Dermal and subdermal fillers have become an accepted nonsurgical procedure for facial rejuvenation because of perceived safety, effectiveness and cost benefits. According to the 2019 survey by the American Society for Aesthetic Plastic Surgery, an estimated 2.7 million of injectable filler material were performed in the United States. Of the many available FDA-approved fillers, hyaluronic acid (HA) gel fillers represented nearly 2.5 million of these injectables. The rationale for selecting this bioengineered material over others may be related to an increased variety of hyalurone products and approved applications, favorable formulation properties, and supposed reversibility. As the Food and Drug Administration (FDA) has approved currently more than 25 dermal fillers, licensed physicians and approved injectors should practice Global Filler Safety, including knowledge of the unique characteristics of each product, appropriate patient selection, approved and off-label usage of product placement, and facial anatomy. Each type of filler possesses distinct properties (isovolume, permanence, cross-linking stability, fluidity, concentration and density) that can produce aesthetically pleasing results as well as a particular complication profile for each product.
However, the popular application of injecting combinations of fillers in one or more sites at one session is apt to produce not only more of the common temporary or prolonged side-effects and distortions but also significant complications. Some of these complications can be devastating and irreversible leading to scarring, tissue loss and blindness.
Despite best practice protocols and safety-training, complications will still occur. Providers must provide a detailed discussion of all risk and potential complications, recognition and prompt management of complications during the informed consent process. Although injecting fillers is an art, experienced and knowledgeable providers will always practice Global Filler Safety protocols that include an accurate patient’s detailed filler history, prior surgical procedures, and evaluation of the unique facial anatomy in order to provide meticulous placement and usage of type of fillers.
Complications can be categorized into either non-ischemic or ischemic (blood vessel) events:
Non-ischemic Complications
• Nodules represent contour irregularities typically within 4 weeks from unintended
superficial product placement or inappropriate product selection. Treatment options
include judicious watch- and-wait approach, massaging, needle drainage, and intralesional
hyaluronidase injections.
• Granulomas represent typically an inflammatory response from unknown reasons. Some
granulomas spontaneously resolve over time. If persistent, off-label steroid injections or
5-fluorouacil injections may improve the lesions but each carries some risks. Occasionally,
simple excisional surgery may result in a rapid resolution but a visible scar is seen.
• Prolonged edema may develop in areas of pre-existing fluid deposits or have a propensity
to retain fluid such as in the lower eyelids and malar cheek bag. Identification of a history
of fluid retention is important to obtain before filling. The usage of a less hydrophilic
product may be helpful. Occasionally, hyaluronidase injections to remove an HA product
may be successful.
• Tyndall effect refers to a bluish hue in the HA-filled area and typically occurs with
superficial product placement in thin, light-skinned patients. Hyaluronidase injections
should resolve this appearance.
• Infection may occur at any time in the injected site. Preventative measures such a removal
of makeup or surface contaminants are highly recommended before injection. Treatment
may include a topical or systemic antibiotic to control the bacterial spread and/or drainage.
• Biofilm inflammatory response may represent a delayed chronic response to the injected
material. Biofilm responses may include the presence of a bacterial infection and tends to
smolder with redness. If a biofilm is suspected, removal of the filler material with tissue
biopsy and culture may be required. Consultation with an infectious disease specialist
should be considered for persistent lesions.
Ischemic Complications
• Skin necrosis results when a sufficient amount of filler in inadvertently introduced into an
artery that supplies blood to critical areas of skin. Although the incidence of vascular
compromise remains uncertain, this complication has been recorded in as many as 3 into
1000 injections. The signs of vascular compromise often occur immediately or within a few
hours after the patient leaves the office as mottling, pain, blister formation, bluish
discoloration and, later, tissue loss. Injectors must have an intimate knowledge of the
vascular anatomy, recognition of the signs and symptoms, and are prepared for prompt
and effective intervention. Various treatment protocols suggest the use of aspirin, warm
compresses, nitroglycerin paste, vasodilators, and hyperbaric oxygen. The only proven
treatment at this time appears to be the administration of high dose hyaluronidase
injections within 24 hours to the entire ischemic area.
• Blindness and visual compromise from inadvertent intra-arterial embolization of filler
material into one of the feeder arteries to the ophthalmic artery. These unfortunate
patients experience immediate visual loss, headache, double vision, droopy eyelids, soft
tissue ischemia, and stroke-like symptoms. The most high-risk areas and danger zones for
visual compromise are between the eyebrows, nasal area, nasolabial fold and temple.
Unfortunately to date, there are no proven treatment protocols to reverse blindness
caused by intra-arterial fillers. Immediate referral to an ophthalmologist is mandatory.
Dr. Sasaki and his master registered nurse injectors practice Global Filler Safety with all injectables. We understand the underlying anatomy, danger zones, recommended injection techniques, product knowledge, early recognition of complications, and aggressive in-place treatment protocols in our Injectable and Device Center to provide you a safe and effective injection experience.
