• INFORMED CONSENT FOR PDO THREAD LIFT PROCEDURE
    A. PURPOSE AND BACKGROUND
    As my patient, you have requested my administration of Polydioxanone (PDO) threads. This is a non-surgical skin rejuvenation procedure that provides a subtle lifting and tightening effect to the skin achieved by the injection of a special thread called polydioxanone, or PDO, which has properties that stimulate the synthesis of collagen and elastin. All medical and cosmetic procedures carry risks and may cause complications. The purpose of this document is to make you aware of the nature of the procedure and its risks in advance so that you can decide whether or not to go forward with the procedure. This product is FDA approved. This product is not Health Canada approved
    B. PROCEDURE
    1. This procedure is administered via the injection of multiple needles into the determined treatment areas of the face or body. The needles contain the PDO filament, or thread. When the needles are placed in the skin and later retrieved, the PDO thread is left in the skin. The PDO is made of bio-absorbable and anti-microbial filament. The PDO thread will dissolve in the skin tissue in approximately 4-12 months. In the process, the PDO will generate collagen and elastin stimulation, producing a natural tightening effect in the treated areas.
    2. The PDO (polydiaxonone) Threat Lift and Smoothing procedure uses absorbable surgical sutures which are placed into the subdermal layer of the skin to initiate collagen production. The PDO Lift procedure is effective in most cases, however there is no guarantee a specific patient will benefit from the procedure. The nature of cosmetic procedure may require a patient to return for numerous visits in order to achieve the desired results or to determine whether the treatment may not be completely effective at treating the particular condition.
    3. Alternative Treatments: Alternative forms form of non-surgical and surgical treatment consist of surgical facelift, Nd:YAG laser, full-face C02 laser, dermal fillers, local muscle relaxer (Botox, Dysport, Xeomin), chemical peels or inaction. Every procedure involves a certain amount of risk. An individual’s choice to undergo a procedure is based on the comparison of the risk to the potential benefit. Although most patients do not experience adverse complications, you should discuss your concerns and potential risks with your practitioner in order to make an informed decision.
    4. The type of PDO threads used, length of the needles, and depth of the injection(s) will depend on the areas being treated.
    5. A topical or injectable anesthesia, depending on the areas being treated, is used to reduce the discomfort of the injections.
    6. The treatment site(s) is/are cleansed first with an antiseptic (cleansing) solution.
    7. Multiple needles will be injected depending on the treatment areas.
    8. The needles will then be removed, leaving the PDO thread in the skin.
    9. If the treated area is swollen directly after the injection, ice may be applied on the site for a short period.
    10. Improvement is gradual and full correction appears between 4 – 6 weeks after treatment.
    11. Regular maintenance treatments help sustain the desired level of correction.
  • Possible Risks and Side Effects Associated with PDO Threat Lift Procedure:
    Discomfort: Some discomfort may be experienced during treatment.
    Scarring: May cause scarring; sutures are inserted using a small needle, which must heal. A scar at entry point may occur.
    Bruising, Swelling, Infection: With any minimally invasive procedure, Some patients may experience bruising around the treatment area, additional swelling and tenderness at the injection site and in rare occasions, pustules might form. These reactions might last for as long as approximately 2 weeks, and in appropriate cases may need to be treated with oral corticosteroids or other therapy. Infection is rare, but with any injection or incision into the skin, the possibility exists.
    Bleeding: You may experience some bleeding during the procedure. Hematoma or a small blood clot may occur and may require treatment by drainage. There is a higher risk of bleeding if you have taken any anti-inflammatory medications (Advil, Motrin, Aspirin, Ibuprofen) within the 10 days preceding the procedure. Damage to Deeper Structures: Deeper structures such as nerves, blood vessels and muscles may be damaged during the 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.
    Allergic Reaction: Allergies to tape, suture material or topical preparations have been reported. Allergic reactions may require additional treatment.
    Anesthesia: Local topical anesthesia may be used and can involve risk of allergic reaction. There is a possibility of the treatment area becoming lighter or darker than the surrounding skin. This is usually temporary, but on rare occasions, may be permanent. Appropriate sun protection is important.
    Partial Laxity Correction: PDO Lift may not correct all your facial laxity or sagging.
    Delay Healing: Complications may ensure as a result of smoking, using a straw, or similar motions. Smoking and similar actions are STRONGLY discouraged. Slight asymmetry, redness, visible sutures, suture breakthrough may require additional treatment or the removal of the sutures.
