Dermal fillers are injectable products that are used to smooth skin and wrinkles. When they are accidentally injected into a blood vessel, they can cause strokes, blindness, and necrosis. In August 2014, the FDA warned against using Expression Injectable.
What is a Dermal Filler?
Dermal fillers are injectable facial implants that are used to help smooth wrinkles and/or make the cheeks or lips appear fuller. Some of the most popular dermal fillers include Restylane and Perlane from Medicis, Juvederm from Allergan Inc. and Radiesse from Bioform Medical.
Types of FDA-approved dermal fillers include:
- Collagen: Protein in the skin that may come from cows or human cells. Effects typically last 3-4 months.
- Hyaluronic acid: Sugar found in body tissues, such as skin and cartilage. Combines with water and swells, which causes a smoothing/filling effect. Effects last 6-12 months.
- Calcium hydroxylapatite: Mineral found in teeth and bones. Injected particles are suspended in a gel. Effects last 18 months.
- Poly-L-lactic acid (PLLA): Biodegradable synthetic polymer used in absorbable stitches. Effects last up to 2 years.
- Polymethylmethacrylate beads (PMMA microspheres): Non-biodegradable polymer that is not absorbed by the body. Beads are injected in a gel made of bovine collagen.
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.
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.”
FDA Warning for Expression Injectable
August 5, 2014 — The FDA has issued a Safety Communication to warn that Expression Injectable, manufactured by Enhancement Medical, LLC, should not be used as a dermal filler because it is not approved for that purpose and it has been linked to a number of adverse events.
FDA inspectors discovered that Enhancement Medical was marketing Expression as an “injectable filler.” Meanwhile, they were failing to report adverse events, waiting to follow up on adverse events, or closing reports without following up. They issued a warning letter in June 2014.
In some cases, patients developed hard nodules that did not respond to 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.”
Expression Injectable is a gel that is used as an intranasal splint for patients who have had surgery or trauma to the nose. It has never been evaluated in clinical trials as a dermal filler. The FDA classifies dermal fillers as Class III (“high risk”) medical devices that must go through rigorous clinical trials and a premarket approval process. Because Expression Injectable has not gone through this process, the FDA cannot be sure that it is safe or effective as a dermal filler.
FDA Panel Recommends Stronger Warnings
In 2008, an advisory panel to the FDA met to review the safety of dermal fillers and consider whether to add stronger warnings or instructions on the products. According to documents posted to the agency’s website, there were 930 adverse events reported between 2003 and September 20, 2008.
Dermal Filler Side Effects
- Facial palsy
- Life-threatening allergic reactions
- Blisters and cysts
- Hard nodules
- Obvious deformity
- And more
- Dermal Fillers — U.S. Food and Drug Administration (FDA)