INSTRUCTIONS
This Informed Consent Booklet has been prepared Gangnam Spa by to help inform you about the potential benefits, associated risks, and alternatives of the Venus Versa™ TriBella™ treatments.
During your consultation and medical assessment, Gangnam Spa will have reviewed with you the potential benefits, associated risks, and alternatives of the Venus Versa™ TriBella™ treatments. that are outlined in this booklet. They will have also provided you with answers to any and all questions you may have had about the procedure.
It is important that you read the information contained in this booklet again carefully and completely. Only when all of your questions and concerns about the procedures have been addressed should you then initial each page, indicating that you have read and fully understood all the items discussed in this booklet. When you reach the end of the booklet, please sign the consent for the procedure as proposed by Gangnam Spa . If you have any remaining questions or concerns about the potential
benefits, associated risks, or alternatives of the Venus Versa™ TriBella™ treatments , do not initial any pages or sign the consent without speaking with Gangnam Spa
INTRODUCTION
Tri-modality, total facial therapy. Three modalities, one powerful treatment.
Step 1:
IPL Venus Versa™ Intense Pulsed Light (IPL) treatments direct IPL energy to the skin in targeted treatment areas. This energy passes through the outer surface of the skin, called the epidermis, and penetrates into the lower layer of the skin, called the dermis. Once in the dermis, the IPL energy stimulates a cell called a fibroblast to produce new collagen, a protein that gives the skin its strength and elasticity. Over several treatments, this new collagen smoothens and softens the appearance of wrinkles, outsized pores, and textural irregularities. Venus Versa IPL treatment utilizes special filters to control the wavelength of the IPL energy to better optimize treatment settings to improve the appearance of rosacea, sun-damaged skin with pigmentation abnormalities, and/or vascular blemishes such as spider veins.
Step 2:
(MP)2 Venus Versa™ (MP)2 treatments use a combination of a Multipolar Radio Frequency and Pulsed Electro Magnetic Fields technologies within one device to tighten the skin, reduce circumference, and/or soften wrinkles. The device delivers radio frequency and pulsed electro magnetic energy to targeted tissue, damaging the existing collagen, in order to stimulate the body’s healing response. Once the collagen has been damaged, the body begins to repair the skin by replacing the damaged tissue with new collagen. The radio frequency energy stimulates the body’s production of new fibroblasts, the “houses” that create collagen, thus increasing the amount of collagen in the tissue. This wound healing response plumps up skin smoothens and softens the appearance of fine lines and wrinkles, and treats acne. Pulsed Electro-Magnetic Fields increase the vascularity of the skin and create new pathways for the blood to flow. This increase in blood flow provides more oxygen to the skin and brings more nutrients to the tissue. A fresher, more youthful glow is common after Venus Versa MP2 treatments.
Step 3:
Nano-Fractional The Venus Versa™ Nano-fractional applicator is designed to resurface the skin through ablation and coagulation. It delivers targeted columns of radio frequency energy to the tissue, designed to damage the existing collagen and stimulate the body’s natural healing response. Once the collagen has been damaged, the body begins to repair the targeted tissue by replacing the damaged collagen with new collagen. The radio frequency energy also stimulates the body to produce new fibroblasts, the “houses” that create collagen, thus increasing the amount of collagen in the tissue. This wound-healing response plumps up skin, smoothens and softens the appearance of fine lines and wrinkles, treats acne scars, and reduces the appearance of pigmented lesions and textural irregularities of the skin.
Following each Venus Versa™ TriBella™ treatment, there may be a minor degree of redness and puffiness to the skin, with some tingling or discomfort. A comprehensive skin care program will be recommended for you to use in conjunction with your Venus Versa™ TriBella™ treatments. It is highly recommended you discuss a maintenance program with and begin a home skin care program to prevent potential complications and to optimize and maintain the cosmetic improvements you obtain through your Venus Versa™ TriBella™ treatments.
