Lumps, nodules, discoloration, swelling and bruising are just some of the side effects possible with a newly popular injectable filler, warns the FDA. Another important point: the filler, called Expression, was never approved for cosmetic facial use in the first place, the agency says.
“The FDA has become aware of adverse events associated with the unapproved use of the Expression product as a dermal filler,” reads the warning. “The FDA has not approved this product for use as a dermal filler and recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance.”
Expression, made and sold by Enhancement Medical, LLC, was approved by the FDA in 2012 as an intra-nasal splint, to be used post-surgery inside the nasal cavity. According to Enhancement Medical, it’s a third-generation hyaluronic acid gel that’s sulfite- and pathogen-free.
Unlike Juvederm, Restylane, Perlane, and other commonly used hyaluronic acid products, which are FDA-approved for cosmetic use, Expression is being used off-label. Nevertheless, in the past couple of years Expression has come into wider use by doctors and cosmetic clinics.
The use of hyaluronic acid fillers was up 18 percent in the past year. (photo: Wikipedia)
More than 1,800,000 Americans used hyaluronic acid cosmetic fillers in 2013, up 18 percent from the previous year, according to statistics kept by the American Society of Plastic Surgeons.
In February, 2014 the FDA contacted Enhancement Medical regarding adverse events reported by Expression users, and in June, 2014 the agency sent Expression a warning letter criticizing the company’s handling of adverse events reported to the agency. The agency criticized Enhancement Medical specifically for closing complaint cases without adequate follow-up to make sure users’ problems were addressed.
Calls and emails to Enhancement Medical were not returned by the time of publication.
One of the properties of hyaluronic acid fillers that makes them so popular is that they are considered to be reversible. An injection of hyaluronidase dissolves the filler. On its website, Enhancement promises:
“When working with Hyaluronic Acids, reversibility becomes one of the most important characteristics. It is essential to know your HA can be reversed if necessary or desired. Using hyaluronidase, the cross-linking is reversed allowing the body to metabolize the gel in just 48 hours.”
In complaints and incident reports, however, people who used Expression describe serious problems that did not resolve with hyaluronidase treatment.
The website RealSelf, which publishes user reviews of cosmetic procedures and products, has a forum for Expression in which users have been posting complaints, concerns and warnings for more than a year. Read back further in the forum, and you’ll see doctors recommending Expression and touting its benefits.
The lesson: If you are interested in using fillers, or just learning more about them, be sure to do careful research. The American Society of Plastic Surgeons has a good round-up on the various fillers available and what they’re best used for.
The FDA’s warning about Expressions is one more example of why beauty consumers – like health care consumers – need to do their own vetting before making decisions about a medical or cosmetic procedure. While we all want to trust our doctors and other professionals – and in most cases we should – you’re safest going the extra mile to find out as much as you can.
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FDA Warns Of Danger From Injectable Filler
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