INFORMED CONSENT FOR FOTOFACIAL RF

This informed consent document has been prepared to help inform you about Fotofacial RF treatments, their risks, benefits and alternative therapies. You need to understand all of these things fully and to indicate that you do. Please initial each section and sign the consent at the end.

Introduction

Intense Pulsed Light ( IPL) and radiofrequency (RF) have been used effectively and safely for a variety of cosmetic skin problems.

Fotofacial RF treatments direct pulsed light into the dermis, or lower layer of skin, which gently heats the dermis. The treated elements attract the RF energy (electricity) producing micro-injuries. The injuries are repaired and because the injuries are micro-injuries they can be repaired rapidly and really are not visible to the naked eye. Part of the repair is new collagen production and fresh collagen is the “anti-wrinkle”. Over a series of treatments, this new collagen can smooth and soften wrinkles present at rest, decrease pore size and textural irregularities. The light portion of the therapy can help minimize pigmentary problems, vascular blemishes (dilated vessels) and rosacea can be lightened and improved.

Fotofacial RF requires 5-8 treatments to achieve maximal aesthetic skin rejuvenation. The results can be long lasting, especially if sun-avoidance to topical antioxidant regimens is followed. However, many patients repeat the treatment 3-4 times a year to maintain optimum effects.

Patients for Fotofacial RF should NOT BE TAN. Tans should be allowed to fade for at least 2 weeks before treatment and should be avoided, for 3-4 weeks after treatments. Pigment absorbs the pulsed light and can lead to burns. Even artificial tan (from a bottle) should be allowed to fade before beginning treatments.

Our practitioner have been trained directly by the physicians who developed Fotofacial RF. The treatments and devices used have been carefully designed to maximize safety but there is always risk of UNCOMMON adverse effects. You should weigh these carefully against the benefits of a smoother, brighter, more even and less red appearance.

Benefits

Rosacea – 50% improvement in redness and flushing.

Redness and small blood vessels – 50% improvement.

Dyschromia (brown spots.freckles and "sun spots") – 30 to 40% improvement.

Photoaging of face, chest, hands – 50% improvement.

Wrinkles – 50 to 60% improvement of fine wrinkles present at rest (not lines of expression)

Textural depression and irregularities – 40 to 50% improvement.

Pore size- 30% improvement.

Venous congestion under eyes – 40 to 50% improvement.

Acne scars (not pitted type) – 40 to 50% improvement.

Alternatives

The safest thing is to have things the same and attempt to camouflage with makeup. Laser resurfacing and deep chemical peels can accomplish the same objectives, but with significant downtime, greater risk and at least some discomfort. Injectible fillers and Botox can reduce wrinkles but don’t deal with the other problems. Cosmetic surgery (face lift) can produce lift, which Fotofacial RF cannot, but at much greater expense. Fotofacial RF combines effectiveness, no downtime, minimal risk, minimal discomfort and readily visible benefits.

Risks of Fotofacial RF and Microdermabrasion

Any cosmetic procedure involving light therapy involves a degree of risk, and although exceedingly uncommon, you need to understand and accept the rare risks involved. The vast majority of Fotofacial RF patients never experience ANY of these complications.

Discomfort: Mild discomfort can accompany Fotofacial RF treatments. We minimize these with topical anesthetic, cooling gel, and surprising effective blown cold air.

Skin Wound: This is an increasingly rare occurrence with Fotofacial RF, but can occur as a blister or wound. This is more common in darker skin types or in TANNED skin. If a blister develops, it may take 10-14 days to heal and sometimes leaves a noticeably lighter or darker area on the skin and even more rarely, a scar. (RISK less than 1%).

Pigment change: Less than 1% chance of temporarily increased pigment (dark spot) or decreased pigment (light spot). Usually these color changes are temporary and resolve over several weeks to months. Permanent pigment change can occur but is exceedingly rare. It is ESSENTIAL that you NOT TAN before the treatment as this will increase the risk of pigment change or skin wound.

Bruising: Very unusual in the face but can happen on the neck. If you are taking blood thinners, aspirin, ibuprofen (Motrin, Advil) or naproxen (Aleve) bruising is a little more likely.

Infection: Because Fotofacial RF does not involve cutting, surgery or breaks in the skin barrier, infection is extremely rare.

Fever Blister: Approximately 1% of patients will experience a flare of fever blisters if areas around the lip are treated. If you have this tendency, we can pretreat to prevent.

Excessive Redness or Swelling: Rarely, a moderate to significant degree of redness and/or puffiness of the skin will follow the treatment. This usually lasts 1-2 hours and is easily covered with makeup. In rare instances, this can persist for 1-2 days and this can be treated with mild topical steroid. (Bottom line: Don’t schedule Fotofacial the day before your daughter’s wedding).

Fragile Skin: Occasionally, the skin overlying the treatment area can become quite fragile. This is uncommon, but the fragile skin can become red and the outer layer peels off. This usually settles in 8-10 days and usually does not result in scar.

Additional Treatment: For most patients, the final result and maximum cosmetic facial enhancement will likely take between 5-8 treatments (most commonly 5 treatments over 15-20 weeks.) Over time gravity, sun exposure and normal aging can provoke the same degeneration changes and problems reappear. Maintenance treatments 3-4 times a year may prevent these changes. All treatments above the 5^th are at $250.00

Lack of Satisfaction: Different patients respond to Fotofacial, and to any procedure, differently. Occasionally people will be unhappy. However, 70-80% of patients who have undergone a series of five treatments report noticeable and significant improvement in appearance, quality and a more youthful appearance in the skin. We will attempt to make as sure as possible that your expectations are in line with what is possible. This is NOT a face lift. We can provide substitute treatments with IPL or Microderm if the progress is not to your satisfaction.

Pregnancy: Although no known adverse reactions to developing fetus are known for Fotofacial RF, we would not take any chances. This is a cosmetic procedure, why take a chance?

OTHER CONCERNS

Health Insurance: Facial wrinkles, pores, textural irregularity and pigmented blemishes and vascular lesions are cosmetic concerns. Fotofacial RF is a cosmetic procedure and is not covered by insurance.

Additional Treatments Needed: People are different. There are many variable conditions in addition to risks and potential complications that may influence the long term result from Fotofacial RF treatment. Even though risks and complications can occur infrequently, the risks cited here are particular to Fotofacial RF. Other complications and risks can occur, but are even more uncommon. The practice of medicine and surgery is not an exact science. Although good results are expected, there is not a guarantee or warranty expressed or implied as to the results that may be obtained. Infrequently, it is necessary to perform additional treatment to improve your results.

DISCLAIMER

Informed consent documents are used to communicate information about the proposed treatment of a condition along with disclosure of risks and alternative treatments. The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients most of the time. However, informed consent documents should not be considered all inclusive in defining other methods of care and risk encountered.

LATENESS / MISSED APPOINTMENTS

This procedure takes 45 minutes. We schedule them back to back. Therefore, if you are more than 10 minutes late, you may have to reschedule. If you come in or call you will not lose your deposit. You will be charged if you do not give us 24 hours notice to cancel an appointment. We may choose to waive this fee if this is a one time occurance.

It is important that you read the above information carefully and have all your questions answered before signing this consent form.