Bioabsorbable Implants for Nasal Valve Collapse: A MAUDE Database Analysis

Introduction: Since FDA approval in 2016, bioabsorbable implants (Latera) have been utilized to address nasal valve collapse as a simple alternative to functional septorhinoplasty. While these implants have generally been considered safe and efficacious, adverse events related to their use have not been well characterized in the literature. The objective of this study is to analyze these adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: A retrospective cross sectional database analysis was performed using the Food and Drug Administration’s MAUDE database from 2012 through 2022. The MAUDE database was reviewed for all reports related to adverse events involving bioabsorbable implant devices (Latera) using the advanced search term “ear, nose, throat, synthetic polymer material” and reviewing all records with the basic search term “Latera”. Reports were individually reviewed and categorized with special attention to adverse events.

Results: A total of 53 medical device reports were identified from the database query, which included 27 cases from 3/30/2017 - 4/28/2022. Reported adverse events include infection (n=12, 44%), pain (n=9, 33%), implant extrusion (n=8, 30%), recurrent nasal obstruction (n=4, 15%), and skin irritation (n=4, 15%). Over half of these complications resulted in explant with either partial (n=5, 19%) or failed removal (n=5, 19%). Six cases noted that the implant was still present despite being in place for 18 months or longer. One report noted open septorhinoplasty with rib grafting was needed for a significantly worsened NOSE score following implant.

Conclusions: Adverse events reported following bioabsorbable implants for nasal valve collapse treatment largely includes implant infection and extrusion. Most patients underwent explantation, which was not always complete or successful. Future clinical studies are necessary to determine the long-term outcomes associated with bioresorbable nasal implants.