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FDA Panel Backs Approval of Restylane for Lip Augmentation

May 5, 2011 |

Dermatologists may not have to use Restylane off label for lip augmentation any longer. On April 27, a Food and Drug Administration panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation.

The panel also voted 6-0 with 1 abstention that the filler is safe and effective for the expanded indication.

Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated by Streptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether. The filler was first approved in 2005 for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

Medicis recently conducted a clinical study (MA-1399-15) to evaluate the safety and effectiveness of the filler in the augmentation of soft tissue fullness of the lips. The study included 135 patients, who received lip augmentation with Restylane, and 45 patients with no treatment. The mean volume of filler was 2.9 cc per patient, with a range of 0.6-5.6 cc per patient. At 8 weeks, 92% of patients who received Restylane were considered responders.

Adverse events occurred in 99% of patients. Expected treatment-emergent adverse events included bruising, redness, swelling, pain, tenderness, itching, and skin exfoliation. Of note, herpes simplex virus 1 outbreaks occurred in 4% of patients. The outbreaks were determined to be associated with injection of the filler in 7 or 10 cases.

Forty percent of patients who received the filler had adverse outcomes that they felt affected their daily activity or were disabling; 15% of Restylane patients experienced adverse events (typically swelling and tenderness) that lasted more than 15 days.

The agency was particularly concerned about the implications of the treatment in younger patients who may still be growing and are likely to receive repeat treatments over time.

“My only problem with voting completely yes … is that I don’t think that the question was worded in such a way that I felt totally comfortable giving my final approval for safety, efficacy, and risk/benefit ratio to all populations,” said panel member Dr. Delora L. Mount, associate professor of surgery and pediatrics at the University of Wisconsin in Madison.

The FDA panel was also concerned about the lack of men and individuals with dark skin in the trial. Only one man was included and 38 individuals were Fitzpatrick skin type IV, 3 individuals were type V, and none were type VI.

The FDA usually follows its panels’ advice, but is not obligated to do so.

Source:  By: Kerri Wachter, Internal Medicine News Digital Network, at

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