Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis.

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  • Additional Information
    • Source:
      Publisher: Wiley Country of Publication: England NLM ID: 8508176 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6817 (Electronic) Linking ISSN: 01945998 NLM ISO Abbreviation: Otolaryngol Head Neck Surg Subsets: MEDLINE
    • Publication Information:
      Publication: 2023- : [Oxford] : Wiley
      Original Publication: [Rochester, Minn.] : The Academy, [c1981-
    • Subject Terms:
      Absorbable Implants*; Humans ; United States ; Databases, Factual ; United States Food and Drug Administration
    • Abstract:
      Bioabsorbable implants (eg, Latera) have recently been approved for addressing nasal valve collapse. The purpose of this study is to summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants queried in the Manufacturer and User Facility Device Experience (MAUDE) database. Of the 26 device reports entered between March 2017 and April 2022, the most frequently reported complications included abscess (n = 13) and implant protrusion (n = 5). Other common symptoms reported greater than 1-year postimplantation included facial pain/discomfort (n = 3) and failure to absorb (n = 3). Management of adverse events included treatment with antibiotics (n = 9), steroid injections (n = 4), and explantation (n = 20). In 3 reports, adverse reactions required a biopsy of adjacent tissue for pathologic analysis. These findings suggest that further research is required to assess the potential long-term complications and optimize the management of bioabsorbable nasal implants. Furthermore, standardized reporting templates may improve the utility of the MAUDE database.
      (© 2023 American Academy of Otolaryngology-Head and Neck Surgery Foundation.)
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    • Contributed Indexing:
      Keywords: Latera; Manufacturer and User Facility Device Experience; OpenFDA; adverse event; device malfunction; endonasal; nasal airway obstruction; nasal implant; nasal valve
    • Publication Date:
      Date Created: 20230320 Date Completed: 20230424 Latest Revision: 20230428
    • Publication Date:
      20240829
    • Accession Number:
      10.1002/ohn.227
    • Accession Number:
      36939542