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. October 15, 2024 |