"The US Food and Drug Administration (FDA) has approved Juvederm Ultra XC (Allergan) for injection into the lips and perioral area for lip augmentation in adults older than 21 years, the company announced today. It is a new indication for t"...
- Defer use of Perlane-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 Perlane-L 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. Refer to the adverse reactions section for details.
- Perlane-L must not be implanted into blood vessels. Localized superficial necrosis may occur after injection in or near dermal vessels, such as the 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.
- Perlane-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. The safety of injecting greater amounts has not been established.
- The safety or effectiveness of Perlane-L for the treatment of anatomic regions other than nasolabial folds has not been established in controlled clinical studies.
- Long term safety and effectiveness of Perlane-L beyond one year have not been investigated in clinical trials.
- As with all transcutaneous procedures, Perlane-L implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
- The safety and efficacy of Perlane-L for lip augmentation has not been established.
- The safety of Perlane-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 Perlane.® Keloid formation was not observed in studies involving 509 patients (including 150 African-Americans and 25 other patients of Fitzpatrick Skin Types IV, V and VI). For additional information please refer to Studies MA-1400-02, MA-1400-01, 31GE0002, and 31GE0101 in the Clinical Trials Section. In study MA-1400-03 with Perlane-L and Perlane, there were 51.7% (31/60) of patients with Fitzpatrick Skin Types IV, V, and VI and no reports of keloid formation.
- Perlane-L 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 6% (9/150). 50% of these events lasted up to six weeks after initial implantation. In study MA-1400-03 with Perlane and Perlane-L, there were 51.7% (31/60) of patients with Fitzpatrick Skin Types IV, V, and VI and no reports of hyperpigmentation
- Perlane-L should be used with caution in patients on immunosuppressive therapy.
- Bruising or bleeding may occur at Perlane-L injection sites. Perlane-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 Perlane-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 Perlane-L, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Perlane-L is administered before the skin has healed completely after such a procedure.
- Injection of Perlane-L into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
- Perlane-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 Medicis Aesthetics Inc. at 1-800-555-5115. Glass is also 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.
- Perlane-L should not be mixed with other products before implantation of the device.
Last reviewed on RxList: 7/5/2013
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