INSTRUCTIONS: This is an informed consent document that has been prepared to help inform you concerning PDO Thread Lift Procedure, it's risks and alternative treatments. It is important that you read this information carefully and completely.

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 numerous treatments 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: ON and OFF LABEL USE only concerns marketing and promotional material for a product. Providers 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.

ALTERNATIVE TREATMENTS: Alternative forms of non-surgical and surgical management consist of facelift, YAG Laser, CO2 Laser, 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. An individual's chouce to undergo a procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your provider to make sure you understand the risks, potential complications and consequences.

POSSIBLE RISKS AND SIDE EFFECTS

1. DISCOMFORT: Some discomfort may be experienced during treatment. I give permission for the administration of the anethesia when deemed appropriate.
2. SCARRING: Threads are inserted via a small acupuncture type needle; although rare, it may take a few days to heal. Scar at entry point is extremely rare but must always be considered a possibilit 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 possibe , though extremely rare, 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 10 days prior to procedure, 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 anethesia may be used and can involve risk of allergic reaction and/or rash.
8. PIGMNT CHANGES (hyper and/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. 
9. PARTIAL LAXITY CORRECTION: Although PDO Threads will give some improvement in laxity, it may not correct all laxity.
10. DELAY HEALING: Complications may ensue as a result of smoking, drinking liquids through a straw or similiar motions. Because of this, smoking and similiar actions are STRONGLY discouraged.
11. CONTRAINDICTATIONS: Any known allergy or foreign body sensitivities to plastic biomaterials.
12. OTHER: Slight asymmetry, redness, visible thread(s) may require additional treatment or removal of threads.

ADDTIONAL PROCEDURES MAY BE NECESSARY: In some situations, it may not be possible to achieve optimal results with a single treatment and other procedures may be necessary. Although good results are expected, there cannot be any guarantee or warranty expressed or implied on the results that may be obtained.

FINANCIAL RESPONSIBILITIES: The cost of procedure may involve several charges for the services provided. The total may include fees charged by provider, cost of supplies, additional treatments. Also, additional costs may occur should complications develop from the procedure.

DISCLAIMER: Informed consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks and alterntative forms of treatment(s). The informed consent process to define principles of risk disclosure should generally meet the needs of patients in most circumstances. However, informed consent documents should not be considered all inclusive in defining the methods of care and risks encountered. Your provider may supply you with additional or different information that is based on all the facts in your particular case and the state of medical knowledge. Informed consent documents are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all the facts involved in an individual case and subject to change as science knowledge and technology advance. It is important that you read the above information carefully and have all of your questions answered before signing this consent.

• I understand that no warranty or guarantee has been made to me as to result or cure. I realize that, as in all medical treatments, complications or delay in recovery may occure which could lead to the need for additional treatments and could result in economic loss to me because of my inability  to return to activity as soon as anticipated.
• I understand that my practioner may discover other or different conditions, which require additional or different procedures than those planned. I authorize the provider and such associates, assistants and other health care providers to perform such other procedures which are advisable in their professional judgement.
• I understand that I may not achieve my desired improvement 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 may relax over time and additional procedures may be required.

CONSENT: Your consent and authorization for this procedure is strictly voluntary. By signing this informed consent form, you hereby grant authority to you provider 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 and purpose of this procedure and the potential complications and 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 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 satisfation and I consent to the terms of this agreement. I have had enough time to consider the information given to me by my provider 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 occure in my medical history I will notify the office.

I hereby give my voluntary consent to this procedure and release my provider, the facility, staff, and designated technicians from liability associated with the procedure. I certify that I am a competent adult of at least 18 years of age and am not under the influence of alcohol or drugs. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representitives, heirs, administrators, successors and assigns.

Should I have any questions or concerns regarding my treatment/results, I will notify this office at 215-422-3690 immediately so that timely follow-up and interventions can be provided.