FDA Approves Contura’s Stress Urinary Incontinence Device

The FDA has approved Contura’s premarket application for its Bulkamid hydrogel for treating stress urinary incontinence (SUI) in adult women with SUI or stress predominant mixed incontinence.

The soft hydrogel is composed of 2.5 percent polyacrylamide and 97.5 percent water. It is injected into the patient and gives additional volume to the urethra, acting as scaffolding for cell growth to provide symptom relief.

SUI is a common urologic condition among women caused by a weakness in the pelvic floor, preventing the urethra from fully closing when pressure is applied on the bladder.