Presentation Authors: Buddima Ranasinghe*, Brooklyn, NY, Beshoy Nazeer, West Indies, Grenada, David Silver, Ariel Schulman, Brooklyn, NY
Introduction: The SpaceOAR System is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. The SpaceOAR has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity. Despite a high safety performance in initial trials, the SpaceOAR remains in early clinical use. Thus, we examined emerging safety reports as the system becomes more widely utilized.
Methods: We reviewed the SpaceOAR manufacturer website and manufacturer-sponsored physician symposia for the safety profile and complications associated with the SpaceOAR hydrogel. We then compared this with reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database.
Results: The manufacturer website and physician symposia reported risks including pain, needle penetration and/or gel injection into a nearby organ or blood vessel, local inflammation, infection, urinary retention and local rectal injury or symptoms. There were 14 unique reports to the MAUDE database from 2015 to 2018, with an increasing number of reports in recent years. Unique major complications including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis, purulent perineal drainage, rectal wall erosion and recto-urethral fistula were reported.
Conclusions: Despite important clinical benefits of the SpaceOAR System, there are a number of severe and debilitating complications recently reported in close proximity to gel injection. This highlights the need for further study of device complications in light of its increasing clinical use.