Dermal Filler Intake & Consent Form

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Dermal Filler Consent Form

Instructions

This is an informed-consent document that has been prepared to help inform you about hyaluronic acid 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

Revanesse, Restylane, Juvederm, Volbella, Voluma and Belotero are made from Hyaluronic acid. These cosmetic dermal fillers are used to enhance facial features or to replace lost volume and restore contours to the skin to smooth away moderate to severe wrinkles and folds, such as the lines from your nose to your mouth (nasolabial folds). Continued treatments are necessary in order to maintain the effect over time. The body will slowly absorb hyaluronic acid once injected. The length of effect is variable. These products are reversible with hyaluronidase injections and reversal may incur additional costs.

I understand that I will be injected with the dermal filler product used is a sterile consisting of non-animal cross-linked Hyaluronic Acid for injection into the skin to correct facial lines, wrinkles and folds, for lip enhancement and for shaping facial contours.

Alternative Treatments

Alternative forms of management include not treating the skin wrinkles or soft tissue depressions by any means. Improvement of skin wrinkles and soft tissue depressions may be accomplished by other treatments: laser treatments, chemical skin-peels, other skin procedures, or dermabrasion, alternative types of tissue fillers, or surgery such as a blepharoplasty, face or brow lift when indicated. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

Patient Eligibility

Risks of Dermal Filler Injections

Every procedure to inject soft tissue filler materials involves a certain amount of risk, and it is important that you understand the risks involved. An individual’s choice to undergo this procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience the following, you should discuss each of them with your provider to make sure you understand the risks, potential complications, limitations, and consequences of filler injections. Upon request, additional information concerning each filler may be obtained from the package insert sheets supplied by the product’s manufacturer. 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.

Effects of Dermal Filler

Patients undergoing dermal filler injections may experience the following events below. The events are described as mild to moderate and typically resolve spontaneously within 1-2 days after injection into the skin and within a week after injection into the lips.

Bleeding and bruising – It is possible, though unusual, to have a bleeding episode from a filler injection or local anesthesia used during the procedure. Bruising in soft tissues may occur. **Aspirin, magnesium, anti-inflammatory medications such as ibuprofen, Alevel, Motrin, Celebrex, platelet inhibitors, anticoagulants, high doses of Vitamin E, Ginko biloba and other “herbs/homeopathic remedies” may contribute to a greater risk of a bleeding problem. Inform your provider of all medications/supplements you are currently taking. Bruising can be minimized by avoiding these, and other blood- thinning medications, for one week (ideally) prior to treatment. For blood thinning agents, such as daily Aspirin, Warfarin, Clopidogrel, etc. that have been instituted by a medical practitioner for the prevention or treatment of cardiovascular or other known or assumed health issues, the patient should discuss the implications of stopping these medications and receive guidance from their health care practitioner prior to initiating any cosmetic procedure. The patient should provide written medical documentation from their respective health care practitioner related to management of these medications prior to, during, and post- cosmetic injections.
Swelling – (Edema) is a normal occurrence following the injections. It decreases after a few days. If swelling is slow to resolve, medical treatment may be necessary.
Erythema (skin redness) in the skin occurs after injections. It can be present for a few days after the procedure.
Needle marks – Visible needle marks from the injections occur normally and resolve in a few days.
Acne-like skin eruptions – Skin eruptions can occur following the injection of dermal fillers. This generally resolves within a few days.

Effects of Dermal Filler Cont’d...

Skin lumpiness – Lumpiness can occur following the injection of dermal fillers. This tends to smooth out over time. In some situations, it may be possible to feel the injected dermal filler material for long periods of time.
Visible tissue filler material – It may be possible to see any type of dermal filler material that was injected in areas where the skin is thin.
Asymmetry – The human face and eyelid region is normally asymmetrical in its appearance and anatomy. It may not be possible to achieve or maintain exact symmetry with dermal filler injections. There can be a variation from one side to the other in terms of the response to dermal filler injections.
Pain – Discomfort associated with injections is normal and usually of a short duration.
Tenderness and itching at the implant site.

