Important Safety Information
Indications:
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 that have failed conservative treatments.
Intended users:
Bulkamid® Uretheral Bulking System is intended for use by qualified physicians, e.g. gynaecologist, urologist, or urogynaecologist.
Contraindications:
Bulkamid® Urethral Bulking System is contraindicated in patients suffering from acute cystitis or urethritis. Do not use in patients who have active Herpes Genitalis.
Do not use Bulkamid® Urethral Bulking System in patients with damaged tissue in the urethra.
Warnings:
Do not inject Bulkamid® Hydrogel intravascularly. It is possible that accidental vascular injection will cause embolism. During the bulking procedure, the blood vessels must always remain visible at the site of injection to avoid the risk of necrosis. Evaluate the condition of the tissue (e.g. hardness, oedema, haematoma, atrophy) at the site of injection prior to treatment. Patients receiving treatment interfering with blood coagulation have an increased risk of haematoma or urethral bleeding.
Precautions:
Do not inject Bulkamid® Hydrogel into sites previously injected with other bulking agents or vice versa. If the patient has undergone major dental work or surgery, Bulkamid® Hydrogel 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. Do not inject Bulkamid® Hydrogel into other sites of the body. The procedure may cause urinary tract infections and scratches in urethra and bladder. Prophylactic antibiotic is recommended. It is possible that inflammatory changes seen at the site of implant may later be misinterpreted for other pathology. Do not mix Bulkamid® Hydrogel with any other substances. Discard any unused material/product per local protocol/procedure. Bulkamid® Hydrogel should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases. Do not introduce Bulkamid Rotatable Sheath into other body cavities. All components of the Bulkamid® Urethral Bulking System are only intended for single patient use and single use. Do not re-use. Reuse increases the risk of contamination and hereby increases the risk of infection. Do not re-sterilize Bulkamid® Hydrogel, Bulkamid® Needle or Bulkamid Rotatable Sheath. Do not use any component of the Bulkamid® Urethral Bulking System components after the expiry date printed on the packaging. The effect of Bulkamid® Hydrogel has not been evaluated in women during pregnancy, delivery, or lactation. A change to the device insertion technique can lead to implant complications.
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 dysuria, stranguria, haematuria, urinary tract infection, and acute retention may occur.
- Scratching of the urethral mucosal may occur during the procedure.
- Long-term side effects such as non-acute retention, abscess formation, fibrosis (tissue hardening), de novo urgency, and 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.