Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review.
Journal
American journal of otolaryngology
ISSN: 1532-818X
Titre abrégé: Am J Otolaryngol
Pays: United States
ID NLM: 8000029
Informations de publication
Date de publication:
Historique:
received:
25
06
2019
revised:
10
09
2019
accepted:
12
09
2019
pubmed:
17
11
2019
medline:
14
4
2020
entrez:
17
11
2019
Statut:
ppublish
Résumé
The Pillar Palatal Implant System is a minimally invasive procedure for the treatment of obstructive sleep apnea and snoring. Prior studies have examined the effectiveness of this procedure, however no prior study has thoroughly evaluated its complications. We anticipate that this analysis will provide valuable insight into these procedures which can be used in patient education and post-operative follow-up. The Manufacturer and User Facility Device Experience (MAUDE) database was queried for cases reporting injury related to the pillar procedure. The case narratives were individually analyzed and categorized by type of complication. A comparison of extruding parts and select complications was also performed using chi-square analysis. Of the 261 cases reported, 73.6% reporting extruding parts, 47.5% described patient pain, and 38.7% included patients describing a foreign body sensation. Infection was reported in 7.7% of the cases with cellulitis and abscess formation specifically mentioned in one case. Cases describing pain and difficulty swallowing were significantly more likely to have reported extruding parts (p < 0.05). This study describes various complications associated with this procedure. The description of these complications and accompanying literature review may provide healthcare professionals and patients with an understanding of the scope of adverse events related to this procedure.
Identifiants
pubmed: 31732316
pii: S0196-0709(19)30597-6
doi: 10.1016/j.amjoto.2019.102303
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
102303Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.