Purpose/Background:
The term “neuromodulator” will be used in the remainder of this document to describe products such as Botox® (onabotulinumtoxinA), Xeomin® (incobotulinumtoxinA), and Dysport® (abobotulinumtoxinA). Injections will be administered in selected facial muscles and/or platysmal bands of the neck muscles to paralyze these muscles temporarily.
Neuromodular injection has been FDA approved for use in the cosmetic treatment for glabellar frown lines only (the wrinkles between the eyebrows). All other areas of the face or neck are considered “OFF LABEL” and have NOT been approved by the FDA.
Injection of neuromodulator 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.
Potential Risks:
Although we expect good results, there can be no guarantee of outcome. The possible side effects/risks of neuromodulator injections include but are not limited to:
· Swelling
· Rash
· Headache following treatment which can last for several days or weeks for a small percentage of patients
· Local numbness
· Pain at injection site
· Bruising which can last from hours to months and become permanent in rare cases
· Tightness or irritation of the skin
· Flu-like symptoms:
o Mild fever
o Back pain
o Respiratory problems such as bronchitis or sinusitis
o Nausea
o Dizziness
· Local weakness of the injected muscles is representative of the expected pharmacological action of the neuromodulator but weakness of adjacent muscles may occur as a result of the spread of the toxin.
· Allergic reaction
· Infections can occur which in most cases are easily treatable but in rare cases permanent scarring in the area can occur.
· When injecting neuromodulators around the eyes risks include corneal exposure because people may not be able to blink the eyelids as often as they should to protect the eye.
· Neuromodulator injections should not be administered to a pregnant or nursing woman. Please inform your healthcare provider if you are pregnant, trying to become pregnant, or nursing.
Payment Obligation:
I understand that payment is due in full at the time of service and is non-refundable. I also understand that it is my responsibility to submit a claim to my insurance company for possible reimbursement. I have been advised that most insurance companies do not consider injectable neuromodulators a covered benefit and that my insurance company might not reimburse me, depending on my coverage. I acknowledge that my provider has no contracts with any insurance company and is not contractually obligated to pre-certify treatment with my insurance company or issue any letters of appeal.
Consent to Treatment:
By knowingly and voluntarily signing my name below, I hereby certify that:
i. I am at least 18 years old.
ii. I have received verbal or written information, and discussed with my provider, about my health status/condition, as applicable, and recommended course of care/procedure/treatment that is generally described in this consent, including but not limited to the course of care/procedure/treatment that is generally detailed in the General Description of Treatment section below, together with the related care associated therewith (collectively, the “Treatment”).
iii. I have been advised of and understand the possible risks, complications, and side effects of the proposed Treatment.
iv. I have been advised of and understand the reasonable alternatives to the proposed Treatment (and related care/procedure(s)/treatment), including the risks and benefits of foregoing treatment altogether.
v. I have been advised of and understand the possible benefits of the proposed Treatment.
vi. I have had the opportunity to think about my health status and condition, as well as educate myself about my health status/condition, the proposed Treatment, and I have had an opportunity to review this Informed Consent.
vii. I have had the opportunity to ask any questions that I have about my health status/condition and the proposed Treatment (and answers have been provided to my satisfaction in terms that I understand).
viii. I agree to immediately report to my practitioner’s office any adverse reactions or problems after the Treatment.
ix. I have not been promised or guaranteed any specific benefits from the course of Treatment.
x. I have informed my practitioner of any known allergies to medications or other substances and of all current medications and supplements I currently take.
xi. Based on the foregoing, I knowingly and voluntarily desire to proceed with the proposed Treatment and related (and future) care/procedure(s) and accept the risk of possible harm. This consent is ongoing for this and all future Treatment. I also consent to the performance of any additional procedures determined in the course of the Treatment to be in my best interests where delay might impair my health.
xii. I agree to having photographs taken as a part of the medical record.
xiii. Allergic/autoimmune reaction-
xiv. I have informed by provider I am not pregnant or nursing on day of procedure.