KYBELLA INFORMED CONSENT

This is an informed consent document that has been prepared to help your plastic surgeon inform you concerning Kybella™, its risks and alternative treatment(s). It is important that you read this information carefully and completely.  Please initial each page, indicating that you have read the page and sign the consent for Kybella as proposed by your plastic surgeon.

 

INTRODUCTION

KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat, also called “double chin,” in adults. The safe and effective use of KYBELLA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

 

ALTERNATIVE TREATMENT

Alternative forms of management consist of not treating the fat under the chin.  Improvement of the fatty deposits may be attempted by other treatments or surgery such as Liposuction of the neck or radiofrequency skin tightening. Risks and potential complications are associated with alternative forms of treatment.

 

INHERENT RISKS OF KYBELLA™ INJECTIONS

Every procedure involves risk and it is important to understand these risks and the possible complications associated with them. In addition, every procedure has limitations.  An individual’s choice to undergo this procedure is based on the comparison of the risk to potential benefit.  Although the majority of patients do not experience the following, you should discuss each of them with your physician to make sure you understand the risks, potential complications, limitations, and consequences of Kybella™ injections.

 

SPECIFIC RISKS OF KYBELLA™ INJECTIONS

 

Bleeding and Bruising:

It possible, though unusual, to have a bleeding episode from an injection or local anesthesia used during the procedure.  Bruising in soft tissue commonly occurs with Kybella™ injections.  Should you develop post-injection bleeding, it may require emergency treatment.  Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginko biloba and other “herbs/homeopathic remedies” may contribute to a great risk of bleeding problems.  Do not take any of these for seven days before or after treatment.

 

 

 

Swelling:

Swelling (edema) is a normal occurrence following the injections. It decreases after a few days.  If swelling is slow to resolve, medical treatment may be necessary.

 

Pain:

Discomfort associated with injections is normal and usually of short duration.

 

Needle Marks:

Visible needle marks from the injections occur normally and resolve in a few days.

 

Skin Sensitivity:

Skin rash, itching, tenderness, and swelling, bruising, pain, numbness, redness, tingling, nodule, itching, skin tightnessand areas of hardness in the treatment area may occur following injections.  After treatment, you should minimize exposure of the treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away. If you are considering laser treatment, chemical peel or any other procedure based on a skin response after treatment, or you have recently had such treatments and the skin has not healed completely, there is a possible risk of an inflammatory reaction at the implant site.

 

Erythema (Skin Redness):

Erythema in the skin occurs after injections.  It can be present for a few days after the procedure.

 

Infection:

Although infection following injection of Kybella™ is unusual, bacterial, fungal, and viral infections can occur.  Herpes simplex virus infections around the mouth can occur following a treatment.  This applies to both individuals with a past history of herpes simplex virus infections and individuals with no known history of herpes simplex virus infections in the mouth area.  Specific medication must be prescribed and taken both prior and following the treatment procedure in order to suppress an infection from this virus.  Should any type of skin infection occur, additional treatment including antibiotics may be necessary.

 

Under/Over Correction:

The injection of Kybella™ to improve the “double chin” may not achieve the desired outcome.  The amount of correction may be inadequate or excessive.  It may not be possible to control the symmetry due to factors attributable to each patient’s situation.

 

Asymmetry:

The human face is normally asymmetrical in its appearance and anatomy.  It may be possible to achieve or maintain exact symmetry.  There can be a variation from one side to the other in terms of response to injection.  This may require additional injections.

 

 

 

Damage to Deeper Structures:

Deeper structures such as nerves and blood vessels may be damaged during the course of injection.  Injury to deeper structures may be temporary or permanent.

 

Skin Lumpiness:

Lumpiness can occur following the injection of Kybella™.  This tends to smooth out over time. 

 

Granulomas:

Painful masses in the skin and deeper tissues are extremely rare.  Should these occur, additional treatments including surgery may be necessary. Kybella should not be used in areas with active inflammation or infections (e.g. cysts, pimples, rashes, or hives).

 

Skin Necrosis:

It is very unusual to experience death of skin and deeper soft tissues after injections.  Skin necrosis can produce unacceptable scarring.  Should this complication occur, additional treatments or surgery may be necessary.

 

Allergic Reactions and Hypersensitivity:

As with all biologic products, allergic and systemic anaphylactic reactions may occur.  Kybella should not be used in patients with a history of multiple severe allergies, severe allergies manifested by a history of anaphylaxis, or known allergies to the chemicals in Kybella™

 

Drug and Local Anesthetic Reactions:

There is a possibility that a systemic reaction could occur from either the local anesthetic or epinephrine used for sensory nerve block anesthesia when Kybella™ injections are performed. This would include the possibility of light-headedness, rapid heartbeat (tachycardia), and fainting.  Medical treatment of these conditions may be necessary.

