Multiple surgical therapies for benign prostatic hyperplasia (BPH) have been developed to decrease complications and increase provider efficiency. We investigated contemporary BPH treatment device related adverse events by searching a publicly available database.
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for contemporary BPH treatments. All devices were evaluated for malfunction, patient complications, and manufacturer review. A MAUDE adverse event classification system was used to standardize complications. Univariate analysis was performed to identify associations between BPH devices and adverse events.
A total of 2567 reports were identified: Transurethral Resection of Prostate (TURP) 197 (7.67%), Holmium Laser Enucleation of the prostate (HOLEP) 39 (1.52%), Greenlight™ 2315 (90.2%) and UroLift® 16 (0.62%). The most common deviations for each modality included cutting loop detachment during TURP 116 (58.9%), morcellator dysfunction for HOLEP 23 (58.9%), tip fracture/detachment for Greenlight™ (68.8%), and failure to deploy during UroLift® 10 (62.5%). Only 18 (0.7%) patients required medical/surgical management (MAUDE II-IV) due to a device complication. No significant relationship was seen between each modality and complications, however morcellator use (27.8%) was observed in higher-grade complications. Manufacturer review occurred in 61.7% of cases, with 41.3% of reviewed cases finding the operator the cause of the malfunction.
Each BPH modality investigated had minimal patient harm with over 99% of patients experiencing no complication after device malfunction. Of note, great care should be taken with morcellator use during HOLEP as it had the greatest number of MAUDE II-IV complications among all devices. Manufacturer review revealed that over 40% of cases were due to misuse by the user. Therefore, urologists should select the modalities they are most familiar with to decrease patient harm and prevent device malfunctions.
Journal of endourology. 2019 Apr 16 [Epub ahead of print]
Neel H Patel, Nikil Uppaluri, Michael Iorga, Ariel Schulman, Jonathan Bloom, John L Phillips, Sean Fullerton, Sensuke Konno, Muhammed Choudhury, Majid Eshghi
New York Medical College, Urology , 40 Sunshine Cottage Rd, Skyline 1S- B50 , Valhalla, United States , 10595., New York Medical College, Urology, Valhalla, United States ; ., New York Medical College, Urology , 40 Sunshine Cottage Road , Valhalla, New York, United States , 10595 ; ., Maimonides Medical Center, 2042, Brooklyn, New York, United States ; ., National Cancer Institute, Bethesda, Maryland, United States ; ., New York Medical College, Department of Urology , Munger 4th floor , Valhalla, New York, United States , 10595., New York Medical College, Department of Urology , Munger 4th floor , Valhalla, New York, United States , 10595 ; ., New York Medical College, Urology , Munger Pavilion 4th Floor , Valhalla, New York, United States , 10595 ; ., Valhalla, United States ; ., New York Medical College, Urology , 4th floor,Munger Pavillion , Valhalla, New York, United States , 10594 ; .