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SkinPen ® Patient Consent Form



DESCRIPTION OF THE PROCEDURE


SkinPen is a medical-grade, state-of-the-art microneedling device designed to improve the appearance of fine lines, wrinkles, and scars on the face and body. The SkinPen device intentionally creates very superficial “micro-injuries” to the outermost layer of the skin to induce the healing process, automatically triggering new collagen production. According to Harvard Health, patients experience between 45 and 55 percent improvement in collagen and elastin after just one treatment.

Micro-needling has been shown to reduce the visibility of acne scars, fine lines, and wrinkles; diminish hyper-pigmentation; and improve skin tone and texture, resulting in smoother, firmer, younger- looking skin. Micro-needling has been safely used in a wide variety of patient types including patients of all skin types. 3-6 treatments are required for best results and up to 6 treatments for more severe

scarring and stretch marks. For anti-aging 1-2 treatments a year.


SIDE EFFECTS

After the procedure, the skin will be red and flushed in

appearance, similar to a moderate sunburn. You may also

experience skin tightness and mild sensitivity to touch on

certain areas. This will diminish significantly within a few

hours following the procedure. Within the next 24 hours, the

skin will have returned to normal. After three days, there is

rarely any evidence that the procedure has taken place.


CONTRAINDICATIONS

Microneedling is contraindicated for patients with: keloid

scars, scleroderma, collagen vascular diseases or cardiac

abnormalities, a hemorrhagic disorder or haemostatic

dysfunction, active bacterial or fungal infection.


PRECAUTIONS AND WARNINGS

Microneedling has not been evaluated in the following

patient populations, and as such, precautions should be

taken when determining whether the SkinPen procedure is

adequate for the patient: scars and stretch marks less than

one year old; women who are pregnant or nursing; keloid

scars; patients with history of eczema, psoriasis and other

chronic conditions; patients with history of actinic (solar)

keratosis; patients with history of herpes simplex infections;

diabetics or patients with wound-healing deficiencies;

patients on immunosuppressive therapy; and skin with

presence of raised moles or warts on targeted area.


Before Your Treatment


Avoid sun exposure for 24 hours prior to the procedure. If you have been overexposed to the sun (sunburn) in the days preceding your appointment, please call our office to reschedule.

Allow 2 weeks after spray or self-tanning lotions before your SkinPen procedure.

Discontinue the use of topical products containing Retin-A, Retinol, or Vitamin A for at least 7 days prior to your SkinPen procedure.

Wait at least six months post isotretinoin (Accutane) use before your SkinPen procedure, as isotretinoin use may impair wound healing and increase the risk of scar tissue formation.

You are advised to keep your skin clean of cosmetics or chemical sunscreen for 48 hours post- procedure. Please ask your provider to recommend a post-procedure-approved physical sunscreen

This procedure may not be performed on active breakouts or open lesions. Please consult your aesthetician prior to your SkinPen procedure to address any such issues. We recommend purchasing Levicyn™ Antimicrobial Dermal Spray, a hypochlorous acid (HOCl) based topical

prescription product that cleanses, moistens, and removes foreign material, to mitigate any risk of infection, if you are actively congested or have more oil production.

You should avoid NSAIDs (Advil, Ibuprofen, Aleve) and supplements such as fish oil which may increase the chance of bruising and bleeding in the treatment area.

Strongly consider enhancing your treatment with Core Recovery Complex, an unrivaled serum of highly concentrated, targeted growth factors and cytokines formulated to aid in the recovery of the skin following Medical Aesthetics Bar skin procedures.


What to Expect During Treatment

Day 1: Skin will be red and flushed after treatment, depending on the intensity of the treatment.

Pinpoint bleeding may occur. Do not apply makeup for at least 12 hours. Preferably 3-4 days.

Day 2: A red or pink hue persists like a moderate sunburn. Swelling and slight bruising may be more noticeable on the second day. Minor scratches may be visible. Dryness may be more noticeable on

the second day and is a part of normal healing. Moisturizing botanical healing serums that can have natural antiseptic properties like hyaluronic, SkinCeuticals Phyto-Corrective Gel, Phyto-C O-Live Gel, and post-procedure botanical oils or moisturizers are great additions for healing relief to and are recommended for purchase. Take your healing seriously and apply as often and as much as needed. Keep your skin well moisturized to support the healing process. A Post Treatment sheet

mask is recommended for 45 mins the day after treatment to help with healing.