    Contraindications: Any known allergy or foreign body sensitivities to synthetic biomaterials.
  • Additional Procedures May Be Necessary:
    In some situations, it may not be possible to achieve optimal results with a single PDO Lift procedure and other procedures may be necessary. Although peak results are expected, there cannot be any guarantee or warranty expressed or implied on the results that may be obtained.
    The cost of the procedure may involve several charges for services provided. The total may include service fees, the cost of supplies, and laboratory tests if necessary. Additional costs may occur should a complication develop from the procedure.
    I understand that no warranty or guarantee of specific result has been made to me. 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 result in a delay to one’s normal daily activities and thus economic loss.
    I understand my practitioner may discover other conditions which require additional or different procedures than planned treatment. I authorize my practitioner and his or her associates, technical assistants and other health care providers to perform such other procedures which are advisable in their professional judgment.
    I understand my cheeks/jowls may not achieve the desired improvement anticipated.
    I understand sutures may extrude, may have to be trimmed or may have to be removed in the future.
    I understand the results may relax over time and additional procedures may be required.
    I consent to the taking of photos before, during or after the procedure to document my progress.
  • The nature of the elective procedure, its risks and potential complications have been fully explained to me along with available alternative treatments and their benefits and risks has been discussed. I understand I have the right to refuse treatment. I have been instructed to and agree to abide by all safety precautions and post treatment instructions and have been given a written copy. I understand no refunds will be given for received treatment and no guarantee(s) have been given regarding the results.
    I release the facility, medical staff, and other technicians from liability associated with this procedure. This consent is voluntarily executed and shall be binding on my spouse, relative, legal representatives, heirs, administrators, successors and assignees. I also certify that if I have any changes in my medical history I will notify my practitioner immediately. I also state that I read and write in English.
    C. DISCLOSURE
    PDO threads should not be used in patients who have previously experienced hypersensitivity, those with severe allergies, and should not be used in areas with active inflammation or infections (e.g., cysts, pimples, rashes, or hives). If you are considering laser treatment, chemical skin peeling, or any other procedure based on a skin response after an PDO thread lift treatment, or you have recently had such treatments and the skin has not healed completely, there is a possible risk of an inflammatory reaction at the injection sites. Prior to treatment, you must disclose any of the above conditions to your practitioner.
    D. POST-TREATMENT CARE
    After treatment, you should minimize exposure of the treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away.
    E. BENEFITS
    PDO threads have been shown to be safe and effective when compared to other thread treatments. Once optimal results have been achieved, the effects of PDO threads can last between 1 to 2 years before additional treatments are required.
    F. ALTERNATIVES
    This is strictly a voluntary cosmetic procedure. No treatment is necessary or required. Other alternative treatments which vary in sensitivity, effect, and duration may include but are not limited to laser or other light therapy treatments, radio frequency or other heat therapy treatments, or ultimately, surgery.
    G. COST/PAYMENT
    The cost of treatment will be billed individually. Since the PDO thread lift procedure is considered cosmetic, it is not reimbursable by government or private health care insurers. Payment in full is required at the time of service and is non-refundable.
  • H. QUESTIONS
    This procedure has been explained to you by your practitioner, or the person who signed below, and all of your questions were answered. If you have any other questions about this product or procedure, you may call our office at any time.
    I. CONSENT
    Your consent and authorization for this procedure is strictly voluntary. By signing this informed consent form, you hereby grant authority to your practitioner to perform the PDO thread lift procedure using PDO filament threads for facial and/or corporeal tightening and/or to administer any related treatment as may be deemed necessary or advisable in the diagnosis and treatment of your condition. The nature and purpose of this procedure, with possible alternative methods of treatment as well as complications, has been fully explained to your satisfaction. No guarantee has been given by anyone as to the results that may be obtained by this treatment. _ I have read this informed consent and certify that I understand its contents in full. I certify that I have disclosed any and all health conditions that may influence the practitioner’s decision to provide or deny treatment. I have had enough time to consider the information from my practitioner and feel that I am sufficiently advised to consent to this procedure. I hereby give my consent to this procedure and have been asked to sign this form after my discussion with the practitioner.
    Please note that all products and services provided are not subject to refund. However, they can be exchanged or be credited the precedingly paid amount or the remaining balance. Please note that results may vary and depends on each person.
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