Informed Consent For Neurotoxin

 I hereby consent to the Botulinum Toxin Injection Treatment and hereby authorize the provider to perform the Botulinum Toxin Injection Treatment. I understand that I will be injected with Botulinum A Toxin in the area of the facial /neck muscles to paralyze temporarily I understand my treatment may include both FDA-approved locations as well as commonly performed cosmetically treated areas based on desired effects.

Botulinum A Toxin injection has been FDA-approved for use in the cosmetic treatment of glabellar frown lines –wrinkles between the eyebrows and crow’s feet. I understand there are other risks for the non-FDA-approved uses of Botulinum A Toxin. Injection of Botulinum A Toxin into the small muscles between the brows causes those specific muscles to halt their function (be paralyzed), thereby improving the appearance of the wrinkles. I understand the goal is to decrease the wrinkles in the treated area. This paralysis is temporary and typically lasts three to four months although longevity varies amongst individuals. It has been explained to me that other alternatives are available. The possible side effects of Botulinum A Toxin include but are not limited to Local numbness, rash, pain at the injection site, flu-like symptoms, and headache.

Infection: Infections can occur which in most cases are easily treatable but in rare cases, permanent scarring in the area can occur. Bruising may occur and may last several weeks Most people have lightly swollen pinkish bumps at injection sites for a couple of hours or even several days. Although many people with chronic headaches or migraines often get relief from Botulinum A Toxin, a small percentage of patients get headaches following treatment with Botulinum A Toxin, most commonly in the first 1-7 days. In a very small percentage of patients, these headaches can persist for several days or weeks. Respiratory problems such as bronchitis or sinusitis, nausea, dizziness, and tightness or irritation of the skin. While the local weakness of the injected muscles is representative of the expected pharmacological action of Botulinum A Toxin, weakness of adjacent muscles may occur as a result of the spread of the toxin.

Treatments: I understand more than one injection may be needed to achieve a satisfactory result. Another risk when injecting Botulinum A Toxin around the eyes included corneal exposure because people may not be able to blink the eyelids as often as they should to protect the eye. This inability to
protect the eye has been associated with damage to the eye as impaired vision, or double vision, which is usually temporary. This reduced blinking has been associated with corneal ulcerations. There are medications that can help lift the eyelid, however, if the drooping is too great the eye drops are not that effective. These side effects can last for several weeks or longer. This occurs in 2-5 percent of patients. I will follow all aftercare instructions as it is crucial I do so for healing. As Botulinum A Toxin injection is not an exact science and facial anatomy and symmetry are highly variable from patient to patient, there might be an uneven appearance of the face with some muscles more affected by the Botulinum A Toxin than others. In most cases, this uneven appearance can sometimes be corrected by injecting Botulinum A Toxin in the same or nearby muscles. However, in some cases, this uneven appearance can persist for several weeks or months until the full effects of the product have subsided. This list is not meant to be inclusive of all possible risks associated with Botulinum A Toxin as there are both known and unknown side effects associated with any medication or procedure. Botulinum A Toxin should not be administered to a pregnant or nursing woman. Additionally, the number of units injected is an estimate of the amount of Botulinum A Toxin required to paralyze the muscles. I understand there is no guarantee of the results of any treatment. As with all injectable treatments, there is a risk of infection, vessel occlusion, granulomas, abscess formation, and hypersensitive reaction.

Approved Uses BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow feet lines and frown lines between the eyebrows in adults. IMPORTANT SAFETY INFORMATION BOTOX® Cosmetics may cause serious side effects that can be life-threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®

Cosmetic: Problems swallowing, speaking, or breathing, due to the weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including loss of strength Approved Uses BOTOX® Cosmetic is prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crows feet lines and frown lines between the eyebrows in adults.

IMPORTANT SAFETY INFORMATION BOTOX® Cosmetic may cause serious side effects that can be life-threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic: Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product. There has not been a confirmed serious case of the spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crowâ€TMs feet lines, or both at the same time. BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Serious and/or immediate allergic reactions have been reported. They include itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint. Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site. Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou
Gehrigâ€TMs disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic. Tell your doctor about all your medical conditions, including plans to have surgery; had surgery on your face; weakness of forehead muscles: trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk). Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past. Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.

