VBeam Treatment Consent
I understand that the VBeam Perfecta device used for rosacea, facial telangiectasia, angiomas, port wine stains, hemangiomas, wrinkle reduction, benign pigmented lesions removal leg veins and other vascular lesion treatments, of which I am consenting to be a patient receiving treatment (specify procedure). I understand the procedure involves using a 595nm flash-lamp excited pulse dye laser designed for the treatment of benign cutaneous vascular lesions, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte and/or benign cutaneous lesions.
The Vbeam Perfecta delivers pulses of laser energy at a wavelength of 595nm that passes through the epidermis and dermis skin layers and is absorbed by the hemoglobin in the blood vessels rather than by the surrounding tissue. The absorbed laser energy is converted into heat, causing coagulation of the target vessels, which are not subsequently regenerated. The pulse duration used is long enough to produce controlled coagulation but short enough to avoid thermal damage to the surrounding tissue. I understand this device will not prevent me from developing or re-developing vascular lesions. No guarantees can be made with regards to clinical outcomes. I understand I may not experience complete clearance, and that it may take multiple treatments. Some conditions may not respond at all, and in rare cases, may become worse.
I understand that clinical results may vary depending on individual factors, including but not limited to medical history, skin type, patient compliance with pre- and post-treatment instructions, and individual response to treatment.
ALTERNATIVE TREATMENTS – Alternative forms of treatment include not undergoing the proposed laser procedure. Other forms of skin treatments such as other laser and light-based treatments, sclerotherapy, topicals and skin care, chemical peels and surgery may be substituted. In certain situations, the laser may offer a specific therapeutic advantage over other forms of treatment. Alternatively, laser treatments in some situations may not represent a better alternative to other forms of skin treatment when indicated. Risks and potential complications are associated with alternative forms of treatment that involve skin laser treatments.
I am aware of the following possible experiences/risks:
PAIN & DISCOMFORT – The level of pain and discomfort varies with a person’s tolerance, and both may be experienced during treatment.
BURNS – Laser energy can produce burns. Adjacent structures, including the eye, may be injured or permanently damaged by the laser beam if appropriate precautions are not taken such as using protective eyewear during treatment. Burns are rare, yet represent the effect of heat produced within the tissues by laser energy. Additional treatment may be necessary to treat laser burns.
REDNESS & SWELLING – Short term redness (erythema) or swelling (edema) of the treated area is common and may occur. An urticarial (hive-like) reaction may occur as well.
PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time.
HEMOSIDERIN STAINING – (Iron leaking into tissue from blood breakdown) may occur and usually resolves over time, but it may be permanent.
SKIN SENSITIVITY – Itching, tenderness, or exaggerated responses to hot or cold temperatures may occur. This typically resolves during the healing process, but in rare situations it may be chronic.
WOUND HEALING – Treatment can result in burning, blistering, or bleeding of the treated areas resulting in a wound. If this occurs, please contact our office.
INFECTION – Infection is a possibility whenever the skin surface is disrupted, though proper wound care should prevent this. If signs of an infection develop, such as pain, heat or surrounding redness, please contact our office at 941-264-1161. Herpes simplex virus infections (cold sores) around the mouth can occur/
reoccur following a laser treatment. This applies to both individuals with a history of Herpes simplex virus infections and individuals with no known history of Herpes simplex virus infections in the mouth area. If you had cold sores in the past, please let your provider know as specific medications can be prescribed and taken both prior to and following the procedure to suppress an infection from this virus.
BLEEDING – It is possible, though unusual to experience bleeding or pinpoint bleeding during or after treatment. Should any post-treatment pinpoint bleeding or bleeding occur, please contact our office immediately. Products and medications such as aspirin, anti-inflammatories and blood thinners can increase the risk of bleeding. Non- prescription herbs and dietary supplements can also increase the risk of bleeding. It is sometimes advised or recommended that you avoid taking any blood thinners seven to fourteen days prior to and/or after your treatment. Speak to your provider before stopping any medications.
PIGMENT CHANGES (Skin color) – There is a possibility that the treated area can become either hypopigmented (lighter or white) or hyperpigmented (darker) in color compared to the surrounding skin. This is usually temporary but can be permanent.
ACCUTANE (Isotretinoin) – Accutane is a prescription medication used to treat certain skin diseases. If you have ever taken Accutane, you should discuss this with your treatment provider. This drug may impair the ability of skin to heal following treatments for a variable amount of time even after the patient has ceased taking it. Individuals who have taken this drug are advised to allow their skin adequate time to recover from Accutane before undergoing skin treatment procedures.
FIRE – Inflammable agents, surgical drapes and tubing, hair, and clothing may be ignited by laser energy. Laser energy used in the presence of supplemental oxygen increases the potential hazard of fire. Some anesthetic gases may support combustion.
EPIDERMAL CRUSTING – Pigmented or vascular lesions may crust or scab as part of the healing process. It is important not to pick or disturb the crusts as they heal. They may require medical attention if sensitivity or redness occurs. Crusts will typically slough off 1-3 weeks after treatment.
