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Copy and paste the PDO (Polydioxanone) Suture Threads

This is an informed consent document that 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. Please initial each section, indicating that you have read the page and sign the consent for the procedure proposed by your practitioner. 

INDICATIONS OF USE: ON or OFF LABEL USE only concerns marketing & promotional material for a product. 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.

Before Receiving your PDO Thread Treatment:

Avoid medications that inhibit clotting such as vitamin E, aspirin, or non-steroidal anti-inflammatory drugs for seven days prior to treatment.

During your PDO Thread Treatment:

You will feel multiple small needle insertions and a slight stinging sensation, which will last about 3-5 seconds.

After Receiving a PDO Threads Injectable Treatment:

·      To stop any incidental bleeding from the insertion, use a gauze and hand pressure.

·      Bruising/swelling at insertion site may occur

·      Ice may be used for any discomfort but usually none is required.

·      Do NOT massage the area, no facials for at least one week.

·      Do NOT do heavy exercise for 7 days, to allow for the threads to settle and to avoid any prolonged bleeding.

·      Avoid exaggerated actions and abrupt movements such as yawning and laughing, as well as facial massage.

·      Avoid any visits to the dentist for 30 days to allow for the threads to settle.

·      Do NOTsmoke, drink liquids through a straw, or similar motions. Complications may ensue as a result.

·      Sleep upright for several nights after procedure

·      Do wear sun protection repeated daily to avoid any color changes in the skin.


 PDO THREAD ADMINISTRATION CONSENT 

PDO THREAD  is a strong synthetic monofilament fiber consisting of one solid fiber of thread. The thread will reabsorb in 4-6 months depending on the thickness. The procedure takes about 30-60 minutes. Results last approximately 9-18 months depending on the patient metabolism, amount received, and location.


ANESTHESIASome discomfort may be experienced during treatment. I give permission for the administration of the anesthesia when deemed appropriate. Local topical anesthesia or local injectable anesthesia may be used and can involve risk of allergic reaction and rash.

RISKS AND COMPLICATIONS It has been explained to me that there are certain inherent and potential risks and side effects in any invasive procedure and in this specific instance such risks include but are not limited to: 1) Post treatment discomfort, swelling, redness, bleeding and bruising, 2) Post treatment bacterial, viral, and/or fungal infection requiring further treatment, 3) Allergic reaction 4) Tissue ischemia 5) Puckering 6) extrusion of threads needing to be trimmed or removed 7)Tissue irregularities 8) Under or over correction 9) Scar at entry point is extremely rare but must always be considered a possibility when puncturing the skin 10)Damage to deeper structures such as nerves, blood vessels and muscles 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. 11) Pigment changes to the skin (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. 12) Other: Slight asymmetry may require additional treatment

ALTERNATIVE TREATMENTS consist of non-surgical facelift, surgical facelift, Nd:YAG Laser, full-face CO2 Laser, dermal fillers, or chemical peels.

PHOTOGRAPHS I authorize the taking of clinical photographs and their use for scientific purposes both in publications and presentations. I understand my identity will be protected.

PREGNANCY, ALLERGIES I am not aware that I am pregnant, have any significant medical diseases, or have any severe allergies.

ADDITIONAL PROCEDURES MAY BE NECESSARYIn 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.

o   I understand that the results will relax over time and additional procedures may be required. 

o   I understand that I may not achieve the desired improvement in shape that was anticipated.

FINANCIAL RESPONSIBILTIES 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 this procedure is cosmetic and that payment is my responsibility at the time of treatment.

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 alternative 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 other methods of care and risks encountered. Your practitioner may provide 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 document are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all of the facts involved in an individual case and subject to change as science knowledge and technology advance and as practice patterns evolve. It is important that you read the above information carefully and have all of your questions answered before signing the consent that follows. *

o   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. 


CONSENT: Your consent and authorization for this procedure is strictly voluntary. By signing this informed consent form, you hereby grant authority to your physician/practitioner 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.

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/practitioner 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 hereby give my voluntary consent to this procedure and release my practitioner, the facility, medical staff, and specific 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 representatives, heirs, administrators, successors and assigns.

Should I have any questions or concerns regarding my treatment / results, I will notify this office at 310-401-9001 x3 Immediately so that timely follow-up and intervention can be provided.


I Agree



First Participant's Name

First Name*

Last Name*
First Participant's Age Acknowledgment*
First Participant's Date of Birth*
I certify that I am 18 years of age or older
First Participant's Signature*
Second Participant's Name

First Name*

Last Name*
Second Participant's Date of Birth*
Third Participant's Name

First Name*

Last Name*
Third Participant's Date of Birth*
Fourth Participant's Name

First Name*

Last Name*
Fourth Participant's Date of Birth*
Fifth Participant's Name

First Name*

Last Name*
Fifth Participant's Date of Birth*
Sixth Participant's Name

First Name*

Last Name*
Sixth Participant's Date of Birth*
Seventh Participant's Name

First Name*

Last Name*
Seventh Participant's Date of Birth*
Eighth Participant's Name

First Name*

Last Name*
Eighth Participant's Date of Birth*
Ninth Participant's Name

First Name*

Last Name*
Ninth Participant's Date of Birth*
Tenth Participant's Name

First Name*

Last Name*
Tenth Participant's Date of Birth*
Parent or Guardian's Email Address

Email*

Confirm Email*
Medical History
History of Anaphylaxis Allergy*
No
Yes
Immunosuppressive Therapy*
No
Yes
History of Herpes*
No
Yes
Any known allergy or foreign body sensitivities to plastic biomaterials *
No
Yes
Active Inflammatory Process/ Acne in area treated*
No
Yes
Active Infection in the area*
No
Yes
History of Hives*
No
Yes
Any Significant Medical Disease*
No
Yes
Pregnant or Lactating*
No
Yes
Parent(s) or Court-Appointed Legal Guardian(s) must sign for any participating minor (those under 18 years of age) and agree that they and the minor are subject to all the terms of this document, as set forth above.


By signing below the Parent or Court-Appointed Legal Guardian agrees that they are also subject to all the terms of this document, as set forth above.
Parent or Guardian's Name

First Name*

Last Name*

Phone*
Parent or Guardian's Age Acknowledgment*
Parent or Guardian's Date of Birth*
I certify that I am 18 years of age or older
Parent or Guardian's Signature*
Electronic Signature Consent*
 By checking here, you are consenting to the use of your electronic signature in lieu of an original signature on paper. You have the right to request that you sign a paper copy instead. By checking here, you are waiving that right. After consent, you may, upon written request to us, obtain a paper copy of an electronic record. No fee will be charged for such copy and no special hardware or software is required to view it. Your agreement to use an electronic signature with us for any documents will continue until such time as you notify us in writing that you no longer wish to use an electronic signature. There is no penalty for withdrawing your consent. You should always make sure that we have a current email address in order to contact you regarding any changes, if necessary.


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