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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
933

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

Sarah G Wilkins1, Amar H Sheth1, Darpan Kayastha1

  • 1Division of Otolaryngology, Department of Surgery, Yale School of Medicine, New Haven, Connecticut, USA.

Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery
|March 20, 2023
PubMed
Summary

Bioabsorbable nasal implants for nasal valve collapse can cause adverse events like abscess and protrusion. Further research is needed to understand long-term complications and improve management strategies.

Keywords:
LateraManufacturer and User Facility Device ExperienceOpenFDAadverse eventdevice malfunctionendonasalnasal airway obstructionnasal implantnasal valve

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Area of Science:

  • Otolaryngology
  • Biomaterials Science

Background:

  • Bioabsorbable implants are a recent innovation for treating nasal valve collapse.
  • Understanding their safety profile and potential complications is crucial.

Purpose of the Study:

  • To summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants.
  • To analyze data from the Manufacturer and User Facility Device Experience (MAUDE) database.

Main Methods:

  • Retrospective review of 26 device reports from March 2017 to April 2022.
  • Analysis of reported complications, symptoms, and management strategies.

Main Results:

  • The most frequent complications were abscess (13 reports) and implant protrusion (5 reports).
  • Long-term symptoms included facial pain/discomfort and failure to absorb (3 reports each).
  • Management involved antibiotics (9), steroid injections (4), and explantation (20).

Conclusions:

  • Bioabsorbable nasal implants present risks including infection and mechanical issues.
  • Long-term outcomes and optimal management protocols require further investigation.
  • Standardized MAUDE reporting could enhance data utility for device safety surveillance.