Jun 29, 2015

FDA Wants You to Know About Wrinkle Injections

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FRIDAY, May 29, 2015 (HealthDay News) -- Soft tissue fillers used in cosmetic procedures can accidentally be injected into blood vessels in the face and cause serious harm, the U.S. Food and Drug Administration warns.

The fillers are approved to treat wrinkles or to enhance cheeks or lips.

Injection of facial fillers into blood vessels can cause blockages that restrict blood supply to tissues. Filler material injected into blood vessels can also travel to other areas and cause stroke, vision problems, blindness and damage and/or death of the skin and underlying facial structures, the agency said in a news release.

Accidental injections of facial filler into blood vessels can occur anywhere on the face. But an FDA analysis of studies and reported problems found it was most likely to occur between the eyebrows and nose, in and around the nose, on the forehead, and around the eyes, the agency said.

The FDA has told makers of facial fillers to update their labeling to include additional warnings about the risk of accidental injection into blood vessels.

Before going ahead with soft tissue filler injections, patients should talk with their doctor about appropriate treatment injection sites and the risks associated with the procedure, and read the product's labeling, the FDA said.

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It's also important to ask about the doctor's training and experience injecting soft tissue fillers in the face, the agency said.

Patients should seek immediate medical attention if they experience any of the following during or shortly after the procedure: unusual pain; vision changes; a white patch of skin near the injection site; or signs of stroke, such as sudden difficulty speaking, numbness or weakness in the face, arms or legs, difficulty walking, face drooping, severe headache, dizziness or confusion.

Doctors should inject soft tissue fillers only if they have appropriate training and experience, and should be familiar with each patient's blood vessel anatomy, which can vary between people, the FDA said.

Doctors also need to fully inform patients about the risks associated with the procedure, know the signs and symptoms of accidental injection of facial filler into blood vessels, and have a plan for treating patients if this occurs.

More information

The U.S. Food and Drug Administration has more about soft tissue fillers.

Copyright © 2015 HealthDay. All rights reserved.


The
Editorial Voice
Roy G. Geronemus, M.D. for the Editorial Voice - ZALEA Roy G. Geronemus, M.D.

Soft tissue fillers for volume enhancement and wrinkles is an extremely popular procedure. Fillers are extremely safe with a very low incidence of complications occuring in far less than 1% of all procedures . Unfortunately, complications may occur however the good news is that they are usually reversible if recognized early and handled properly. Complications include allergic reactions ( extremely rare), lumpiness ( most commonly technique related) and accidental injection into blood vessels. The FDA's warning of the potential risks from injection of soft tissue fillers into facial vessels underscores the importance of choosing a physician with not only the knowledge of the filler but the facial anatomy to allow for the safe and effective administration of the filler. Most of the potential complications from blockage of a facial vessels can be reversed if recognized early and treated effectively with the appropriate medicines. In these cases permanent complications can be avoided altogether. The bottom line---injectable fillers are effective tools in the cosmetic toolbox and with the proper choice an experienced physician , the outcome should meet expectations.

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