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:

• • redness,
  • pain/tenderness,
  • firmness,
  • swelling,
  • lumps/bumps,
  • bruising,
  • itching,
  • discoloration.

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
  • stroke
  • 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.