Background Balloon sinuplasty (BSP) has become a common, minimally invasive treatment for chronic sinusitis. Like any surgical procedure, there are definite risks when using it as a stand-alone procedure or in conjunction with other revision procedures. Objective To explore the adverse events of BSP using the openFDA cloud with regard to malfunction and injury following surgery. Methods Between January 2015 and December 2018, the Food and Drug Administration’s (FDA) openFDA database was queried for adverse event use. Reports were further categorized by procedure location, injury type, device malfunction, procedure (stand-alone BSP vs hybrid), and source of complication (anatomical or surgeon related). Results Seventy-eight events were reported to the FDA in the study period. Majority of cases consisted of device malfunctions (64.1%), while patient injuries consisted of 43.5%. Frontal sinus procedures had the greatest presence of adverse events (47.4%) with the majority reporting significant cerebrospinal fluid (CSF) leaks ( P < .001) and device retention ( P = .021). Orbital complications ( P = .004) were found to be significantly associated with dilation of the maxillary sinus. Skull-based injuries were the only factor incident in which surgeon-reported anatomical complications were significant ( P = .018). Conclusions As balloon dilation procedure continues to rise in the United States, significant adverse events continue to occur. Frontal sinus BSP leads to the highest number of complications and a 4.75 reported CSF leaks yearly. Based on real data, surgeons performing the procedure should be acquainted with common BSP-related injuries so they can prepare for those circumstances and share informed consent with their patients.

Background A randomized controlled trial was held to compare nonabsorbable packs to steroid‐eluting absorbable stents as middle meatal spacers after endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS). Methods CRS patients were randomly assigned to receive either nonabsorbable Merocel packs wrapped in non‐latex glove material (packing type A) or Propel steroid eluting stents (packing type B). Twenty‐two–item Sino‐Nasal Outcome Test (SNOT‐22) scores were collected preoperatively and postoperatively during the initial 4 debridements up to 3 months. Recording of the nasal endoscopy was also collected during all postoperative visits. In addition, Lund‐Kennedy scores and middle turbinate lateralization scores, using a new visual analogue scale, were compared between the 2 types of packing. Results Forty CRS patients were prospectively enrolled in this institutional review board (IRB)‐approved study. Patients with packing type A had significantly lower middle turbinate lateralization scores at their first (∼10 days) postoperative visit (p = 0.02 and p = 0.04, for left and right sides, respectively). This difference disappeared by later postoperative visits (from 20 days to 3 months). Overall, patients receiving packing type A had significant lower SNOT‐22 scores at 20 days postsurgery (p = 0.05). This difference also disappeared at 1 and 3 months postoperation. There were no statistically significant differences in Lund‐Kennedy scores. Conclusion In this study, nonabsorbable packing materials showed significant superior middle meatal spacing capacities as evidenced by greater middle turbinate medialization capability at the first postoperative visit. Additionally, patients with this type of packing saw improvements in their SNOT‐22 scores at the 20‐day postoperative visit. This study showed that there was no significant improvement in postoperative outcomes with drug‐eluting stents when compared to nonabsorbable packing.

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