Studies conducted by the manufacturer showed that the device, Restylane, is safe and effective for filling moderate to severe wrinkles around the nose and mouth. Most patients needed one injection to get optimal correction; about one-third of patients needed more than one injection to get a satisfactory result. The effect lasted about six months.

Restylane is made with hyaluronic acid. Two other injectable products are approved by FDA for treating wrinkles. Collagen injections are approved for correcting soft tissue deficiencies such as wrinkles and acne scars, and botulinum toxin is approved for treating frown lines between the eyebrows. Other treatments for wrinkles include topical creams, chemical peels and laser and electro-surgical resurfacing.

FDA’s approval is based on a review of the clinical studies conducted by the manufacturer and on the recommendation of the General and Plastic Surgery Devices Panel of FDA’s Medical Devices Advisory Committee.

In the pivotal study, conducted at six medical centers in the United States, 138 patients with naso-labial folds were injected with Restylane on one side of the face and Zyplast, a bovine collagen product, on the other side of the face. Most of the patients were caucasian women who did not smoke and had minimal previous sun exposure.

The results showed that, six months after treatment, the effects of Restylane and Zyplast as wrinkle fillers were comparable.

As reported by patients within 14 days following the first treatment, the Restylane treated side had a lower incidence of severe redness (5.1% vs. 5.8) and an increased incidence of severe bruising (3.6% vs. 0.7%), severe swelling (3.6% vs. 1.4%), severe pain (3.6% vs. 1.4%), and severe tenderness (2.9% vs. 1.4%) compared with the Zyplast treated side. These incidents were lower with follow up injections for both products.

There was limited data in the study on the safety of Restylane in non-caucasians. The firm, Q-Med AB of Sweden, has agreed to conduct a post approval study in people of color to determine the product’s safety for this population. The firm will also provide training to physicians on the correct use of the device.