Important Safety Information


Bulkamid® Hydrogel is intended to be used as a urethral bulking agent for the treatment of female urinary incontinence where the stress component is significant. Bulkamid® Hydrogel is intended for female patients, above the age of 18 years.

Intended Users:

Bulkamid® Uretheral Bulking System is intended for use by qualified physicians, e.g. gynaecologists, urologists, or urogynaecologists.


Bulkamid® Urethral Bulking System must not be used in patients suffering from acute infection in the urinary tract (cystitis and urethritis), having active Herpes Genitalis, or having damaged tissue in the urethra.


Patients receiving treatment with blood thinners have an increased risk of bleeding (haematoma or urethral bleeding).


If the patient has undergone major dental work or surgery, Bulkamid® should not be injected until the patient is fully recovered. If the patient needs surgery or major dental work post Bulkamid® Hydrogel injection, antibiotic treatment to reduce risk of infection should be considered by physician. Patients with acute or chronic infection in other sites of the body must be treated with caution. Only patients with well-controlled diabetes should be considered for Bulkamid® Hydrogel injection. The procedure may cause urinary tract infections and scratches in urethra and bladder as with any other minimally invasive procedure in the urinary tract. Prophylactic antibiotics is recommended. It is possible that inflammatory changes seen at the site of implant may later be misinterpreted for other pathology. Bulkamid® must not be injected into other sites of the body. Safety and effectiveness of the device has not been established in patients during pregnancy, delivery or lactation. Bulkamid® should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases. Safety and effectiveness of Bulkamid® Hydrogel have not been established in patients under 18 years.

Adverse Events:

General side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the placement of Bulkamid® Hydrogel. Specifically, the following side effects may be associated with the use of the device system; postoperatively, transient symptoms such as painful urination (dysuria), Blood in urine (haematuria), swelling (oedema), urinary tract infection and acute retention and pain during voiding may occur, scratching of the urethral mucosal may occur during the procedure, and long-term adverse events such as non-acute retention, Bacterial infection (abscess formation), tissue hardening (fibrosis), migration (material leakage) and tissue injury (necrosis) are possible but rare.

Results and experiences may vary and are unique to each patient. The efficacy of the device may diminish over time and no promise or guarantee is made about specific results or experiences.