Regarding: A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant

We enjoyed reading the recent article by Stolovitzky et al. published in this journal regarding “A Prospective Study for Treatment of Nasal Valve Collapse Due to Lateral Wall Insufficiency: Outcomes Using a Bioabsorbable Implant.” The prospective study of 101 patients with lateral wall insufficiency (LWI) treated with bioabsorbable implants showed patient-reported improvement and objective endoscopic physical exam improvement with or without adjuvant therapy (septoplasty and turbinate reduction). Although their study had short-term follow-up (6 months), the degree of improvement was consistent with initial reports by Nicoló and Berghaus (12 months, and 24 months) that popularized this product. We believe that the rate of adverse events related to this device is not insignificant and that possible risks should be clearly discussed with the patient before the procedure. Nicoló and Berghaus reported four of 30 (13.2%) patients experienced five device-related adverse events (infection, hematoma, inflammation, and requiring device retrieval). Stolovitzky et al.’s study reports similarly 17 out of 103 patients (16.5%) experienced 19 device-related adverse events. Both studies report device retrieval related due to device migration as the most common adverse event. There were no long-term sequelae for any of the patients in the study. Recently, we encountered a patient who 3 weeks postprocedure presented with pain, redness, and purulent drainage. On exam, the implant flange was exposed at the right nasal dorsum, which required device retrieval. This prompted us to review the MAUDE (Manufacturer and User Facility Device Experience by the U.S. Food and Drug Administration [FDA]) database to categorize reported adverse outcomes. The device was approved by the FDA in 2016, and the first MAUDE report was in 2017. A total of 10 patients with bilateral implants have been reported. Of 20 implants, 12 implants had complications. Infectionwithout extrusion occurred in six implants; infection with extrusion occurred in three; and extrusion alone occurred in one. Pain was reported for five implants. The other adverse outcomes reportedwere cosmetic deformity and failure of the implant to deploy. Ten of the 12 implants with adverse outcomes underwent attempted removal. One implant required a twostage removal requiring an additional incision, whereas two implants were incompletely removed. Long-term followup of these patients is not reported. In summary, based on our literature review and MAUDE, device migration and infection are the most commonly reported complications for bioabsorbable lateral wall implants. We hope that, based on these observations, providerswill provide appropriate preoperative counseling.