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Informed Consent and Patient Education:

Neuromodulator (Botox®, Dysport®) Injection

The purpose of this informed consent and patient education form is to provide written information
regarding the risks, benefits and alternatives of the procedure named above. This material serves as a
supplement to the discussion you have with your doctor/healthcare provider. It is important that you
fully understand this information, so please read this document thoroughly. If you have any questions
regarding the procedure, ask your doctor/healthcare professional prior to signing the consent form.

General Information

Botox®, Dysport®, and Xeomin® are various types of botulinum toxin injection medications processed
and purified from the Clostridia botulinum bacteria. This purification process yields a sterile product
suitable for specific therapeutic uses. Once the diluted neuromodulator is injected, it causes temporary
paralysis of target muscles by preventing the transmission of nerve impulses to the muscle. These
neuromodulators generally are effective for 3-4 months.

Treatment

Treatment with botulinum toxin can cause your facial lines to become less noticeable or essentially
disappear by paralyzing the underlying muscles. The areas most commonly treated for cosmetic
purposes include: 1) the glabella (frown lines between the eyebrows); 2) forehead; 3) crows’ feet (lateral
to the eyes); 4) smokers’ lines around the mouth; 5) other head and neck muscles. These
neuromodulators are injected into the muscle with 31-guage needles (these are the same as diabetic
insulin needles), which are almost painless.
How much neuromodulator do I need?
Using Botox® as an example: The amount of Botox used varies greatly from patient to patient. However,
according to Allergan (the producer of Botox® Cosmetic), approximately 15 to 20 units are required to
effectively treat an area. This means that 15-20 units are often needed to treat the glabella (the area
between your eyebrows), 15-20 units for the forehead, and another 15-20 units for the crow's feet.
Botox works by blocking the release of acetylcholine from nerves that interact with adjacent muscles.
Normally, acetylcholine is released from nerves, travels to the muscle, binds to its receptor there, and
causes the muscle to contract through what is known as a "signaling cascade". When Botox inhibits the
release of acetylcholine, the muscle will no longer contract in response to acetylcholine released from
the nerves. Therefore, the overlying skin won't wrinkle due to muscle contraction, and patients normally
appear more relaxed and younger.

Alternative Treatments

Alternative treatments will be further discussed during your appointment as these vary from individual
to individual. The primary alternative treatment would simply to not have neuromodulators injected.

Risks and Complications

No procedure is without risk. The risk of an adverse effect due to neuromodulator injection is small, but
not zero, and every procedure has its limitations. Although the majority of patients do not experience
any of these complications, you should discuss these with your cosmetic surgeon in order to make
certain that you understand the risks, potential complications, limitations, and possible consequences of
neuromodulator injections. The risks include, but are not limited to:

