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The F.D.A. has not approved or cleared P.R.F.M. derived in a Selphyl centrifuge to be marketed for any cosmetic indication.
Initial cosmetic indication was the glabellar area, but its use has now expanded to successfully treat a variety of hyperfunctional facial lines, such as peri orbital wrinkles (crow's feet), lower eyelid wrinkles, nasolabial lines and horizontal forehead rhytides.
4 While BoTo-A is used "off-label" (that is, for applications not specifically approved by the FDA) in many practices, including for treatment of facial rhytids around the eyes or from the frontalis muscle, the only approved cosmetic indication for either Botox or Dysport is in the treatment of glabellar rhytids.
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In plastic and reconstructive surgery, autologous fat grafting enables soft tissue augmentation and is increasingly used for cosmetic indications but also for correction of defect following tumor treatment.
Radiesse is not appoved in Australia for cosmetic indications.
42, 45 To the authors' knowledge, another botulinum toxin type A formulated without complexing proteins has not been studied systematically in cosmetic indications.
It was just several months ago that Dysport™ gained FDA approval for cosmetic indications although it has been used widely in Europe for several years.
As such, botulinum toxin is widely recommended by international treatment guidelines for movement disorders and it has a plethora of other clinical and cosmetic indications.
This is of particular significance given the widespread offlabel use of BTX-A for cosmetic indications, 18, 19 and the administration of BTX-A preparations by nonmedically trained individuals.
The few feared systemic complications have been reported only when the toxin is used for large muscle disorders and in much higher doses than typically used for cosmetic indications.
With FDA approval of this formulation for the treatment of glabellar lines has come a new warning, generated primarily by concerns for safety in therapeutic, in contrast to cosmetic, indications.
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