Bene Beyond 8530 FM 1960 Rd E, STE 106 Humble, TX 77346

INFORMED CONSENT- DEOXYCHOLIC ACID AESTHETIC INJECTION

DEOXYCHOLIC ACID INJECTION BRAND NAMES MAY INCLUDE, BUT ARE NOT LIMITED TO:  KYBELLA

Informed Consent Instructions: This is an informed consent document to provide written information about the above named procedure regarding risks, benefits, and alternatives. It is important that you understand the information provided to you prior to proceeding with this procedure; please ask your healthcare professional any/all questions prior to signing this consent form. 

Purpose of Treatment and General Information:  

Deoxycholic Acid is a cytolytic drug approved for improvement in the appearance of moderate to severe convexity or fullness associated with submental (neck) subcutaneous fat in adults. Any other cosmetic use is considered “off label.”
Deoxycholic acid is a naturally occurring molecule in the body produced by our livers that aids in the breakdown and absorption of dietary fat. Kybella® is a synthetic form of this naturally-occuring bile acid. When Kybella® is injected into the fat under the chin, it destroys fat cells, resulting in a reduction in fullness under the chin. Once destroyed, these cells can no longer store or accumulate fat.

At each treatment, you will receive multiple small injections in your target area(s). The injection process takes approximately 15-20 minutes. You may require multiple treatments to achieve desired results, which depends on the amount of fat you have and your desired profile. Should you require multiple treatments, Kybella® injections will be given at least one month apart. No more than six treatments total should be administered.

Alternative Treatments:

Alternative treatment to Kybella® to improve excessive deposits of subcutaneous fat may be accomplished by other treatments including not treating the excess fat by any means. Non-surgical alternatives may include: topical products, weight loss, and homeopathic treatments. Surgical alternatives such as liposuction also exist. Risks and potential complications are associated with alternative forms of treatment.

 

Possible Risks and Side Effects:

The possible side effects and risks of Kybella® include but are not limited to:  

1.General Side Effects: I understand there is a risk of swelling, rash, headache, local numbness, pain at the injection site, bruising, allergic reaction, nerve injury, or irritation of the skin that may occur.

2. Infection: Kybella should not be injected if there is a current, pre-existing infection in the treatment area. Although rare,aninfection occurs as a result of treatment, additional treatment including antibiotics or an additional procedure may be necessary. Notify treatment provider if you get cold sores, fever blisters, or have been diagnosed with the herpes simplex virus. For your comfort, it is recommended that you call your physician before treatment so you can take preventive medication to avoid an outbreak, as injections in this area can trigger a non-active outbreak.

 

3. Bleeding/Bruising: It is possible, though unusual, to have a bleeding episode from a Kybella injection. Bruising in soft tissues may occur. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginkgo biloba, and other "herbs / homeopathic remedies may contribute to a greater risk of a bleeding problem.  Do not take these for 10 days before or after Kybella injections. 

4. Nerve Injury: Although rare, Kybella injections can cause nerve injury in the area injected resulting in uneveness smile or muscle weakness. In clinical trials, these symptoms resolved without treatment in an average of six weeks. Tell your provider if you develop signs of nerve paresis (e.g., asymmetry, muscle weakness), difficulty swallowing, or if any existing symptom worsens.

5. Difficulty Swallowing: Although unlikely, Kybella® injections can temporarily cause difficulty swallowing. Tell your provider if you have any pre-existing conditions affecting your swallowing or if you havehistory of difficulty swallowing before your treatment.  If you experience problems swallowing after your treatment, notify your provider immediately. 

6. Skin Ulcerations and Necrosis: Although rare, Kybella® injections may sometimes cause open sores (ulcers), deep tissue damage, and tissue cell-death (necrosis) around the injection site. Should any of these complications occur, additional treatment or surgery may be required and could result in permanent scarring.

7. Hair Loss (Alopecia): In rare occurrences, Kybella® injections can cause small patches of hair loss in the treatment area.  The hair on a man's beard can potentially experience permanent patches of hair loss.  

8. Damage to Deeper Structures: Deeper body structures such as nerves, blood vessels, and muscles may be inadvertenly damaged during treatment with aesthetic injectables. The potential for this to occur varies according to where the treatment is being performed. Injury to deeper structures may be temporary or permanent.

