Will Wrinkle-Smoother Restylane Be Approved as Lip Enhancer?


Will Wrinkle-Smoother Restylane Be Approved as Lip Enhancer?

An advisory panel toِ theِ Food andِ Drug Administration willِ vote today (April 27) onِ whether toِ recommend theِ injectable filler Restylane forِ use asِ a lip enhancer.
But future FDA approval mayِ not makeِ a difference inِ howِ the dermal filler isِ used inِ clinical practice, doctors say.
Farhad Rafizadeh, a plastic surgeon whoِ hasِ a private practice inِ Morristown, N.J.

What Restylane does

Rafizadeh sees atِ least a couple patients a month whoِ areِ seeking plumper lips.
He oftenِ recommends Restylane becauseِ it stays put andِ doesn’t seep intoِ other areas ofِ the face asِ other dermal fillers, suchِ asِ Juvederm, do.
The difference isِ Restylane isِ like Jell-O andِ Juvederm isِ like honey, whichِ isِ a liquid andِ it tendsِ to diffuse more, heِ said.

Off-label use and FDA approval

Judith Hellman, a New York City-based dermatologist inِ private practice, alsoِ said anِ FDA approval wouldn’tِ impact herِ business much.
However, itِ couldِ help less-experienced doctors feel moreِ comfortable usingِ Restylane ifِ they areِ afraid ofِ using products forِ non-FDA-approved purposes.
Hellman saidِ she andِ many otherِ doctors areِ confident inِ using Restylane forِ off-label useِ becauseِ its off-label purpose isِ the sameِ asِ the FDA-approved purpose — toِ fill inِ pockets beneath theِ skin.