Hyaluronidase Consent Form

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Hyaluronidase Consent Form

Instructions

This is an informed-consent document that has been prepared to help inform you about treatment with hyaluronidase to dissolve hyaluronic acid dermal fillers, its risks, as well as alternative treatment(s). It is important that you read this information carefully and completely. Please read the page and sign the consent as proposed by your provider and agreed upon by you.

General Information

Hyaluronidase is 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.

Alternative Treatments

Alternative forms of management include 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. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

Inherent Risks

Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a medical procedure is based on the comparison of the risk to potential benefit. Results of treatment will vary from client to client. Some clients may require more treatment to achieve desire results. This will be discussed between you and your provider.

Spesific Risks

Before undergoing this procedure, understand that no procedure is completely risk-free. The following risks may occur, but there may be unforeseen risks and risks that are not included on this list:
  • Hyaluronidase 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.
  • 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, it can take up to 14 days for the final results to be seen and the treatment may need to be repeated.
  • Anaphylaxis (a severe allergic reaction which in itself is life threatening and requires immediate medical attention).
  • Common injection-related reactions might occur- redness, swelling, pain, itching, bruising and tenderness at the injection site.
  • Bruising may occasionally be more significant.

Additional Treatments

Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with hyaluronidase injections. Other complications and risks can occur but are even more uncommon. Should complications occur, additional surgery or other treatments may be necessary. Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. The practice of medicine and surgery is not an exact science.

Off-Label

Hyaluronidase 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 Hyaluronidase® 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 Hyaluronidase cannot be carried out. Erythema or redness and slight vasodilation may be expected. It is important that you understand this proposed use is not experimental and your provider believes it to be safe and effective.

Marketing

We use a variety of ways to inform our patients about various procedures. Examples include radio, TV and print advertising, the internet, patient seminars, consultations with staff members, phone calls, mailings, brochures, videos and literature. Some of these materials are generated by the product manufacturers and/ or advertising companies. Medicine is constantly changing and therefore the information in these materials may have changed. Reading this informed consent, consulting with your provider about the procedure, its alternatives and risks and asking questions is the best way to understand potential complications and decide if this procedure is right for you.

Joint Decision Making

I understand I must work together with my provider to agree on treatment plan. My provider relies on the information I give. I have fully disclosed my medical history; including allergies, prior surgeries, medications and supplements I am taking, and current health conditions. I understand that following the pre-procedure and post-procedure instructions will affect the success of my procedure. I will follow those instructions carefully, asking questions when they arise.

Communication

We encourage you to be direct about any concerns you are having, particularly during your post- procedure period. Often patients are not sure whether their recovery is typical and we want to address that. We encourage you to bring a list of any questions or concerns you have. State them clearly so your provider can respond to them:
  • “I have some concerns today, and they are...”
  • “I have one concern today, and it is...”
  • “I have no concerns today.”

Patient Responsibility for Costs

The cost of treatment may involve several charges. This includes the professional fee for the injections, follow up visits to monitor the effectiveness of the treatment, and the cost of the material itself. It is unlikely that injections to treat cosmetic problems would be covered by your health insurance. Additional costs of medical treatment would be your responsibility should complications develop from treatment. You would also be responsible for additional forms of treatments. If additional interim injections are recommended in order to maintain or improve results, you will be responsible for the costs of this additional treatment.

Medical Records

I understand and agree that this consent document will become a part of my medical record. Patient's Statement of Acceptance and Understanding I certify that I can speak, read and write English. The details of this procedure have been presented to me in full in a way that I understand. All of my questions have been answered and, as needed, I have been provided further explanation to my satisfaction. I have read this informed consent (or it has been read to me) and I fully understand the procedure, the possible risks, complications, alternatives and benefits. I understand that there are other options for treatment available and each of these other options has been fully explained to me to my satisfaction. I acknowledge that no guarantee has been given by anyone as to the results that may be obtained. I consent to the administration of such anesthetics considered necessary or advisable. I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than originally planned. I understand that there is a possibility of rare side effects and I further understand the importance of carefully following the post-care instructions and that failure to comply may increase the probability of complications. I consent to treatment with hyaluronidase injections.

Acknolowdgement

Before and after treatment instructions have been discussed with me. The procedure, potential benefits and risks, and alternative treatment options have been explained to my satisfaction. I consent to the administration of such anesthetic considered necessary or advisable. I understand that all forms of anesthetics involve risk and the possibility of complications, injury, and sometimes death. I have been given the opportunity to ask questions and consult with the medical practitioner and hereby certify that I have read and fully understand the contents of this consent form.

I confirm that the medical health history form has been completed truthfully and I am fully aware that withholding medical information may be detrimental to the safe and optimal outcome of any treatment that the practitioner agrees to undertake. If there are any changes in my medical history, I must inform the practitioner. I certify that l am a competent adult of at least 18 years of age and am not under the influence of alcohol or drugs and have disclosed to the service provider of any relevant medical history.

I have answered these entire questions as honestly and completely as possible and I have not withheld any medical information from the nurse injector or nurse practitioner. Andrea Gounden – Nurse Practitioner CNO #11470035 and nurse injectors from Anastasija Medical Aesthetics, are not responsible for any adverse events that occurs for the failure to disclose health information as asked.

I understand that the procedure is purely elective, that the results may vary with each individual, and multiple treatments may be necessary. I agree to adhere to all safety precautions and instructions after the treatment. I have been instructed in and understand post treatment instructions and have been given a written copy of them. I have been informed about the “Off-Label” Health Canada status and I understand it is not experimental and accept its use. I am not pregnant, and I am not breastfeeding. (Female patients only). I understand that there can be no guarantee or assurance as to the final result that may be obtained. Any expenses which may being cured for medical care I elect to receive outside of this office, such as, but not limited to dissatisfaction of my treatment outcome will be my sole financial responsibility. I understand and agree that all services rendered to me are charged to me directly and that I am personally responsible for full payment. I hereby give consent to perform this and all subsequent treatments with the above understanding. I hereby release the doctor, the person injecting, and the facility from liability associated with this procedure and agree not to take legal action. This consent form is freely and voluntarily executed and binding upon my spouse, relatives, legal representatives, heirs, administrators, successors and assigns. I am aware that by signing this agreement I am waiving certain legal right which I or my heirs, next of kin, executors, administrators, assigns and representative may have against the operator.
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Client Signature
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Health Care Practitioner Signature
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