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.

Brief Statement

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.

The use of Durasphere with needles other than those recommended in the DFU may result in Durasphere beads clogging the injection needle.

Warnings
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.

Precautions

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.

Durasphere is supplied steam sterilized in sealed package and is intended for single use only. Carefully examine the unit to verify that neither the contents nor the sterile package has been damaged in shipment. Do not use if damaged. Immediately return damaged product to Carbon Medical Technologies.

Do not re-sterilize. This may damage or distort contents. Unless the packaging is damaged, Durasphere will remain sterile until used.

Do not expose to organic solvents, ionizing radiation or ultraviolet light. This may damage or distort contents.

Rotate inventory so that product is used prior to the last day of the labeled month of the expiration date on package label.

After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state and federal requirements.

Potential Complications
Potential complications include acute retention, dysuria, urinary urgency, urinary tract infection, hematuria, non-acute retention, outlet obstruction (slow prolonged stream), excreted bulking material, GI (nausea, vomiting, diarrhea), genitourinary (infection, tenderness), urinary frequency, overbulking/abscess/cyst, infection, worsening of incontinence (onset of urge), neurological (headache), pelvic pain, allergic reaction to antibiotic, and fever.

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.

Minneapolis, MN
06/01/2018
PM-04817

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