CONSENT FOR TREATMENT with PDO (Polydioxanone) SUTURE THREADS
This informed consent document has been prepared to help inform you concerning PDO Thread Lift Procedure, its risks, and alternative treatments. It is important that you read this information carefully and completely.
Thread Lift, is effective in most cases; no guarantees can be made that a specific patient will benefit from this procedure. Additionally, 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 Thread Lift may not be completely effective at treating the particular condition.
INDICATIONS OF USE
Physicians are free to use any medical device for any purpose, even a use that the FDA or Health Canada has not approved. PDO threads are used in soft tissue approximation where the use of absorbable sutures is appropriate.
Alternative forms of non-surgical and surgical management consist of surgical facelift, or fillers.
Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with Thread Lift and it is important that you understand the risks involved. An individual's choice to undergo a procedure is based on the comparison of the risk to the potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with
your practitioner to make sure you understand the risks, potential complications, and consequences. Should complications occur, additional surgery or other treatments may be necessary.
POSSIBLE RISKS and COMPLICATIONS
1. DISCOMFORT: You may experience discomfort during treatment. I give permission for the administration of anesthesia when deemed appropriate.
2. SCARRING: PDO Threads are inserted through a small puncture wound; although rare, it may take a few days to heal. Scar at entry point is extremely rare but must always be considered a possibility when entering the skin.
3. BRUISING, SWELLING, INFECTION: With any minimally invasive procedure, bruising of the treated area may occur. Additionally, there may be swelling noted. Finally, skin infection is rare, but a possibility with any injection or incision into the skin.
4. BLEEDING: It is possible, though extremely unusual, 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 any aspirin or anti-inflammatory medications (Advil, Motrin, Ibuprofens) for ten days before procedure, as this may contribute to a greater risk of bleeding.
5. DAMAGE TO DEEPER STRUCTURES: Rarely may deeper structures such as nerves, blood vessels and muscles be damaged during the course of procedure. Injury to deeper structures is usually temporary.
6. ALLERGIC REACTIONS: In very rare cases, local allergies to tape, suture material, or topical preparations have been reported. Systemic reactions, which are more serious, may result from drugs used during procedure and prescription medicines. Allergic reactions may require additional treatment.
7. ANESTHESIA: Local Topical anesthesia may be used and can involve risk of allergic reaction and rash.
8. PIGMENT CHANGES (SKIN COLOR) (hyper or hypo-pigmentation): There is a remote possibility of the treatment area either becoming lighter or darker in color than the surrounding skin. This is usually temporary, but on rare occasions, may be permanent. Appropriate sun protection is very important.
9. PARTIAL LAXITY CORRECTION: Although PDO Threads will give some improvement in laxity, but will not correct all your facial laxity.
10. DELAYED HEALING: Complications may follow because of smoking, drinking liquids through a straw, or similar motions. Because of this, smoking and similar actions are STRONGLY discouraged.
11. CONTRAINDICATIONS: Any know allergy or foreign body sensitivities to plastic biomaterials.
12. OTHER: Slight asymmetry, redness, visible thread(s) may require additional treatment and or the
removal of the threads.
13. ADDITIONAL PROCEDURES MAY BE NECESSARY. In some situations, it may not be possible to achieve optimal results with a single procedure and other procedures may be necessary. The practice of medicine is not an exact science. Although good results are expected, there cannot be any guarantee or warranty expressed or implied on the results that may be obtained.
The cost of procedure may involve several charges for the services provided. The total may include fees charged by your doctor/practitioner, the cost of supplies, or laboratory tests if needed. Additional costs may occur should complications develop from the procedure.
It is important that you read the above information carefully and have all of your questions answered before signing the consent that follows.
I understand that sutures may extrude, and may have to be trimmed or removed in the future. I understand that the results may relax over time and additional procedures may be required.
I understand that my cheeks or jowls may not achieve the desired improvement in shape that was anticipated.
Your consent and authorization for this procedure is strictly voluntary. By signing this informed consent form, you hereby grant authority to your physician to perform insertion of PDO Suture Threads for lifting and rejuvenation purposes and/or to administer any related treatment as may be deemed necessary or advisable in the diagnosis and treatment of your condition.
The nature & purpose of this procedure and the potential complications & side effects have been fully explained to me. Alternative treatments and their risks and benefits have been explained to me as well and I understand that I have a right to refuse treatment. I agree to adhere to all safety precautions and instructions after the treatment. I have been instructed in and understand post treatment instructions and have been given a written copy of them. I understand that No Refunds will be given for treatments received. 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. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. I have had enough time to consider the information given me by my physician and feel that I am sufficiently advised to consent to this procedure. I accept the risks and complications of the procedure. I certify if any changes occur in my medical history I will notify the office.
I certify that I am a competent adult and am not under the influence of alcohol or drugs.
Should I have any questions or concerns regarding my treatment /results, I will notify this office immediately so that timely follow-up and intervention can be provided.