9.Skin Hardening: On rare occasions, skin hardness may occur in the treatment area. This is temporary and should resolve within a few days.

10. Drug Interactions: Please advise your provider prior to undergoing treatment of any medications, antibiotics, herbs, or supplements you are taking, as they may interfere with the ability of the aesthetic injectables to function. It is not recommended that you undergo this treatment if you are on blood thinners for any reason, including bleeding disorders.

11. Pregnancy and Nursing Mothers: It is not recommended that pregnant women or nursing mothers receive Kybella® treatments.

12. Allergic Reactions: In rare cases, allergic reactions to Kybella® have occurred. Kybella® injections should not be with history of multiple severe allergies, manifested by a history of anaphylaxis or allergy to gram-positive bacterial proteins.  Lidocaine, a pain reliever used in many doctor's and dentists' offices, is an ingredient in many injectables.  Tell your provider if you have an allergy to lidocaine or other allergies. 

13. Previous or Planned Surgeries: Tell your treatment provider about all past or planned surgeries and treatments of the: face, neck, or chin as these could affect the effectiveness and safety of Kybella®.

This list is not meant to be inclusive of all possible risks associated with Kybella®, as there are both known- and unknown-side effects associated with any medication or procedure.

 

Patient Disclosure Required Prior to Treatment:

Before receiving Kybella®, tell your healthcare provider about all of your medical conditions, including if:

• You've had or plan to have surgery on your face, neck, or chin
• You've had cosmetic treatments on your face, neck, or chin Have had or currently have medical conditions in or near the neck area
• You've had or currently have trouble swallowing
• You have bleeding problems
• You are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Unsatisfactory Result:

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

2. Asymmetry: As Kybella® injections are not an exact science, uneven appearance of body parts may occur after injection as there can be variation between one side to the other in terms of response to injection. This may require additional injections.

Maintaining Results: For continued results, it is suggested that you maintain your current weight to avoid any further creation of excess fat in the treatment area(s).

No Guarantee of Results: In some situations, it may not be possible to achieve optimal results with a single aesthetic injectable treatment. Multiple sessions may be necessary. It is also possible that Kybella® injections may fail to produce the desired results in the targeted areas. Should complications occur, additional injectables or other treatments may be necessary.

Financial Responsibility: I understand the regular charge applies to all subsequent treatments. 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 cost and reasonable legal fees, should this be required.  

Consent:

By signing below, I acknowledge and agree:

• I have fully disclosed on my client intake form any medications, previous complications, planned or previous surgeries, allergies, or current conditions that may affect my treatment.
• I have read the foregoing informed consent for Kybella® injections and agree to the treatment with its associated risks
• I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.
• I will follow all aftercare instructions as it is crucial to do so for good healing and to minimize the risk of complications.
• I hereby give consent to perform this, and all subsequent Kybella® Injection Treatments, with the above understood. I hereby release the physician / provider, the person injecting the Kybella®, and the clinic facility from liability associated with this procedure.
• I consent to the photographing of the procedure(s) to be performed, including appropriate portions of my body for medical, scientific, or educational purposes, (does not include promotional or advertising consent) provided that my identity is not revealed by the pictures.
• For purposes of advancing medical education, I consent to the admittance of observers to the treatment room.
• It has been explained to me in a way that I understand:
  • The above treatment or procedure to be undertaken.
  • There may be alternative procedures or methods or treatment.
  • There are risks, known and unknown, to the procedure or treatment proposed.

Model Release: In consideration for treatment received, I hereby grant permission to the individual or company that provided my treatment to use any photographic treatment records for the purposes of advertising or promotion (including, but not limited to: social media, print ads, online publications, websites, etc), without any additional compensation to me.

Treatment Liability Waiver:

I acknowledge that beauty treatments, the practice of skin care, including, but not limited to, microablation, microdermabrasion, waxing, electrolysis, facial toning, body treatments, laser treatments, brown spot removal, Botulinum Toxin (A) injections, Collagen, Dermal Fillers, non-surgical chin and body fat cell treatments, Sclerotherapy, Mesotherapy, Dermaplaning, and various other beauty procedures is not an exact science and no specific guarantees can, or have been made, concerning the outcome.

