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:

  • Have an infection in the treatment area
  • Have had or plan to have surgery on the face, neck or chin
  • Have had cosmetic treatments on the face, neck, or chin
  • Have had or have medical conditions in or near the neck area
  • Have trouble swallowing
  • Have bleeding problems or are taking blood thinners
  • Are pregnant or plan to become pregnan It is not known if KYBELLA™ will harm an unborn baby.
  • Are breastfeeding or plan to breastfeed. It is unknown if KYBELLA™ passes into your breast mil

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.

FINANCIAL RESPONSIBILITIES

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.

DISCLAIMER

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.

CONSENT FOR PROCEDURE or TREATMENT

  1. I hereby authorize Skinlogic Med Spa’s injectionists to perform the following procedure or treatment:
  • KYBELLA INJECTION
  1. I recognize that during the course of the procedure and medical treatment, unforeseen conditions may necessitate  different  procedures than those I therefore authorize the injectionist  to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my injectionist at the time the procedure is begun.
  1. I understand what my injectionist can and cannot do, and understand  there are no warranties  or guarantees, implied or specific about my outcome. I have had the opportunity to explain my goals and understand which desired outcomes are realistic and which are not. All of my questions have been answered, and I understand the inherent  (specific)  risks to the procedures  I seek, as well as those additional  risks and complications, benefits, and alternatives. Understanding all of this, I elect to proceed.
  1. I consent to be photographed which will used for medical records. I understand before any future touch up or correction that I must have photos taken before anything can be performed and if I refuse no service will be performed.
  1. I realize that not having the procedure is an option.
  1. IT HAS BEEN EXPLAINED TO ME:
        1. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
        2. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
        3. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED

 

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.

Issues in signing document?  Scroll up to see required areas marked in red that you need to fill out then re-sign.

IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:  

  1. A. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN.  
  2. B. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT.  
  3. C. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED.

I certify that I have read all pages of this document and give my consent for my injectable procedure.  

  Date:

 

 

KYBELLA PRE AND POST INSTRUCTIONS

Pre Treatment

  • If you have a special event or vacation coming up, please keep in mind that you may want to schedule your treatment at least two weeks in advance. Swelling will occur. It is the body's natural, healthy response to go through an inflammation process to remove the fat cells from the
  • It is recommended to discontinue the use of aspirin, Nonsteroidal anti-inflammatory drugs - NSAIDS (Aleve, Motrin, etc), fish/flax oil or any other blood thinning supplements one week before treatment to minimize bruising or bleeding. Please consult with your primary physician prior to discontinuing any prescribed blood thinning medications.
  • Avoid alcohol, niacin supplement, high-sodium foods, high sugar foods, refined carbohydrates, and spicy foods 24-48 hours before and after your treatment. These items may contribute to increased swelling or irritation.
  • If you develop a cold/flu, infection, blemish, or rash, in the area to be treated prior to your appointment, we recommend that you please reschedule your appointment until it resolves.
  • We will not perform Kybella treatments on patients with current or past history of dysphagia “trouble swallowing”, currently pregnant or breastfeeding, with presence of infection at or near the injection sites, or under the age of 18.
  • We will take careful consideration in performing Kybella treatments on patients with excessive skin laxity, prominent platysmal bands, enlarged thyroid, enlarged neck lymph nodes, pronounced submandibular glands, prior surgery or aesthetic treatment to the treatment area, presence of scar tissue in the treatment area, sunburned or irritated skin, and current use of blood thinning agents.
  • We will assist and advise in coordinating Kybella treatments when being treated with other aesthetic services to provide optimal results and efficacy of concurrent treatments.

I have read all of the pre treatment instructions.

Post Treatment

  • Ice may be used as much as needed for the first 24-48 hours after your treatment for 20-30 minutes at a time, 2-4 times per day.
  • Use Arnica to help decrease bruising, swelling, and discomfort.
  • Take (over the counter) acetaminophen if needed to decrease post treatment discomfort.
  • Sleep on your back and with head elevated for the next 3-5 days after Keep head elevated as much as possible for the first 24-48 hours after your treatment.
  • Drink plenty of water and fluids after
  • Avoid vigorous exercise, sun and heat exposure for 3-5 days after
  • Avoid steriods (prednisone), , Nonsteroidal anti-inflammatory drugs - NSAIDS (Motrin, Aleve, etc), alcohol, caffeine, niacin supplement, high-sodium foods, high sugar foods, refined carbohydrates, and spicy foods 24-48 hours after your treatment.
  • It is absolutely normal to feel and see mild to moderate swelling, numbness, hardness to touch, tingling, redness and tenderness at the site of injections. You may occasionally see bruising or small bleeding that should resolve spontaneously.
  • Most swelling happens immediately and the following day after treatment and will start improving by day 5-7 days, but residual minimal swelling can last up to 3-4 weeks. Cold compresses may be used to reduce initial swelling. Avoid salt in your diet during this time.
  • Please report to your practitioner immediately if you develop an asymmetric smile or facial muscle weakness, skin ulceration in the treatment area, difficulty swallowing, or if any existing symptom worsens. These are very rare. Please communicate with us.
  • Your next treatment can be done in 4 weeks. It may take 4-6 treatments to reach the desired endpoint.

I have read all of the post treatment instructions.

 

Leave this empty:

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Signature Certificate
Document name: Kybella Consent Form
lock iconUnique Document ID: 4cdec10ce9d714e5d44cc89888f2782234d558a9
Timestamp Audit
March 21, 2021 11:49 pm PDTKybella Consent Form Uploaded by Skinlogic Med Spa - infossc2001@gmail.com IP 67.183.34.85