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Informed Consent

Coolsculpting Body Contouring Treatment

ACKNOWLEDGMENT, WAIVER, AND CONSENT TO RECEIVE CoolSculpting® BODY CONTOURING PROCEDURES. DO NOT SIGN THIS FORM WITHOUT READING AND UNDERSTANDING ITS CONTENTS.

 

HOW DOES COOLSCULPTING WORK:

CoolSculpting works by a process called cryolipolysis, or freezing of the fat cells. As the fat cells freeze, they go through a process called apoptosis, or cell death, and then are naturally eliminated from the body over a period of a few months. When you gain weight the fat cells in your body get larger, and when you lose weight, the fat cells shrink. Instead of shrinking the fat cells, CoolSculpting is effective at removing the fat cells from the body altogether, resulting in up to a 20%-25% fat reduction in the treated area.

WHAT YOU CAN EXPECT:

Once a patient has been assessed, marking the peak areas of fat and applying a protective pad to the skin, the device is applied to the marked areas for treatment. After the cooling device is applied, the patient experiences a gentle suction to the skin, almost like a vacuum. Initially the skin becomes cold, but after a few minutes,the treatment area becomes completely numb. During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. The CoolSculpting device does not affect the skin becausethe device is designed to target and freeze fat cells only. After the CoolSculpting procedure, a massage is performed on the treated area to break up the cold subcutaneous fat. The massage is an extremely important part of the procedure to initiate the breakdown of the fat cells. 

 

The CoolSculpting® procedure is a non-invasive procedure that is intended to change the appearance of the treatment area by delivering controlled cooling at the surface of the skin to break down fat cells that are just beneath the skin. This procedure is not a treatment for obesity or a weight-loss solution. This procedure is specifically designed to treat subcutaneous fat, which is the fat you can pull or grab. However, the CoolSculpting® procedure does not replace traditional methods such as diet, exercise or liposuction. Therefore, a good candidate is someone who is in good health, eats well and exercises regularly, but has stubborn fat in one or more of the FDA cleared areas, and does not have a contraindication to treatment.

Clinical studies of a treatment site have shown that the CoolSculpting® procedure can break down fat cells to change the appearance of visibly localized bulges of fat that is just beneath the skin on the abdomen, thighs, flanks and submental area. The submental area is the area under the chin. Following the procedure, the treated fat cells are naturally processed by the body. Visible results can vary from person to person.

Temporary Sensations / Symptoms :

  • The suction pressure of a vacuum applicator may cause sensations of deep pulling, tugging and pinching. A surface applicator may cause sensations of pressure. You may experience intense cold, stinging, tingling, aching or cramping as the treatment begins. These sensations generally subside during treatment as the area becomes numb. 
  • You may have dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or immediately after the treatment. 
  • The treated area may look or feel stiff after the procedure and transient blanching (temporary whitening of the skin) may occur. These are all normal reactions that typically resolve within a few minutes. 
  • Bruising, swelling, redness, cramping and pain can occur in the treated area and the treated area may appear red for one to two weeks after treatment.  
  • After submental area treatment, a feeling of fullness in the back of the throat may occur.
  • You may feel a dulling of sensation in the treated area that can last for several weeks after the procedure. Prolonged swelling, itching, tingling, numbness, tenderness to the touch, pain in the treated area, cramping, aching, bruising and/or skin sensitivity also have been reported.

 

 

Potential Side Effects / Risks:

  • Paradoxical Hyperplasia -- A small number of patients have experienced gradual development of a firmer enlargement, of varying size and shape, of the treatment area, known as “paradoxical hyperplasia”, in the months following the treatment. If such paradoxical hyperplasia occurs, it will be distinguishable from temporary swelling and will probably not resolve on its own. The enlargement/lump can be removed by means of a surgical procedure such as liposuction. 
  • Treatment area demarcation -- A small number of patients have experienced excessive fat removal in the treatment area, resulting in an unwanted indentation. The indentation may be improved through corrective procedures.
  • In rare cases, patients have reported the CoolSculpting treatment area to have darker skin color, hardness, discrete nodules, frostbite (local injury due to cold), hernia or worsening of pre-existing hernia. Surgical intervention may be required to correct hernia formation.
  • Patient experiences may vary. Some patients may experience a delayed onset of the previously mentioned symptoms. Contact your physician immediately if any unusual side effects occur or if symptoms worsen over time. 
  • I understand that these and other unknown side effects may also occur.  