Before beginning a Venus Versa™ TriBella™ treatment program, you must first attend an assessment and information consultation with a treatment professional, during which your skin type, facial cosmetic concerns, expectations, and goals will be discussed and assessed. The treatment professional will work with you to select the best treatment or combination of treatments for your skin type, facial cosmetic concerns, expectations, and aesthetic goals. The estimated duration and cost of each session or series of sessions will also be provided to you during this time. If you are a qualified candidate, you may schedule your Venus Versa™ TriBella™ treatments and test spots at the time of this initial consultation.
POTENTIAL BENEFITS OF VENUS VERSA™ TRIBELLA™ TREATMENTS:
The primary potential benefits are an improvement in the appearance of wrinkles, pore size, textural irregularities, acne scarring, vascular and pigmentation blemishes as a result of aging or sun-damaged skin, as well as an improvement in overall skin appearance. While discussing the potential benefits of this treatment with you, may have shown you a variety of before-and-after images. It is important to remind you that these images were used as an educational tool to allow you to visualize the general range of skin improvements that may be achieved with your proposed treatment; the before-and-after images are not meant to be guarantees of actual or exact outcome.
RISKS ASSOCIATED WITH VENUS VERSA™ TRIBELLA™ HAIR REMOVAL TREATMENTS
Every cosmetic procedure involves a very small degree of risk and, although exceedingly uncommon, it is important that you understand and accept the rare risks involved with the Venus Versa™ TriBella™ treatment. An individual’s informed decision to undergo any cosmetic procedure is based upon a comparison of the risks against the potential benefits, alternatives, and costs.
Although the vast majority of Venus Versa™ TriBella™ treatment clients never experience any complications, you should discuss each of them with your treatment provider to ensure you fully understand the alternatives, risks, and average outcomes of Venus Versa™ TriBella™ treatments.
Venus Versa™ TriBella™ treatments will leave your skin photosensitized (sensitive to light) for 48 hours after each treatment. You must avoid sunlight during this time. Failure to do so will result in significant redness and swelling, and may increase the rare risk of disfiguration, and complications like blistering, scarring, or pigment changes.
Discomfort:
Venus Versa™ TriBella™ treatments are very well-tolerated office treatments. Patient comfort is optimized with the cooling crystal that is integrated into the Venus Versa™ IPL applicator to assist with patient comfort during the photofacial portion of the treatment. Topical anesthetic cream may also be used. You may experience a minor and tolerable degree of heat and/or a tingling sensation with each treatment.
Swelling:
Edema (swelling of the tissue) is common and will resolve in a few days. Edema may occur as early as immediately post procedure and as late as a few days post treatment. It is advised to seek a consultation and follow-up appointment with Gangnam Spa should you require medical attention or have concerns.
Blistering:
In rare cases, a blister may occur as a result of the treatment. In this instance, Gangnam Spa will recommend for the treatment of the blister.
Scarring:
Scarring occurs in less than 0.1% of patients. If you have developed a wound and a scar, the scar may become flat and white (hypotrophic) or large and red (hypertrophic), or it may extend beyond the margins of the original injury (keloid). Subsequent treatment or surgery may be required to improve the appearance of the scar. In some cases, the scar may be permanent. Not following pre- and post-treatment care instructions may increase the likelihood of a skin wound or scar.
Pigment Change:
With the IPL energy used in Venus Versa™ TriBella™ treatments, there is a small risk (less than one per cent) of temporary hyperpigmentation (increased pigment or brown discoloration) or hypopigmentation (whitening of the skin). These pigment effects are usually temporary and resolve over several weeks or months. Permanent hyperpigmentation or hypopigmentation is very rare and may occur in less than one per cent of cases. The majority of Venus Versa™ TriBella™ patients will receive skin care products. The use of these medical skin care products is important to obtain optimal results.
Tanning:
It is essential that you do not tan your skin or use tanning creams prior to your Venus Versa™ TriBella™ treatments, as the pigment in your skin will absorb some of the IPL energy, increasing your risk of pigment changes or skin wounds. If you have tanned skin, you should not have Venus Versa™ TriBella™ treatments until the tan has faded appreciably (at least 6 weeks). Sun exposure, tanning beds, and artificial tanning lotions are not allowed in the treated areas during the course of the treatment and healing. If you are using artificial tanning creams, allow these to fade for 2 to 3 weeks prior to beginning treatment.
