A review of complications associated with injectable fillers published in JAMA Facial Plastic Surgery shows that swelling and infection remain the most common of adverse events, but more serious events occur as well, serving as a reminder to carefully review pre-operative informed consent documents with patients, the authors state.
The review evaluated complications for eight fillers by using the U.S. Food and Drug Administration’s manufacturer and user facility device experience (MAUDE) database for January 2014 to December 2016.
Researchers analyzed 1,748 adverse events and nine litigation cases, two of which were for major complications: embolized retinal artery resulting in blindness and supratrochlear injection resulting in pain and necrosis. The malpractice cases were resolved with a median payment of $262,000. Swelling (43.2%) or infection (41.5%) accounted for most adverse events.
The fillers assessed included Juvederm (Allergan), Restylane (Galderma), Belotero (Merz), Sculptra (Dermik/Aventis), Radiesse (Merz), Artefill (Suneva), Bellafill (Suneva) and Juvederm Voluma (Allergan).
Radiesse was implicated in most cases of severe complications. “It has a relatively high elastic modulus (G prime) so when you inject it you cannot really do a pullback with the needle to see if the filler comes back into the syringe, therefore placing the filler at higher risk for complication. But Radiesse is still a very safe filler, with a complication rate of less than 0.01%,” said the study’s corresponding author, Hani Rayess, M.D., a resident in otolaryngology at Wayne State University in Detroit.
Fillers are “extremely safe,” Dr. Rayess says, but safety depends on how well the healthcare professional is trained. Most infections are due to technique, not product, he said. Training for administering injectable fillers should include a review of complications — whether minor or more serious, such as blindness — and treatment for those complications.
“Having been involved in taking care of patients with fillers and injecting fillers for the past few years, I personally find them very safe. In my experience, I have seen very minimal complications. And although the number of complications in the study might seem high, you have to put it into perspective with the number of injections that occur in millions,” he said.
Fillers by other professionals
Fillers are also administered by non-traditional sources, such as physicians from other specialties and aesthetic specialists at spas. A key limitation of the study was that it was unable to determine the association between specific medical professional or non-medical professional type and complications.
“There is an increase in the people who are injecting fillers. No longer is the pool limited to those specialties that are highly trained, such as dermatologists, ENTs and plastic surgeons. Besides OB/GYNs and aestheticians, family medicine doctors are now injecting fillers too,” Dr. Rayess says. Informed consent
This is potentially problematic because fillers administered in medical spas by non-healthcare professionals, for example, are reportedly increasingly performed without written informed consent. Informed consent with patient education materials and pre-procedural discussions with patients that cover potential complications is critical for the patient to clearly understand the extent of possible complications, he wrote in the study.
“The best way to avoid being litigated is to have the patient sign a comprehensive pre-operative informed consent form. The patient needs to understand the informed consent, including the risks and benefits and alternatives to the fillers,” he said.
Because, as other studies have shown, litigation is largely due to a practitioner’s lack of training and the lack of informed consent for the patient.
“One of the most important issues raised appears to be a lack of informed consent. Hence, it is paramount that patients be aware of what they are getting into even though, for example, the chance of developing blindness is roughly one in 1 million,” Dr. Rayess said.
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