"The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
There are two types of vei"...
- Defer use of Restylane-L at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present until the process has been controlled.
- Injection site reactions (e.g., swelling, redness, tenderness, or pain) to Restylane® have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration in the nasolabial folds and less than 14 days duration in the lips. Rare post-market reports of immediate post-injection reactions included extreme swelling of lips, the whole face and symptoms of hypersensitivity such as anaphylactic shock.
- Restylane-L must not be implanted into blood vessels. Localized superficial necrosis and scarring may occur after injection in or near dermal vessels, such as in the lips, nose, or glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels.
- Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules that may occur rarely should be considered and treated as a soft tissue infection.
- Injections of greater than 1.5 mL per lip (upper or lower) per treatment session significantly increases the occurrence of the total of moderate and severe injection site reactions. If a volume of more than 3 mL is needed to achieve optimal correction, a follow-up treatment session is recommended.
- In a meta-analysis of all Restylane Pre-market Approval Studies (that included 42 patients under the age of 36 and 820 over the age of 35), the incidence of swelling was higher in younger patients (28%) compared to older patients (18%) and incidence of contusion was higher in older patients (28%) compared to younger patients (14%). The majority of these events were mild in severity.
- Restylane-L is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
- Based on U.S. clinical studies, patients should be limited to 6.0 mL per patient per treatment in wrinkles and folds such as nasolabial folds and to 1.5 mL per lip per treatment. The safety of injecting greater amounts has not been established.
- The safety or effectiveness of Restylane and Restylane-L for the treatment of anatomic regions other than nasolabial folds or lips has not been established in controlled clinical studies. Refer to the clinical studies section for more information on implantation sites that have been studied.
- The safety and efficacy of Restylane-L for lip augmentation has not been established in patients under the age of 22 years.
- As with all transcutaneous procedures, Restylane-L implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
- The safety of Restylane-L for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
- Formation of keloids may occur after dermal filler injections including Restylane. Keloid formation was not observed in studies involving 430 patients (including 151 African-Americans and 37 other patients of Fitzpatrick Skin Types IV, V and VI). For additional information please refer to Studies MA-1400-02, MA-1400-01, and 31GE0003 in the Clinical Trials Section. In study MA-1100-001 with Restylane and Restylane-L, there were 53.3% (32/60) of patients with Fitzpatrick Skin Types IV, V, and VI and no reports of keloid formation.
- Restylane injection may cause hyperpigmentation at the injection site. In a clinical study of 150 patients with pigmented skin (of African-American heritage and Fitzpatrick Skin Types IV, V, and VI), the incidence of post-inflammatory hyperpigmentation was 9% (14/150). 50% of these events lasted up to six weeks after initial implantation. In study MA-1100-001 with Restylane and Restylane-L there were 53.3% (32/60) of patients with Fitzpatrick Skin Types IV, V, and VI and no reports of hyperpigmentation.
- The safety profile for Restylane lip augmentation in persons of color is based upon information from 38 and 3 subjects with Fitzpatrick Skin Types IV and V, respectively. Within this population, the incidence of adverse events was similar to the overall study population, with the exception that swelling occurred more frequently in persons of color.
- Restylane-L should be used with caution in patients on immunosuppressive therapy.
- Bruising or bleeding may occur at Restylane-L injection sites. Restylane-L should be used with caution in patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- After use, syringes and needles should be handled as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local, state and federal requirements.
- The safety of Restylane-L with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials.
- Patients should minimize exposure of the treated area to excessive sun, UV lamp exposure and extreme cold weather at least until any initial swelling and redness has resolved.
- If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane-L, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane-L is administered before the skin has healed completely after such a procedure.
- Injection of Restylane-L into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
- Restylane-L is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe and notify Galderma Laboratories, L.P. at 1-855-425-8722. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
- Restylane-L should not be mixed with other products before implantation of the device.
Last reviewed on RxList: 3/28/2016
Additional Restylane-L Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.