Polyform^® Synthetic Mesh

Prescriptive Information

Polyform^® Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient’s needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.

Polyform Synthetic 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 mechanical support or bridging material for the fascial defect.

Contraindications

Polyform Synthetic Mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated. These patients include those with:

• Pathology of the soft tissue into which the Polyform Synthetic Mesh is to be placed.
• Pregnant patients, patients with the potential of future growth or patients that are considering future pregnancies.
• Any pathology which would compromise implant placement.
• Any pathology that would limit blood supply and compromise healing.
• Patients diagnosed with autoimmune connective tissue disease.
• Pre-existing local or systemic infection. Treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before using Polyform Synthetic Mesh.

Warnings

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Effects

• Foreign body reaction.
• Allergic, hypersensitivity or other immune reaction.
• Infection.
• Erosion, rejection or extrusion.
• Acute or chronic inflammation.
• Dehiscence and/or necrosis.
• Vaginal and/or perineal bleeding.
• Dyspareunia.
• Fecal incontinence.
• Vaginal shortening or stenosis.
• Adhesion formation.
• Fistula formation.
• Granulation tissue formation.

Cautions

• Do not use this product without reading and understanding the complete instructions enclosed herein.
• Aseptic technique must be adhered to throughout procedure.
• Inspect packaging and reject product if packaging is previously damaged or opened.
• Do not use product if past the date of expiration indicated on the package label.

Trademark

Polyform is a trademark of Boston Scientific Corporation or its affiliates. Copyright ©2007 - All Rights Reserved

Polyform Synthetic Mesh is manufactured by Proxy Biomedical Limited and is distributed by Boston Scientific Corporation.