 

Results:

  • You may start to see changes in as early as three weeks after your CoolSculpting procedure, and will experience the most dramatic results after one to three months. Your body will continue to naturally process the injured fat cells from your body for approximately four months after your procedure.
  • Results vary from person to person. You may decide that additional treatments are necessary to achieve your desired outcome. Although highly unlikely, it is possible that you will not experience any noticeable result
  • from the procedure.

 

I acknowledge photographic documentation may be taken.

 

I certify that the information contained in this Informed Consent was explained to me using terms I could understand, and all my questions and concerns have been answered. After reviewing all the information provided to me about CoolSculpting® procedure and reviewing my health status, I give my consent to be treated with the CoolSculpting® procedure by Bared Monkey Laser Spa Inc. and all its affiliated companies and the trained and licensed staffs in this practice. 

I certified the information provided in this consent form is true and correct. I am aware that it is my responsibility to inform the technicians of Bared Monkey Laser Spa my current medical and health conditions and to update this history is essential for the caregiver to execute the appropriate treatment procedures.

I acknowledge and accept the risks inherent in the CoolSculpting® procedure. I voluntarily assume the risk of possible complications and side effects which may arise from the CoolSculpting® procedure set forth herein; and any of my heirs, executors, representatives or assigns hereby release Bared Monkey Laser Spa Inc. and all its affiliated companies from any and all claims, liabilities for personal injury, and property damages of any kind sustained while on the premises, during the treatments set forth herein by any employees or representatives of Bared Monkey Laser Spa Inc. and all its affiliated companies.

 

December 4, 2024 

 

 

 

 

 

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First Patient's Name

First Name*

Middle Name

Last Name*

Phone*
First Patient's Date of Birth*
First Patient's Signature*
Patient's Address
Address Line 1:*
Street address, P.O. box, company name, c/o
Address Line 2:
Apartment, suite, unit, building, floor, etc.
Country:*
City:*
State/Province:*
Zip/Postal:*
Parent or Guardian's Email Address

Email*

Confirm Email*
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Ethnicity
Please specify your genetic origin:*
African American
Asian
Caucasian
Hispanic
Mediterranean
Middle Eastern
Native American
Other
Females Only
Are you pregnant?*
No
Yes
N/A
Are you breastfeeding?*
No
Yes
N/A
Are you planning pregnancy during the course of your treatments?*
No
Yes
N/A
Do you currently have or have had any of the following?
Cryoglobulinemia (a condition in which an abnormal level of proteins thicken the blood in cold temperatures), or paroxysmal cold hemoglobinuria or cold agglutinin disease (blood disorders in which cold temperatures lead to red blood cell death).*
No
Yes
Known sensitivity to cold such as cold urticaria (hives triggered by cold), Raynaud's disease (disorder in which cold leads to reduced blood flow in the fingers, which appear white, red, or blue), pernio or Chilblains (itchy and/or tender red or purple bumps that occur as a reaction to cold)*
No
Yes
Neuropathic (nerve) disorders such as post-herpetic neuralgia or diabetic neuropathy*
No
Yes
Impaired skin sensation*
No
Yes
Open or infected wounds*
No
Yes
Bleeding disorders or use of blood thinners*
No
Yes
Recent surgery or scar tissue in the area to be treated*
No
Yes
A hernia or history of hernia in the area to be treated or adjacent to treatment site*
No
Yes
Skin conditions such as eczema, dermatitis, or rashes*
No
Yes
Any active implanted devices such as pacemakers and defibrillators*
No
Yes
Any major health problems such as liver disease*
No
Yes
Any known sensitivity to isopropyl alcohol (rubbing alcohol) or propylene glycol*
No
Yes

Patient goals and timeline (eg, special occasion in 3 months), please notate if "NONE"
Parent(s) or court-appointed legal guardian(s) must sign for any participating minor (those under 18 years of age) and agree that they and the minor are subject to all the terms of this document, as set forth above.


By signing below the Parent or Court-Appointed Legal Guardian agrees that they are also subject to all the terms of this document, as set forth above.
Parent or Guardian's Name

First Name*

Middle Name

Last Name*

Relationship*

Phone*
Parent or Guardian's Date of Birth*
Parent or Guardian's Signature*
Electronic Signature Consent*
By checking here, you are consenting to the use of your electronic signature in lieu of an original signature on paper. You have the right to request that you sign a paper copy instead. By checking here, you are waiving that right. After consent, you may, upon written request to us, obtain a paper copy of an electronic record. No fee will be charged for such copy and no special hardware or software is required to view it. Your agreement to use an electronic signature with us for any documents will continue until such time as you notify us in writing that you no longer wish to use an electronic signature. There is no penalty for withdrawing your consent. You should always make sure that we have a current email address in order to contact you regarding any changes, if necessary.


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