The injection of wrinkle fillers into certain areas of the face has been linked to serious side effects including embolization, vision impairment / blindness, stroke and severe skin damage (necrosis).

Beware of Embolization with Wrinkle Fillers: FDA Warning

May 28, 2015 – The U.S. Food & Drug Administration (FDA) warned today that when unintentionally injected into certain places on the face, cosmetic wrinkle fillers can block blood vessels and restrict blood supply to tissues, potentially causing vision loss / blindness, stroke and damage to the skin and facial structures (necrosis). These problems occur most often when fillers are injected into the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).

What is a Wrinkle Filler?

Wrinkle fillers (also called dermal fillers, soft tissue fillers and injectable facial implants) are injected directly into specific treatment areas to reduce the appearance of wrinkles and create a smoother appearance of the face. Wrinkle filler manufacturers include Galderma and Allergan Inc, which was introduced by Actavis Plc in March 2015.

Label Changes

FDA said it was working with manufacturers to update labeling to include additional warnings, precautions and information about the risks associated with wrinkle filler usage. While current labels include some information about this risk, the agency said it believed that additional verbiage could be included to better inform healthcare providers and patients.

Healthcare Provider Recommendations

FDA recommends that healthcare providers take the following precautions when administering wrinkle filler treatment:

  • Do not inject soft tissue fillers if you do not have the appropriate training or experience.
  • Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy disclaimer icon can vary among patients.
  • Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
  • Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body.
  • Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.
  • Know the signs and symptoms disclaimer icon associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
  • Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure. Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
  • Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.
  • Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.

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