Possible Complications

The following are possible complications attributable to the injection of dermal fillers, and not limited to:

Infection – Although infection following injection of dermal fillers is unusual; bacterial, fungal, and viral infections can occur. Herpes simplex virus infections around the mouth can occur following a dermal filler treatment. This applies to both individuals with a past history of Herpes simplex virus infections and individuals with no known history of Herpes simplex virus infections in the mouth area. Specific medications may be prescribed and taken both prior to and following the treatment procedure in order to suppress an infection from this virus. Should any type of skin infection occur, additional treatment including antibiotics may be necessary. It is advisable to begin prevention with antiviral medications prior to injections, though in some cases, treatment beginning immediately after injection is sufficient. Patients should obtain a prescription from their primary care provider if clinically relevant.
inflammation, abscess formation or greyish discolouration near the area treated (known as Tyndall effect), and allergic reaction.
Damage to deeper structures – Deeper structures such as nerves, blood vessels, and the soft tissues may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.
Skin necrosis – It is very unusual to experience death of skin and deeper soft tissues after dermal filler injections. Skin necrosis can produce unacceptable scarring. Should this rare complication occur, additional treatments or surgery may be necessary.
Granulomas – Painful masses in the skin and deeper tissues after injections are extremely rare. Should these occur, additional treatments including surgery may be necessary.

Possible Complications Cont’d...

Migration – There is a risk that the dermal filler may migrate away from the injection site after treatment. This may or may not be reversible.
Combination of procedures – In some situations, BOTOX/DYSPORT injections or other types of tissue filler materials may be used in addition to dermal fillers in order to specifically treat areas of the face or to enhance the outcome from dermal fillers therapy. The effect of other forms of external skin treatments (laser and other light therapies, microdermabrasion, dermabrasion, or chemical peels) on skin that has been treated with dermal fillers is unknown.
Drug interactions – It is not known if dermal fillers react with other drugs within the body.
Long term effects – Dermal filler injections should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, the material is slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. Continuing treatment (injections) are necessary in order to maintain the effect of dermal fillers. Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss or gain, sun exposure, or other circumstances not related to dermal filler injections. Dermal filler injections do not arrest the aging process or produce permanent tightening of the skin or improvement in wrinkles.
Redness, swelling, pain, itching, discolouration, hyper/hypopigmentation, tenderness or hardening of the skin at the injection site.
Formation of a small scab or scar at the injection site. Temporary visible lumps forming after injections; nodules and discolouration may also occur.
Flu-like symptoms, including nausea, dizziness, headaches, blurred vision, tingling, numbness and difficulty breathing.
Allergic reactions (immediate, delayed).
Vascular occlusion if filler injected into a blood vessel or the quantity of filler in an area compresses blood flow of the vessel and loss of circulation. This may lead to discolouration, scabbing, shedding and possible scarring. In very rare causes, vascular occlusion could result in tissue necrosis, irreversible blindness, stroke, pulmonary embolism.
Other types of reactions are rare, but approximately 1 in 2000 treated patients have experienced localized reactions thought to be of a hypersensitivity nature. These have usually consisted of swelling at the implant site, sometimes affecting the surrounding tissues.
On very rare occasions (less than 1 in 15,000 treatments) prolonged firmness, abscess formation or grayish discoloration at the implantation site has occurred. These reactions can develop weeks to months following the injections and may persist for several months but normally resolve with time. Even more rarely, the formation of a scab and sloughing (shedding) of tissue at the treatment site has been noted, which could result in a shallow scar.
COVID-19 VACCINE: Some side effects such as swelling and allergic reactions can occur to the filler treatment sites after receiving a COVID-19 vaccine. The side effects are not severe and are resolved quickly with the use of oral steroids and/or antihistamines resulting in no long-term adverse effects. I understand that while this reaction is rare, it has occurred before and may occur in myself. An interval of three weeks after COVID-19 vaccination should be left before injecting filler in order to avoid the peak immune response, which occurs in 21 days.

