Restylane® Lyft

• Help complete your aesthetic look with natural-looking volume in your cheeks and hands for a smoother, fuller appearance..
• Restylane® Lyft is a safe, effective and dissolvable HA filler.
• Treatment can be administered in your hands and face at the same appointment — and can result in a more youthful-looking appearance

What is Restylane® Lyft with Lidocaine?

Restylane® Lyft with Lidocaine is a clear injectable gel composed of hyaluronic acid, a natural substance that already exists in the body. Restylane® Lyft with Lidocaine is non animal-based and free from animal protein. Allergy pretesting is not necessary. Restylane® Lyft with Lidocaine also contains 0.3% lidocaine. The lidocaine in Restylane® Lyft with Lidocaine has been added to reduce the discomfort associated with the treatment.

How does Restylane® Lyft with Lidocaine work?

Restylane® Lyft with Lidocaine is injected into the skin with an ultrafine needle to plump the skin to smooth away wrinkles and folds such as the lines from your nose to the corners of your mouth and is injected with an ultrafine needle or a small, blunt-tipped cannula to increase the fullness of your cheeks. Restylane Lyft with Lidocaine may also be injected, using an ultrafine needle under the skin to address volume deficiency in the back of the hand.

Why is there lidocaine in Restylane® Lyft with Lidocaine?

The lidocaine in Restylane® Lyft with Lidocaine reduces pain and discomfort during and after injection.

The effectiveness of the lidocaine was studied in a split-face clinical study of 60 patients. Each patient received Restylane® Lyft without Lidocaine on one side of the face and Restylane® Lyft with Lidocaine on the other side of the face for the treatment of lines around the nose and mouth. Restylane® Lyft with Lidocaine significantly reduced the pain of the injection.

• For the side of the face treated with Restylane® Lyft without Lidocaine, patients rated their pain as about 47 on a scale of 0 to 100 after injection.
• For the side of the face treated with Restylane® Lyft with Lidocaine, patients rated their pain as about 15 on the same scale.
• Pain relief from the lidocaine in Restylane® Lyft with Lidocaine lasted up to 60 minutes after treatment.

How long does Restylane® Lyft with Lidocaine last?

• When Restylane® Lyft with Lidocaine is used for the treatment of wrinkles and folds such as the lines from your nose to the corners of your mouth, the benefits generally last about 6 months as the filler gradually disappears from the body.
• When Restylane® Lyft with Lidocaine is used to increase the fullness of your cheeks, the benefits generally last between two and twelve months as the filler gradually disappears from the body. The graph below compares patients who were treated with Restylane Lyft with Lidocaine using a needle and patients who had no treatment, who showed a positive treatment response at 2, 4, 6, 8, 10 and 12 months, as assessed by blinded evaluators (e.g., physicians not aware of the patient treatment assignment).
• When Restylane® Lyft with Lidocaine is used to increase fullness in the back of the hand, the benefits usually lasts 6 months as the filler gradually disappears from the body.

What were the outcomes in the clinical trials? Restylane® Lyft without Lidocaine and Restylane® Lyft with Lidocaine were tested in several clinical trials for each of its intended uses.

For the treatment of wrinkles around the nose and mouth, Restylane® Lyft without Lidocaine was tested in 4 prospective randomized controlled clinical trials involving 509 Restylane® Lyft without Lidocaine –treated patients.

• Patients reported significant improvement in the appearance of the wrinkles and folds around the mouth that lasted for 6 months.

Are there any reasons why I should not use Restylane® Lyft with Lidocaine? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use Restylane® Lyft with Lidocaine if

• You have severe allergies with a history of severe reactions (anaphylaxis). An injection of Restylane® Lyft with Lidocaine may result in an allergic reaction..
• You are allergic to lidocaine or to any of the proteins used to make the hyaluronic acid in Restylane® Lyft with Lidocaine (bacterial proteins). An injection of Restylane® Lyft with Lidocaine may result in an allergic reaction.
• You are prone to bleeding or have been diagnosed with a bleeding disorder. An injection of Restylane® Lyft with Lidocaine may have a higher risk of severe bleeding or bruising

If you are not sure about your medical history concerning these allergies, please discuss further with your doctor.

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, or vision abnormalities including blindness

Rarely, a few people have developed infections that must be treated with antibiotics or other treatment (such as surgery). Infection may be hard to treat, but will generally go away when the gel is absorbed.

In clinical trials, 2 patients reported 4 serious adverse events (SAEs) that were considered to be related to the device and/or the procedure. One subject reported gel injection site swelling (late onset inflammatory reactions) in both cheeks at separate times. Treatments for the left and right cheeks each included antibiotics, NSAID nonsteroidal anti-inflammatory medications (such as ibuprofen and naproxen) and hyaluronidase (a medicine to help break down the Restylane® Lyft with Lidocaine so that it is more easily absorbed). The second patient experienced gel injection site bruising (hematoma) in the right cheek and gel injection site infection/abscess. Treatment of the right cheek infection/abscess and gel injection site bruising included antibiotics and a surgical procedure (incision and drainage). In the clinical trial for the hand, 4 patients with adverse events of swelling, nodules (small bump), or tenderness that were considered to be related to the device and/or the procedure received treatments that included antibiotics, NSAID nonsteroidal anti-inflammatory medications (such as ibuprofen and naproxen) and medicine used to help breakdown HA in the body (hyaluronidase). All events resolved with treatment and time.

Do the injections hurt?

As with all injections, there may be pain or discomfort during the procedure.

Restylane® Lyft with Lidocaine contains lidocaine, a local anesthetic, to reduce the pain or discomfort associated with an injection. In addition, Restylane® Lyft with Lidocaine is injected directly into the skin in tiny amounts by an ultrafine needle.

To help maximize your comfort, you should discuss the use of numbing medicines with your doctor before treatment.