Complications of Temporary Fillers

Injection Site Reactions

According to the US Federal Drug Administration (FDA), some of the most common adverse events associated with fillers are local injection site reactions. These reactions are manifested by tenderness, erythema, and edema and are typically mild, localized, and transient, resolving within 4 to 7 days. Many injectors consider these reactions adverse sequelae rather than true complications. Irrespective of the type of filler used, injection of the product alone will cause a local tissue injury response due to the stretch, vasodilation, and increased permeability of the blood vessels in the treated area, leading to redness, swelling, and bruising. Despite this, there are actions that can be taken to minimize these effects, including excellent injection technique and postprocedure icing.

Pain

Pain during injection is a commonly reported adverse event associated with filler agents. Pain is often attributable to hydrostatic dissection of tissue during injection, as well as the discomfort of numerous needle punctures during the implantation of the product. Certain anatomic sites, including the lips and perioral region, are more sensitive as these sites harbor increased sensory innervation. Regardless of the treatment area, a number of techniques may be used to minimize the pain associated with injections. These include the use of topical anesthetics, local anesthetics (“numbing dots”), application of ice before and after injection, and vibratory distraction. The latter can be achieved with an assistant tapping the patient’s skin or with the use of handheld massagers. When treating the perioral region, some clinicians use infraorbital and mental nerve blocks or place small aliquots of lidocaine in a few points along the gingival sulcus to minimize pain associated with lip injections. However, local anesthesia is also uncomfortable. Most products are now packaged with the filler syringe premixed with lidocaine to alleviate pain as the treatment progresses. Pain can also be reduced with excellent injection technique. In a blinded, prospective, randomized study by Galadari et al., subjects were found to have less pain with anterograde injections compared to retrograde injections when using an automated motorized injection device for lip augmentation. These participants also had less bruising and fewer injection site reactions when the anterograde technique was employed. Other strategies to reduce pain include use of a smaller gauge needle or prioritization of fewer insertion points through use of a blunt-tipped cannula. In a prospective, case control, single-center study by de Felipe et al., 72% of subjects reported less pain when treated with a cannula in comparison to needles. Similar results were noted in a comparative study whereby subjects graded pain as a 3 (mild) for cannula injections and 6 (moderate) for needle injections, using the visual analog scale (VAS) for pain assessment.

Edema and Ecchymosis

Bruising and swelling occur due to local trauma from the injection and are common postprocedural events ( Fig. 35.1 ). Bruising can be severe, particularly in patients taking anticoagulation or antiplatelet agents, such as irreversible cyclooxygenase inhibitors like aspirin or adenosine diphosphate (ADP) receptor inhibitors like clopidogrel ( Fig. 35.1 ). With regard to hyaluronic acid (HA), a phenomenon of delayed bruising can occur in some patients. HA is a member of the glycosaminoglycan (GAG) polysaccharide family, which includes heparin. Structural similarity of the HA molecule to heparin is important as it has been shown to weakly interact with the coagulation cascade and possibly lead to the phenomenon of delayed bruising in some patients. Reviewing all medications and supplements that a patient is taking and stopping any unnecessary agents prior to their procedure can minimize the degree and duration of edema and ecchymosis. Most supplements should be held at least 5 to 7 days before treatment, including garlic and ginkgo biloba , which have an inhibitory effect on platelets, as well as vitamin E, niacin (vitamin B ₃ ), omega-3 fish oils, glucosamine, ginger, ginseng, green tea, chamomile, St. John’s wort, and celery root, all of which can inhibit coagulation pathways. While avoidance of agents that interfere with coagulation is recommended, patients should continue any medically necessary medications, as risk of holding these (e.g., stroke, blood clot) outweighs any procedure-related bleeding risks. Finally, recent alcohol consumption should be reviewed prior to injection, as alcohol-induced vasodilation can, theoretically, exacerbate bruising.

Similar to pain-reduction strategies, bruising can be minimized by reducing the number of injection points, using a smaller-gauge needle when possible, and adjusting the direction and speed of the injection. Some injectors incorporate blunt-tipped cannulas in certain treatment areas, which may reduce the risk of traumatizing blood vessels and negate the need for multiple injection points. In de Felipe’s study, the incidence of bruising was lower in the cannula group (7% cannula vs. 17.4% needle), and this finding was reproduced in Fulton’s study.

It has also been suggested that the direction of needle insertion into the skin is key. Perpendicular insertion reduces the length of the dermal track and the duration of time the needle is in the dermis, thereby minimizing the likelihood of vessel transection. Similarly, slow infiltration of product decreases tissue distortion and trauma. Conversely, fanning, a technique commonly used to provide structural support to overlying skin, causes increased dissection of the subepidermal plane and may increase risk of ecchymosis.

