PHOENIX (3TV/CBS 5) - Dermal fillers are one of the most popular cosmetic procedures in the United States but there are serious risks patients may not know about. Injected into the skin, the soft tissue fillers are approved by the FDA to smooth wrinkles and fine lines and create a fuller look in the face. According to the American Society of Plastic Surgeons, more than 3.4 million injections were done in 2020. The most popular fillers are gel-like substances made up of hyaluronic acid, a substance naturally present in the body.
Although fillers have been around in various forms for about 30 years, increasing popularity over the last decade has led to an increase in the number of serious injuries reported to the FDA. There have been more than 1,100 annually for the last three years but some health experts believe the number of actual serious injures is severely underreported.
The most serious risks listed on the FDA's website include stroke, necrosis (skin death), severe allergic reaction, blindness, permanent hard nodules and death.
Other more common risks include bruising, swelling, infection, allergic reaction, open wounds and nodules under the skin that may need to be surgically removed. Former model Carol Bryan started the Saving Face Initiative after fillers disfigured her face. Instead of smoothing a few lines, the filler injected into her face contracted.
The disfigurement was so severe Bryan spent years as a recluse, unable to go out in public until she found a plastic surgeon willing to try to repair the damage. Bryan underwent six surgeries and now speaks out about potential complications, potential risks and the importance of being informed about fillers.
Injections carry risks
It's not just illegal injections that can lead to serious injuries. Multiple people have died after being injected with substances ranging from silicone to superglue, even construction-grade caulk. The FDA has not approved any fillers for large-scale body contouring and warns silicon, which permanently stays in the body, can lead to disfigurement, stroke, and even death.
Bryan's injections were done by a doctor. According to the FDA, fillers are a medical device and warn the procedure should only be done by a licensed healthcare practitioner. However, there is no national standard of training or required training before a health care professional can perform the procedure.
A search online reveals courses offering dermal filler training that last as little as one day or are completely online. In May of 2021, the FDA held a virtual meeting to discuss the risks vs. benefits of fillers. A point repeated throughout the meeting by experts was the need for extensive training.
Being an expert on the anatomy of the face is crucial when doing Dermal fillers, according to plastic surgeon Brian Gawley who runs MD Skin Lounge, where fillers are a popular procedure. "Our face has the most prolific network of blood vessels in the entire body," explains Dr. Gawley.
Serious injuries can result if fillers are accidentally injected into a blood vessel, blocking the blood flow to the vessel downstream.
If not immediately treated, and depending on the location of the blockage, skin can quickly start to die. Blindness can result even if the injection is not near the eye. "What's so amazing about the human body is that you can inject right by your nose and if it gets in the right blood vessel, it can go back up and find its way behind your eye," says Dr. Gawley.
Lack of warnings
During the FDA public meeting, experts also discussed taking additional steps to ensure patients are informed of the risks. A statement submitted by Dr. Diana Zukerman, president of the National Center for Health Research, highlighted the importance of patients being provided stronger and clear warnings, including a checklist outlining the risks patients would have to initial. Dr. Zuckerman pointed out the difficulty in finding information on risks, even in online searches. "If you wonder why patients say they were not informed of the risks, just go to Google or another search engine and type in the name of one of these products with the term "risks." You will be bombarded with ads and other promotional information, and you will see how difficult it is to find any meaningful risk information," wrote Dr. Zuckerman.
Even for patients who go directly to the manufacturers' websites, it can be difficult to find warnings. On one manufacture's website, Dr. Zuckerman pointed out warnings regarding stroke, blindness and death were not listed under "important safety information" but were found farther down the website in another section labeled "What are possible side effects?"
Social media trend self-injections
A trend on social media takes a lack of training to a new level. Online videos show people how to do their fillers. Dermal fillers are prescription devices and should only be purchased by licensed health care professionals but are easily available to anyone online. The videos demonstrate injections done with needles and injector pens that use pressure to shoot filler into the lips.
In her statement to the FDA, Dr. Zuckerman says the agency needs to be more aggressive and issue stronger warnings. "FDA clearly needs to do more to ensure that companies provide risk information in a more prominent position, rather than inserted after much less important 'safety' information. A black box warning is needed, should be prominently displayed, and should include warnings about off-label uses as well as approved indications and well-trained providers. FDA should also warn against self-injections in the strongest possible terms."
The FDA has issued recommendations on injector pens for use with drug or biological products but the agency confirmed it has not approved any needleless injection system for fillers. The videos raise serious concerns for Dr. Gawley over the possibility of damage both with the injections and pressure devices. "Her whole lip could die, and guess what. When your lip dies, you can't fix it," says Dr. Gawley.