Contraindications to Treatment

The nurse will not knowingly treat any clients that are/have:

Severe allergies or with a history of anaphylaxis or any previous reaction to any skin treatment, injection, dermal filler, or hyaluronic acid.
Recent dental procedure (within past 2 weeks) (i.e. procedures beyond a simple dental cleaning that could lead/have lead to an infection).
Any planned dental procedure within 2 weeks after proposed administration of dermal fillers in the lower face.
Porphyria, history of a bleeding disorder, or any active skin condition including inflammation, infection, or tumour in or near the intended injection site. Prior surgery in or around the proposed treatment area.
Taking immunosuppressants, those with a tendency to form hypertrophic scars or those with healing disorders.
Pregnant, breastfeeding, or patients that may be pregnant or are trying to conceive within the next 3 months.

Elective Cosmetic Procedures Results

It is important that all patients seeking to undergo cosmetic procedures have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional procedures and often are stressful. Please openly discuss with your nurse, prior to the procedure, any history that you may have of significant emotional depression or mental health disorders. Although many individuals may benefit psychologically from the results of elective cosmetic procedure, effects on mental health cannot be accurately predicted.

Additional Treatment

There are many variable conditions in addition to risk and potential complications that may influence the long-term result of dermal filler injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with dermal filler 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 with the use of dermal filler injections. The practice of medicine and surgery is not an exact science.

Patients Responsibility for Costs

The cost of dermal filler injections 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 dermal filler 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 dermal filler injections. You would also be responsible for additional forms of treatments recommended to improve the appearance of facial wrinkles and soft tissue depressions. If additional interim injections of dermal filler are recommended in order to maintain or improve results, you will be responsible for the costs of this additional treatment.

Off-Label Use

Radiesse, Perlane and Juvederm have been approved to treat areas of facial wrinkling and soft tissue depressions. These products have not been studied for safety and effectiveness in any other anatomic regions other than naso-labial folds and are not approved for any other sites. When a drug or device is approved for medical use, the manufacturer is required to produce a “label” to explain its use. Providers, using their best medical judgment, may not follow Health Canada protocols exactly and/or may use a drug or device for things not on the label. This is called “off-label.” We cannot guarantee to document every off-label use in every patient.

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.”

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 understand that all forms of anesthesia involve risk and the possibility of complications, injury and sometimes death. I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than originally planned. I therefore authorize the nurse to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. 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 dermal filler injections.

Acknowledgment

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.

Signed In Ontario

Date

Client Printed Name

Client Signature

Health Care Practitioner Printed Name

Health Care Practitioner Signature

Photography and/or Video Record

Consent Form

Your provider may need to photograph and/ or record you to document a medical condition, help with diagnosis and/ or treatment of a condition, and/ or to help plan the details of a treatment. Photographs and/ or recordings taken for these clinical reasons do not require your written permission. Your provider does need your written permission to use your photographs and/ or recordings for the non-clinical reasons below. I hereby authorize Anastasija Medical Aesthetics, including the nurse injector or other designated person(s), to photograph and/ or video me for the following purposes: Check YES or NO.

For the advancement of not-for-profit medical purposes, including teaching, research, and education. I understand that education is an important part of Anastasija Medical Aesthetics commitment to teaching healthcare providers.

Yes

To show or release to current or future Anastasija Medical Aesthetics patients for the purpose of education and consultation. I understand these photos and/or videos can be taken at any time during my treatment which includes pre-treatments and post-treatments.

Yes

For external not-for-profit educational purposes outside Anastasija Medical Aesthetics such as lectures, presentations at professional conferences, news publications, website publications, social media posts, and email blasts.

Yes

I consent to photographs and/ or video recordings under the following conditions:

Copies of the photos, videos, and/ or films may be released to me if I ask for them.
I can refuse to have photos and/ or video taken without any change in my patient care at Anastasija Medical Aesthetics.
I understand and agree that although my name will not be used, it may be possible to identify me from a photo and/ or video.
I understand that once released outside of Anastasija Medical Aesthetics does not have control over the photos or videos.

I have read and understand the information. I hereby release Anastasija Medical Aesthetics, its personnel, and any other persons participating in my care from any and all liability which may or could arise from the taking or unauthorized use of such photographs and/ or video recordings.

Signature