Bruising:
It is exceedingly uncommon to have any skin bruising following Venus Versa™ TriBella™ treatments. As the bruising fades, there may be a rust-brown discoloration of the skin (hyperpigmentation) that may require a medical cream or ointment to fully address—consult your treatment provide
Infection:
Venus Versa™ IPL hair removal treatments involve no actual cutting, surgery, or skin penetration. Infection is exceedingly rare.
Excessive Redness and Swelling:
Excessive Redness and Swelling: A moderate degree of redness and/or puffiness of the skin may follow treatment. This may be easily camouflaged with makeup 24 hours after the treatment. In some instances, redness and swelling may persist for 3 to 4 days. Gangnam Spa will assess and prescribe the appropriate treatment
Fragile Facial Skin:
The skin overlying the treatment area may become quite fragile. Although uncommon, this fragile skin can become reddened and the outer layer may peel off, much like a blister. This usually settles in 8 to 10 days. Fragile skin or blisters may be more common after TriBella™ treatments if post-treatment care instructions are not followed.
Viral Susceptibility:
If you are susceptible to cold sores, please notify your treatment provider prior to treatment, as cold sore eruptions can be common with Venus Versa™ TriBella™ treatments. You may need to go on an anti-viral medication during your treatment to control cold sore eruptions.
Isotretinoin:
If you are currently taking Isotretinoin, an acne medication (e.g. Roaccutane), you must stop taking it at least 6 months prior to your TriBella™ treatments
Additional Treatments:
In most instances, it is recommended that you book a Venus Versa™ TriBella™ maintenance session every 6 months after completion of the initial course of treatments.
Lack of Satisfaction:
Not all facial wrinkles, blemishes, and skin types respond the same to Venus Versa™ TriBella™ treatments. Your skin’s response may be subject to variation. However, the overwhelming majority of clients who have undergone Venus Versa™ TriBella™ treatments report a noticeable improvement in the appearance of skin quality and youthful vitality, by 40-70%. There is a risk that you may not see an appreciable improvement in the quality and appearance of your skin.
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Pregnancy:
Although Venus Versa™ IPL hair removal treatments have no known adverse reactions upon a fetus, we do not recommend proceeding with treatments if you are known to be pregnant.
There are many variable conditions in addition to the risks and potential complications listed above that may influence your long-term results from Venus Versa™ IPL hair removal treatments. Even though risks and complications can occur infrequently, the risks cited in this booklet are specific to Venus Versa™ IPL hair removal treatments. Other complications and risks can occur but are even less common. Should complications occur, additional surgery or treatment(s) may be necessary. The practice of medicine is not an exact science. Although good results are expected, there is no guarantee or warranty, expressed or implied, as to the results that may be obtained. Infrequently, it is necessary to perform additional treatment(s) to improve your results.
HEALTH INSURANCE
Facial wrinkles, pores, textural irregularities, and vascular and pigment blemishes are cosmetic concerns that pose no medical or healthcare threat. Most health insurance companies exclude coverage for these treatments.
Complications that may occur from such treatments are usually considered a healthcare concern and may be covered. Please carefully review the health insurance subscriber-information pamphlet specific to your plan if you have a private insurance carrier.
FINANCIAL RESPONSIBILITIES
You will be responsible for all necessary payments. Additional costs may occur should complications develop from treatment. There are no refunds once a treatment has been performed.
DISCLAIMER
Informed Consent Booklets are used to communicate information about the proposed treatment of a condition along with disclosure of risk and alternative treatment(s). The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.
The contents of this booklet and any discussions with Gangnam Spa outline the material risks, both common and uncommon, that Gangnam Spa feels a reasonable person would want to know, understand, and consider when deciding how and if they wish to proceed with the proposed treatment of their condition.
However, Informed Consent Booklets should not be considered all-inclusive in defining other methods of care and risk encountered.Gangnam Spa may provide you with additional or different information based on all the facts in your
particular case and the 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.
It is important that you read the above information contained on this and all preceding pages carefully and have all of your questions answered by Gangnam Spa before signing the consent on the last page