Adverse Events Associated With Aesthetic Dermal Fillers: A 10-Year Retrospective Study of FDA Data | Semantic Scholar (2024)

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@article{Povolotskiy2018AdverseEA, title={Adverse Events Associated With Aesthetic Dermal Fillers: A 10-Year Retrospective Study of FDA Data}, author={Roman Povolotskiy and Nicholas C Oleck and Christopher M. Hatzis and Boris Paskhover}, journal={The American Journal of Cosmetic Surgery}, year={2018}, volume={35}, pages={143 - 151}, url={https://api.semanticscholar.org/CorpusID:79540093}}
  • Roman Povolotskiy, N. Oleck, B. Paskhover
  • Published 9 February 2018
  • Medicine
  • The American Journal of Cosmetic Surgery

The authors queried and compiled the MAUDE database for injury cases reported with aesthetic dermal fillers between January 2007 and July 2017 and found the most common complications associated with aesthetic Dermal filler use were nodule formation, infection, inflammation, allergic complications, and vascular complications.

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19 Citations

Adverse reactions associated with the esthetic use of soft tissue fillers and neurotoxins: a 53-year retrospective analysis of MedEffect™, Health Canada’s reporting database
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ARs associated with the use of neurotoxins and soft tissue fillers are underreported in Canada, and more complete and representative information regarding ARs is necessary for the development and validation of treatment algorithms and management strategies.

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Filler migration distant from the injection site can occur even several years after the primary treatment, and permanent fillers bear a higher risk of very late filler migration.

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Autologous fat was the most common filler associated with blindness despite HA fillers being the most commonly used across the globe, however, the blindness caused by other soft-tissue fillers like collagen and calcium hydroxylapatite was represented.

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Postmarket Safety Surveillance of Delayed Complications for Recent FDA-Approved Hyaluronic Acid Dermal Fillers
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Although delayed nodules and inflammatory events are rare, reports for these events were extracted from the MAUDE database from 2016 to 2020 for HAVLR, HAVOB, HADEF, HARH4, HAREF, and HARH2 (most to least frequent).

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A systematic review supports the development of American Society for Dermatologic Surgery practice guideline on the management of adverse events of skin fillers and suggests practitioners must have adequate knowledge of anatomy, elicit history of skin filler use, and establish preemptive protocols that prepare the clinical practice to manage complications.

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Five practical considerations were recommended: patient assessment and individualization of treatment plan, choice of an appropriate HA filler, adequate knowledge of facial anatomy, strict adherence to aseptic methods, and proper injection technique, which support practitioners in optimizing safety and quality of aesthetic treatment with HA fillers.

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A filler emergency kit (FEK) is proposed to deal with complications of hyaluronic acid fillers according to the new protocol to manage the stresses caused by these situations to avoid distressing the physician and the patient.

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In conclusion, the high-pressure and high-volume filler injections probably caused a detachment of the tissues, with the orbicularis oris muscle concurrently acting as a pump and moving the HA implant, causing migration to the area with low-density tissue such as the cheek.

Case Report: The role of intradermal micro‐droplet hyaluronic acid injection in the correction of filler nodules complication
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To the best of the knowledge, there has been no report of using the intradermal injection of the micro‐droplet HA to correct filler nodule and simultaneously revitalize the skin quality, suggesting this novel treatment technique could be a safe alternative for nodule formation correction.

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Worldwide and country-specific total and textured implant sales data are needed to determine critical incidence and prevalence analysis and federal reporting of breast implant–associated ALCL has limitations in providing clinical history, treatment, and oncologic follow-up.

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Impending Facial Skin Necrosis and Ocular Involvement After Dermal Filler Injection: A Case Report
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The case of a young patient who presented an acute and severe complication after a dermal filler injection by an unlicensed therapist is reported, leaving the patient with a full thickness scar on the forehead region.

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