Important Safety Information:
Indications: The 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.
Contraindications: Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection.
Warnings: 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 the Bulkamid Rotatable Sheath into the urethra. Do not force the Bulkamid Rotatable Sheath into the urethra or inject Bulkamid Hydrogel if the urethral tissue is damaged. The Bulkamid Urethral Bulking System should not be used in patients with urethral or bladder neck strictures until the strictures have been corrected. Use of the 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.
Precautions: The Bulkamid Urethral Bulking System is only to be administered by a qualified physician, e.g. gynecologist, urologist, or urogynecologist. Safety and effectiveness of Bulkamid have not been established in patients with a fragile urethral mucosal lining, with urethral hypermobility with a straining angle >30º 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, less than 18 years of age, have active Herpes Genitalis, or for re-injection of Bulkamid Hydrogel less than 4 weeks after initial injection. 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.
Adverse Events: Adverse events may include: pain at the implant site, acute retention, urinary tract infection, hematuria, de novo urge incontinence, dysuria, urinary urgency, vaginal infection/irritation/Lichen Sclerosus, and worsening urinary incontinence.
Caution: U.S. Federal law restricts this device to sale and use by, or on the order of, a physician.
For a complete listing of indications, contraindications, warnings and precautions, go to www.bulkamid.com/isi.
