BACKGROUND: Ethylene vinyl alcohol copolymer was approved for use by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of stress urinary incontinence. CASE: We report on two patients who underwent injection with ethylene vinyl alcohol copolymer who were later found to have urethral erosions. CONCLUSION: Information regarding complications after ethylene vinyl alcohol copolymer urethral injections is currently limited. We performed a search of the FDA labeling information, Manufacturer and User Facility Device Experience database, and abstracts presented at scientific meetings regarding complications with this material. Symptomatic and asymptomatic erosions of ethylene vinyl alcohol copolymer in the urethra, bladder, and vaginal mucosa are possible complications after this procedure.
BACKGROUND:Ethylene vinyl alcohol copolymer was approved for use by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of stress urinary incontinence. CASE: We report on two patients who underwent injection with ethylene vinyl alcohol copolymer who were later found to have urethral erosions. CONCLUSION: Information regarding complications after ethylene vinyl alcohol copolymer urethral injections is currently limited. We performed a search of the FDA labeling information, Manufacturer and User Facility Device Experience database, and abstracts presented at scientific meetings regarding complications with this material. Symptomatic and asymptomatic erosions of ethylene vinyl alcohol copolymer in the urethra, bladder, and vaginal mucosa are possible complications after this procedure.