The Role of Bacterial Biofilm in Adverse Soft-Tissue Filler Reactions: A Combined Laboratory and Clinical Study

Saththianathan, Mayuran; Johani, Khalid; Taylor, Alaina; Hu, Honghua; Vickery, Karen; Callan, Peter; Deva, Anand K.

doi:10.1097/prs.0000000000003067

Cited by 57 publications

(57 citation statements)

References 37 publications

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“…Multiple needle passes through a biofilm-contaminated surface, resulted in a 10 000 factor increase in risk of contamination of filler material. 40 Swelling can be secondary to a local inflammatory response to foreign material or superficial placement of the filler. Studies have shown that using a blunt-tip cannula instead of a hypodermic syringe produces less edema.…”

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

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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

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“…The most common strains forming the biofilm include: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus viridans, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa. The complex structure of biofim is the cause of their high resistance to various bactericidal agents, including antibiotic resistance [10,[22][23][24]. The treatment is complicated and long.…”

Section: Biofilmmentioning

confidence: 99%

“…Do najpowszechniejszych szczepów tworzących biofilm zalicza się: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus viridans, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis i Pseudomonas aeruginosa. Złożona struktura biofimu jest przyczyną ich wysokiej oporności na działanie różnych czynników bakteriobójczych, w tym na antybiotyki [10,[22][23][24]. Leczenie jest skomplikowane i długotrwałe.…”

Section: Biofilmunclassified

Management of complications associated with the use of hyaluronic acid fillers. Recommendations of the Aesthetic Dermatology Section of the Polish Dermatological Society

Zegarska¹,

Ambroziak²,

Ornatowska³

et al. 2020

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“…Als pathogenetische Faktoren werden sowohl kontaktallergische Mechanismen als auch eine mikrobiologische Komponente mit bakterieller‐ bzw. Biofilmkontamination diskutiert .…”

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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The Role of Bacterial Biofilm in Adverse Soft-Tissue Filler Reactions: A Combined Laboratory and Clinical Study

Abstract: Therapeutic, V.

Cited by 57 publications

References 37 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

Management of complications associated with the use of hyaluronic acid fillers. Recommendations of the Aesthetic Dermatology Section of the Polish Dermatological Society

Nicht‐infektiöse granulomatöse Dermatosen

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