compression stockings. You MUST wear these for three days and nights after treatment and five days during the daytime only after that. Please bring your stockings at each subsequent appointment to avoid additional stocking charges. 

Alternative Treatments

Your practitioner will always advise you of the safest and most effective treatment based on your medical history and skin appearance. However, you should also consider the option of no treatment at all. Other treatment options, including laser and topical products, are available outside of Lumiere Medispa to reduce leg veins. Please discuss these options with your practitioner if you wish to explore alternative options.

Contraindications:

You cannot have Fibrovein Micro-Sclerotherapy if: 

  • You are, or think you might be, pregnant or are breastfeeding.

  • You have a known sensitivity to Sodium Tetradecyl or Fibrovein 0.2% excipients.

  • You have an active infection or open skin to the intended injection site.

  • You are unable to walk or have severe mobility constraints.

  • You have a history of venous or arterial leg ulceration.

  • You have signs of poor circulation to the legs and feet.

  • You have a high risk of thrombosis, e.g. patients with a congenital predisposition to blood clots or with multiple risk factors such as hormonal contraception or hormone replacement therapy, significant obesity, smoking or extended periods of immobility.

  • You have a history of deep vein thrombosis, pulmonary embolism, or recent acute superficial thrombophlebitis.

  • You are taking blood thinning medications.

  • You have lymphodema of the legs.

  • You have an uncontrolled systemic disease such as diabetes mellitus, hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias (abnormal blood content structure) and acute respiratory or skin diseases.

  • You have symptomatic patent foramen (A hole in the heart).

  • You have severe hepatic or renal disease.

  • You have a recent history of surgery (Thrombosis risk).

  • You have multiple visible varicosities of the veins or a history of significant valvular incompetence within the deep veins.

  • You have veins caused by tumours (unless tumours have been removed and the area is benign).

  • The veins are located on the foot, under or around the ankle. 

Cautions:

You need to tell your aesthetic practitioner if:

  • You have a history of migraines (requires smaller volumes).

  • You have asymptomatic patent foramen (Hole in the heart) (Requires smaller volumes and the avoidance of the Valsalva manoeuvre).

  • You have had recent sun exposure to the area (under two weeks) or are planning to be in the sun (within a month). There is a risk of haemosiderin developing or worsening.

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. Bruising is usually mild and lasts less than a couple of weeks but can last longer. Patients using medications that prolong bleeding, such as aspirin, warfarin, steroids and ibuprofen (and other NSAIDs), may experience increased bruising or bleeding at the injection site. Certain vitamins and supplements can also have this effect.

  • Localised pain, swelling, rash, and itching. The simple action of the needle passing into the skin can be uncomfortable for some people; however, this is usually very well tolerated by most patients and is often described as mild. The intended action of Fibrovein medication is to cause localised vascular irritation. This means you will likely experience localised mild swelling, red nettle rash, and itching for up to a week. 

  • Transient Hyperpigmentation. Approximately 5-10% of patients receiving Fibrovein micro-sclerotherapy may develop hyperpigmentation (brown marks) at the injection site or where the veins were once located. This is called Haemosiderin and is thought to occur as the iron content of the blood leaches into the skin tissue as the vessel breaks down. This is most likely to fade completely; however, very rarely, it can take up to two years to clear. You must avoid sun exposure to the area for one month after the treatment, especially if you develop these haemosiderin marks. 

  • Little to no effect. Most patients will experience a 60-80% reduction in thread and spider veins following Fibrovein micro-sclerotherapy. However, approximately 10% of patients receiving Fibrovein micro-sclerotherapy may experience little or no decrease in the treated veins. If you feel the treatment is not working, discuss it with your practitioner at your earliest convenience. Whilst we will endeavour to increase the effect for you, there is no guarantee it will be effective, and no refunds will be given in this case.

  • Telangiectatic Matting - Appears as a pink/red blush to the skin that contains tiny vessels; this can occur if the body tries to compensate for the vein breaking down and grows tiny new ones in place. Often, these are too small to canulate and cannot be treated with further microsclerotherapy. We may advise Intense Pulsed Light treatment if these do not disappear within a few months.

  • Migraine. Very rarely, it has been documented that some patients experience migraines with aura episodes. It is not fully understood why this can occur. If you suffer from regular migraines, this Fibrovein Micro-Sclerotherapy may induce a migraine episode or increase its intensity.

  • Infection. As with any procedure that involves a break to the skin’s surface, there is a risk that an injection of any material could introduce an infection which may require treatment. Contact your practitioner if you experience skin redness, irritation or pain in the treatment area that is spreading from the original treatment site or not settling within seven days.

  • Sloughing/skin Ulceration.  Inadvertent arterial injection and possible severe tissue damage are very rare complications. This occurs in less than 3% of patients who receive micro-sclerotherapy. Sloughing consists of a small ulceration at the injection site that heals slowly. A blister may form, open, and become ulcerated. After healing, the skin should return to a normal colour but may be lighter or darker than the surrounding tissue. You may have what looks like chicken pox or a vaccination scar permanently. You must inform us immediately if you think you are experiencing a break to the skin; it may require our medical attention and dressing.

  • Thrombosis/Blood Clot. Deep vein thrombosis (Blood Clot in the veins) is a rare complication, seen in approximately 1 out of every 1,000 patients treated (0.1%). The dangers of thrombosis include the possibility of pulmonary embolus (a blood clot carried to the lungs) and post-phlebitis syndrome, resulting in permanent swelling of the leg, as well as permanent disability and death. You must contact the clinic immediately for advice if you experience swelling and redness of the leg. You must attend your local emergency department if you experience shortness of breath or disorientation following micro-sclerotherapy.

  • Hypersensitivity/Allergy/Anaphylactic Shock. Most medications carry a potential risk of allergic reactions. Allergic reactions, such as anaphylaxis, serum sickness, skin itching, swelling, and difficulty breathing, have been reported very rarely with Fibrovein. You should contact your practitioner if you feel unwell or have had an allergic reaction. You should seek immediate emergency medical care in cases of a severe allergic reaction (anaphylaxis).

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 Fibrovein Micro-Sclerotherapy 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 Fibrovein Micro-Sclerotherapy treatment.

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

Risks and complications

You have discussed the potential risks and benefits of a Fibrovein Micro-Sclerotherapy treatment 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 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 Fibrovein Micro-Sclerotherapy treatment, and you 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 Fibrovein Micro-Sclerotherapy treatment 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.