The U.S. Food and Drug Administration (FDA) recently updated both its webpage on Dermal Fillers (Soft Tissue Fillers) and on Dermal Fillers Do’s and Don’t for Wrinkles, Lips and More. A spokesman for the FDA reported that the update was made 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.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
Patient & Practitioner Recommendations
The FDA also added separate sections of recommendations geared to patients and health care providers, including a reccomendation that patients seek a practitioner in dermatology or plastic surgery to perform dermal filler treatments. These are valuable changes that will help clarify possible issues and lead consumers and practitioners to more easily find the vital information needed to make safe decisions when it comes to choosing where, when and if they should get these treatments. Sue Ellen Cox, M.D., a past president of ASDS and one of the authors of a 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," is pleased with these additions, stating, “These are not procedures to be done in an unsupervised spa setting.”
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise,” she adds.
Delayed Inflammation Rare & Easily Treatable
Lawrence J. Green, M.D., George Washington University Department of Dermatology, commented that the FDA “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
In addition to the rarity of these complications, the spokesperson for the FDA also mentioned 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. According to the FDA’s spokesperson, “Typically, the reported inflammation is responsive to treatment or resolves on its own. 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.”