The purpose of this informed consent 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.
THE TREATMENT
JeuveauTM is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines). JeuveauTM can relax the muscle contractions that form frown lines. Treatment with JeuveauTM can temporarily reduce the appearance of moderate to severe frown lines. JeuveauTM is injected into the muscles with a very thin needle. Patients may experience localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising associated with the injection. In 2 long-term safety studies, patients received an average of 3 treatments over the course of 1 year.1
RISKS AND COMPLICATIONS
Before undergoing this procedure, understanding the risks is essential. The following risks may occur, but there may be unforeseen risks and risks that are not included on this list: allergic reactions (such as itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical emergency help right away if you experience a serious side effect.
The most common side effects observed in the clinical trials included: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.
PREGNANCY, ALLERGIES & NEUROLOGIC DISEASE
I am not aware that I am pregnant and I am not trying to get pregnant, I am not lactating (nursing). I do not have any significant neurologic disease including but not limited to myasthenis gravis, multiple sclerosis, lambert-eaton syndrome, amyotrophic lateral sclerosis (ALS), and parkinson’s. I do not have any allergies to the toxin ingredients, or to human albumin.
ALTERNATIVE PROCEDURES
Alternatives to the procedures and options that I have volunteered for have been fully explained to me.