This is an informed consent for treatment using Sculptra / Radiesse. Sculptra / Radiesse (+) are both defined as a resorbable implant product and is approved by the United States Food and Drug Administration for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

Risks and complications that may be associated with Sculptra / Radiesse (+) and the implant procedure include, but are not limited to:

1. Facial Bruising, Redness, Swelling, Itching and Pain: I understand that there is a risk of bruising, redness,swelling, itching and pain associated with the procedure. These symptoms are usually mild and last less than a week but can last longer. Patients who are using medications that can prolong bleeding, such as aspirin, warfarin, or certain vitamins and supplements, may experience increased bruising or bleeding at the injection site.
2. Nodules, and palpable material: I understand that there is a risk that small lumps may form under my skin due to the Sculptra / Radiesse (+) Filler material collecting in one area. I also understand that I may be able to feel the Sculptra / Radiesse (+) Filler material in the area where the material has been injected. Any foreign material injected into the body may create the possibility of swelling or other local reactions to a filler material.
3. Nodules in Lips: I understand that Sculptra / Radiesse (+) should not be injected in the lips. There have been published reports of nodules associated with the use of Sculptra / Radiesse (+) Filler injected in the lips.
4. Migration: I understand that Sculptra / Radiesse, as with any filler material, may move from the place where it was injected.
5. Infection: As with all transcutaneous procedures, I understand that injection of any filler material carries the risk of infection.
6. History of Herpes Infection: I understand that there is a risk that injection of any filler material carries the risk of a recurrence of an outbreak of herpes (fever blisters/cold sores/shingles) and that the outbreak may be severe in nature. I have disclosed to the health care provider my medical history and, in particular, disclosed prior herpes outbreaks.
7. Allergic Reactions: I understand that Sculptra / Radiesse (+) should not be used in patients with severe allergies, a history of anaphylaxis, or history or presence of multiple severe allergies or hypersensitivity to any of the ingredients in Sculptra / Radiesse (+) filler.
8. Keloids/Scarring: I understand that the safety of Sculptra / Radiesse (+) in patients with known susceptibility to keloid formation or hypertrophic scarring has not been studied.
9. Accidental Injection into a Blood Vessel: I understand that Sculptra / Radiesse (+) can be accidentally injected into a blood vessel, which may block the blood vessel and cause local tissue damage, or potentially even a heart attack, stroke, or blindness.
10. Radio-opacity: I understand that Sculptra / Radiesse (+) is radio-opaque and is visible on CT Scans and may be visible in x-rays.
11. Duration of Effect: I understand that the outcome of treatment with Sculptra / Radiesse (+) will vary among patients. In some instances, additional treatments may be necessary to achieve the desired outcome.
12. Concomitant Dermal Therapies: I understand that the safety of Sculptra / Radiesse (+) injectable implant with concomitant dermal therapies such as epilation, UV radiation, laser, mechanical or chemical peeling procedures, or radio frequency or ultrasound-based devices used for skin tightening has not been evaluated in controlled clinical trials. The application of laser or other energy-based treatments within weeks of Sculptra / Radiesse (+) treatment is not recommended, as such treatments may alter the characteristics of Sculptra / Radiesse (+) injectable implant. If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with Sculptra / Radiesse (+) injectable implant, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Sculptra / Radiesse (+) injectable implant is administered before the skin has healed completely after such a procedure.

No studies of interactions of Sculptra / Radiesse (+) with drugs or other substances or implants have been conducted.

This above list is not meant to be inclusive of all possible risks associated with Sculptra / Radiesse (+) or dermal fillers in general, as there are both known and unknown side effects and complications associated with any medication or dermal filler injection procedure. I understand that medical attention may be required to resolve complications associated with my injection.

I understand that I should minimize exposure of the treated area to the sun or heat for approximately 24 hours after treatment or until any initial swelling or redness goes away.

The safety of Sculptra / Radiesse (+) for use during pregnancy or in breastfeeding women has not been established.

I have discussed the potential risks and benefits of RADIESSE or RADIESSE (+) with my doctor. I understand that there is no guarantee of any particular results of any treatment.

By signing below, I acknowledge that I have read the foregoing informed consent, have had the opportunity to discuss any questions that I have with my doctor to my satisfaction, and consent to the treatment described above with its associated risks. I understand that I have the right not to consent to this treatment and that my consent is voluntary. I hereby release the doctor, the person performing the Sculptra / Radiesse (+) filler injection and the facility from liability associated with this procedure.

Your consent and authorization for this elective procedure is strictly voluntary. By signing this informed consent form, you hereby grant authorization to our medical staff to perform 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 elective procedure and the complications and side effects have been fully explained to me. Alternative treatments and their risks and benefits have been explained to me 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 offered 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 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 elective procedure and release 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.

I agree, if I should have any questions or concerns regarding my treatment / results I will notify this office at immediately so that timely follow-up and intervention can be provided.