Complications of injectable fillers and neurotoxins

Cox, Sue Ellen; Adigun, Chris G.

doi:10.1111/j.1529-8019.2012.01455.x

Cited by 71 publications

(70 citation statements)

References 38 publications

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“…Larger-gauge needles become necessary for products with larger particle size. The use of these needles may translate into larger epithelial tears and greater disruption of dermal structures, with subsequent capillary leakage, edema, and stimulation of inflammatory cascades [9]. The frequency for complications also depends on the injection site.…”

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

“…Mild, immediate-onset complications often are related to the injection site and resolve spontaneously [9,36]. Due to the gauge of the needle and the needle prick itself, the skin becomes mechanically traumatized in all facial augmentation procedures resulting in bruising, redness, swelling, pain, tenderness, itching, and rash [31,35].…”

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

“…Sculptra® contains poly-L-lactic acid microspheres in a powdered form, is biocompatible, and resorbable. Because PLLA is a biostimulatory filler, the augmentation effect is less based on a direct volume boost but rather caused by a stimulation of fibroblasts and a growth of type-I collagen [9]. Therefore, Sculptra® is used for global volumetric augmentation of the mid and lower thirds of the face [24].…”

Section: Temporary Fillersmentioning

confidence: 99%

“…Frequently used temporary fillers are collagen, hyaluronic acid (HA), poly-l-lactic acid (PLLA), and calcium hydroxylapatite (CaHA) [1••, 8••]. Filler substances, such as polymethyl-methacrylate (PMMA) and silicone, are considered permanent by the FDA because the products are not absorbed by the human body [9,10] (Table 1).…”

Section: Filler Substancesmentioning

confidence: 99%

“…Most AEs are related to incorrect injection technique or poor patient and localization selection [10]. Improper technique can lead to lumps and nodules after injection [31][32][33] or may result in deformity and asymmetry of the facial shape [9,34,35]. "Overcorrection" refers to the injection of too much product into an area and can result in visibility of the substance under the skin (Tyndall effect) or lumpiness at the site [1••].…”

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

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Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

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Injectable cosmetic wrinkle fillers are soft-tissue fillers approved as medical devices by the U.S. Food and Drug Administration (FDA). These devices are injected into the skin for correcting soft-tissue contour defects, such as moderate and severe wrinkles and folds, and for restoring the signs of facial fat loss in people with human immunodeficiency virus. Although the aesthetic treatment with injectable dermal fillers is considered to be safe, adverse events are involved with this minimally-invasive treatment. The FDA received 930 post-marked reports of adverse event from 2003 through 2008, of which 823 were deemed severe and 638 required medical treatment and follow-up.

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Section: Material-independent Adverse Eventsmentioning

confidence: 99%

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

Section: Temporary Fillersmentioning

confidence: 99%

Section: Filler Substancesmentioning

confidence: 99%

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

See 3 more Smart Citations

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

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A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers

Rayess

Svider

Hanba

et al. 2018

JAMA Facial Plast Surg

108

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are increasing in popularity as a noninvasive option to address concerns related to facial aging and volume loss. To our knowledge, there have been no large-scale analyses of adverse events and associated litigation related to filler injections. OBJECTIVES To determine risks of injectable fillers and analyze factors raised in litigation related to injectable fillers. DESIGN, SETTING, AND PARTICIPANTS In this cross-sectional review, the US Food and Drug Administration's (FDA) manufacturer and user facility device experience (MAUDE) database was evaluated for complications from the use of the following fillers: Juvederm, Restylane, Belotero, Sculptra, Radiesse, Artefill, Bellafill, and Juvederm Voluma from 2014 to 2016. The Westlaw Next database was used to identify jury verdicts. MAIN OUTCOMES AND MEASURES Complications were organized by type of filler used, location of injection, and severity. Intra-arterial injections without sequelae and those resulting in blindness or necrosis were considered severe complications. Factors raised during the litigation process were also analyzed. RESULTS Of 1748 adverse events analyzed, most cases stemmed from cheek (751 [43.0%]) or lip (524 [30.0%]) injection. Commonly reported adverse events reported included swelling (755 [43.2%]) and infection (725 [41.5%]). Among FDA-reported complications, blindness was significantly associated with dorsal nasal injections (P < .001). Vascular compromise with and without sequela of dermal necrosis and blindness were significantly associated with Radiesse injections P < .001. Of the 9 malpractice cases identified, two-thirds involved allegations of inadequate informed consent, and the median award in cases resolved with payment was $262 000. CONCLUSIONS AND RELEVANCE Although specific complication profiles vary by material and injection site, common adverse events associated with injectable fillers include swelling and infection. More serious events include vascular compromise, resulting in necrosis and blindness; these events are also raised in cases involving litigation. This analysis illustrates the importance of outlining these risks in a comprehensive preoperative informed consent process. LEVEL OF EVIDENCE NA.

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Iatrogenic Occlusion of the Ophthalmic Artery After Cosmetic Facial Filler Injections

et al. 2014

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for the Korean Retina Society IMPORTANCE Iatrogenic occlusion of the ophthalmic artery and its branches is a rare but devastating complication of cosmetic facial filler injections.OBJECTIVE To investigate clinical and angiographic features of iatrogenic occlusion of the ophthalmic artery and its branches caused by cosmetic facial filler injections. DESIGN, SETTING, AND PARTICIPANTS Data from 44 patients with occlusion of the ophthalmic artery and its branches after cosmetic facial filler injections were obtained retrospectively from a national survey completed by members of the Korean Retina Society from 27 retinal centers. Clinical features were compared between patients grouped by angiographic findings and injected filler material. MAIN OUTCOMES AND MEASURESVisual prognosis and its relationship to angiographic findings and injected filler material.RESULTS Ophthalmic artery occlusion was classified into 6 types according to angiographic findings. Twenty-eight patients had diffuse retinal and choroidal artery occlusions (ophthalmic artery occlusion, generalized posterior ciliary artery occlusion, and central retinal artery occlusion). Sixteen patients had localized occlusions (localized posterior ciliary artery occlusion, branch retinal artery occlusion, and posterior ischemic optic neuropathy). Patients with diffuse occlusions showed worse initial and final visual acuity and less visual gain compared with those having localized occlusions. Patients receiving autologous fat injections (n = 22) had diffuse ophthalmic artery occlusions, worse visual prognosis, and a higher incidence of combined brain infarction compared with patients having hyaluronic acid injections (n = 13).CONCLUSIONS AND RELEVANCE Clinical features of iatrogenic occlusion of the ophthalmic artery and its branches following cosmetic facial filler injections were diverse according to the location and extent of obstruction and the injected filler material. Autologous fat injections were associated with a worse visual prognosis and a higher incidence of combined cerebral infarction. Extreme caution and care should be taken during these injections, and physicians should be aware of a diverse spectrum of complications following cosmetic facial filler injections.

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Complications of injectable fillers and neurotoxins

Cited by 71 publications

References 38 publications

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

A Cross-sectional Analysis of Adverse Events and Litigation for Injectable Fillers

Iatrogenic Occlusion of the Ophthalmic Artery After Cosmetic Facial Filler Injections

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