Dr. Z wants to share another great article from Medscape:
April 27, 2011 — Today, the US Food and Drug Administration's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee recommended the injectable wrinkle-filler Restylane (Medicis Aesthetics Inc) for use as a lip enhancer.
Restylane, an injectable gel composed of hyaluronic acid, is indicated for mid- to deep-dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. The company is seeking to amend the product's indication to include submucosal implantation for lip augmentation.
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.
The panel heard an overview of data from the pivotal 12-center study of 180 patients randomly assigned to lip augmentation with Restylane injectable gel or to no treatment.
After weighing the evidence of effectiveness, "the panel generally believes that Restylane has been shown to be effective for lip augmentation," Susan Galandiuk, MD, professor of surgery, University of Louisville in Kentucky, who chaired the panel, said.
In general, treatment emergent adverse events in the study were common, transient, and mild. No unanticipated adverse events occurred; anticipated adverse events included bruising, redness, swelling, pain, tenderness, and itching.
After weighing the evidence on safety, "the panel generally believes that Restylane for lip augmentation is generally safe," Dr. Galandiuk said. Panel member Michael J. Miller, MD, chief of the Division of Plastic Surgery, The Ohio State University, Columbus, noted that, overall, adverse effects are "self-limited and most [patients] came back for further treatment."
FDA statistician Alvin Van Orden noted that in the pivotal study on Restylane for lip augmentation, a "wide range of volume" of Restylane gel was used and an increase in injected volume did not predict increased effectiveness; "volume injected was not a predictor of lip fullness in any model," he said, "but a higher injected dose does appear to increase safety concerns."
Summing up the panel's discussion on this issue, Dr. Galandiuk said that in general, "the panel has no significant concern regarding the lack of correlation between the injected dose and the change in lip fullness, and the panel does not feel a need to cite a maximum injectable dose."
However, she said, the panel recognizes that the product will have "widespread applicability to numerous types of physicians, and possibly dentists, and feels there is a need to set some type of limit for an individual dose per lip and that there should be training guidelines for physicians and users of this product."
Data on Restylane as a lip enhancer in people with darker skin types and men are limited. However, panel consensus was that no additional premarket studies are necessary in these 2 populations.
Several panel members also had "philosophical" concerns about its use in younger patients age 18 to 22. Only 4 patients in the pivotal 180-patient study were in this age group.
The majority of the panel also do not feel that a postmarketing study is required, but several members believe that a registry should be created to follow outcomes, particularly in younger patients.
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.
Article by: Megan Brooks
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