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In Response to Letter to the Editor Regarding: A Prospective Study for Treatment of Nasal Valve Collapse Due to Lateral Wall Insufficiency: Outcomes Using a Bioabsorbable Implant
Author(s) -
Stolovitzky Pablo,
Sidle Douglas M.,
Ow Randall A.,
Nachlas Nathan E.,
Most Sam P.
Publication year - 2019
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.28013
Subject(s) - otorhinolaryngology , medicine , atlanta , nose , head and neck surgery , general surgery , surgery , metropolitan area , pathology
Thank you for your comments regarding our recent article and your diligence in researching adverse events associated with this bioabsorbable implant. As you state, a total of 10 patients (with 20 implants) experienced adverse outcomes and were reported via the Manufacturer and User Facility Device Experience, or MAUDE database, in 2017. For perspective, to date over 32 thousand implants have been placed nationwide. We absolutely agree that patients should be counseled regarding benefits and potential risks (as reported in our article) before any procedure. Similarly, patient selection and proper training are paramount to use of any new device. In sum, we thank you for highlighting the importance of informed consent before surgical procedures.