Bulkamid Urethral Bulking System is indicated for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women. The Cystoscope is indicated for endoscopic surgical procedures.
Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection. Consult your physician if you are suffering from other pelvic infections, pelvic trauma, or pelvic inflammatory disease.
Potential risks may include infection, inability or difficulty to urinate, painful urination, excreted bulking material, embolism, blood in the urine, frequent urination at night, urinary tract infection, intense sudden need to urinate, infection or irritation in the vagina/genital area, worsening urinary incontinence, abnormal blood lab results (Immunoglobulin E), back/neck pain, dizziness/fainting, pain, blockage of blood vessels by a clot, redness of the skin, inflammation, migration of injected Bulkamid material, and urethral erosion.
Patients suffering from blood coagulation disorders are at higher risk of complications including hematoma or urethral bleeding, as with any invasive procedure. If a patient has undergone major surgery or dental work, Bulkamid should not be injected until the patient has fully recovered. The effect of Bulkamid has not been evaluated in women during pregnancy, delivery or lactation. Patients should be counseled that one or more repeat Bulkamid Hydrogel injection procedures may be required.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.