Day 3: Skin can be pink or normal color. Swelling subsides. The skin can feel dry or feel tight. A slight outbreak of acne or milia is possible. Staying as hydrated as possible usually helps minimize breakouts. Light peeling usually occurs.



Post-Treatment Instructions

Wash your hands with warm, soapy water then use a gentle cleanser and wash your face using only your fingers. Gently massage the face with lukewarm or cold water. Remove serum and other

debris such as dried blood. Do not use a scrub, washcloth, or a Clarisonic brush. Cleanse areas treated twice daily. Do not use exfoliating products or retinol for 7-10 days.

Clean, cold compresses may be applied following treatment for comfort. If neck or decolletage is treated, the redness might last slightly longer.

Apply Levicyn spray or gel on treated areas 2-3 times a day to reduce excessive itching or redness, and to clean from infection until skin is visibly healed.


Continue to avoid sun exposure to the treatment areas and apply a physical block sunscreen with a minimum of SPF 40, apply it at least 30 minutes prior to sun exposure, and repeat after every 2

hours while exposed to the sun. A hat is highly recommended for sun protection.

After 4-5 days patients can return to regular skin care products or as soon as it is comfortable to do so. Mineral makeup or tinted mineral spf may be applied 12-48 hours following treatment.

Do not exercise for 24 hours after treatment.

Avoid dirty gyms for 48 to 72 hours as they are breeding grounds for bacteria.

Avoid saunas, steam rooms, hot baths, or showers until the redness is gone as they are excessively drying.

Avoid waxing, facials, peels, lasers, and any other abrasive treatments until two weeks after treatment.

Make sure you are drinking at least 6-8, 8 oz. glasses of water a day as your body needs internal nourishment for new cell regeneration.


If you feel you are having an adverse event, please contact Medical Aesthetics Bar at (860) 841 6403

SkinPen Micro-needling Consent Form

The nature of the Micro-needling procedure has been explained to me. I understand that just as there may be benefits from the procedure, all procedures involve risk to some degree. Side effects can have pain, prolonged redness, broken capillaries, white heads & pimples, hyper

and/or hypopigmentation, infection, bleeding, scarring, sensitivity, allergic reactions, damage to eyes and/or surrounding structures, burns, dissatisfaction with results, need for further procedures, &

unforeseen side effects may occur. I understand that the following are among the expected side effects of the Micro-needling procedure:


Discomfort:

Most people will feel some heat-related discomfort (pain) with the treatment. This discomfort is usually temporary but may persist for a few days.


Persistent Redness, Itching, AND/OR Swelling:

Itching, redness, and swelling are normal parts of the healing process. These symptoms rarely persist

longer than 24 hours.


Blisters:

Mild to moderate blisters developing after the treatment are uncommon but have been reported. If Blisters do develop, care should be taken not to disturb or unroofed, blistering should be evaluated by the treated provider.


Transient acne flare-ups:

Whiteheads & pimples can pop up after the treatment as purging can sometimes happen but can be

easily controlled by homecare products, consult with your provider on how to manage purging.


Temporary skin dryness:

Temporary mild skin dryness is common after the treatment. Itching sensations often occur if the

skin dries or as the old skin is shed and the new skin is formed. Temporary skin dryness typically

resolves within a week. Make sure to hydrate and nourish properly.


Scarring:

Scarring is a rare occurrence, but it is a possibility whenever the skin's surface is disrupted. To minimize the chances of scarring, it is important that patients follow all post-treatment instructions

provided by their provider. Good post-treatment care will help reduce the possibility of scarring.


Pigment/Color Change (hyperpigmentation):

During the healing phase, the treated area may appear to be darker. Brown darkening of the skin (hyperpigmentation) can occur either following blistering or crusting or as a result of inflammation

during the recovery period. PIH occurs as a part of the normal skin reaction to injury. The skin functions become hyperactive during the healing process, including cells that produce pigment. PIH

occurs more frequently with darker-colored skin, after sun exposure to the treatment area, or with patients who already have a tan. To reduce the risk of PIH, the treated area must be protected from exposure to the sun (sunscreen for 2 months after treatment); however, in some patients, increased skin coloring may occur even if the area has been protected from the sun. This pigmentation usually fades in 3 to 6 months. Hyperpigmentation is very rarely permanent. Your treating provider may

recommend topical skin-lightening products to accelerate the return to normal pigmentation levels.

