Cancellation Policy
This policy is in place to ensure the smooth operation of our courses, as last-minute cancellations can potentially impact the live injection experience for a student if the spots can't be filled. Please contact info@aestrainstitute.com.
Cancellations Made 3+ Weeks Prior to Course Date
Refunds will be considered minus a $200 processing fee.
Cancellations Made Within 2–3 Weeks of the Course Date
Refunds are not issued; however, you will receive a credit toward a future course.
Late Cancellations (Less Than 2 Weeks Before Course Date)
No refund will be issued.
No-Shows
If you do not show up for your scheduled course, no refund or credit will be issued. Additionally, you will not be eligible to serve as a model for future courses.
Thread Lift is effective in most cases; no guarantees are made that a specific patient will benefit from this procedure. Additionally, the nature of this cosmetic procedure may require a patient to return for multiple visits to achieve desired results or to determine whether Thread Lift may not be completely effective at treating a particular concern. This consent for and treatment is effective for (1) year from the date of execution unless revoked by the patient in writing.
PDO/PCL/PLA threads are FDA approved for FACIAL REJUVENATION. Currently, PDO threads are not FDA approved for rejuvenation of the body, however the material the PDO/PCL/PLA threads are made of are FDA APPROVED. These PDO/PCL/PLA aesthetic duration is from 18-24 months.
By signing this consent, I understand if I choose to have PDO/PCL/PLA threads used for OTHER THAN facial rejuvenation, I am aware the FDA has not approved these threads for rejuvenation of the body.
DISCLOSURE: Denise Merdich, APRN is a Consultant/Trainer for Les Encres distributors of the PDO, PCL, and PLA threads used in her practice.
POSSIBLE RISKS and SIDE EFFECTS
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1. DISCOMFORT: Some discomfort may be experienced during treatment. I give permission for the administration of the anesthesia when deemed appropriate.
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2. SCARRING: PDO Thread Lift for Mid-Face. Threads are inserted via a small acupuncture type needle; it may take a few days to heal. A scar at entry point is rare, but is always a possibility when entering the skin.
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3. BRUISING, SWELLING, INFECTION: With any minimally invasive procedure, bruising or swelling of the treated area may occur. Additionally, skin infection can occur even with appropriate infection control measures.
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4. BLEEDING: It is possible, though not common, to experience a bleeding episode during or after the procedure. Should bleeding occur, it may require treatment to drain accumulated blood (hematoma). Do not take aspirin, aspirin based products or anti-inflammatory medications (Advil, Motrin, Ibuprofen) for ten (10) days after treatment, as this may contribute to a greater risk of bleeding.
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5. DAMAGE TO DEEPER STRUCTURES: Deeper structures such as nerves, blood vessels and muscles may be damaged during the course of this procedure. The potential for this to occur varies according to the location on the body the procedure is being performed. Injury to deeper structures may be temporary or permanent.
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6. ALLERGIC REACTIONS: in very rare cases, local allergies to tape, suture material, topical preparation or anesthesia have been reported. Systemic reactions, which are more serious, may result from drugs used during the procedure and/or prescription medications. Allergic reactions may require additional treatment.
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7. ANESTHESIA: Local topical anesthesia and injectable anesthesia may be used and can involve risk of allergic reaction and rash.
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8. PIGMENT CHANGES (SKIN COLOR) (hyper or hypo-pigmentation): There is a remote possibility of the treatment area becoming lighter or darker in color than the surrounding skin. This is usually temporary, but on occasion, may be permanent. Appropriate sun protection is very important and recommended.
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9. PARTIAL LAXITY CORRECTION: Although PDO Threads will give some improvement in laxity, they may not correct all facial laxity.
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10. DELAY HEALING: Complications may ensue as a result of smoking, drinking liquids through a straw, or similar motions. Because of this, smoking and similar actions are STRONGLY discouraged, as well as any activity involving overuse of the muscles of the face, such as chewing gum.
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11. CONTRAINDICATIONS: Any allergy or foreign body sensitivities to plastic biomaterials.
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12. OTHER: Slight asymmetry, redness, visible thread(s) may require additional treatment and or the removal of the thread(s).
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I understand that no warranty or guarantee has been made to me as to result or cure. I realize that, as in all medical treatment, complications or delay in recovery may occur which could lead to the need for additional treatment, and could also result in economic loss to me because of my inability to return to activity as soon as anticipated. I understand, acknowledge and consent to the procedure with the knowledge of these risks.
By registering, paying and attending the AESTRA Institute course, you understand that you may be photographed, filmed or videotaped and you expressly give the AESTRA Institute, its owners, agents and principals the right to take pictures and/or recordings of you and use your likeness, image, photo without compensation, for broadcast, display, and exhibition in any medium for purposes of advertisement and education and to put the finished pictures /recordings to any use without limitation. You further expressly release AESTRA Institute from any or all claims or actions arising out of or resulting from any use of your image. However, the AESTRA Institute shall not be obligated to use your image.
***By consenting to this treatment, I agree, affirm and represent that I am waiving my right to seek any recovery for any damages that occur as a result of receiving this treatment whether such damages are as the result of an inherent risk or latent or unintended risk including any damages that may occur which are not the result of a known or expected risk. I waive any and all recovery for damages of any kind whatsoever.***
I have been informed and I understand that the practitioners who will perform this procedure may or may not be licensed to practice in the state of Florida. I have been informed and understand that Aestra Institute and Denise Merdich have not reviewed or investigated whether the practitioners performing this procedure have appropriate licensure within the state of Florida. Despite knowing that the practitioner(s) performing my procedure may or may not be licensed in Florida, I am voluntarily giving consent for the practitioners who may be licensed in other states to practice medicine, nursing, advanced registered nurse practitioners and physician's assistants to perform the procedure on me.
