FDA approves Restylane for facial wrinkles
On Friday, December 12, 2003 The Food and Drug Administration (FDA) approved
an injectable gel to treat facial wrinkles.
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.
FDA Approves New Product for Facial Wrinkles
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.
Last year, more than 1.5 million Americans smoothed wrinkles with
injectables, according to the ASPS plastic surgery procedures statistic data.
Almost 5 million Americans had non-surgical cosmetic plastic surgery procedures
in 2002.
The arrival of Restylane has been long-awaited by physicians and consumers
alike. We will offer this product to our patients.
To schedule a consultation with our physicians,
click here.
