Bulkamid Urethral Bulking System and Bulkamid Cystoscope

Bulkamid Urethral Bulking System is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.

The Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Note: For this medical application, you should comply with national statutory regulations and guidelines.

Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection. Contraindications may exist depending on the patient’s general condition or specific symptoms. The decision to perform a procedure remains with the responsible surgeon and must be made on the basis of an individual risk/benefit analysis. Cystoscopy may be contraindicated by the following clinical conditions, depending on their severity or extent: acute urethritis, acute cystitis, new urethral trauma, acute pelvic inflammatory disease

• Do not inject Bulkamid Hydrogel intravascularly. Injection of Bulkamid Hydrogel into blood vessels may cause vascular occlusion leading to a possible embolism.
• Discontinue injection of Bulkamid Hydrogel if the superficial capillaries of the mucosa start to fade in order to avoid ischemia.
• Prior assessment of the tissue is recommended before introducing Bulkamid Rotatable Sheath into the urethra. Do not force the Bulkamid Rotatable Sheath into the urethra if the tissue is damaged. Do not inject Bulkamid Hydrogel if the tissue is damaged.
• Bulkamid Urethral Bulking System should not be used in patients with urethral or bladder neck strictures until the strictures have been corrected. Use of Bulkamid Urethral Bulking System in patients with strictures may cause injury and/or urethral obstruction.
• Over-correction using Bulkamid Hydrogel may lead to obstruction.
• Patients receiving treatment affecting blood coagulation have an increased risk of hematoma or urethral bleeding, as with any invasive procedure.
• Do not use Bulkamid Hydrogel in male patients. Testicular abnormalities have been observed in some male animals implanted with Bulkamid; however, their relationship with Bulkamid has not been definitively established.

• Contact of bladder cancer patients with Cidex® OPA Possible anaphylactic reaction
  • Do not bring patients with a history of bladder cancer in contact with devices that were disinfected using Cidex® OPA

• Bulkamid Urethral Bulking System is only to be administered by a qualified physician, e.g., gynecologist, urologist, or urogynecologist.
• Safety and effectiveness of Bulkamid has not been established in patients with a fragile urethral mucosal lining.
• Safety and effectiveness of re-injection of Bulkamid Hydrogel less than 4 weeks after initial injection has not been established.
• Safety and effectiveness of Bulkamid have not been established in patients with any of the following conditions:
  • Urethral hypermobility with a straining angle >30˚ from horizontal bladder neck.
  • Predominant urge incontinence.
  • Detrusor overactivity.
  • Known polyuria (≥ 3L/24h).
  • Unevaluated hematuria.
  • Prolapse stage greater than Stage II using the ICS Pelvic Organ Prolapse Quantification (POPQ) exam.
  • BMI >35 kg/m2.
  • Neurogenic bladder.
• Safety and effectiveness of Bulkamid Urethral Bulking System have not been established in patients less than 18 years.
• Only patients with well-controlled diabetes should be considered for Bulkamid Hydrogel injection.
• Safety and effectiveness have not been established in patients who have active Herpes Genitalis.
• Bulkamid should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases. Patients with acute or chronic infection in other sites of the body should be treated with caution.
• If the patient has undergone major surgery or dental work, Bulkamid should not be injected until the patient has fully recovered. Please also advise Bulkamid patients that if they need to undergo a surgical procedure in the future, especially a dental procedure, there is a risk of infection developing in Bulkamid or near where the Bulkamid was placed. This is due to the possibility of bacteria migrating to the implant, which is the case with many other medical implants. Please consider advising patients that if they require a surgical or dental procedure in the future, they should tell the treating physician that they have a permanent implant and that they should discuss the possible need for prophylactic antibiotic therapy with their treating physician.
• The effect of Bulkamid has not been evaluated in women during pregnancy, delivery or lactation.
• The effect of Bulkamid on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of Bulkamid, is unknown. Therefore, the risks and benefits of the device in women of childbearing potential should be carefully assessed.
• Do not mix Bulkamid Hydrogel with any other substances.
• Do not inject Bulkamid Hydrogel into sites previously injected with another bulking agent or inject another bulking agent into a site previously injected with Bulkamid Hydrogel.
• Patients should be counseled that one or more repeat Bulkamid Hydrogel injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence.
• All components of the Bulkamid Urethral Bulking System are intended for use in a single patient. Do not re-use. Re-use increases the risk of contamination and thereby increases the risk of infection.
• All components of the Bulkamid Urethral Bulking System are sterile when supplied. Only use the components if the packaging and products are intact and undamaged. Do not re-sterilize any of the components.

No Precautions for Bulkamid Cystoscope

Adverse events include Acute retention, de novo urge incontinence, dysuria, excreted bulking material, hematuria, nocturia, non-acute urinary retention (>7 days), outlet obstruction, pain at implant site, pelvic pain, urinary frequency, urinary tract infection, urinary urgency, vaginal infection/irritation/Lichen Sclerosus, worsening urinary incontinence, abnormal laboratory value (elevated total Immunoglobulin E), back/neck pain, dizziness/fainting, extremity nerve pain/tingling, and inflammatory condition (gout), embolic phenomena, erythema, excreted material, granuloma, incomplete bladder emptying/outlet obstruction, migration of injected material, urethral erosion, urinary frequency, and vascular occlusion.