Pelvic Floor Reconstruction - Anterior Repair

Prescriptive Information

The Capio Suture Capturing Device is intended for use in general suturing applications during open and endoscopic surgery to assist in the placement of suture material in tissues at the operative site and is to be used under direct visualization only.

Contraindications

The use of the Capio Suture Capturing Device is contraindicated as follows: When, in the judgement of the physician, open or endoscopic procedures would be contrary to the best interests of the patient; and for placing sutures into or through bone.

Warnings

For single use only. Do not reuse, reprocess or resterilize. Use only needles and sutures specified for use with the Capio Suture Capturing Device.

Potential Adverse Effects

The potential adverse effects which may result from suture placement procedure include, but are not limited to: injury to internal vessels and nerves, bleeding, hematoma, inflammatory reaction to the suture material or to the trauma of being sutured.

Cautions

Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.

Prescriptive Information

The Repliform Tissue Regeneration Matrix is intended for the repair or replacement of damaged or inadequate integumental tissue such to repair enteroceles, rectoceles and/or cystoceles and for pelvic floor reinforcement.

Contraindications

The Repliform Tissue Regeneration Matrix is contraindicated for use in any patient in whom soft tissue implants are contraindicated. These patients include those with preexisting local or systemic infection, pathology of the soft tissue where the implant is to be placed, any pathology that would limit the blood supply and compromise healing, patients diagnosed with autoimmune connective tissue disease, and patients sensitive to specific antibiotics listed on the Repliform graft package.

Warnings

Processing of the tissue, laboratory testing and careful donor screening minimize the risks of the donor graft transmitting disease to the patient. As with any processed donor tissue, the graft cannot be guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential of reproductive impact of the clinical application of Repliform grafts.

Potential Adverse Effects

Potential adverse effects which may result from placement of an implant graft include, but are not limited to: dehiscence due to poor vascularization, loss of support, which may cause dehiscence at the implant wound site, hypersensitive, allergic, or other immune response to the Repliform graft, which is composed of proteins, proteglycans, and other components of human dermis.

Cautions

The Repliform Tissue Regeneration Matrix is packaged aseptically into a PEEL POUCH and sealed within a FOIL BAG. The FOIL BAG and PEEL POUCH are NOT STERILE, and therefore, should not be placed inside sterile field. If packaging is damaged, DO NOT USE. Immediately return the package and product to Boston Scientific.

Trademark

Repliform Tissue Regeneration Matrix is regulated by the FDA and complies with US regulations in 21 CFR part 1270 and 1271 - Human Tissue Intended for Transplantation.

Repliform is a trademark of LifeCell Corporation.

Repliform Matrix is exclusively distributed in the USA by Boston Scientific Corporation.

Prescriptive Information

Indicated for use in the retraction of soft tissue away from the operative suface allowing for enhanced access during urologic and gynecologic reconstructive procedures.

Contraindications

Contraindicated for procedures other than urologic and gynecologic reconstructive procedures.

Warnings

For single use only. Do not reuse, reprocess or resterilize.

Potential Adverse Effects

Potential adverse effects which may occur during urologic or gynecologic reconstructive procedures, include accidental perforations of the patient's anatomy.

Cautions

Federal (USA) law and governing law outside the USA restrict this device to sale by or on the order of a physician.

Trademark

TLC Retractor is manufactured by Applied Medical Technology, Inc. and exclusively distributed in the USA by Boston Scientific Corporation.

TLC is a trademark of Applied Medical Technology, Inc.

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.

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.