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- W4387095446 abstract "To characterize adverse events related to use of the perirectal spacing agent SpaceOAR™, we examined the Manufacturer and User Facility Device Experience (MAUDE) database.The MAUDE database was queried for SpaceOAR™ and Augmenix from June 2015 (when SpaceOAR was approved by the Food and Drug Administration), to October 2022. Reports were reviewed for adverse events (AEs), operative procedures performed because of the AE, and changes to the radiation plan. AEs were categorized using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.Six hundred fifty-four reports were reviewed. Eighty-four were excluded and four reports reviewed two separate cases of SpaceOAR™ administration. Five hundred seventy four cases were ultimately included. Three deaths were reported (0.5% of all AEs). One point six percent of cases represented CTCAE grade 4 injuries (life-threatening consequences; urgent intervention indicated), 15.9% grade 3 (severe but not immediately life-threatening; hospitalization), 24.2% grade 2 (moderate; local/noninvasive intervention), and 57% of events were CTCAE grade 1 (mild; asymptomatic or mild symptoms). Bowel diversion occurred in 29 cases (9%).Both asymptomatic (n=311) and debilitating (n=12) complications of SpaceOAR™ hydrogel use were identified. Death, gel embolization, anaphylaxis, rectal ulcerations, and infections requiring bowel or urinary diversions were among the complications reviewed. Providers should consider these potential complications before perirectal spacer administration and during patient counseling." @default.
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- W4387095446 date "2023-09-01" @default.
- W4387095446 modified "2023-10-14" @default.
- W4387095446 title "Real-World Complications of the SpaceOARTM Hydrogel Spacer: A Review of the Manufacturer and User Facility Device Experience Database" @default.
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- W4387095446 doi "https://doi.org/10.1016/j.urology.2023.09.016" @default.
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