CONSENT TO RECEIVE RESTYLANE® INJECTION
A. PURPOSE AND BACKGROUND
As my patient, you have requested the administration of Restylane®; a stabilized hyaluronic acid used in the correction of wrinkles on the face and undesired folds in the facial skin. All medical and cosmetic procedures carry risks and may cause complications. The purpose of this document is to make you aware of the nature of the procedure and its risks in advance so that you can decide whether or not to go forward with the procedure.
- This product is administered via a syringe, or injection, into the areas of the face
sought to be filled with the hyaluronic acid to eliminate or reduce the wrinkles
- An anesthesia, numbing medicine used to reduce the discomfort of the injection,
may or may not be used.
- The treatment site(s) is washed first with an antiseptic (cleansing) solution.
- Restylane is a clear transparent gel that is injected under your skin into the tissue
of your face using a thin gauge (30 G) needle.
- The depth of the injection(s) will depend on the depth of the wrinkle(s) and its
- Multiple injections might be made depending on the site, depth of deformity, and
- Following each injection, the correction site will be massaged to conform to the
contour of the surrounding tissues.
- If the treated area is swollen directly after the injection, ice may be applied on the
site for a short period.
- After the first treatment, additional implantation of Restylane may be necessary to
achieve the desired level of correction.
- Periodic touch-up injections help sustain the desired level of correction.
- Although a very thin needle is used, common injection-related reactions could occur. These could include: some initial swelling, pain, itching, discoloration, bruising or tenderness at the injection site. Those reaction could increase if you are using substances that reduce blood clotting such as aspirin or other non-steroidal anti-inflammatory drugs such as Advil.®
- These reactions generally lessen or disappear within a day or two.
- As with all injections, this procedure carries the risk of infection. The syringe is
sterile and standard precautions associated with injectable materials have been taken.
- Some temporary lumpiness may occur before the balance of a normal tissue pressure can result from absorption of the Restylane compound.
- Some patients may experience additional swelling or tenderness at the implant
site and rarely pustules might also form. These reactions might last for as long as
approximately 2-weeks, and in appropriate cases may need to be treated with oral
corticosteroids or other therapy.
- Restylane should not be used in patients who have experienced this
hypersensitivity, those with severe allergies, and should not be used in areas with
active inflammation or infections (e.g., cysts, pimples, rashes or hives).
- It also should not be used in areas other than the tissues of the face.
- If you are considering laser treatment, chemical skin peeling or any other
procedure based on a skin response after Restylane treatment, or you have
recently had such treatments and the skin has not healed completely, there is a
possible risk of an inflammatory reaction at the implant site.
- Most patients are pleased with the results of Restylane use. However, like any
cosmetic procedure, there is no guarantee that you will be completely satisfied.
There is no guarantee that wrinkles and folds will disappear completely, or that
you will not require additional treatments to achieve the results you seek. While
the effects of Restylane use can last longer than other comparable treatments, the
procedure is still temporary. Additional treatments will be required periodically,
generally within 6-months to one-year, involving additional injections for the
effect to continue.
- After treatment, you should minimize exposure of the treated area to excessive sun or UV lamp exposure and extreme cold weather until any initial swelling or redness has gone away.
Restylane has been shown to be safe and effective when compared to other approved collagen skin implants and related products to fill in wrinkles, lines and folds in the skin on the face. Its effect, once the optimal location and pattern of cosmetic use is established, can last 6-months or longer without the need for re-administration.
This is strictly a voluntary cosmetic procedure. No treatment is necessary or required. Other alternative treatments which vary in sensitivity, effect and duration include: animal-derived collagen filler products, dermal fillers derived from the patient's own fat tissues, synthetic plastic permanent implants, or bacterial toxins that can paralyze muscles that cause some wrinkles.
The cost of treatment will be billed to you individually. Since most uses of Restylane are considered cosmetic, they are generally not reimbursable by government or private heath care insurers.
This procedure was explained to you by your physician, and all your questions were answered. If you have any other questions about this product or procedure, you may call Dr. Pryor.
You have been given a copy of this consent form. 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 Facial Augmentation and Filler Therapy/Injections using Restylane 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, with possible alternative methods of treatment as well as complications, have been fully explained to your satisfaction. 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. I have had enough time to consider the information from my physician and feel that I am sufficiently advised to consent to this procedure. I hereby give my consent to this procedure and have been asked to sign this form after my discussion with the physician.