Kybella Consent Form
INTRODUCTION: KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe fullness associated with submental fat, also called “double chin,” in adults. Deoxycholic acid is a bile acid naturally produced by our livers. KYBELLA is a synthetic form of this. The safe and effective use of KYBELLA™ for treatment of subcutaneous fat outside of the submental region has not been established. KYBELLA™ is injected into the fat under the chin. Multiple treatments are required and will be given at least 1 month apart.
RISKS OF KYBELLA™ INJECTIONS: Every injection of a drug involves a certain amount of risk. Below are risks reported during clinical studies that are specific to the injection of KYBELLA™:
Common potential side effects include: swelling, bruising, pain, numbness, redness, and areas of hardness in treatment area. KYBELLA™ injections can also cause tingling, nodules, itching, skin tightness, and headache. These side effects typically resolve without treatment and do not usually result in patients stopping treatment.
Less common potential side effects include: Nerve injury—KYBELLA™ injections could cause nerve injury in the area of the jaw resulting in an uneven smile or facial muscle weakness. In the clinical trials these all resolved without treatment in an average of 6 weeks. Swallowing—KYBELLA™ injections can temporarily cause trouble with swallowing (this is thought to be due to neck swelling). Skin Ulceration—KYBELLA™ injections could cause superficial skin erosions. Hair Loss—KYBELLA™ injections could cause small patches of hair loss in the beard area. Unsatisfactory results: There is a possibility of unsatisfactory results. The procedure may also result in more noticeable platysmal bands, unacceptable visible deformities or asymmetry in the treatment area.
BEFORE RECEIVING KYBELLA™ INJECTIONS: Tell your healthcare provider about all of your medical conditions, including if you:
Tell your treatment provider about all medications you currently take, including prescriptions and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take a medicine that prevents the clotting of blood (antiplatelet or anticoagulant medications such as aspirin, non-steroidal anti-inflammatory medications).
In clinical trials 72% of subjects treated with KYBELLA experienced injection site hematoma/bruising. KYBELLA should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
Patients should inform their treatment provider if they develop signs of marginal mandibular nerve paresis (e.g., asymmetric smile, facial muscle weakness) difficulty swallowing or if any existing symptoms worsen. The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain numbness, erythema, and induration.
The practice of medicine is not an exact science. Although good results are expected, there cannot be any guarantee, or warranty, expressed or implied b by anyone as to the results that may be obtained.
The cost of filler injection may involve several charges. The fees charged for this procedure do not include any potential future costs for additional procedures that you elect to have or require in order to revise, optimize, or complete your outcome. Additional costs may occur should complications develop from the injections and will also be your responsibility. In signing the consent for this procedure, you acknowledge that you have been informed about its risk and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments.
I understand and unconditionally and irrevocably accept this.
The informed-consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.
However, informed-consent documents should not be considered all-inclusive in defining other methods of care and risks encountered. Your injectionist may provide you with additional or different information which is based on all of the facts pertaining to your particular case and the current state of medical knowledge.
Informed-consent documents are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve.
I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-6). I AM SATISFIED WITH THE EXPLANATION.
I understand that multiple treatments will be needed to achieve desired results and if I decide not to have further treatments that desired results will not be achieved.
I understand that if I decided to not have a treatment today that I will be charged $100 for the kybella consultation.
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IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
I certify that I have read all pages of this document and give my consent for my injectable procedure.
KYBELLA PRE AND POST INSTRUCTIONS
I have read all of the pre treatment instructions.
I have read all of the post treatment instructions.
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Document Name: Kybella Consent Form
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