Bulkamid® is a urethral bulking agent for the treatment of female urinary incontinence where the stress component is significant.
Bulkamid® is a biocompatible and non-absorbable hydrogel consisting of 97.5% water and 2.5% cross-linked polyacrylamide. The visco-elastic properties are optimized for urethral bulking.
The hydrogel exchanges water with the surrounding tissue, making it resemble normal tissue. It is particle-free, so there is no tissue hardening or other impairment to the urethral function.
The hydrogel is injected using the Bulkamid® Urethral Bulking System (patents pending). The procedure is performed under endoscopic control to ensure correct placement of the bulking agent.
Bulkamid® meets all the health and safety requirements of the European Medical Devices directive 93/42/EEC. The FDA has granted Bulkamid® Investigational Device Exemption, allowing its use in a clinical trial that has now started in the United States.
Follow-up data up to 24 months after treatment demonstrates excellent safety and efficacy. A major European multicenter clinical trial is ongoing.
ETHICON, a Johnson & Johnson company, is the exclusive worldwide distributor of Bulkamid®.
Learn more about Bulkamid® at www.bulkamid.com
Bulkamid® is not approved for sale in the United States.