What is Restylane®? Restylane® is a crystal clear injectable gel composed of hyaluronic acid, a natural substance that already exists in the body. Restylane® is crosslinked with BDDE, an ingredient that helps form a network of HA to provide a gel filler that lasts longer. Restylane® is nonanimal based and free from animal protein. Allergy pretesting is not necessary.
How long does Restylane® last? Restylane® effects generally last six months and gradually disappear from the body. If you are treated again at 4 ½ or 9 months after your first treatment, Restylane® can last up to 18 months.
Has Restylane® been studied? Restylane® has been studied in facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds), and the lips. The studies show that Restylane® effects generally last at least six months and gradually disappear from the body. If you are treated again at 4 ½ or 9 months after your first treatment, Restylane® can last up to 18 months.
Who should not use Restylane® (Contraindications)? Safety has not been established for use in people who are: • Pregnant • Breastfeeding • Wishing to be pregnant • Under 18 years or over 65 years • Highly allergic (for example gram-positive bacteria) • Prone to bleeding disorders
What are some warnings to consider? The use of Restylane® at sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. The use of Restylane® in these instances could delay healing or make your skin problems worse. You may experience skin discoloration (bruising), swelling, redness, tenderness, pain, itching, or small lumps in the area where you are injected. If any of these events occur, the majority usually last less than seven days. If any symptom lasts longer than two weeks, call the doctor who administered the Restylane® injection. Red or swollen small bumps (inflammatory papules) may rarely occur. You may need antibiotics to treat them.
What are some potential risks you may encounter? As with all procedures like this, the injection of Restylane® carries a risk of infection and formation of scar tissue. The safety and effectiveness of Restylane® have not been established in pregnant, or nursing mothers, and in patients under 18 or over 65 years of age. Restylane® use in nursing could harm you or the nursing child.
The use of Restylane® in African-American patients can result in darkening of skin color (hyperpigmentation ), which may take several weeks to correct. If you have previously had facial cold sores, an injection can cause them to come back.
The safety of Restylane® used with other skin therapies such as laser, mechanical or chemical peeling, and hair removal has not been established. The use of Restylane® with these skin therapies may lead to other side effects such as inflammation.
You should avoid exposing the area(s) treated with Restylane® to excessive sun or UV lamps, and extreme heat and cold until any redness or swelling has disappeared.
Clinical volunteers keeping diaries reported the following short-lived events: Bruising, redness, swelling, pain (includes burning), tenderness, and itching. Most of these symptoms were considered tolerable and resolved in less than a week.
What are the major side effects? Rarely, the doctor may inadvertently inject the product into a blood vessel, which can cause injury to the blood supply and damage to the skin.
In rare cases injection into a blood vessel could also result in vision changes (including blindness) and stroke.
Rarely, a few people have developed infections that must be treated with antibiotics or other treatment. Infection may be hard to treat, but will generally go away when the gel is absorbed. |