The U.S. FDA is updating its page on dermal fillers, or injectable implants or wrinkle fillers, to reflect information from reports of delayed onset inflammation such as swelling or redness that can develop near the dermal filler injection site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation is responsive to treatment or resolves on its own, the FDA says.
Dermal fillers have gained FDA approval for specific uses in adults aged 22 or older. Temporary fillers are ideal for addressing moderate to severe facial wrinkles, skin folds, and augmenting areas like lips, cheeks, chin, and the back of the hand. On the other hand, permanent fillers are approved for nasolabial folds, cheek acne scars, and for restoring facial fat loss in individuals with HIV.
However, the FDA strongly advises against unapproved uses of dermal fillers, such as body contouring, breast augmentation, buttock enhancement, and injections into sensitive areas like the glabella, nose, periorbital region, forehead, or neck. Injectable silicone, in particular, is not approved for any aesthetic procedure due to the associated risks of long-term pain, infections, scarring, embolism, stroke, and even death.
While dermal fillers offer temporary results, patients must be aware of potential risks, according to the FDA. Common side effects include swelling, bruising, redness, and pain, which typically resolve within a few days or weeks. However, more serious risks include unintentional injection into blood vessels, potentially leading to blocked blood vessels, tissue death, vision abnormalities, and stroke.
Allergies can also occur, particularly with fillers derived from animal sources, necessitating allergy testing. Other risks include inflammation, raised bumps, infection, and the formation of permanent hard nodules. The FDA has also reported rare risks such as severe allergic reactions; migration of filler material, leakage, or rupture; and injury to blood supply.
In the event of side effects or the need for removal or reduction, additional interventions like injections or surgery may be required, carrying their own set of risks, according to the FDA. It is essential for patients to consult with qualified healthcare providers and understand the limitations and potential risks involved in dermal filler treatments, FDA officials add.
