Risk Management



GentleMAX Laser Treatment Consent Form

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PLACE LETTERHEAD HERE AND REMOVE NOTE.   Version 3/25/2009
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NOTE:  THIS FORM IS INTENDED AS A SAMPLE ONLY OF THE INFORMATION YOU AS THE PHYSICIAN SHOULD PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY.

(This form is courtesy of John W. Shore, M.D., a practicing ophthalmologist in Austin, Texas.)

Informed Consent for GentleMAX 755/1064 Laser Treatment of Vascular and Pigmented Lesions

WHAT ARE THE INDICATIONS FOR THE GENTLEMAX LASER?
The GentleMAX Laser is a device that produces an intense but gentle burst of light that treats the abnormal vascular and pigmented blemishes (including freckles, age spots, spider veins) without permanently affecting the surrounding skin.

WHAT ARE THE POTENTIAL BENEFTS OF TREATMENT?
Lesions usually fade slowly over time as the treated vessels or areas of pigmentation are eliminated by normal post-treatment healing.  Immediately following treatment the areas treated are surrounded by a red flush. This reaction is normal and should resolve over 2 hours to 2 days after treatment.  Most vessels will disappear during the treatment.  Some larger vessels may only be reduced in size and require a second treatment. Pigmented spots will turn darker during treatment and will remain visible until the superficial crust, which forms only over the treated spots, falls off naturally 7 to 14 days after the treatment.  After the crust falls off the treated areas may look slightly pink for a short time. Gradually a normal skin color returns.

WHAT ARE SOME OF THE POTENTIAL SIDE EFFECTS OF TREATMENT?
Areas treated for abnormal vessels may also form a linear scaly surface crust over the vessels treated.  These will fall off after a few days.  Discomfort is minimal and can be treated with an application of cool compresses or topical antibacterial ointment following the procedure.

WHAT ARE SOME OF THE TREATMENT ALTERNATIVES?
There are various other treatment options available for the treatment of vascular and pigmented lesions including topical creams and ointments, surgery, or freezing. You can also choose to accept the appearance of these areas and not change them.

WHAT ARE THE RISKS/COMPLICATIONS OF USING THE GENTLEMAX LASER?
Some possible complications of GentleMAX laser treatments include but are not limited to:

Wound Healing:  The GentleMAX laser causes a disruption to the skin that takes several days to heal.  The superficial injury of the outer layers of skin may result in swelling or crusting over the treated area.  After the surface has healed, it may become sensitive to the sun for another two to twelve weeks.

Pigment Changes:  The treated area may heal with increased or decreased pigmentation (coloring).  This occurs most often in darker pigmented skin and following exposure of the area to the sun.  It is recommended to protect the treated area from any sun exposure with an SPF of 30+ for 3 – 4 weeks following treatment.  If increased pigmentation occurs, it usually fades in three to six months; however, pigment changes can be permanent.

Scarring:  There is a small chance of scarring including hypertrophic scars or very rarely, keloid scars.  Keloid scars are raised scar formations.  To minimize chances of scarring, it is important that you follow all postoperative instructions carefully.  It is important to tell your doctor about any prior history of unfavorable healing.

Lesion Recurrence:  Some vascular and pigmented lesions may not go away completely or may recur after treatment despite the best efforts made.

Complete clearing of lesions may not be possible and will depend upon the type, age and color of the lesion. Multiple treatments may be needed for the best results. If additional laser treatments are necessary, subsequent treatments will normally follow at four to six week intervals.
There is no guarantee as to the result that will be obtained by these procedures.

PATIENT’S ACCEPTANCE OF RISKS
By providing your signature below, you acknowledge that you have read or have had read to you the contents of this form.  Further, your signature indicates that you understand the information presented above and feel that you have been adequately informed of alternative treatment options and potential risks of the proposed laser treatment.

Please initial: _____ I am not currently using Accutane (acne treatment) nor have I used Accutane in the past 12 months.  Please initial: _______I am not pregnant (female clients).

I have read and understood all information presented to me before signing this consent form.

Signed: ________________________________________________Date:________________

Provider: _______________________________________________Date:________________

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