Neurotoxin Intake and Consent Form

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Neurotoxin Consent Form

Instructions

This is an informed-consent document that has been prepared to help inform you about DYSPORT (Abobotulinum Toxin A) injections and BOTOX (Botulinum toxin A), 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

Clostridia botulina bacteria produce a class of chemical compounds known as “toxins”. The Dysport and Botox are processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary paralysis (chemo denervation) of muscle by preventing transmission of nerve impulses to muscle. The duration of muscle paralysis generally lasts for approximately three to four months.

Dysport and Botox, has been approved by Health Canada for the cosmetic treatment of: Forehead Wrinkles, Crow’s feet wrinkles and between the Eyes Brow. Other areas of the face and body such as smoker’s lines around the lips and neck bands may be treated in an “off-label” fashion.

Dysport and Botox injections are customized for every patient, depending on his or her needs. These can be performed in areas involving the eyelid region, forehead, and neck. Dysport and Botox cannot stop the process of aging. It can, however, temporarily diminish the look of wrinkles caused by muscle groups.

Alternative Treatments

Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers, injection of filling material, or other skin treatments. 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.

Specific Risks

Incomplete Block:

It is possible to not experience a complete block of desired muscles. Additional injections to reach the desired level of block can be performed until the goal is achieved.

Asymmetry:

The human face and eyelid region are normally asymmetrical with respect to structural anatomy and function. There can be a variation from one side to the other in terms of the response to Dysport and Botox.

Drooping Eyelid (Ptosis):

Muscles that raise the eyelid may be affected by Dysport and Botox should this material migrate downward from other injection areas.

Pain:

Discomfort associated with Dysport and Botox injections is usually of short duration.

Migration of BOTOX:

Dysport and Botox may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects. Dysport and Botox has been reported to cause swallowing problems in patients treated for spastic muscle disorders of the cervical region (cervical dystonia).

Bleeding and Bruising:

It is possible, though unusual, to have a bleeding episode from a Dysport and Botox injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper Dysport and Botox injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginkgo biloba, and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding problem. Do not take these for ten days before or after Dysport and Botox injections.

Damage to Deeper Structures:

Deeper structures such as nerves, blood vessels, and the eyeball may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.

Corneal Exposure Problems:

Problems: Some patients experience difficulties closing their eyelids after Dysport and Botox injections and problems may occur in the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye drops, contact lenses, or surgery may be necessary.

Unknown Risks:

The long-term effect of Dysport and Botox on tissue is unknown. The risk and consequences of accidental intravascular injection of Dysport and Botox is unknown and not predictable. There is the possibility that additional risk factors may be discovered.

Dry Eye Problems:

Individuals who normally have dry eyes may be advised to use special caution in considering Dysport and Botox injections around the eyelid region.

Double-Vision:

Double-vision may be produced if the Dysport and Botox material migrates into the region of muscles that control movements of the eyeball.

Eyelid Ectropion:

Abnormal looseness of the lower eyelid can occur following Dysport and Botox injection.

Other Eye Disorders:

Functional and irritative disorders of eye structures may rarely occur following Dysport and Botox injections.

Blindness:

Blindness is extremely rare after Dysport and Botox injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. In a period of 10 years of Dysport and Botox administration, complications of blurred vision, retinal vein occlusion, and glaucoma have been reported in three patients. The occurrence of eye problems appears to be very rare.

Allergic Reactions:

As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment.

Antibodies to DYSPORT and BOTOX:

Presence of antibodies to Dysport and Botox may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to Dysport and Botox is unknown.

Infection:

Infection is extremely rare after Dysport and Botox injection. Should an infection occur, additional treatment including antibiotics may be necessary.

Skin Disorders:

Skin rash, itching, and swelling may rarely occur following Dysport and Botox injection.

Neuromuscular Disorders:

Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis, myasthenia gravis, and motor neuropathies) may be at greater risk of clinically significant side effects from Dysport and Botox.

Migraine Headache Disorders:

Dysport and Botox has been used to treat forehead muscle groups that are involved with the migraine headache condition. Patients are advised that results of Dysport and Botox treatment for migraine headaches may be variable and improvement in this disorder may not occur following Dysport and Botox treatments.

Unsatisfactory Result:

There is the possibility of a poor or inadequate response from Dysport and Botox injection. Additional Dysport and Botox injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity.

Long-Term Effects:

Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss, weight gain, sun exposure, pregnancy, menopause, or other circumstances not related to Dysport and Botox injections. Dysport and Botox injection does not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary.

Pregnancy and Nursing Mothers:

Animal reproduction studies have not been performed to determine if Dysport and Botox could produce fetal harm. It is not known if Dysport and Botox can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive Dysport and Botox treatments.

Drug Interactions:

The effect of Dysport and Botox may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.

Contraindications To Treatment

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

Allergic to eggs, egg products or albumin if using Botox
Allergic to cow’s milk protein if using Dysport
Autoimmune or neurological diseases (MS [Multiple Sclerosis], Myasthenia Gravis, Lambert Eaton Syndrome, ALS [Amyotrophic lateral sclerosis/Lou Gehrig’s Disease], Parkinson’s Disease, SLE [lupus] or active RA [Rheumatoid Arthritis] without a written assessment and approval from a neurologist (MS/ALS/Parkinson’s) or Rheumatologist (SLE/RA) and subsequent approval by the NP
Pregnant, breastfeeding, or patients that may be pregnant or are trying to conceive within the next 3 months
Active skin infection, inflammation, tumour, or prior surgery in the treatment site
Other skin treatments within the last week including laser, other injections, chemical peels, facials, microneedling and microdermabrasion (relative contraindications – may proceed provided patient is aware that further skin irritation or infection may occur)
Prior allergic or otherwise adverse reaction to treatment with neurotoxin
Taking any of the following medications: aminoglycosides, nerve blockers (anticholinesterases, succinylcholine), lincosamides, polymyxins, quinidine or magnesium sulfate).
Any marked facial asymmetry (i.e. Bell’s Palsy

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 neurotoxin injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with neurotoxin 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 neurotoxins injections. The practice of medicine and surgery is not an exact science.

Off-Label

There are many devices, medications, and injectable Dysport and Botox that are approved for specific use by the Health Canada, but this proposed use is “Off-Label”, that is not specifically approved by the Health Canada. It is important that you understand this proposed use is not experimental and your provider believes it to be safe and effective. I understand Dysport and Botox may be applied in areas that are considered “off-label” and performed by the nurses upon approval of the medical director based on my aesthetic goals as discussed during consultation.

Dysport and Botox are used off-label to soften:

Lipstick or smoker’s lines
Chin dimpling
Downturned mouth corners
Gummy smile
Facial shaping
Necklace lines
Neck bands
Bunny lines at the side of the nose

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 neurotoxins 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 neurotoxin 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 neurotoxin 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 neurotoxins 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 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 neurotoxins 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 of Dysport and Botox 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

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.

1. 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

2. 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

3. 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