Veteran Owned and Operated

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Sheila L. Uridil, MSN, APRN, AGACNP-BC, ANP-BC
Joseph E. Uridil IV, MSN, APRN, AGACNP-BC
NeighborhoodHealthcareJ.S@gmail.com

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NEUROMODULATOR CONSENT FORM

PURPOSE
The purpose of this informed consent form is to provide written information regarding the risks, benefits and alternatives to this procedure. This material serves as a supplement to the discussion you have with your 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 healthcare provider prior to signing this consent form.

 

INDICATIONS AND ALTERNATIVES
JEAVEAU (probotulinumtoxinA-xvfsz) is a botulinum toxin type A. It is a prescription medicine that is injected into the muscles and used for a short period of time (temporarily) to improve the look of moderate to severe lines that have formed in your face. The FDA has  approved for frown lines (glabellar lines) or “the 11’s” (corrugator muscle)  although your provider may utilize off label  it in other areas, forehead (frontalis), crows feet (orbicularis Occuli), “smokers lines” (orbicularis oris) and for downward mouth pull (depressor anguli Oris). Treatment with neuromodulators  can cause your facial expression lines or wrinkles to be less noticeable or essentially disappear. The effects become apparent in 2-5 days after injection and generally last 3-6 months. The treatment can be repeated indefinitely with the resistance to the effects of the neuromodulator occurring only rarely. The alternatives to neuromodulator treatments are no treatment or surgery.

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RISKS AND COMPLICATIONS
Before undergoing this procedure, understanding the risks is essential. No procedure is completely risk free. The following risks may occur, but there may unforeseen risks that are not included in this list. Some of these risks, if they occur, may necessitate hospitalization and or extended outpatient therapy. It has been explained to me that there are certain inherent and potential risks and side effects in any invasive procedure and in this specific instance, such risks include but are not limited to post treatment discomfort, swelling, redness, and bruising at injections site, double vision, allergic reaction, minor temporary droop of the eyelids (which can last 3-6 months), and headache. Injections around the mouth may lead to difficulty whistling, drinking through a straw and some difficulty with words that begin with P or B. These symptoms can occur hours, days or weeks after you receive an injection on JEAVEAU. The most COMMON side effects include headache, eyelid drooping, upper respiratory infection and increased white blood cell count in your blood.

JEUVEAU contains human derived albumin and carries a theoretical risk of virus transmission. Rare but serious complications include difficulty breathing and generalized weakness.

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CONTRAINDICATIONS
You should not have the treatment with neuromodulators, if you are pregnant, nursing or are allergic to albumin, have an infection, skin conditions or muscle weakness at the site of injection. Eaton-Lambert syndrome, Lou Gehrig's disease or Myasthenia Gravis are also contraindications to treatment .Women who are pregnant, attempting to get pregnant or breast feeding should not be treated with neuromodulators.

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I understand that when small amounts of purified botulinum toxins are injected into a muscle it causes weakness or paralysis of that muscle. This appears in  2-10 days and usually lasts up to 3 months but it can be shorter or longer duration. In a very small number of patients, the injection does not work as satisfactorily or for as long as usual and there are some individuals who do not respond at all. I understand that I will not be able to use the muscles that have been injected, but this will reverse after a period of months at which time retreatment is needed. I understand I should not exercise for 24 hours, should stay upright for 4 hours after injection and do not massage the treated area. I understand the risks, benefits and alternatives have been explained to me to my satisfaction No guarantees about the results have been made. I understand that this treatment is cosmetic in nature and is not covered by insurance.

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I am the treating healthcare provider. I have discussed the above risks, benefits, and alternatives to the patient. The patient had an opportunity to have all questions answered and was offered a copy of this informed consent.

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To be signed by the healthcare provider only.