When injected carefully by skilled practitioners, dermal fillers can rejuvenate facial skin, returning much of the firmness, fullness, and smoothness lost to age.
Filler can easily pool, or gather in unintended concentrations, giving the skin a bumpy texture that only worsens with time. When too much filler is injected in one spot, the body cannot break it down and dispose of it as intended, and the filler hardens into a semisolid mass that can take multiple surgeries to remove.
While complications from poorly injected dermal filler are rarely life-threatening, evidence suggests that improperly injected filler may restrict the flow of blood to the eye, causing vision problems including blindness. When filler enters the bloodstream directly, it may lead to necrosis (or tissue death), blindness, or stroke.
Nearly three million dermal-filler procedures are performed in the US alone each year with the most popular filler compound, hyaluronic acid. Though the worst problems associated with faulty filler injections can be grave, the common wisdom among practitioners and patients is that they are almost vanishingly rare.
Two recent studies tested that assumption. Using the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which collects reports of deaths and serious complications associated with medical devices, the studies give consumers the first quantitative accounting of the rate and nature of filter-related complications.
Boris Paskhover, MD, first got the idea when a patient approached him seeking relief from the effects of a botched filler procedure eight years prior. Paskhover, a Professor of Facial Plastic and Reconstructive Surgery at Rutgers New Jersey Medical School, helped the patient recover fully, and was left wondering how frequently people suffer similar misfortune.
Evaluating MAUDE records from 2007 through mid-2017, Paskhover identified more than five thousand dealing with problems related to fillers. The most common problems were relatively benign: infection, allergic reaction, and inflammation are risks associated with any surgical procedure, leaving the formation of lumps as the other most common complaint.
But not the only one. 47 cases of blindness and 62 incidents of strokes or stroke-like events were among the reports. These serious complications represent roughly 2% of the total number of complaints registered against filler-related treatment, which in turn represent a fraction of a per cent of all such procedures estimated to have been performed during the study’s timeframe.
Otolaryngology resident Hani Rayess, MD, of Wayne State University School of Medicine also used the MAUDE database but limited his focus to the years 2014 through 2016. He found nearly 1,750 reports of complications arising from dermal fillers, a significant increase from the rate Paskhover identified for ten years including the range Rayess studied.
Of the reports, Rayess identified, the most common complaints were of swelling and infection, as expected. The next two most common complaints were of dire complications: blindness and necrosis. But Rayess also found that these severe complications were reported at a lower rate in the time frame he studied than in Paskhover’s ten-year study.
Before drawing conclusions from the studies, we should take a few factors into consideration.
The MAUDE database is completely voluntary, and reports submitted to it are not verified. What effect this has on the data is not certain, but since MAUDE records are neither exhaustive nor confirmed, studies based on those records do not reflect absolute numbers.
But they can reveal statistical trends. Rayess’ more recent timeframe showed a lower rate of severe complications but a higher rate of minor ones than Paskhover’s decade-long view. Combined with what we know of dermal fillers’ increased popularity and of the expanded range of practitioners offering dermal-filler injections, this suggests that more mistakes are being made overall, while catastrophic mistakes have declined significantly. This, in turn, suggests that the best hedge against serious complications from dermal filler injections is a practitioner with a long and successful track record.
Dermal fillers have become so popular and so common that patients are in danger of overlooking the risk they present. The best way to minimize that risk, experts agree, is to find a practitioner who is both highly trained and deeply experienced with the procedure.
The patient who encouraged Paskhover to undertake his study got his filler from a self-described cosmetologist working out of her home. In this case, the practitioner lacked the medical training to know when the injection went wrong—her response to the patient’s first complaint was to inject more filler—and the facilities and supplies needed to respond to a crisis. An antidote exists for hyaluronic acid that quickly erases the results of mis-injected filler, but precious few amateur injection clinics have access to it.
Plastic surgeons, dermatologists, and even ophthalmologists are generally in a good position to administer dermal filler, making it relatively easy to find a practitioner with enough medical training to exercise good judgment and to respond appropriately to a misstep.
A practitioner’s experience can be largely established with dates and figures, but patients are also advised to consider the attention a practitioner gives to each individual case. A doctor experienced in dermal-filler treatment will be ready to respond to each patient’s questions and to adapt the course of treatment to reflect each patient’s goals and concerns.