FDA Warns About Severe Side Effects of Dermal Fillers

May 28, 2015 — The FDA is warning that soft-tissue fillers, facial implants, and wrinkle fillers can cause disfiguring or even life-threatening side effects when they are accidentally injected into blood vessels.

Injecting soft-tissue fillers into certain locations on the face increases the risk of side effects, according to the FDA. These high-risk locations include the glabella (skin between eyebrows and above nose), in and around the nose, forehead, and around the eyes.

According to the Safety Communication:

“Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.”

The FDA has asked manufacturers to update labels to emphasize these side effects. All FDA-approved injectable dermal fillers are class III (high-risk) medical devices.

The warning was issued after a study involving 61 patients with severe complications found that the most common site for necrosis was the nose followed by the nasolabial fold (“smile lines”). Blindness was most often associated with injection of the glabella. Researchers estimated that one in 10,000 patients would experience a severe complication.

This is not the first time the FDA has warned about serious risks associated with soft-tissue fillers. In August 2014, the agency warned about “scarring, blurred vision, partial vision loss, and blindness if the dermal filler is inadvertently injected into a blood vessel.”

The agency specifically warned about a product called Expression Injectable, made by Enhancement Medical, LLC. The gel injection was supposed to be used to splint the nose after surgery, but was marketed off-label as an “injectable filler” for wrinkles. Many adverse events were reported to the FDA, including severe swelling, fever, and disfiguring nodules on the face.

Warning Signs & Symptoms

The FDA recommends seeking immediate medical attention for symptoms, including:

• Unusual pain
• Vision changes
• Blindness
• A white appearance of the skin near the injection site (blanching)
• Any signs of a stroke (sudden problems speaking, numbness or weakness in the arms, face, legs, difficulty walking, face drooping, headache, dizziness, and confusion)

What Are Dermal Fillers?

Dermal fillers are used to create a smoother or fuller appearance of the face, primarily to reduce the appearance of wrinkles or augment lips and cheeks.

Products may be temporary, permanent, synthetic, or made of biological material (such as bovine collagen). The approved indications vary depending on the product, and not all products have been evaluated for use on the face.

Popular dermal fillers include:

• Restylane (Medicis)
• Perlane (Medicis)
• Juvederm (Allergan, Inc.)
• Radiesse (Bioform Medical)