Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis.
Sarah G WilkinsAmar H ShethDarpan KayasthaHisham AbdouParsa P SalehiMartin J CitardiR Peter ManesPublished in: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (2023)
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.
Keyphrases
- adverse drug
- soft tissue
- chronic rhinosinusitis
- chronic pain
- risk factors
- heart failure
- spinal cord injury
- pain management
- risk assessment
- squamous cell carcinoma
- depressive symptoms
- climate change
- electronic health record
- lymph node
- replacement therapy
- human health
- transcatheter aortic valve replacement
- data analysis
- smoking cessation
- atrial fibrillation