01Aug 2023
Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database

This study analyzed the real-world safety of sacral neuromodulation (SNM) devices, which have been implanted in over 350,000 patients since FDA approval in 1998. The study conducted searches in the FDA's MAUDE database for adverse events (AEs) related to SNM devices and also examined legal databases for lawsuits related to these devices. The analysis revealed 44,122 SNM-related AEs, with the majority related to patients needing assistance with device use or experiencing a loss of efficacy. Surprisingly, the number of lawsuits was low, suggesting overall device safety. Many reported "complications" were attributed to the need for improved technical support or better-informed consent.

  • #urology

Like

Save

Share