(Poster 54) Summary of Safety Event Reports for Polyacrylamide Hydrogel for Urethral Bulking

Objectives: Polyacrylamide hydrogel (PAHG) [Bulkamid], the most recently FDA-approved urethral bulking agent, has seen increasing use in the treatment of stress urinary incontinence. Unlike traditional particulate agents, PAHG is a non-particulate hydrogel that integrates into urethral tissue, reducing the risk of migration. Although PAHG has demonstrated excellent safety, reported adverse events include urinary tract infection, acute urinary retention, and transient hematuria. The objective of this study was to describe and classify the provider, manufacturer, and patient safety event reports related to PAHG [Bulkamid] as documented in the Food and Drug Administration (FDA) Manufacturer and User Facility Device (MAUDE) database since its FDA approval in 2020.

Methods: The MAUDE database was queried for reports involving the brand name “Bulkamid” from January 1, 2020 through February 20, 2025. Adverse events and device malfunctions were identified and categorized based on the narrative descriptions provided in each report.

Results: Forty unique medical device reports for Bulkamid were reviewed and categorized by complication. A total of 66 patient and device complications within the reports were identified. The most frequently reported adverse events were urinary retention or catheterization (14/66; 21.2%), hematuria or hematoma (7/66; 10.6%), urinary tract infection (6/66; 9.1%), abscess (4/66; 6.1%), and persistent or worsened incontinence (4/66; 6.1%). Erosion, erosion with bladder stone, or fistula occurred in four patients (4/40; 10%). Seven cases (7/40, 17.5%) required explantation or revision due to complications including abscess, malposition, pain, hematuria, or chronic urinary retention. Serious complications such as sepsis and death were reported in two cases (2/40; 5.0%), and six patients required hospitalization related to the device (6/40, 15%). Additionally, three reports described device malfunctions involving function of the syringe or sheath (3/40; 7.5%).

Conclusions: The most reported complications associated with PAHG [Bulkamid] in the MAUDE database align with existing safety literature. However, rare but serious events such as migration or explantation – potentially due to improper injection technique – were also identified. Although serious complications such as sepsis and death have not been previously reported in the literature, their occurrence in this dataset highlights the limitations of the MAUDE database, including lack of detailed clinical context. This MAUDE database review of PAHG underscores the importance of continued post-market surveillance and aims to inform patient counseling and provider decision-making regarding urethral bulking procedures.