Monday, May 2, 2011

FDA Update: Restylane

The FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee met on April 27, 2011 to review the request for expanding the use of Restylane for augmentation of the lips.  The panel voted 6 to 0 (1 abstaining) that Restylane for lip augmentation is generally safe and effective for this purpose and that the benefits outweigh the risks.

The FDA still has to make a final decision on Restylane injectable gel for lip augmentation, but the agency usually follows the advice of its advisory panels, which consist of outside experts.

Restylane was approved by the FDA in 2003. It is a non-animal stabilized hyaluronic acid gel. Restylane is free from animal proteins. This limits any risk of animal-based disease transmissions or development of allergic reactions to animal proteins. Allergy pretesting is not necessary.

Perlane is a more robust form of Restylane intended for use in the deep dermis and at the dermal-fat junction. Restylane is indicated for the correction of moderate to severe facial wrinkles and folds.

The most commonly observed side effects are temporary redness and swelling at the injection site, which typically resolve in less than seven days. Both are made by Medicis.  Both are available with lidocaine (Restylane-L, Perlane-L).  Patients should be limited to 6.0 mL per treatment.

According to Medicis, Restylane is the most-studied aesthetic dermal filler in the world, and has been used in over 10 million treatments worldwide.

 

From Medscape news article:

During the public comment portion of the meeting, Gloria Duda, MD, board-certified plastic surgeon from McLean, Virginia, who was representing the American Society for Aesthetic Plastic Surgery, noted that Restylane is commonly used off-label to augment and contour the lips, and she encouraged the panel to support its use for this indication.

Lip augmentation is a "very frequently" requested procedure, Dr. Duda said, and, in her experience, the results are "immediate and reproducible and the risks with hyaluronic acid are minimal."

"I perform over 120 lip augmentations per year with no complications and 95% retention with return visits at 8 to 12 months for repeat procedures," Dr. Duda said.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. Meeting held April 27, 2011, in Gaithersburg, Maryland.

 

 

 

Related posts:

Dermal Fillers (August 30, 2007)

Lip Augmentation (January 25, 2008)

Guest Post by Dr Val--Lip Plumping With Restylane: What Your Doctor Might Not Tell You (September 25, 2008)

Injectables Roundup (November 11, 2010)

 

 

REFERENCES

Medicis Press Release, April 27, 2011

FDA:

Restylane™ Injectable Gel  (approval date December 2003)

April 27, 2011: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

2011 Meeting Materials of the General and Plastic Surgery Advisory Panel (April 27, 2011)

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