Exosomes (Vitti Pure) Consent
Human cells, tissues, and cellular and tissue -based products (HCT/Ps) consist of human cells or tissues intended for implantation, transportation, infusion or transfer into a human recipient. The original samples are obtained from placental and/or umbilical cord tissue and are minimally manipulated into HCT/P allographs intended for human transplant use and are considered allogeneic (from another person) and not autologous (from me as a patient).
NON-STANDARD THERAPY
I understand that this procedure, while relatively simple, is not approved by the FDA or acknowledged as a safe or effective therapy for any disease or condition by the majority
of practicing physicians in the United States. While there is enormous promise for HCT/P therapies, developers of these types of therapies are continuing to seek and establish efficacy, through the proper regulatory channels. The FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
The Federation of State Medical Boards and The Food and Drug Administration have posted guidance documents on the internet, and I have been advised of these resources. It is my understanding after discussion and/ or after reviewing the available resources on the internet that I am agreeing to proceed with therapy based on principles that are outlines in these documents as summarized below:
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A shared decision framework including: an explanation, discussion, and comparison of treatment options; an assessment of values and preferences and possible adverse reaction; and an arrival at a decision in partnership between the physician/ licensed provider and myself.
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In making this decision, I have not been influenced by unreasonable or unfounded claims of unrealist outcomes.
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Novel, experimental, or unproven interventions should be proposed when traditional or other proven treatment modalities have been exhausted or have not been considered to be appropriated after discussion.
BENEFITS AND ALTERNATIVES TO REGENERATIVE THERPY
TREATMENT
My provider has explained to me the nature and purpose of the treatment including potential methods of therapy for my condition, which I could use if I so desired. This product maybe used topically or injected into the dermal tissue.
ADVERSE EVENTS/ SIDE EFFECTS/ RISKS
My provider has told me there are potential risks and complication, from both know and unknown causes, that could occur or be reasonable possible. These include but are not
limited to:
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Local reactions at the site of treatment (pain, swelling, burning, or stinging)
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Infection or potential exposure to infection, Hypersensitivity or allergic reactions
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Rashes, flu-like symptoms, Auto Immune flare ups, Jarisch-Herxheimer reaction
WITHDRAWAL OF CONSENT
I understand that I am free to withdraw this consent and to discontinue treatment at any time.
NO GUARANTEES: I acknowledge that no guarantees or assurances have been made
to me concerning this treatment.
FINANCIAL RESPONSIBILITY
I understand that is an elective treatment that is no filed with insurance. I acknowledge I have read this document in its entirety and understand the risks, benefits, and potential alternatives to HCT/P treatment.
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I acknowledge that I am not taking any form of prescription blood thinners (e.g. Coumadin , Warfarin, Lovenox, Enoxaprin, Eliquis, Apixaban).
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I understand that multiple treatments may be needed an in rarecases no improvement may be seen. No guarantee, warranty, or assurances has been made
to me as the results that may be obtained.
I am aware that additional treatment may be necessary for desired results. Clinical results vary patient to patient and I understand that. I agree to adhere to all safety precautions, pre and post care during treatments. I understand all payments are non-refundable.
Informed Consent for HCT/P Therapy: My physician or Licensed medical provider has informed me that this procedure, based on current medical evidence, is appropriate for
my condition. I understand there is no guarantee the treatment will be effective or that my condition will improve. In addition, my provider has explained there is the
possibility of recurrence of my condition. Although benefits often occur, some patients will experience all of them, some will experience a portion of them and some patient will be non-responders and not experience any of them. We do not know the long-term effects of HCT/P therapy, length of potential benefits nor the effects on an undiagnosed cancer or future cancer risk from HCT/P exposure.
Description of Treatment: This treatment involves the collection of your blood (approximately 8-16 ml), then your blood is spun down using a centrifuge to separate out the plasma and platelet portion using the separator gel as a special filter. The PRP portion of your blood is then injected back into your skin to stimulate new collagen production, and to re-
energize your cells into rejuvenating themselves. The product injected is 100% your own blood by-product (autologous).
Contraindications: You should not have PRP treatment done if you have any of the following conditions: Skin conditions and diseases including: Facial cancer, past and present. This includes SCC, BCC and melanoma, systemic cancer, chemotherapy, steroid therapy, dermatological diseases affecting the face (i.e. porphyria), blood disorders and platelet
abnormalities, anticoagulation therapy (i.e. Warfarin)
Side Effects: You will likely experience mild to moderate swelling of the treated area. This will last for about 12-24 hours; ice or cold compresses can be applied to reduce swelling if required. You may notice a tingling sensation while the cells are being activated. In rare cases, skin infection may occur, which is easily treated with an anti-biotic.
Client Consent: I understand that due to the natural variation in quality of Platelet Rich Plasma, results will vary between individuals. I understand that although I may see a change after my first treatment, I may require a series of up to 6 sessions to obtain my desired outcome. This procedure and side effects has been explained to me including alternative methods as have the advantages and disadvantages.
I am advised that thought good results are expected, the possibility and nature of complications cannot be accurately anticipated and that, therefore, there can be no guarantee as expressed or implied either as to the success or other result of the treatment. I am aware that the PRP treatment is not permanent as natural degradation will occur over time.
The following side effects are rare, but have been reported:
Temporary redness
Bruising, swelling, or hematoma
Incomplete or no response
Burning and/or pain at injection sites
Discoloration and/or scab/scar formation
Unknown complications
I have had the opportunity to ask any questions about the treatment including risks or alternatives and acknowledge that all my questions have been answered in a satisfactory manner and that all blanks were filled in prior to my signature. If you are unsure about any of above mentioned conditions, please ask!
Platelet Rich Plasma (PRP) Consent Form
Thank you for your consent!
