What is Restylane Kysse?
Restylane Kysse is a clear injectable gel composed of hyaluronic acid (HA). HA is a naturally occurring sugar, found in the human body.
INDICATIONS FOR USE
What is Restylane Kysse for?
Restylane Kysse is injected into the lips and the lines around the upper lip to temporarily add fullness to the lips and help smooth the wrinkles around the upper lip (perioral lines) in patients over the age of 21.
How is Restylane Kysse used?
Restylane Kysse is injected with an ultrafine needle into your lips to add fullness. It can also be injected into the skin above your lips to help smooth the wrinkles around your upper lip (perioral lines). The picture below shows the treatment areas for Restylane Kysse.
Are there any reasons why I should not receive Restylane Kysse?
Your provider will ask about your medical history to determine if Restylane Kysse is right for you. Patients with any of these conditions should not use Restylane Kysse:
- Highly allergic (for example: a history of severe allergic reaction or multiple severe allergies). Use may result in an allergic reaction.
- If you have previous experience with allergic reactions to HA fillers. Use may result in an allergic reaction.
- Allergic to anesthetics, such as lidocaine. Use may result in an allergic reaction.
- The use of Restylane Kysse where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed until healing is complete. Use of Restylane Kysse where these are present could delay healing or make your skin problems worse.
- As with any injection procedure, you may have a higher risk of bruising or bleeding at the injection site if you have a bleeding disorder.
- Tell your provider if you are using St. John’s Wort, high doses of Vitamin E supplements, aspirin, and other NSAIDs, such as ibuprofen, because these may increase bruising or bleeding at the injection site.
- Tell your provider if you are planning other skin therapies such as laser, mechanical or chemical peeling, microneedling and hair removal after treatment. The use of Restylane Kysse with these skin therapies may lead to other side effects such as inflammation.
- After treatment with Restylane Kysse, you should minimize exposure to the sun and avoid being in the heat and cold until any redness or swelling has disappeared. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site.
- Tell your provider if you are pregnant or breastfeeding. The safety and effectiveness of Restylane Kysse has not been established in pregnant women or nursing mothers.
- Tell your provider if you are on a therapy to decrease the body’s immune response. Treatment may result in an increased risk of infection.
- Tell your provider if you have a history of thick, hard scars (excessive scarring). The safety and effectiveness of Restylane Kysse in patients with a history of thick, hard scars has not been studied and may result in additional scarring.
What will Restylane Kysse do for me?
Restylane Kysse will temporarily add volume to the lips and help smooth the wrinkles above your mouth.
Restylane Kysse was studied in many subjects like yourself to determine if it was effective and to ensure that it is safe for use.
What side effects were seen in the clinical study?
In the study of Restylane Kysse, most side effects were mild or moderate in nature and their duration was short lasting (7 days or less). The most common side effects included, but was not limited to, temporary injection site responses such as:
Other potential risks may arise from an injection of a dermal filler gel such as Restylane Kysse including the following:
- Infection - Any time a dermal filler gel like Restylane Kysse is injected into facial skin there is risk of infection, which could appear as small, swollen or red bumps. These are called inflammatory papules. These infections are rare, however you should talk to your provider about further treatment if you see any of these signs or symptoms.
- Scarring - While it is very rare, scarring may occur with an injection procedure. When Restylane Kysse was studied, there was no excessive scarring (a condition called keloids) observed in patients who received Restylane Kysse.
- Change in skin tone - If you are African American, you may have a higher risk of darkening of the skin tone (hyperpigmentation) in the treated area. This may take several weeks to disappear. When Restylane Kysse was studied, this change in skin tone did not occur in patients who received Restylane Kysse.
- Cold sores - If you have had cold sores in the past, there is a risk that they will return after your procedure with Restylane Kysse.
- Age and pregnancy – Restylane Kysse has not been studied in patients under 22 years of age, patients who are pregnant or patients who are breastfeeding. If you are pregnant, trying to become pregnant, or breastfeeding, the safety and effectiveness of Restylane Kysse has not been proven in patients like yourself.
- Vision changes - Vision abnormalities have rarely been reported after treatment with other dermal filler gel treatments.
- Use of other skin therapies - The safety of Restylane Kysse has not been established in patients who have had other skin therapies, such as laser, mechanical, or chemical peeling, and hair removal. If you use Restylane Kysse with any of these skin therapies you may experience other side effects such as redness, swelling, heat and/or pain of the skin (inflammation).
- Ultraviolet (UV) exposure - You should avoid exposing the area(s) treated with Restylane Kysse to excessive sun, UV lamps or indoor tanning beds/booths, and extreme heat and cold until any redness or swelling has disappeared. Exposure to UV sources may result in irritation at the site of treatment.
- One of the risks of Restylane Kysse is that it may be unintentionally injected into a blood vessel during the procedure. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include:
- vision abnormalities, or blindness
- temporary scabs
- permanent scarring of the skin
You should tell your provider immediately if you experience any of these side effects or if you notice anything unusual at the site of treatment. There are also other potential side effects that can occur with dermal filler gel injections. Although most side effects will resolve with time, some side effects may persist longer than 30 days. Your provider may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase (an enzyme that breaks down HA). You should discuss the potential treatment risks and benefits with your provider.
What happens in the office before the injection?
The following is an example of what your provider may do before the injection procedure.
- Talk to you about your medical history, including questions about prior procedures, surgeries, illnesses and medications you have taken.
- Talk to you about your desired results for your procedure.
- Examine your face and discuss whether Restylane Kysse is the right treatment for you.
- Review what you should expect during and after the procedure.
- Let you know of any possible side effects that you may experience, and what to do if you experience these.
- Take photos of the area of your face that will be treated.
What happens during the procedure?
Your skin will be cleansed prior to treatment.
- Use a cream or ointment called a topical anesthetic to numb the area where you will receive your injection.
- Your provider will begin the procedure by giving you the first injection, then pausing to allow the anesthetic that is part of Restylane Kysse to continue to numb the area around your injection. The anesthetic part of Restylane Kysse has been shown to significantly reduce the pain and discomfort that may occur with a dermal filler gel injection.
- Your provider will continue the injection of Restylane Kysse until the area being treated shows the desired results.
- After the injection is completed, your provider may gently massage the area that was treated to ensure the dermal filler gel is distributed evenly and looks natural.
What should patients do after receiving treatment?
- A clean cloth dipped in cold water (cold compresses) wrung out, and applied to the injected area may be used immediately after treatment to reduce swelling.
- Avoid touching the treated area within six hours following treatment so you do not accidentally injure your skin while the area is numb. After that, the area can be gently washed with soap and water.
- Avoid taking aspirin, NSAID, St. John’s Wort, blood thinners, and high doses of Vitamin E supplements for one week after treatment. These agents may increase bruising and bleeding at the injection site.
- Minimize strenuous exercise and exposure to excessive heat, sun, or UV lamps for the first 24 hours after treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site. Until there is no redness or swelling, avoid exposure of the treated area to intense cold or heat such as sun lamps or sunbathing.