Abstract
PURPOSE: Increasingly, polyethylene glycol (PEG) hydrogel spacers are being used to help reduce rectal toxicity in men undergoing radiation therapy for prostate cancer. Device-related issues and patient event rates from the Manufacturer and User Facility Device Experience (MAUDE) were assessed to contextualize spacer reports in the United States. METHODS AND MATERIALS: PEG hydrogel spacer medical device reports (MDRs) from January 1, 2015, through December 31, 2023, were collected from the MAUDE database, which reports suspected device-associated malfunctions, injuries, and deaths submitted to the United States Food and Drug Administration. United States sales data during the same period were obtained from the manufacturer. Reported rates of device-related and patient events were calculated by dividing MDRs by total units sold, recognizing that not all units sold are necessarily placed. RESULTS: A total of 1005 unique MDRs reported from the United States for PEG hydrogel spacers were identified in the MAUDE database, and 251,836 spacer units were sold during the study period. Five deaths were reported, representing 0.002% of total units sold. The annual MDR rate increased from 0.00% in 2015 to 0.57% in 2023 (overall rate 0.40%). The most frequently reported device-related events were placement/positioning problems (0.295%) and adverse events without an identified device or use problem (0.084%). The most frequently reported patient events were "no clinical signs, symptoms, or conditions" or asymptomatic (0.175%), pain/discomfort (0.110%), infection (0.052%), fistula formation (0.037%), and hemorrhage/blood loss/bleeding (0.033%). CONCLUSIONS: With respect to estimated device usage in the United States, overall device-related events and patient event rates for PEG hydrogel spacers consistently remained below 1%, with the majority having minimal or no reported clinical consequence.