On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as 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.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Dr. Lawrence J. Green
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “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.”
Dr. Sue Ellen Cox
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“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.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.