The SkinStylus® SteriLock® MicroSystem is a minimally invasive, micro-needling device. The SkinStylus device creates microchannels into the skin’s outer layers. As these microchannels heal, the remodeling process works to improve the skin’s appearance. There are several brands of microneedling devices on the market. All medical and cosmetic procedures carry risks and may cause complications. The purpose of this document is to make you aware of the nature of the procedure and its risks in advance so that you can decide whether to go forward with the procedure or not.
Microneedling may cause discomfort during and after the treatment. To minimize the discomfort, a topical numbing cream may be applied to your skin before the procedure. Let your provider know if you have allergies to the numbing cream. The skin will then be thoroughly cleansed and a pre treatment serum may be applied to the treatment area During the treatment, the SkinStylus device will be passed multiple times over your skin to create the microchannels. It is normal to experience a small amount of bleeding from these punctures. After the treatment, the skin will be cleaned.
The most common side effects to the treatment area are redness, swelling, a feeling of skin tightness, sensitivity to touch, burning, tingling, stinging, itching, dryness, scaling, and pigment changes. These side effects are transient. There is a possibility that you could develop an infection (with subsequent tenderness, redness, swelling, itching, and formation of pus), striae (linear marks), extended redness, reactivation of herpes simplex virus (cold sore), and pigment changes that may be permanent.
The safety and effectiveness of the SkinStylus SteriLock MicroSystem has been established in a clinical study to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. Other indications for the SkinStylus SteriLock MicroSystem have not been cleared by the FDA.
Prior to treatment, please observe the following:
• Do not use any retinoid products or applications 12 hours prior to your treatment. • Do not expose yourself to prolonged sun exposure (i.e.: 4 hours) pr ior to your treatment. A SkinStylus treatment will not be administered on sunburned skin.
• On the day of the treatment, please keep the treatment area clean
Post Treatment:
• Do NOT use any Alpha Hydroxy Acids, Beta Hydroxy Acid, Retinoids (Vitamin A), Vitamin C (in a low pH formula) or anything perceived as ‘active’ skincare for at least 2 hours after the treatment
• Avoid direct sunlight to the treatment area for 24 hours. No tanning beds. • Do not go swimming for at least 24 hours post-treatment
• No exercising or strenuous activity for the first 24 hours post-treatment
The SkinStylus SteriLock MicroSystem has not been evaluated in some patient populations. Therefore, if you have a history of the following conditions or have taken the following medications, please let your provider know, as treatment with the SkinStylus SteriLock MicroSystem may not be appropriate for you: Actinic (solar) keratosis; active acne; collagen vascular diseases or cardiac abnormalities; diabetes; eczema, psoriasis and other chronic conditions in the treatment area or on other areas of the body; immunosuppressive therapy; history of contact dermatitis; raised moles in the treatment area; rosacea; active bacterial or fungal infection, active viral herpes simplex infections (cold sores); warts; keloid scars; use of anticoagulants (also known as ‘blood thinners’); scars and stretchmarks less than 3 months old; scleroderma; and wound-healing deficiencies.
Let your provider know if you are allergic or sensitive to any of the ingredients used in the pre-treatment serum.
Be sure to report to your provider any redness and/or visible swelling that lasts for more than a few days or any other symptoms that cause you concern.
Most individuals are pleased with the results from their microneedling treatments. However, like any cosmetic procedure, results may vary, and there is no guarantee that you will be completely satisfied, or that you will not require additional treatments to achieve the results you seek.
I have read the information about microneedling in its entirety and have discussed the risks and benefits of treatment with . I have disclosed all pertinent information to my provider. I understand the information that was provided to me, and that there is no guarantee of any particular results. I agree to being treated with the SkinStylus SteriLock MicroSystem.
This consent covers all microneedling treatments today and for all subsequent treatments until such consent is revoked in writing.