FDA Warns of Delayed Onset Dermal Fillers Inflammation Risks

Federal health officials have issued an updated warning about delayed-onset inflammation risks associated with dermal fillers, which are injectable treatments sometimes used to create a smoother or fuller appearance in the face or lips.

The Food and Drug Administration (FDA) updated its warnings on dermal fillers on July 6, adding new information about problems with delayed-onset inflammation near the treatment area to the growing list of possible dermal filler side effects.

Common reactions to dermal fillers can include bruising, redness, swelling, and pain, but the new warning indicates the agency has also received reports of delayed-onset inflammation near the treatment area, which can lead to serious health complications.

Dermal fillers, also known as injectable implants, are soft tissue fillers, lip and facial fillers, or wrinkle fillers. The treatments are approved by the FDA to help create a smoother or fuller appearance of parts of the face or body, including areas of the nose, edges of the mouth, cheeks, chin, lips, and back of hands.
However, patients often need repeat treatments to achieve the desired effect, and success rates will depend on the underlying tissue structure of the body, the volume, and the type of filler used. Additionally, the time the effect lasts depends on the filler material and the area where it is injected.

Some dermal fillers are naturally absorbed over time, but some patients can experience side effects after receiving filler injections.

In 2015, the FDA required new warning labels for tissue fillers, detailing the risk of problems patients can face after injection, including some serious and permanent side effects. The FDA convened a panel of experts in 2008 to review reports of dermal filler side effects and consider if stronger warnings were needed, then later issued new warning labels for the products.

Dermal Filler Patient Risks

The updated warning information indicates delayed inflammation at the treatment site can occur after viral or bacterial illness, infections, vaccinations, or dental procedures. While delayed-onset inflammation can occur, it is rare.

Side effects of dermal fillers, including inflammation, typically resolve on their own. But other less common risks can include nodules, or bumps, in or under the skin which may need to be treated with injections, oral antibiotics, or surgical removal, as well as infections, open or draining wounds, a sore at the injection area, allergic reactions or necrosis of the skin area.

Other side effects reported to the FDA include severe allergic reactions like anaphylactic shock, filler migrating from the injection site, leakage or rupture of the filler material at the injection site or through the skin, formation of permanent hard nodules, injury to the blood supply after an unintentional injection into a blood vessel, vision abnormalities, loss of vision, or stroke.

When dermal fillers are unintentionally injected into blood vessels, tissue death can occur, and it can also lead to stroke or blindness. The risk of this happening is low but can lead to serious complications that can be permanent.

Similar problems were seen with injectable silicone for body contouring. The FDA warned patients about the risks of pain, infection, scarring, permanent disfigurement, embolism, and death as possible side effects after receiving injectable silicone.

FDA Dermal Filler Safety Recommendations

The new warning indicates it is important for doctors to provide patients with fully informed consent before undergoing dermal injections. The FDA also recommends patients search for a dermatologist or plastic surgeon to perform these types of procedures to ensure the best results.

The agency says doctors should make sure to use fillers from properly labeled and sealed vials or pre-filled syringes. It is also important for patients to be tested for allergies before receiving dermal fillers made with certain materials, especially those from animals.

Patients should never use products not approved by the FDA, purchased bootleg from other countries, sold directly to the public, or sold online, the agency warned. These products are often contaminated or not approved for use in the U.S. These types of unauthorized products pose the greatest risk of side effects to patients.