1) Bleeding and Bruising: Serious bleeding from neuromodulator injections is extremely, extremely
rare. However, mild bruising may occur. Aspirin, anti-inflammatory medications, platelet
inhibitors, anticoagulants, Vitamin E, ginkgo biloba, alcohol, and other herbs or homeopathic
remedies may contribute to a greater risk of bleeding/bruising. Do not take these for seven days
before or after neuromodulator injections. If you are prescribed any blood thinning medications,
you must speak with the physician who prescribed the medication prior to stopping it. Again, do
not stop these medications before speaking with your prescribing physician.
2) Incomplete Block: It is possible to experience an incomplete block of the muscle, especially with
strong hyperactive facial muscles. This is often seen with patients who receive less than the
recommended 15-20 units per area treated (using Botox as an example). This is not a
complication of the neuromodulator, and additional injections may be necessary to reach the
desired effect.
3) Asymmetry: The human face is normally asymmetrical with respect to anatomy and function.
There can be a variation from one side to the other in terms of response to neuromodulator
injections. This may require repeat injections to achieve the desired effect.
4) Pain: Diabetic insulin needles are used for the injections. These needles are extremely small. If
any pain occurs, it is normally very short-lived.
5) Infection: Infection after neuromodulator injection is extremely rare. Should infection occur,
additional treatment (including antibiotics) may be necessary.
6) Skin Disorders: Itching and rashes are possible after neuromodulator injections, but extremely
rare. Swelling will occur just after the injections, and normally lasts 10-15 minutes. This is simply
due to placement of the product under the skin and resolves as the product diffuses through the
tissues. The risk of long-term swelling is present, but almost non-existent.
7) Ptosis (Drooping Eyelid): A drooping eyelid (upper or lower) is possible after neuromodulator
injections. This is uncommon.
8) Migration of the Neuromodulator: There is an extremely slight risk of distant migration of
neuromodulator from the injection site reported in literature. For example, Botox has been
reported to cause swallowing issues in patients treated for spastic muscle disorders of the
cervical (neck) region.
9) Damage to Deeper Structures: Deep structures (nerves, blood vessels, eyeballs) may be
damaged during injections of neuromodulators. This is extremely rare.
10) Corneal Exposure/Dry Eye: Individuals who normally have dry eyes should use caution when
receiving injections near the eyes.
11) Double-Vision: Double vision has been reported in literature when neuromodulators have been
injected very close to the eye. This is very rare.
12) Allergic Reactions: The injection of any substance into the skin has the potential to produce an
allergic reaction. This is very rare.
13) Blindness: Blindness is extremely rare after neuromodulator injections; however, it could occur
with a needle stick directly to the eyeball. This has been reported 3 times in a 10 year period of
Botox administration.
14) Unknown Risks: The long term effects of Botox on tissues is unknown. The risk (and
consequences) of accidental intravascular injection of neuromodulator is unknown. There is a
possibility that additional risks of neuromodulators will be discovered in the future that are not
covered in this informed consent.
15) Unsatisfactory Result: There is a possibility of inadequate/poor response from neuromodulator
injections. Additional injections may be necessary to achieve the desired result.

Medications

As stated above: Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E,


ginkgo biloba, alcohol, and other herbs or homeopathic remedies may contribute to a greater risk of
bleeding/bruising. Stop these medications 7 days prior to your neuromodulator injection appointment.
However, never stop a prescribed medication without first speaking with your prescribing physician.
Stopping a prescribed blood thinner (i.e. Plavix, Coumadin, etc) without your physician’s consent may
increase your risk of heart attack, stroke, or even death.
Pregnancy and Neurologic Diseases

Pregnant women or nursing mothers should not receive neuromodulator injections. The risk to the
fetus/infant is not known. Neuromodulators should also not be used in patients with motor neuropathic
disorders (amyotrophic lateral sclerosis, myasthenia gravis, other motor neuropathies).

Mental Health Disorders and Cosmetic Surgery/Procedures

All patients seeking to undergo elective procedures and/or surgery should have realistic expectations
and be of sound judgment. Please discuss any history of significant emotional depression or mental
health disorders with your provider before any elective procedure or surgery.

Additional Treatment Necessary

There are many variables which affect the longevity of neuromodulator injection effects. Using Botox as
an example, the results normally last 3-4 months. After this, the individual will require additional
injections to continue to experience the results.

Financial Responsibilities

We make every effort to help you achieve the results that you seek. However, these are cosmetic
injections and are non-refundable as the product cannot be returned. The cost of neuromodulator
injections bundles several charges. This includes the product itself, professional fees for the injections,
and follow-up visits.

Right to Discontinue Treatment

The patient may discontinue treatment at any time. If a neuromodulator has been injected, the effects
will slowly wear off. However, neuromodulators cannot be quickly reversed.

I understand and agree that all services rendered will be charged directly to me, and I am personally
responsible for payment. I further agree, in the event of non-payment, to bear the cost of collection,
and/or court costs and reasonable legal fees, should they be required. By signing below, I
acknowledge that I have read the foregoing informed consent and consent to the treatment described
above with its associated risks. I understand that I have the right not to consent to this treatment and
that my consent is voluntary. I hereby release the doctor, the person performing the neuromodulator
injection, and the facility from liability associated with this procedure.