Durasphere EXP Brief Statement
Durasphere is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD).
Durasphere must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infection.
The use of Durasphere with needles other than those recommended in the DFU may result in Durasphere beads clogging the injection needle.
Do not inject Durasphere into blood vessels. Injection of Durasphere into blood vessels may cause vascular occlusion, platelet aggregation, infarction or embolic phenomena.
Durasphere should not be used in patients with bladder neck or urethral strictures until such strictures have been corrected. Use of Durasphere on uncorrected strictures may cause occlusion.
The safety and effectiveness of Durasphere treatment during pregnancy has not been established. The effect of Durasphere on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effectiveness of Durasphere, is unknown. Therefore, the risks and benefits of the device in women of childbearing potential could be carefully assessed.
Durasphere containing pyrolytic carbon coated graphite beads is not visible under X-ray and requires magnetic resonance imaging (MRI) for visualization.
Physicians must have training in diagnostic and therapeutic cystoscopy.
The treatment procedure and instrumentation associated with the injection of Durasphere carry a small risk of infection and/or bleeding, as do similar urologic procedures. The usual precautions associated with urologic procedures, specifically cystoscopy, should be followed.
Adverse events may include but are not limited to urinary tract infection, urinary urgency, dysuria, acute retention (duration :: ≤ 7 days), respiratory (infection), GI (nausea, vomiting, diarrhea, rectal bleeding, inflammation), non-acute retention (duration > 7 days), genitourinary (infection, tenderness, urethral prolapse, uterine bleeding, detrusor instability), hematuria, muscoskeletal (back/leg problems, arthritic changes), urinary frequency, outlet obstruction (slow prolonged stream), cardiac (angina, MI, hypertension, edema, CAD), excreted bulking material, pain (pelvic, flank, back, ear), surgery (hysterectomy, cataract, foot, chole), infection (dental, viral, groin), accident (fractures/fall), overbulking/abscess/cyst, abnormal lab values, peripheral vascular (edema, phlebitis), dermatology (rash), allergic reaction to antibiotic, fever, worsening of incontinence (onset of urge), neurological (headache, dizziness), renal symptoms (failure), psychological (depression)
Based on the literature, possible adverse events that might be expected, but have not been reported as adverse events in the clinical trial include: local tissue infarction and necrosis, embolic phenomena, and vascular occlusion.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.