LASER SMOKE (Plume) – Laser smoke may be noxious to those who encounter it. This smoke may represent a possible biohazard.
SKIN TISSUE PATHOLOGY – Laser energy directed at skin lesions may potentially vaporize the lesion. Laboratory examination of the tissue specimen may not be possible.
VISIBLE SKIN PATTERNS – Vbeam Perfecta treatments may produce visible patterns within the skin. The occurrence of this is not predictable.
DAMAGED SKIN – Skin that has been previously treated with chemical peels or dermabrasion, or damaged by burns, electrolysis (hair removal treatments), or radiation therapy may heal abnormally or slowly following treatment by lasers. The occurrence of this is not predictable. Additional treatment may be necessary. If you have ever had such treatments, you should inform your treatment provider.
SCARRING – Scarring is a rare occurrence, but it is a possibility whenever the skin surface is disrupted. To minimize the chances of scarring, it is IMPORTANT that you follow all post-treatment instructions carefully.
TEXTURAL CHANGES/CUTANEOUS INDENTATIONS – Textural and/or skin changes may occur because of treatment.
UNDESIRERABLE HAIR REDUCTION – Hair reduction may occur at treatment sites. This is typically temporary but can be permanent.
ALLERGIC REACTIONS – In some cases, local allergies to products used during or after treatment such as adhesive, numbing agents, topical preparations and topical post-care have been reported. Systemic reactions which are more serious may occur to drugs used during the procedure. Allergic reactions may require additional treatment.
EYE EXPOSURE – Eye injury is possible from laser procedures. Protective eyewear (shields or goggles) will be provided. It is important to keep these on always during the treatment to protect your eyes from injury.
SUN EXPOSURE/ TANNING BEDS/ ARTIFICIAL TANNING – May increase risk of side effects and adverse events. It has been advised that you discontinue and avoid UV exposure and artificial tanning before, during, and after your treatment and recommended that you discontinue this practice all together as the effects of the sun are damaging to the skin. A broad spectrum (UVA/UVB) sunscreen should be used to prevent further pigmentation. Exposing the treated areas to sun may result in increased scarring, color changes, and poor healing. Patients who tan, either outdoors or in a salon, should inform their treatment provider and either delay their treatment or avoid UV exposure until your provider says it is safe to resume. The damaging effects of UV exposure occurs even with the use of sunscreen or clothing coverage.
TREATMENTS – The number of treatments vary but multiple treatments are typically required. The number of treatments needed to clear your vascular lesion or obtain optimal results is unknown.
LACK OF PERMANENT RESULTS – Vbeam Perfecta or other skin treatments may not completely improve or prevent future skin disorders, lesions, or wrinkles. No technique can completely reverse the signs of aging. Additional Vbeam Perfecta treatments may be necessary to further improve results. You may be required to continue with a skin care maintenance program after a Vbeam Perfecta treatment.
OTHER – You may be disappointed with the results of your Vbeam Perfecta treatment. Infrequently, it is necessary to perform additional Vbeam Perfecta treatments to improve your results.
UNKNOWN RISKS – There is the possibility that additional risk factors of Vbeam Perfecta treatment may be discovered.
Additional Advisories
TRAVEL PLANS – Any treatment holds the risk of complications that may delay healing and delay your return to normal life. Please let the treatment provider know of any travel plans, important commitments already scheduled or planned, or time demands that are important to you, so that appropriate timing of your treatment can occur. There are no guarantees that you will be able to resume all activities in the desired time frame.
SKIN CANCER/SKIN DISORDERS – Vbeam Perfecta treatments and skin treatment procedures do not offer protection against developing skin cancer or skin disorders in the future.
BODY PIERCINGS – Individuals who currently wear body-piercing jewelry in the treated region are advised that an infection could develop from this activity.
MENTAL HEALTH DISORDERS AND ELECTIVE PROCEDURES – It is important that all patients seeking
to undergo elective treatments have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional treatments, and can be stressful. Please openly discuss with your treatment provider, prior to the treatment, any history that you may have of significant emotional distress or mental health disorders. Although many individuals may benefit psychologically from the results of elective procedures, effects on mental health cannot be accurately predicted.
Your consent and authorization for this elective procedure is strictly voluntary. By signing this informed consent form, you hereby grant authorization to our medical staff to perform and/or to administer any related treatment as may be deemed necessary or advisable in the diagnosis and treatment of your condition.
The nature and purpose of this elective procedure and the complications and side effects have been fully explained to me. Alternative treatments and their risks and benefits have been explained to me and I understand that I have a right to refuse treatment. I agree to adhere to all safety precautions and instructions after the treatment. I have been instructed in and understand post treatment instructions and have been offered a written copy of them. I understand that no refunds will be given for treatments received. No guarantee has been given by anyone as to the results that may be obtained by this treatment.
I have read this informed consent and certify that I understand its contents in full. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. I have had enough time to consider the information given me and feel that I am sufficiently advised to consent to this procedure. I accept the risks and complications of the procedure. I certify if any changes occur in my medical history I will notify the office.