Xenform^® Soft Tissue Repair Matrix

Prescriptive Information

Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Contraindications

Xenform Soft Tissue Repair Matrix 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 Xenform Soft Tissue Repair Matrix is to be placed. Known history of hypersensitivity to collagen or bovine products. 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 Xenform Soft Tissue Repair Matrix.

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. Dispose of unused portions 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 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. Rinse surgical gloves, if necessary, to remove any glove powder prior to touching product. Inspect packaging and reject product if packaging is previously damaged or opened. Do not expose to any chemicals or substances other than room temperature sterile 0.9% saline. Do not bend product prior to hydration. Ensure that each Xenform Soft Tissue Repair Matrix is properly hydrated prior to suturing.

Federal (USA) law and governing law outside the USA restricts these devices to sales by or on the order of a physician. Do not use product if past the date of expiration indicated on the product label.

Trademark

Xenform is a Registered Trademark of Boston Scientific Corporation and its affiliates. Copyright © 2006 - All Rights Reserved

Xenform Soft Tissue Repair Matrix is manufactured by TEI Bioscience, Inc., and distributed by Boston Scientific.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.