The U.S. Food and Drug Administration (FDA) recently updated its recommendations on dermal fillers, reportedly in response to postmarketing data from the FDA’s adverse event–reporting databases, including the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature and recommendations from federal agencies and professional societies.
The U.S. Food and Drug Administration (FDA) recently updated its recommendations on dermal fillers, reportedly in response to postmarketing data from the FDA’s adverse event–reporting databases, including the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature and recommendations from federal agencies and professional societies.
The FDA website was updated to include certain risks of using dermal fillers such as swelling and bruising, as well as less common risks like inflammation following viral or bacterial illnesses or infections, vaccinations or dental procedures.
Some new safety benefits include a recommendation against using soft tissue fillers in the body to increase breast or gluteal size, using dermal fillers in high-risk locations, the use of permanent fillers like silicone for cosmetic treatment and the use of needle free or any over-the-counter injection device.
The FDA also added separate sections of recommendations geared to patients and health care providers, including a recommendation that patients seek a practitioner in dermatology or plastic surgery to perform dermal filler treatments.
“Main takeaway for patients: Seek out a board-certified dermatologist or plastic surgeon who only uses FDA approved products, never treat yourself and educate yourself about the risks,” said Sue Ellen Cox, M.D., FAAD, the founder and medical director of Aesthetic Solutions and a past president of the American Society for Dermatologic Surgery (ASDS).
Dr. Cox also co-authored the 2021 report in Dermatologic Surgery, “Preventing and Treating Adverse Events of Injectable Fillers: Evidence-Based Recommendations From the American Society for Dermatologic Surgery Multidisciplinary Task Force.” She thinks the FDA should regularly update and re-evaluate its recommendations to keep consumers educated on important medical risks.
“It is necessary so that consumers are educated regarding proper use of a dermal filler for cosmetic treatment as well as the inherent risks of such treatments,” Dr. Cox said.
In addition to the rarity of these complications, the FDA also claimed that they tend to be easily treatable. Despite this, it is still important to be aware of all possible risks associated with the use of dermal fillers, as this allows the patient and practitioner to discuss these risks and their likelihood, so both parties can make the safest choice for that patient and be prepared in case complications do arise. The FDA encourages consumers and patients to discuss all treatment options, including dermal filler procedures, with their health care provider to understand the benefits and risks associated with the use of these medical devices.
Dr. Cox would like to see further evaluation and guidelines from the FDA that details infections and complications beyond the most severe cases.
“The guidelines focus on the most severe risk of fillers—intravascular events which can lead to stroke, blindness or necrosis,” Cox said. “It does not go into any detail about the risks of allergic reactions both Type I (immediate) or Type IV (delayed type) hypersensitivity. It also does not discuss the possible infectious complications from improper technique.”