Injectable wrinkle fillers are a popular way to fight the signs of aging. Unfortunately, they can cause strokes, blindness, and necrosis when they are accidentally injected into blood vessels. Furthermore, products like Expressions Injectable have been linked hard lumps and nodules on the face, swelling, and disfigurement.
FDA Orders Stronger Warnings for Wrinkle-Filler Side Effects
May 28, 2015 — Wrinkle fillers can cause a number of disfiguring and debilitating side effects when they are accidentally injected into blood vessels, according to a Safety Communication issued by the FDA.
The agency was particularly concerned about injections into the skin between the eyebrows and nose (glabella), forehead, around the eyes, and around the nose. Manufacturers must update the labels to include this information. Click here to read more.
Some complications could even be life-threatening:
“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.”
What are Wrinkle Fillers?
Wrinkle fillers are injectable medical implants that are used to fill in wrinkles, smooth sagging skin, and make cheeks and lips appear fuller. There are several types of FDA-approved products. For more information from the FDA, click here.
The shortest-lasting products are made of collagen, a protein found in cows and human cells, that last 3-4 months. There are also hyaluronic acid products made of sugars found in body tissues (such as skin and cartilage) that last 6-12 months.
Longer-acting products can be made of calcium hydroxylapatite, a mineral found in teeth and bones, with effects that last 18 months. Poly-L-lactic-acid (PLLA) is a biodegradable synthetic polymer with effects lasting up to 2 years.
The FDA has only approved one product that is not eventually absorbed into the human body. This product, Polymethylmethacrylate beads (PMMA), is injected in a gel made of bovine collagen.
Popular Brands of Wrinkle Fillers
- Restylane (Medicis)
- Perlane (Medicis)
- Juvederm (Allergan, Inc.)
- Radiesse (Bioform Medical)
FDA Warning for Expression Injectable
Expression Injectable is a gel that is supposed to be used to splint the nose after surgery or trauma. However, according to a warning letter issued in June 2014, it was marketed as an “injectable filler” and used to treat wrinkles.
The FDA received a number of adverse event reports, including reports involving hard nodules, severe swelling, fever, and other side effects. In some cases, the disfiguring complications did not improve with treatment:
“The FDA has received a report of a patient developing firm masses in the face after being injected with the Expression product, which was used as a dermal filler. An attempt was made to dissolve the masses, but the report notes that the patient was left with an “obvious deformity.”
FDA-approved dermal fillers are Class III (“high risk”) medical devices that must be approved through a special process and undergo rigorous clinical trials to prove safety and effectiveness. Because Expression Injectable has not gone through clinical trials for wrinkle filling, the FDA does not know if it is safe.
Do Wrinkle Fillers Need Stronger Warnings?
In 2008, an advisory panel to the FDA met to decide whether to strengthen warnings on the label for wrinkle filling products. They were concerned because 930 adverse events were reported between 2004 and September 2008.
- Facial palsy
- Life-threatening allergic reactions
- Blisters and cysts
- Hard nodules
- Obvious deformity
- And more