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.
This study was done with the purpose to explore the adverse events of BSP using the openFDA cloud with regard to malfunction and injury following surgery.
The FDA open FDA database was queried for adverse event use. Reports were further categorized by procedure location, injury type, device malfunction, procedure, and source of complication.
78 events were reported to the FDA in the study period. The majority of cases consisted of device malfunctions, while patient injuries consisted of 43.5%. Frontal sinus procedures had the greatest presence of adverse events with the majority reporting CSF leaks and device retention. Orbital complications were found to be significantly associated with dilation of the maxillary sinus.
The study concluded through its findings that 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 4.75 reported CSF leaks yearly.
Reference: https://journals.sagepub.com/doi/full/10.1177/1945892420920505
