Pelvic Floor Reconstruction - Posterior Repair

Prescriptive Information

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

Please refer to the package insert provided with the products for complete indications for use, contraindications, warnings, precautions, adverse events, and instructions prior to using these products. Training on the use of the Pinnacle PFR kits is recommended and available. Contact your company sales representative to arrange for this training. Physicians should have experience in the management of complications resulting from procedures using surgical mesh.

WARNING
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.

DEVICE DESCRIPTION
The Pinnacle Pelvic Floor Repair Kits are sterile, single use devices for transvaginal placement, consisting of (1) one Pinnacle Synthetic Mesh Assembly and (1) one Capio^® Suture Capturing Device. The mesh assembly is available in two configurations: Anterior/Apical and Posterior. The mesh assembly is a polypropylene knitted mesh with 2 or 4 integrated leg assemblies. The leg assemblies include a needle, lead, dilator and protective sleeve. The needle at the distal end of the leg assembly was designed to be placed into the needle carrier at the distal end of the Capio Suture Capturing Device. The leg assembly was designed to facilitate the passage of the Pinnacle Synthetic Mesh Assembly through bodily tissues for placement through the sacrospinous ligament and arcus tendineous fascia pelvis. For orientation purposes, the dilators are uniquely color coded. The white dilators identify the leg assemblies to be placed into the arcus tendinous and the blue dilators identify the leg assemblies to be placed into the sacrospinous ligament. Stripes are also present on the dilators on one side of the mesh assembly to differentiate each side (Left/Right). This Product Contains No Detectable Latex.

INDICATIONS FOR USE
The Pinnacle Pelvic Floor Repair Kits are 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
The Pinnacle Synthetic Mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated. In addition patients with:

• Pathology of the soft tissue into which the Pinnacle Synthetic Mesh is to be placed.
• Pregnant patients, or patients that are considering future pregnancies.
• The potential of future growth (e.g. infants, children).
• Any pathology, including known or suspected uterine pathology, which would compromise implant placement.
• Any pathology that would limit blood supply and compromise healing.
• Blood coagulation disorder.
• Autoimmune connective tissue disease.
• Renal insufficiency and upper urinary tract obstruction.
• Pre-existing local or systemic infection. Treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the Pinnacle Synthetic Mesh.

WARNINGS/POTENTIAL COMPLICATIONS

• Hysterectomy may be needed in the future; Use of mesh may make future hysterectomies more difficult due to tissue in-growth and scarring.
• Cervical length must be evaluated during the preoperative workup; Patients with cervical elongation may not be appropriate candidates for apical repair procedures; Cervical amputation may be considered for patients with cervical elongation who choose to undergo the procedure.
• Continued screening and surveillance for cervical and uterine disease may be required; Regular pelvic exam, Pap test and endometrial biopsies should be continued as medically indicated.
• Performing an apical repair for cases involving uterine enlargement, in the presence of benign disease, should be at the physician’s discretion; An enlarged uterus may compromise the effectiveness of the procedure in some cases.
• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
• Patients should be counseled to refrain from heavy lifting, exercise and intercourse for a minimum of six (6) weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
• In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
• Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
• Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure though the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal or revision of the mesh.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Mild to moderate incontinence may occur due to incomplete support.
• Known risks of surgical procedures for the treatment of prolapse include pain, infection, erosion/exposure, device migration, complete failure of the procedure resulting in recurrent or de Novo prolapse and/or incontinence.
• Punctures or lacerations of vessels, nerves, bladder, urethra, or bowel may occur during placement and may require surgical repair.
• A digital rectal exam should be performed to detect possible rectal perforation.
• Cystoscopy is recommended to confirm bladder integrity or detect possible bladder or ureteral perforation.
• Overweight women may be prone to intraoperative and postoperative complications (weight parameters to be determined by the physician).

PRECAUTIONS

• Surgical treatment of female pelvic organ prolapse should be performed by clinicians with adequate training and experience.
• Training on the use of the Pinnacle^® Pelvic Floor Repair Kit is recommended and available. Contact your company sales representative to arrange for this training.
• The physician is advised to consult the DFU and the medical literature regarding techniques, complications and hazards associated with the intended procedures.
• Individual patient’s anatomy may vary greatly. For each procedure it is important that the intended planes for mesh placement and the intended location for mesh leg placement are planned and known for each individual patient. Employment of imaging methods before and after mesh placement may aid in proper mesh placement and confirm absence of injury to non-target anatomical structures.
• Standard surgical practices should be followed for pelvic floor procedures as well as for the management of contaminated or infected wounds.
• The procedure should be performed with care, using the Capio^® Suture Capturing Device provided with the kit, to avoid puncture or laceration of any vessels, nerves, bladder, urethra and bowel.
• Avoid excessive tension on the mesh during handling and positioning to prevent damage to the device.
• Do not remove the protective plastic sleeve covering mesh legs until proper position has been confirmed.
• Avoid excess tensioning of the mesh when positioning to avoid over correction of the defect.
• Take special care in cases of bladder prolapse because of anatomical distortion.
• Use only size 0 Capio Sutures with the Capio Suture Capturing Device.
• Do not affix mesh with any staples, clips, or clamps as mechanical damage to the mesh may occur.

ADVERSE EVENTS
Potential adverse reactions that may be associated with surgically implanted materials include:

• Abscess formation/Foreign body reaction;
• Adhesion formation;
• Allergic, hypersensitivity or other immune reaction;
• Bruising, hematoma, hemorrhage;
• Constipation;
• Dehiscence and/or necrosis;
• Dyspareunia;
• Erosion/extrusion;
• Fistula formation;
• Granulation tissue formation;
• Infection/Sepsis potentiation;
• Inflammation (acute or chronic);
• Mesh and/or tissue contracture;
• Organ perforation;
• Pain, discomfort, irritation;
• Post-operative bleeding;
• Recurrent prolapse;
• Surgical site wound irritation, erythema, edema;
• Ureteric injury;
• Ureter Obstruction;
• Urinary Incontinence;
• Urinary retention;
• Vaginal discharge;
• Vaginal shortening or stenosis;
• Vessel/Nerve injury/perforation;
• Wound dehiscence.

Prescriptive Information

Please refer to the Directions for Use provided with the product for complete instructions for use, contraindications, warnings and precautions.

Indications

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

Indications

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

Indications

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

Indications

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

Indications

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.

Caution:
Federal (USA) law and governing law outside the USA restricts these devices to sales by or on the order of a physician.

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.