8-Jun-15 3:00 PM  CST

FDA Puts Out New Warnings Against Facial Fillers

It seems these days we are bombarded with products that promise to return youth. From facial creams and ointments to surgical procedures and facial fillers, the younger look is a very profitable industry. However, lack of understanding and experience may make some of these products extremely dangerous.


Last week the Food and Drug Administration put out a warning against facial fillers. Facial fillers are products that promise to reduce wrinkles and lines of age without surgery. Facial fillers are not the same as Botox. Facial fillers relax the muscle under the wrinkle then fill the wrinkle or crease with a substance, most commonly, hyaluronic acid. Products such as Juvederm and Restylane use hyaluronic acid as their main ingredient.


While generally an effective alternative to surgical procedures, facial fillers also come with some very serious associated risks, especially at the hands of those who have not been adequately trained in their use. The warning about facial fillers from the FDA involves the increasing risk for accidental injection into the blood vessels surrounding the areas where the drug is being used. If the drug is accidentally injected in the small blood vessels within the face there is a risk that the vessel may become blocked. If the vessel becomes blocked blood flow will be interrupted causing numerous and potentially serious side effects.


Stroke, vision problems, including blindness, as well as damage and death of the facial tissue are just a few of the warning the FDA has investigated and confirmed. Because of these serious and rather alarming risks, the FDA is requiring drug manufactures of facial fillers to change their package labeling. All manufactures of facial fillers must now include a warning on their drug packaging stating that the drug product comes with an increased risk for accidental injection into the small blood vessels of the face as well as the potential side effects from accidental injection.


The FDA further states that patients should take the time to have detailed consultation with their physician before deciding to use facial filler. Patients should seek out a registered and licensed Dermatologist with extensive knowledge and experience with facial fillers. Facial fillers should only be injected into the soft tissues of the skin where small blood vessels will not be affected. Being proactive in their decision to use facial filler may very well save the patient from the potential for extreme harm. 



Predit, R., (2015), “FDA Warns of Complications from Facial Fillers”, WebMD, http://www.webmd.com/beauty/facial-fillers/20150529/fda-warns-of-complications-from-facial-fillers, retrieved, 5 June 2015



For additional information on this article, please contact:
Kelley Simmons
Source: Sandy Andrews, CPhT, BLS  

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