I, ______________________________________________________, understand that I will be injected with Botulinum A Toxin (Botox), Dysport, and/or Xeomin. Botulinum A Toxin (Botox), Dysport, and/or Xeomin injection has been FDA-approved for use in the cosmetic treatment for glabellar frown lines only – the wrinkles between the eyebrows.

Injection of Botulinum A Toxin (Botox), Dysport, and/or Xeomin into the small muscles between the brows causes those specific muscles to halt their function (be paralyzed), thereby improving the appearance of the wrinkles. I understand the goal is to decrease the wrinkles in the treated area. This paralysis is temporary, and re-injection is necessary within three to four months. It has been explained to me that other temporary and more permanent treatments are available. The possible side effects of Botulinum A Toxin (Botox), Dysport, and/or Xeomin include but are not limited to:

1. Risks: I understand there is a risk of swelling, rash, headache, local numbness, pain at the injection site, bruising, respiratory problems, and allergic reaction.

2. Infection: Infections can occur which in most cases are easily treatable but in rare cases, permanent scarring in the area can occur.

3. Most people have lightly swollen pinkish bumps where the injections went in, for a couple of hours or even several days.

4. Although many people with chronic headaches or migraines often get relief from Botulinum A Toxin (Botox), Dysport, and/or Xeomin, a small percentage of patients get headaches following treatment with Botox, for the first day. In a very small percentage of patients, these headaches can persist for several days or weeks.

5. Local numbness, rash, pain at the injection site, flu-like symptoms with mild fever, and back pain.

6. Respiratory problems such as bronchitis or sinusitis, nausea, dizziness, and tightness or irritation of the skin.

7. Bruising is possible anytime you inject a needle into the skin. This bruising can last for several hours, days, weeks, or months, and in rare cases, the effect of bruising could be permanent.

8. While the local weakness of the injected muscles is representative of the expected
pharmacological action of Botulinum A Toxin (Botox), Dysport, and/or Xeomin, weakness of adjacent muscles may occur as a result of the spread of the toxin.

9. Treatments: I understand more than one injection may be needed to achieve a satisfactory result.

10. Another risk when injecting Botulinum A Toxin (Botox), Dysport, and/or Xeomin around the eyes included corneal exposure because people may not be able to blink the eyelids as often as they should to protect the eye. This inability to protect the eye has been associated with damage to the eye as impaired vision, or double vision, which is usually temporary. This reduced blinking has been associated with corneal ulcerations. There are medications that can help lift the eyelid, however, if the drooping is too great the eye drops are not that effective. These side effects can last for several weeks or longer. This occurs in 2-5 percent of patients.

11. I will follow all aftercare instructions as it is crucial I do so for healing.

As Botulinum A Toxin (Botox), Dysport, and/or Xeomin is not an exact science, there might be an uneven appearance of the face with some muscles more affected by the Botox than others. In most cases, this uneven appearance can be corrected by injecting Botox in the same or nearby muscles. However, in some cases, this uneven appearance can persist for several weeks or months. This list is not meant to be inclusive of all possible risks associated with Botulinum A Toxin (Botox), Dysport, and/or Xeomin as there are both known and unknown side effects associated with any medication or procedure. Botulinum A Toxin (Botox), Dysport, and/or Xeomin should not be administered to a pregnant or nursing woman.
Additionally, The number of units injected is an estimate of the amount of Botulinum A Toxin (Botox), Dysport, and/or Xeomin required to paralyze the muscles. I understand there is no guarantee of the results of any treatment. I understand the regular charge applies to all subsequent treatments. I take full liability and responsibility for any and all risks, undesired outcomes, or adverse events associated with the injections and will not hold the providers or liable for any unfavorable outcome or adverse event. I release Sei Tu Bella Aesthetics LLC, owners, and medical staff from liability associated with the procedure. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors, and assigns. I relieve Heather Merlo, FNP-C, APRN, Medical Director Dr. Fernando Jara, and Sei Tu Bella Aesthetics LLC, from all legal action pertaining to this treatment.

I understand and agree that all services rendered to me are charged directly to me and that 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 this be required. By signing below, I acknowledge that I have read the foregoing informed consent and agree to the treatment with its associated risks. I hereby give consent to perform this and all subsequent Botulinum A Toxin (Botox), Dysport, and/or Xeomin treatments with the above understood. I hereby release the doctor, the person injecting the Botulinum A Toxin (Botox), Dysport, and/or Xeomin and the facility from liability associated with this procedure.

Patient Signature______________________________________Date:____