Managing complications of fillers: Rare and not-so-rare

Haneke, Eckart

doi:10.4103/0974-2077.172191

Cited by 74 publications

(73 citation statements)

References 95 publications

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“…Prior studies also suggest that the type of filler used is not associated with infection risk, and that complications may be more related to technical faults and breaks in sterile technique. 2,24,[35][36][37] Infections generally result from natural skin flora, Staphylococcus and Streptococcus species, being introduced through the injection site. 38 These infections often respond to oral antibiotics.…”

Section: Complications By Filler Typementioning

confidence: 99%

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

Rayess

Svider

Hanba

et al. 2018

JAMA Facial Plast Surg

100

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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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Section: Complications By Filler Typementioning

confidence: 99%

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

Rayess

Svider

Hanba

et al. 2018

JAMA Facial Plast Surg

100

View full text Add to dashboard Cite

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“…53,54 Hematoma and obstruction of vessels are also possible. 25 The zone of caution, an area believed to be associated with the highest complication rate, is the anterior half of the lower temporal compartment that contains these crucial neurovascular structures. 5,25 Several materials and surgical methods were not covered in our review due to the lack of cosmetic indications.…”

Section: Discussionmentioning

confidence: 99%

“…25 The zone of caution, an area believed to be associated with the highest complication rate, is the anterior half of the lower temporal compartment that contains these crucial neurovascular structures. 5,25 Several materials and surgical methods were not covered in our review due to the lack of cosmetic indications. Two of the more commonly used implants for temporal augmentation include PTFE (i.e., Gore-Tex) and porous polyethylene (i.e., MEDPOR) implants.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Temporal Augmentation: A Systematic Review

et al. 2019

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Clinicians employ various modalities in order to achieve temporal augmentation; however, no literature comprehensively describes these methods or provides perspective on available options. Understanding the available methodologies for cosmetic temporal augmentation allows for improved patient satisfaction with limited risk of complications. To synthesize the available literature on cosmetic temporal augmentation, including all available methodologies, patient satisfaction data, and complication rates, as well as to identify gaps in the available literature to encourage further research. A literature search was performed using the databases PubMed, Ovid Medline, Cochrane Library, and Web of Science. Using the key terms “temporal” or “temple” and “augmentation” or “rejuvenation,” all article formats presenting primary literature data involving cosmetic temporal augmentation were included. Articles not presenting patient data or not discussing cosmetic indications were eliminated. A total of 12 articles were deemed appropriate for analysis. Of the 12 articles included, 6 (50%) evaluated filler techniques, 3 discussed fat grafting (25%), and 3 reviewed solid implant (25%) techniques. Eight (67%) of these were retrospective reviews, with the remaining being prospective trials (33%). All studies found high patient satisfaction rates and a small number of complications with their respective methodology. Several methods are employed for cosmetic temporal augmentation, including various types of injectable fillers, solid implants, and fat grafting, with all reporting successful satisfaction and complication outcomes. Further research is necessary to properly compare these modalities. Clinician discretion should guide procedural choice until future well-controlled studies are able to provide standardized outcomes.

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“…Aus der Histologie lassen sich oft Rückschlüsse auf die möglicherweise ursächliche Filler‐Substanz ziehen, was gegebenenfalls therapeutische oder gutachterliche Relevanz hat . Die Prognose und die Behandlungsoptionen sind unter anderem abhängig von der jeweils verwendeten Substanz .…”

Section: Granulomatöse Fremdkörperreaktionen Und Kontaktallergienunclassified

Nicht‐infektiöse granulomatöse Dermatosen

Schmitt¹,

Völz

2019

J Deutsche Derma Gesell

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Zusammenfassung Granulomatöse Dermatosen umfassen ein breites Spektrum ätiologisch und klinisch heterogener Dermatosen, deren Gemeinsamkeit in einem histologisch von Histiozyten‐ bzw. Makrophagen‐Akkumulation geprägten Bild liegt. Die Pathogenese der einzelnen Krankheitsbilder ist unvollständig verstanden. Als Mechanismus wird zumeist ein Reaktionsmuster des Organismus auf einen immunogenen Stimulus angenommen. Antigenpräsentierende Zellen und der Einfluss unterschiedlicher Zytokine spielen eine Schlüsselrolle. Erkenntnisse zu granulomatösen Reaktionen unter iatrogener Immunmodifikation sowie bei genetisch determinierten Schwächen der Immunabwehr verbessern unser Verständnis granulomatöser Reaktionsmuster. Üblicherweise werden infektiöse granulomatöse von nicht‐infektiösen granulomatösen Dermatosen unterschieden. Der vorliegende Artikel behandelt granulomatösen Dermatosen ohne nachweislich kausalen Erregerbezug. Zu den klassischen Vertretern nicht erregerbedingter granulomatöser Dermatosen zählen das Granuloma anulare, die Necrobiosis lipoidica und die kutane Sarkoidose. Granulomatöse Dermatosen können kutane Manifestation einer systemischen Erkrankung darstellen oder mit einer solchen assoziiert sein. neoplastischen Erkrankungen, können das Bild einer granulomatösen Dermatose imitieren. Das klinische Bild ist entsprechend der pathogenetischen Vielfalt heterogen, insgesamt jedoch meist charakteristisch für das jeweilige Krankheitsbild. Die Diagnosestellung erfordert regelhaft eine gute klinisch‐pathologische Korrelation. Die Behandlung orientiert sich an der Pathogenese und erfolgt oft antientzündlich. Allerdings besteht meist eine unzureichende Datenlage und der dermale Charakter der Erkrankung erschwert die topische Behandlung.

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Managing complications of fillers: Rare and not-so-rare

Cited by 74 publications

References 95 publications

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

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

Temporal Augmentation: A Systematic Review

Nicht‐infektiöse granulomatöse Dermatosen

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