Restylane is the brand name for a gel of hyaluronic acid generated by the Streptococcus bacteria that is manufactured by Q-Med AB in Sweden and marketed in the United Stated by Medicis Aesthetics. The U.S. Food and Drug Administration approved Restylane in 2003. According to the product label, Restylane is indicated for mid- to deep implantation for the correction of moderate to severe facial wrinkles and folds, such as laugh lines.
Benefits
Restylane is a popular product that dermatologists and cosmetic surgeons use to make people's faces look younger. The human body naturally produces hyaluronic acid, the active substance in Restylane. According to the Food and Drug Administration, doctors inject Restylane gel into facial tissue to smooth wrinkles and folds around the nose and mouth, temporarily adding volume to the face. The effect lasts for about six months.
Who Should Not Use Restylane
According to the product label, Restylane should not be used in patients with bleeding disorders, severe allergies and a history of anaphylaxis or multiple severe allergies to gram-positive proteins. Anaphylaxis is characterized as a sudden condition when exposed to an allergen that can cause difficulty breathing, dizziness, nausea, coma or death. Restylane should not be used in women who are pregnant or breastfeeding and anyone younger than 18. The Food and Drug Administration says Restylane should not be used for breast augmentation or implantation outside the skin such as the bone, tendon, ligament, muscle or blood vessels.
Warnings
The Restylane product label includes several warnings. Restylane use should be deferred in patients who have an infection or inflammatory process of their face, such as pimples, cysts, hives or rashes. Restylane could exacerbate these conditions and spread the risk of infection from bacteria, virus or fungi. If Restylane is implanted into the blood vessels it can cause superficial necrosis, also known as skin death, particularly in the smooth area between the eyebrows. This can cause scarring. Restylane can also cause a delayed reaction of inflammatory papules, or red bumps on the skin.
Adverse Reactions
Side effects from Restylane include bruising, redness, swelling, pain, tenderness and itching. These adverse experiences were based on reports by 430 patients in four clinical trials in the United States. Postmarketing surveillance of Restylane, as indicated on the product label, includes reports of the above side effects plus inflammatory and allergic adverse events. Research published in Dermatologic Surgery demonstrates that injection techniques by physicians can increase the incidence of adverse reactions, particularly when the needle enters tissue below the epidermis layer of the skin.
Expert Opinion
Research published in the journal Plastic and Reconstructive Surgery concluded that Restylane is safe, effective and long lasting as a technique in nonsurgical facial rejuvenation. Doctor's Medical Center in Duluth, Ga., stated the following on its website about Restylane: "Safe, effective, and FDA-approved, it is, in our opinion, the finest lip-enhancement and skin filler in the world, exceeding the results of many other skin fillers and contouring agents available today."
References
- Food and Drug Administration: Restylane™ Injectable Gel - P020023
- Medicis Aesthetics: Restylane Prescribing Information
- "Dermatologic Surgery"; Effect of Injection Techniques Hyaluronic Acid Gel Dermal Fillers; R.G.Glogau; June 2008
- "Plastic and Reconstructive Surgery"; The Role of Restylane in Facial Cosmetic Surgery; R.J. Rohrich; November 2007
- Doctors Medical Center: Restylane
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