Complications of Palatal Pillar Implants: An analysis of the MAUDE database and literature review.

ABSTRACT

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.