Lastly, avoid picking and/or peeling the skin during the healing period.


Hypopigmentation:

Lightening or loss of skin pigmentation is very rare, however, it is a possible adverse event, especially in patients with a history of vitiligo or pigmentary disorders.


Infection:

Infection is possible after treatments; herpes simplex virus infections can occur following treatments. This applies to both individuals with a history of cold sores and individuals with no known history. We recommend purchasing Levicyn™ Antimicrobial Dermal Spray, a hypochlorous acid (HOCl) based topical prescription product that cleanses, moistens, and removes foreign material, to mitigate any risk of infection. Other signs of an infection can be high fever, purulence (pus),

worsening redness, increased swelling in the area, blisters, pustules, and worsening pain. Should these symptoms occur, the clinician must be immediately notified to prescribe appropriate medical

care. Topical and/or oral antibiotics may be necessary.


Allergic Reactions:

Allergic reactions can occur. Some persons may have a hive-like appearance in the treated area. Some persons have localized reactions to topical ointments/creams. Systemic reactions are rare.


Lack Of Permanent Result:

Micro-needling will not completely or permanently improve skin texture, tone, elasticity, hyperpigmentation, or scars, or minimize fine lines and wrinkles. It is important that your expectations be realistic, and that you understand that the procedure has its limitations. Additional

procedures may be necessary to achieve your desired effect.


Unsatisfactory Result:

Although rare from micro-needling, there is a possibility of a poor result from any cosmetic procedure. Micro-needling may induce undesirable results, including but not limited to skin sloughing, scarring, permanent pigment change, and/or other undesirable skin changes. There is

always a possibility that you may be disappointed with the results of micro-needling.

I acknowledge the following has been discussed with me:


I understand the Risks / Complications / Side effects / Consequences of Micro-Needling: allergic

reactions, swelling, itching, infection / cold sores, color/texture change, visible skin laser patterns, bleeding, burns, abnormal/slow/delayed healing, scarring, distortion of anatomic features, redness, dry eyes with corneal irritation, eye damage, chronic pain, delay in skin cancer

diagnosis, and lack of permanent results or unsatisfactory results, need for further procedures.

I understand that compliance with pre- and post-care instructions is crucial for the success of my treatment and to prevent unnecessary side effects or complications.


During the healing phase, sun exposure can cause darkening of the treated area(s) called post-inflammatory hyperpigmentation, therefore, sun avoidance must be followed. Failure to follow instructions may increase risks. Additional risks include unknown rare risks and the need for

additional treatments or surgery. Follow all aftercare instructions to minimize the risk of having adverse effects. Although improvement is expected, there is no guarantee or warranty expressed

or implied with respect to the results that may be obtained. AVOID SUN EXPOSURE FOR THE NEXT 8

WEEKS.


I understand that many variable conditions influence the long-term results of skin resurfacing treatments. The practice of medicine and surgery and the subsequent use of lasers is not an exact science.

Although good results are expected, there is no guarantee, expressed or implied, on the results that may be obtained. Repetition of treatment, skin care regimen, and other procedures aid in results.


Financial Responsibilities – This procedure is elective and not medically necessary and therefore, not covered by insurance. Any complications requiring additional medical care and/or treatment

or revisionary procedures would be the patient's responsibility also. There are no refunds.


For women of childbearing age:

By signing below, I confirm that I am not pregnant and do not intend to become pregnant at any time during the course of the treatment. Furthermore, I agree to keep Medical Aesthetics Bar and my

provider informed should I become pregnant during the course of the treatment.


WRITTEN CONSENT

Photographic documentation will be taken. I hereby do authorize the use of my photographs for teaching purposes.


BY MY SIGNATURE BELOW, I ACKNOWLEDGE THAT I HAVE READ AND FULLY UNDERSTAND THE CONTENTS OF THIS INFORMED CONSENT FORM FOR THE TREATMENT OF SKINPEN AND THAT I HAVE HAD

ALL MY QUESTIONS ANSWERED TO MY SATISFACTION BY MEDICAL AESTHETICS BAR TEAM.

I have read this form and understand it, and I request the performance of the procedure.

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