 

Antibodies to Kybella™

Presence of antibodies to Kybella™ may reduce the effectiveness of this material or produce a reaction in subsequent injections.  The health significance of antibodies to Kybella™ is unknown.

 

Accidental Intra-Arterial Injection/Marginal Mandibular Nerve Injection:

It is extremely rare that during the course of injection that Kybella™ could be accidentally injected into arterial structures and produce a blockage of blood flow.  This may produce skin necrosis in facial structures or damage blood flow to the eye, resulting in some loss of vision. The risk and consequences of accidental intravascular injection of Kybella™ is unknown and not predictable.  Kybella™ injections could cause nerve injury in the area of the jaw resulting in an uneven smile or facial muscle weakness.  In clinical trials these all resolved without treatment in an average of 6 weeks.

 

 

 

Scarring:

Kybella™ should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.  The safety of patients has not been studied.

 

Swallowing (Dysphagia):

KYBELLA™ injections can temporarily cause trouble with swallowing. Patients with a current or history of Dysphagia should not be treated with Kybella™.

 

Skin Ulceration:

KYBELLA™ injections could cause superficial skin erosions.

 

Alopecia:

KYBELLA™ injections could cause small patches of alopecia in the treatment area.

 

Unsatisfactory Results:

There is a possibility of an unsatisfactory result from injections of KYBELLA™.  The procedure may result in unacceptable visible deformities or asymmetry in the treatment area. Additional injections may be necessary.  Surgical procedures or other treatments may be recommended along with additional treatments.

 

Unknown Risks:

The long term effects of Kybella™ beyond 1 year are unknown.  The possibility of additional risk factors or complications attributable to the use of Kybella™ as an improvement in the appearance of moderate to severe convexity or fullness associated with submental fat may be discovered.

 

Pregnancy and Nursing Mothers:

Animal reproduction studies have not been performed to determine if Kybella™ could produce fetal harm.  It is not known if Kybella™ or its breakdown products can be excreted in human milk.  It is not recommended that pregnant women or nursing mothers receive Kybella™ treatments.

 

Drug Interactions:

It is not known if Kybella reacts with other drugs within the body.

 

Long-Term Effects:

Kybella™

 

Additional Treatment Necessary:

There are many variable conditions in addition to risks and potential complications that may influence the long-term results of Kybella™ injections.  Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with Kybella™ injections. Other complications and risks can occur but are even more uncommon.  Should complications occur, additional surgery or other treatments may be necessary.  The practice of medicine and surgery is not an exact science.  Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained.

 

 

Consent for Surgery/Procedure or Treatment

 

 

  1. I hereby authorize FLAWLESS MEDSPA and such assistants as may be selected to perform the following procedure or treatment: Kybella™

 

  1. I recognize that during the course of the medical treatment unforeseen conditions may necessitate different procedures than those above. I therefore authorize the above physician and assistants or designees to perform such other procedures that are in the exercise of his or her professional judgement necessary and desirable.  The authority granted under this paragraph shall include all conditions that require treatment and are not known to my physician at the time the procedure began.

 

 

  1. I consent to administration of such anesthetic considered necessary or advisable. I understand that all forms of anesthesia involve risk and possibility of complications, injury, and sometimes death.

 

  1. I understand what my provider 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. 

 

 

  1. I consent to be photographed or televised before, during and after the procedure(s)to me performed, including appropriate portions of my body, for medical scientific or educational purposes, provided by identity is not revealed by the pictures. 

 

  1. For purposes of advancing medical education I consent to the admittance of observers to the treatment room. 

 

 

  1. I consent to the disposal of any tissue, medical devices or body parts that may be removed.

 

  1. I understand that the surgeons’ fees are separate from the anesthesia and hospital charges, and the fees are agreeable to me. If a secondary procedure is necessary, further expenditure will be required.

 

  1. I realize that not having this treatment is an option

 

  1. It has been explained to me in a way that I understand:

 

  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 the treatment proposed.

 

I understand that Flawless Medspa has a 24-hour cancellation policy. Should you need to cancel or reschedule an appointment please give us 24-hour notice so we can make the time available to other clients. Failure to show up for a scheduled appointment will result in forfeiture of prepaid services booked. No refunds are made for products, service packages and prepaid treatments once they are purchased.

 

 

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