CONSENT FOR TREATMENT with PDO (Polydioxanone) Suture Threads
OFF LABEL USE: Although marketing materials are not permitted to promote additional uses, physicians are free to use any medical device for any purpose, even a use that the FDA has not approved. PDO threads are to be used in soft tissue approximation where the use of absorbable sutures is appropriate.
INTRODUCTION: 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.
ALTERNATIVE TREATMENTS: Alternative forms of non-surgical and surgical management consist of facelift, full-face laser resurfacing, dermal fillers, or chemical peels. Risks and potential complications are associated with alternative forms of treatment. Every procedure involves a certain amount of risk, and it is important that you understand the risks involved.
POSSIBLE RISKS and SIDE EFFECTS ASSOCIATED PDO SUTURES
1. DISCOMFORT: Some discomfort may be experienced during treatment. I give permission for the administration of the anesthesia when deemed appropriate.
2. SCARRING: PDO Thread Lift. Threads are inserted via a small needle; 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 (10) days before surgery, as this may contribute to a greater risk of bleeding.
5. DAMAGE TO DEEPER STRUCTURES: Deeper structures such as nerves, blood vessels and muscles may be damaged during the course of 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.
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 may not correct all your facial laxity.
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.
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.
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.
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 that my cheeks, neck, or jowls may not achieve the desired improvement in shape that was anticipated. I understand that sutures may extrude, and may have to be trimmed or removed in the future. I understand that the results will relax over time and additional procedures may be required.