Medicis, which distributes Restylane in the United States, just obtained FDA clearance for lip augmentation with Restylane.  Many people have already heard about (or used) Restylane or another hyaluronate filler for lip augmentation.  So why is this clearance big news?  Until now, this use has been “off-label”.  In other words, physicians are using the product Restylane for a use other than what the FDA cleared it for.  This is a commonplace practice in medicine.  Now with the clearance, Restylane placed in the lip for augmentation has been studied and found safe and efficacious by the FDA regulators who have allowed this additional clearance.

This means two things for patients.  First, this is an additional assurance of the safety of this use.  The lip is more sensitive to being injected, and more prone to tissue reaction than other areas of the face.  Knowing that large, careful multicenter studies have confirmed safety is reassuring.  Second, this clearance allows Medicis to market this use to the public and train physicians in the use.  This will raise awareness and provide even greater sharing of information and techniques among physicians.


The Most Important Take-Away

Many people think of “duck lips” or  “Angelina Jolie” lips when they think about lip augmentation.  This is a stereotype, of course.  Lip augmentation is best focused on shaping the lip and restoring volume that is lost with age.  Such an augmented lip would look perfectly natural, not overdone.  Like everything in life, there can be too much of a good thing.  All things in plastic surgery look best when they create a natural appearance.  Injectable filler treatments are extremely dependent on the skill of the injector.  An experiences and artistic aesthetic provider is essential to get outstanding results and look your best.

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