Durasphere® EXP

Durasphere EXP is an injectable bulking agent indicated to treat female stress urinary incontinence due to intrinsic sphincter deficiency. It is composed of pyrolytic carbon coated beads suspended in a beta glucan and water based carrier gel.

For ordering information, please call 800.258.3476.

Indications

Durasphere is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency (ISD).

Contraindications

Durasphere must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infection.

Warnings / Precautions

Do not inject Durasphere into blood vessels. This may cause vascular occlusion, platelet aggregation, infarction or embolic phenomena.

Adverse Events

Adverse events related to Durasphere that were reported by >5% of patients during the clinical study include: retention, dysuria, urinary urgency, urinary tract infection and hematuria.

See the Instructions for Use for detailed information regarding the implant procedure. Warnings /precautions, adverse reactions, prior to using this product.

For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

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