Filler type may also impact the development of ecchymoses. Although collagen-based fillers were less likely to cause bruising secondary to their inherent platelet-aggregating properties, they are no longer commercially available for a variety of reasons including their associated relatively high risk of allergic reaction.

When postinjection bruising does occur, there are several options to minimize its degree and duration, including supplements and laser and light treatment. Supplements such as bromelain, homeopathic arnica, or topical vitamin K may help reduce the incidence and length of posttreatment ecchymosis. In animal models, bromelain has been shown to decrease vascular permeability by lowering the levels of bradykinin, which may result in less edema, pain, and inflammation. Helenalin, an extract of arnica, has anti-inflammatory effects and inhibits platelet function in vitro. However, clinical studies of these compounds have demonstrated conflicting results, with some reporting a decrease in posttreatment bruising while others showed no statistically different effect. A comprehensive review by Ho et al. concluded that there are insufficient data to routinely support use of arnica and bromelain to prevent and/or treat postprocedure ecchymosis and edema. Their review included published clinical trials using oral and topical arnica and oral bromelain. The beneficial effects of these agents, if observed, were best demonstrated when administered preoperatively and continued 1 to 4 days postoperatively. Further investigations are recommended to substantiate their efficacy and the safety of these supplements.

Finally, vascular lasers and light sources at subpurpuric treatment settings hasten resolution of posttreatment bruising. It is important that the patient understands that laser/light treatment will accelerate bruise resolution but will not make it disappear immediately. Settings vary for each device, but in general, subpurpuric settings are achieved with lower fluences, and pulse durations between 3 and 10 ms. Although variations exist, useful settings for the 585/595 nm pulsed dye laser (PDL) (Vbeam Perfecta, Syneron Candela) include a 10 mm spot size, 6.0 to 7.5 J/cm ² fluence, and 6 ms to 10 pulse duration with dynamic cooling (40/30 or 30/20) for one to two passes. When a bruise is dark purple, stacking pulses is not recommended due to concern for bulk heating and subsequent damage to surrounding tissues. With milder bruising, pulses may be stacked with a 2- to 3-second delay in between. PDL can be used immediately after onset of ecchymosis, including on the same day as filler treatment, but studies demonstrate that results are best when performed 1 day after onset of bruising. Laser treatments are effective within the first few days after bruising onset, as long as the bruise is still purple in color, indicating the presence of deoxyhemoglobin, a target chromophore of the laser. As the ecchymosis fades to green (biliverdin) and then orange-yellow (bilirubin), the target chromophore is lost, and PDL is no longer effective. Other modalities for postinjection bruising include 532 nm potassium titanium phosphate (KTP) and lithium triborate (LBO) lasers and intense pulsed light (IPL). In our practice, we use KTP (Excel V, Cutera) with similar settings to PDL: 10 mm spot, 7.0 to 8.4 J/cm ² fluence, and 6 to 7 ms pulse duration with contact cooling for one to two passes. IPL with the Max G handpiece (Icon Pulsed Light System, Cynosure Inc., Westford, MA) was found to be effective in 15 patients with bruising within 24 to 48 hours after filler injection (28 J/cm ² fluence, 30 ms pulse duration). The mean reduction in bruising was 85% within 72 hours of treatment. Caution should be taken with use of IPL devices, which have varying absorption filters, particularly in darker skin types. PDL and KTP are considered safe in most skin types, although longer pulse durations and lower fluences are generally recommended for Fitzpatrick skin types IV to VI. The long-pulsed neodymium-doped yttrium aluminum garnet (Nd:YAG) laser is an excellent alternative in darker Fitzpatrick skin types, as this wavelength still treats ecchymoses but has less absorption by epidermal melanin, reducing the risk of laser-associated pigmentary changes.

Incorrect Filler Placement

Inappropriate placement of fillers may result in the development of subcutaneous nodules and papules. The majority of these are manifested as palpable and/or visible bumps under the skin. Injecting too superficially can lead to lumps of visible product or bluish bumps under the skin explained by the Tyndall effect with HA fillers ( Fig. 35.2 ). Such reactions can for the most part be prevented by use of correct technique. Treatment of visible papules can often be accomplished by firm digital pressure, by aspiration, or by incision and drainage. When persistent papules and nodules are due to the use of a HA filler, the enzyme hyaluronidase can be used to treat them. Small amounts of hyaluronidase (10–12 units for each 0.1 mL of biphasic or monophasic HA product, respectively) can be injected locally to dissolve the HA.