A new paper sheds light on what can go wrong with face fillers, which are on the rise
Filler injections are "very safe," experts say; common complications include swelling or minor infection
On extremely rare occasions, severe complications can cause blindness
Injectable fillers, which contain materials like hyaluronic acid or collagen to give your skin or features a cosmetic boost, are growing in popularity around the world. Along with other cosmetic procedures, fillers have become popular holiday gifts.
Among those millions of procedures, which are minimally invasive, most are performed in a safe and effective way, with few adverse side effects. Yet with a rise in popularity, the overall number of complications has also climbed.
A paper published Thursday in the journal JAMA Facial Plastic Surgery spotlights both common and rare complications associated with fillers, and raised in litigation, in the US.
“The paper demonstrated that fillers are very safe and that the most common complications are swelling and infection, which are relatively benign complications, with no permanent side effects,” said Dr. Hani Rayess, an otolaryngology resident in the Wayne State University School of Medicine in Detroit and lead author of the paper.
“This research is important because fillers are being increasingly used for facial rejuvenation,” Rayess said. “It is important for patients to understand the risks, alternatives and benefits prior to receiving fillers.”
The cost of fillers ranges from several hundred to thousands of dollars.
Dermal fillers approved by the US Food and Drug Administration include Restylane, Juvederm Vollure, Juvederm Volbella, Juvederm Voluma, Radiesse, Sculptra and Belotero.
The FDA warns against using unapproved versions of Juvederm. The agency also notes that it has not approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.
The rare risks of face fillers revealed
For the new paper, researchers analyzed data from the FDA’s manufacturer and user device experience database, which contains medical device reports of suspected deaths, injuries and malfunctions. They searched for adverse events from injectable fillers reported between January 1, 2014, and December 31, 2016.
The researchers also analyzed data from the American Society of Plastic Surgeons on the overall projected number of filler injections performed during that time, and they analyzed litigation and court records related to fillers in the Westlaw Next Database.
The researchers identified 1,748 reported events involving injury between 2014 and 2016. Of those, the most common complications were swelling, infection, the presence of a nodule or lump, and pain. Many cases – 43% – stemmed from a cheek injection, and 30% were from a lip injection, the researchers found.
“Swelling comprised about 0.01% of all injections,” Rayess said
Blindness was involved in eight injections in the study, and nasal injections were significantly associated with blindness, the researchers found, though rare.
For instance, among Radiesse injections, the researchers found that only .0001% resulted in blindness.
Globally, only about 50 cases of blindness after aesthetic facial injection have ever been reported, according to a study published last year in The Journal of Clinical and Aesthetic Dermatology.
Though it’s a rare risk, what’s the connection between the nose and the eye that could lead to such a severe complication from nasal injections?
“Blood vessels around the eye and nose tend to be the most dangerous because they’re in continuity with the blood vessels in the back of the retina and the back of the eye,” said Dr. Daniel Maman, a board-certified plastic surgeon at 740 Park Plastic Surgery in New York, who was not involved in the new paper.