Warning: One of the risks with using this product is unintentional injection into a blood vessel. 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, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness
in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
There are several other important precautions to discuss with your doctor to ensure a satisfactory result and to avoid any complications. Please be sure to discuss the following with your doctor:
- Which areas of the face you would like to have treated
- Restylane® Lyft with Lidocaine is intended for use in the areas around the nose, mouth, and cheeks. Results have not been studied in other areas of the face in the United States.
- The use of Restylane® Lyft with Lidocaine on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use ofRestylane® Lyft with Lidocaine in these areas of skin could delay healing or make your skin problems worse.
- If you would like to have treatment in the hands
- Tell your doctor if you have had previous hand surgery including sclerotherapy or history of hand trauma.
- History of Raynaud’s disease or Raynaud’s phenomenon, or history of other disease
- If you are of appropriate age to receive Restylane® Lyft with Lidocaine
- For injections around the nose and mouth, the safety of Restylane® Lyft with Lidocaine has not been studied in people younger than 18 years or older than 65 years.
- For injections to the cheek and hands, safety has not been studied in patients younger than 22 years.
- If you are breastfeeding, pregnant, or trying to become pregnant
- The safety of Restylane® Lyft with Lidocaine for use during pregnancy, or in women who are breastfeeding, has not been studied.
- If you are on any medications to decrease your body’s immune response (immunosuppressive therapy)
- Use of these medications may increase your risk of infection.
- If you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding
- Using these medications may increase your risk of bruising or bleeding at the gel injection site.
- If you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general
- In clinical trials of Restylane® Lyft with Lidocaine, some African-American patients experienced a darkening of skin tone (hyperpigmentation) that resolved after 6 weeks.
- No excessive scarring (keloids) was reported by clinical trial patients across different skin tones (pale to dark).
- If you have any additional questions about any topic in this section, please discuss further with your doctor.
Source: [https://www.galderma.com/us/sites/default/files/2020-09/90-88360-06%20Restylane%20Lyft%20eIFU.pdf](https://www.galderma.com/us/sites/default/files/2020-09/90-88360-06 Restylane Lyft eIFU.pdf)