Sample Medical Profile/informed Consent Form - Fractora Page 2
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3Specific Informed Consent for Fractora™ Treatments
This form is designed to give you the information you require to make an informed choice of whether or
not to undergo treatment with Fractora™ technology. If you have any questions before your treatment
please feel free to ask.
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I hereby authorize Dr._____________ and/or such assistants as may be selected to
perform the Fractora procedure.
•
The physician obtained my medical history and found me eligible for treatment.
I have received the following information about the technology:
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Fractora™ technology utilizes fractional radiofrequency (RF) indicated for
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facial/neck/ chest and back of hands, as well as small body areas.
The Fractora™ treatment induces ablation, thus improving the appearance of
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rough texture, fine lines, wrinkles, and depressed scars, such as acne scars
along with superficial pigments that will be ablated. The treatment also induces
skin rejuvenation by heating of the dermis which stimulates collagen generation
and replenishment, as well as closure of superficial fine blood capillaries.
The treatment requires anesthesia that involves topical cream, injections, or
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sedation according to the treatment parameters and the physician discretion.
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I understand that taking the treatment course is my choice and that I am free to withdraw
at any time, without giving any reason.
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There may be alternative procedures or methods of treatment, such as fractional lasers for
ablation (CO
) and lasers, IPL or RF based systems for skin rejuvenation. As of today, there are
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no systems in the market that can address the variety of lesions that Fractora does. Details were
explained to me.
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I was told about the possible side effects of the treatment including: local pain, skin
redness (erythema), swelling (edema), damage to the natural skin texture (crust, blister,
burn), change of skin pigmentation (hyper- or hypo-pigmentation), and scarring.
Although these effects are rare and expected to be temporary, redness and swelling may
last up to 3 weeks, and are part of a normal reaction to the treatment. Burns and
resulting pigmentation change and scarring are rare and may happen in dark skin that is
not taken care according to instructions. Tiny scabs appear on the face for a few days as
part of a normal healing, however make-up may be applied as soon as 1-3 days after the
session to mask them and residual redness. Any adverse reaction should be reported
immediately.
I understand that the treatment involves a few sessions (1-5), a few weeks apart (3-6
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weeks), according to treatment parameters and individual response.
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I understand that I have to comply with treatment schedule, otherwise results may be
compromised.
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I recognize that during the course of the procedure unforeseen conditions may
necessitate different procedures than this above and I authorize the physician or
assistants to perform such other procedures if they find them professionally desired.
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I understand that not everyone is a candidate for this treatment and results may vary.
Therefore, there is no guarantee as to the results that may be obtained.
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