Restorelle® DirectFix

DirectFix is a pre-shaped ultra-lightweight polypropylene mesh, and is a synthetic mesh constructed of a medical grade knitted, non-absorbable, monofilament polypropylene.  DirectFix is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or a bridging material for the fascial defects.

For ordering information, please call 800.258.3476.

Indications:

Restorelle DirectFix transvaginal mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended, either as a mechanical support or a bridging material for the fascial defects.

Contraindications:

Restorelle DirectFix transvaginal mesh should not be used in pregnant women, or in women planning future pregnancies or any patient with potential for future growth. Restorelle transvaginal products should not be used in those who are taking anticoagulant therapy, have a sensitivity to polypropylene, have a pre-existing local or systemic infection, or women that have a known or suspected pathology which would compromise implant or implant placement.

Warnings/Precautions:

It is the responsibility of the surgeon to advise prospective patients or their representatives, prior to surgery, of the warnings and precautions associated with the use of this product and the associated surgical risks. Restorelle mesh should only be used by surgeons familiar with the surgical procedures and techniques involving non-absorbable meshes and who have adequate education and experience in the treatment of pelvic organ prolapse. Based on physician experience and education, a thorough assessment of each patient should be made to determine the suitability of a synthetic mesh procedure.

Patients should be counseled that there are alternative non-mesh prolapse surgeries, and the reason for choosing a mesh procedure should be explained. Physician should also obtain patient consent to surgery with an understanding of the post-operative risks and potential complications of mesh surgery.

Adverse Reactions:

Potential adverse events are those associated with surgery using implantable synthetic mesh materials. As with all foreign bodies, Restorelle DirectFix mesh is likely to exacerbate any existing infection. Local irritation at the wound site and/or a foreign body response may occur. There is also the risk of complete failure of the procedure resulting in recurrent prolapse.

The following complications are known to occur with synthetic mesh implantation: mesh erosion (e.g., vaginal, bladder), mesh extrusion, mesh exposure, infection, pain (acute or chronic), and bladder, bowel, urethra, vagina, vessel, and/or nerve perforation/injury.  Serious adverse tissue responses or infection may require removal of mesh.  See the device instructions for use for detailed information regarding the implant procedure, warnings /precautions, and 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.com.

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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