I further understand that some clients experience more change and improvement than others. In nearly all cases, multiple treatments are required to achieve desired results or see a difference in appearance. I understand that response to treatment varies on an individual basis and that specific results are not guaranteed.

I also understand and agree to assume the following risks and hazards which may occur in connection with any particular treatment including but not limited to: unsatisfactory results, soreness, poor healing, discomfort, redness, blistering, nerve damage, scarring, infection, and change in skin pigmentation, allergic reaction, and bleeding. I understand that even though precautions may be taken in my treatment, not all risks can be known in advance.

Therefore, in consideration for any treatment received, I agree to unconditionally defend, hold harmless and release from any and all liability the company and the individual that provided my treatment, the insured, and any additional insured's, as well as any officers, directors, or employees of the above companies for any condition or result, known or unknown, that may arise as a consequence of any treatment that I receive.

I understand and agree that any legal action of any kind related to any treatment I receive will be limited to binding arbitration using a single arbitrator agreed to by both parties.

Covid-19 and Communicable Diseases:

Acceptance of Risk; Release; Indemnification. I am fully aware that there are a number of risks associated with me entering the property containing Bene Beyond Clinic during the COVID-19 pandemic under the circumstances of receiving treatments, including without limitation: (a) I could contract COVID-19 or other diseases such as the flu or legionnaires disease which could result in a serious medical condition requiring medical treatment in a hospital or could possibly lead to death; and (b) I will be subject to normal risks associated with general exposure to viruses and other communicable diseases.

By signing below, I acknowledge and agree: I have carefully read the information on this page and understand that I may be giving up some important legal rights by signing.

After your Kybella® injections, it is normal to experience some swelling, pinpoint bleeding, and bruising underneath the chin. You may continue to experience localized numbness for 1-2 hours post-treatment in the area of your treatment due to the numbing creme applied prior to your injections. Please be sure to read and follow these aftercare instructions to help minimize swelling and bruising and to decrease downtime.

Post-Treatment:

• Use a cold pack as needed to reduce swelling, bruising, or discomfort at the treatment site:
  • Ice 20 minutes on and 20 minutes off, repeat as needed for the first 48 hours.
  • To help avoid injury to the skin, it is important to not place ice packs directly on the skin. Wrap the ice pack in a thin cloth or place a thin fabric barrier between the ice pack and your skin.
  • Be aware that your skin may feel numb, so you may not feel the normal sensation when the skin has gotten too cold.
• Sleep with your head elevated for the first 3 nights after your treatment to help minimize swelling.
• Avoid picking, scratching, massaging, or manipulating the treated area to achieve best results.
• You may apply your normal skin care regimen to the area, including cleanser, moisturizer, sunscreen, makeup, etc. You may use makeup to cover any bruising in the area, as needed.
• Please avoid alcohol, aspirin, vigorous exercise, sunbathing, and extreme heat or cold for 14 days post-reatment as these activities may increase and prolong swelling.
• Avoid vigorous exercise the day of your treatment.
• Swelling should begin to improve after about 48 hours. Please notify the office if any new or increased swelling occurs after this timeframe.
• Notify the office if any significant swelling, bleeding, pain, dusky discoloration, difficulty swallowing, difficulty smiling, or fever occurs.

Over-The-Counter Remedies: 

These tips may help address minor bruises and swelling.

• Ice packs: Ice for 20 minutes on, 20 minutes off, repeat as needed.
• Acetaminophen: as needed.
• Arnica Cream or Supplements: sometimes recommended a few days before and a few days after treatment to help reduce bruising. Use as directed on the container.
• Pineapple: Consider adding Pineapple to your diet for its natural anti-inflammatory properties that may help to minimize swelling after injections if there are no medical restrictions to eating this food.

Results:

Results may not be noticeable until several weeks post-treatment.

• You may experience swelling and bruising during the first several days post-treatment in the treated area. It may take several weeks before your results are noticeable. Please give your body adequate time to melt fat in treatment area and for your swelling/healing process to complete before judging results. Multiple treatments may be necessary to achieve desired results.

 

For questions or concerns during office hours, please call: 855-236-3492 

In case of emergency, call 911.