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
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
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.