Hyaluronidase Consent Form

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Appendix 1: Consent for treatment with Hyalase® to dissolve hyaluronic acid dermal fillers Hyaluronic acid (HA) fillers are sterile gels consisting of non-animal stabilised hyaluronic acid for injection into the skin to correct facial lines, wrinkles and folds, for lip enhancement and for shaping facial contours. Occasionally these fillers need to be dissolved when the aesthetic treatment has not produced the desired outcome or there is a possibility of vascular occlusion or impending necrosis (tissue death) which could lead to compromise of healthy tissue. Hyalase® (hyaluronidase 1500 units) has an off-license use in aesthetic medicine and except in the case of emergency administration requires the patient to undergo a skin patch test at least twenty minutes prior to the procedure being undertaken. The skin patch test is carried out by injecting Hyalase® into the subcutaneous tissue of the forearm and observed for signs of reaction (i.e. hives or wheals). If a positive patch test result is observed, treatment with Hyalase® cannot be carried out. Erythema or redness and slight vasodilation may be expected. Hyalase® is an enzyme which breaks down hyaluronic acid fillers, but it can also break down naturally occurring hyaluronic acid present in the body, the results can be unpredictable and the effect dramatic. I understand that there will be loss of volume and there can be some skin laxity which in itself may not provide a good aesthetic result. Although some of the effects can be immediate, I understand that it can take up to 14 days for the final results to be seen and the treatment may need to be repeated. Hyalase® administration can result in anaphylaxis (a severe allergic reaction which in itself is life threatening and requires immediate medical attention) and I understand this and have been given full counselling and the opportunity to discuss the treatment with Hyalase®, conservative treatment options or leaving the dermal filler to break down naturally which may take several months dependent on the type of filler used and the area treated. The use of and the indications for the administration of Hyalase® have been explained to me by my practitioner and I have had the opportunity to have all questions answered to my satisfaction. After the treatment some other common injection-related reactions might occur. These reactions include redness, swelling, pain, itching, bruising and tenderness at the injection site. They have generally been described as mild to moderate and typically resolve spontaneously a few days after injection. Bruising may occasionally be more significant. I acknowledge that I will have to remain at the clinic for ____ minutes after the procedure so that I can be observed by the medical staff and that I may need to return to the clinic ____ days/weeks after treatment to assess if further Hyalase® is to be administered. I have answered the questions regarding my medical history to the best of my knowledge. I have also received the aftercare information and its contents have been explained to me and I will follow the advice given. I consent to being treated with Hyalase®

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