Informed Consent For Dermal Filler Injection
This is an informed consent document that has been prepared to help inform you concerning Hyaluronic Acid fillers such as Restylane®, Juvaderm, Versa, & Belotero. (Non-Animal Stabilized Hyaluronic Acid) tissue filler injection therapy, its risks, and alternative treatments. As well as Radiesse, a sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal, injectable implant, whose principal component is synthetic calcium hydroxylapatite, a biocompatible material with over 20 years of use in medicine, approved for use in hands, cheeks, and pre-jowl sulcus. Hyaluronic acid is a naturally occurring substance that is found within all mammals. It is a material that is contained in various soft tissues. Hyaluronic acid
can be synthetically produced from a process of bacterial fermentation, chemically stabilized, and purified for use as an injectable soft tissue filler (nonanimal, stabilized hyaluronic acid). The hyaluronic acid in Dermal-Fillers is biocompatible and is a totally non-animal product; there is little risk of animal-based disease transmission or allergic reaction. Dermal-fillers can be performed in areas involving the face, eyebrows, temples, under eyes, nose, jaw, chin, jowls, cheeks, hands, forehead, and lips, just to name a few and some areas are considered Off-Label use, not FDA approved areas. Dermal-Filler injections contain local anesthetic in the syringe to diminish discomfort. Continuing treatments are necessary in order to maintain the effect of Fillers over time, they do not stop the aging process. Once injected, dermal fillers will be slowly absorbed by the body. The length of effect for fillers injections is variable and depends on the person.
Alternative forms of management include not treating the skin wrinkles or soft tissue depressions by any means. Improvement of skin wrinkles and soft tissue depressions may be accomplished by other treatments: laser treatments, chemical skin-peels, other skin procedures, or alternative types of tissue fillers.
RISKS OF FILLER INJECTIONS
An individual’s choice to undergo this procedure is based on the comparison of the risk to the potential benefit. Normal Occurrences during Tissue Filler Injections
-Bleeding and Swelling – Swelling (edema) is a normal occurrence following the injections. It decreases after a few days or weeks. Erythema (Skin Redness) – Erythema in the skin occurs after injections. It can be present for a few days after the procedure. Needle Marks – Visible needle marks from the injections occur normally and resolve in a few days.
-Acne-Like Skin Eruptions – skin eruptions can occur following the injection of tissue fillers that generally resolve within a few days. Skin Lumpiness – Lumpiness can be treated with ethylene to smooth it out if necessary.
-Visible Tissue Filler Material – This can be resolved with hylenex
-Asymmetry – It may not be possible to achieve or maintain exact symmetry with
tissue filer injections.
-Pain – Discomfort associated with injections is normal and usually of short duration.
RISKS OF DERMAL-FILLER INJECTIONS
-Damage to Deeper Structures – Deeper structures such as nerves and blood vessels may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.
-Infection – unusual, herpes outbreaks can be triggered
-Vascular compression and vascular occlusion- if this were to occur immediately or delayed, the appropriate protocol would be initiated for reversal. Therefore, it is imperative you follow the post instructions template and what to look for such as pain, skin color changes ext. if you notice or feel anything that makes you concerned you are to contact the clinic immediately or seek emergency evaluation.
-Skin Necrosis – It is very unusual to experience the death of skin and deeper soft tissues after dermal-filler injections. Skin necrosis can produce unacceptable scarring. Should this complication occur, additional treatments, or surgery may be necessary.
-Allergic Reactions and Hypersensitivity
-Scarring – Dermal-fillers maybe susceptible to keloid formation or hypertrophic scarring.
-Granulomas – Painful masses in the skin and deeper tissues after dermal-filler injections are extremely rare. Should these occur, additional treatments including surgery may be necessary.
-Antibodies to Fillers – The presence of antibodies to hyaluronic acid tissue fillers may reduce the effectiveness of this material or produce a reaction in subsequent injections. The health significance of antibodies to hyaluronic acid tissue fillers is unknown.
-Accidental Intra-Arterial Injection – It is extremely rare and unpredictable
-Under /Over Correction – The amount of correction may be inadequate or excessive. It may not be possible to control the process of injection of tissue fillers due to factors attributable to each patient’s situation. If under correction occurs, you may be advised to consider additional injections of tissue filler materials. If over correction occurs, the use of hylenex can decrease the volume.
-Migration of Dermal-Fillers – Dermal-fillers may migrate from their original injection site and produce visible fullness in adjacent tissue or other unintended effects.
-Drug and Local Anesthetic Reactions – There is the possibility that a systemic
reaction could occur from the local anesthetic when tissue filler injections are performed. This would include the possibility of light-headedness, numbness, and, allergic reaction, and fainting. Medical treatment for these conditions may be necessary.
-Unsatisfactory Result – Dermal-filler injections alone may not produce an outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response from filler injection(s).
-Pregnancy and Nursing Mothers – Animal reproduction studies have not been performed to determine if dermal filler could produce fetal harm. It is not known if Restylane®, Juvaderm, Versa, or Beloteo or other filler brand names or its breakdown products can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive dermal-filler treatments.
-Drug Interactions – It is not known if fillers react with other drugs within the body. Label FDA IssuesThere are many devices, medications and injectable fillers that are approved for specific use by the FDA, but some proposed use is “Off-Label”, which is not specifically approved by the FDA. It is important that you understand this proposed use is not experimental and your physician believes it to be safe and effective.
I understand and agree that all services rendered to me are charged to me directly and that I am personally responsible for payment. The fees charged for this procedure does not include any potential future costs for additional procedures that you elect to have or require in order to revise, optimize, or complete your outcome. Additional costs may occur should complications develop from the injections and will also be your responsibility. In signing the consent for this procedure, you acknowledge that you have been informed about its risk and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments. I understand and unconditionally and irrevocably accept this & that all costs are NONREFUNDABLE
I have received and read the INFORMED CONSENT and PRE & POST PROCEDURE INSTRUCTIONS that were explained to me & I agree to follow all instructions, to follow up as directed, and to notify the office if any problems or questions arise.
The nature and purpose of the treatment have been explained to me. I understand what my provider can and cannot do, and I understand there are no warranties or guarantees implied or specific about my outcome. I have had the opportunity to explain my goals and understand which desired outcomes are
realistic and which are not. I have read and understand this agreement. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. Alternative methods of treatment and their risks and benefits have been explained to me.
I understand that I have the right to refuse treatment. By signing this form, I elect to proceed with treatment.
I consent to be photographed or televised before, during, and after the procedure(s) to be performed, including appropriate portions of my body, for medical, scientific, or educational portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.
I take full liability and responsibility for any and all risks, undesired outcomes, or adverse events associated with the injections and will not hold the providers liable for any unfavorable outcome or adverse event. I release Sei Tu Bella Aesthetics LLC, owners, and medical staff from liability associated with the procedure. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors, and assigns. I relieve Heather Merlo, APRN, FNP-C, Medical Director Dr. Fernando Jara and Sei Tu Bella Aesthetics LLC, from all legal action pertaining to this treatment.