Gynecology

Prescriptive Information

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

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

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. 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.

WARNING
This product is intended for use only by clinicians with adequate training and experience in the surgical treatment of stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.

DEVICE DESCRIPTION
This Product Contains No Detectable Latex. The Advantage ™ System and the Advantage Fit™ System are sterile, single use systems, consisting of one delivery device and one mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly are two dilators designed to be placed over the shaft end of the delivery device. The disposable delivery device consists of a handle with a curved shaft, a sliding metal cannula with a blunt distal end and a pusher component. delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.

INDICATIONS FOR USE
The mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

CONTRAINDICATIONS
A mesh implant is contraindicated in the following patients:

• Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
• Any patients with soft tissue pathology into which the implant is to be placed.
• Patients with any pathology which would compromise implant placement.
• Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

GENERAL WARNING
The risks and benefits of performing a suburethral sling procedure in the following patients should be carefully considered:

• Women planning future pregnancies.
• Overweight women (weight parameters to be determined by the physician).
• Patients with blood coagulation disorder.
• Patients with a compromised immune system or any other condition that would compromise healing.
• Patients with renal insufficiency or upper urinary tract obstruction.
• Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling procedure.
• Vaginal and urinary tract infection should be treated prior to a suburethral sling implantation procedure.
• User should be familiar with surgical procedures and techniques involving nonabsorbable meshes.
• This product is intended for use only by clinicians with adequate training and experience in treatment of female stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.
• Good surgical practices should be followed for management of contamination or infected wounds.

PROCEDURAL WARNING

• User should note the importance of placing the mesh tension free under mid-urethra.

POST PROCEDURAL WARNING

• If subsequent infection occurs, follow appropriate medical intervention practices.
• The patient should be advised that future pregnancies may negate the effects of this procedure and the patient may again become incontinent.

PRECAUTIONS

• Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
• The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
• Retropubic bleeding can occur. Check carefully before releasing patient from the hospital.
• Cystoscopy must be performed to confirm bladder integrity.
• Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
• Ensure the mesh is placed tension free under the mid-urethra.
• Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
• Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
• Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
• Avoid excessive tension on the mesh during handling.

ADVERSE EVENTS
The following complications have been reported due to the suburethral sling placement, but are not limited to:

• As with all implants, local irritation at the wound site and/or foreign body response may occur.
• Tissue responses to the implant could include vaginal erosion/extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formulation and inflammation. The occurrence of these responses may require removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an existing infection.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement and may require surgical intervention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion of the vaginal or urethral mucosa or bladder wall, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
• In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dyspareunia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, bruising/hematoma, edema and erythema at the wound site, have been reported due to suburethral sling procedures.

Prescriptive Information

Indications

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Contraindications

A mesh implant is contraindicated in the following patients:

• Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
• Any patients with soft tissue pathology into which the implant is to be placed.
• Patients with any pathology which would compromise implant placement.
• Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

Warnings

GENERAL WARNING:

• The risks and benefits of performing a suburethral sling procedure in the following patients should be carefully considered:
• Women planning future pregnancies.
• Overweight women (weight parameters to be determined by the physician).
• Patients with blood coagulation disorder.
• Patients with a compromised immune system or any other condition that would compromise healing.
• Patients with renal insufficiency or upper urinary tract obstruction.
• Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a cystocele repair, it should be done prior to the suburethral sling procedure.
• Vaginal and urinary tract infection should be treated prior to a suburethral sling implantation procedure.
• User should be familiar with surgical procedures and techniques involving nonabsorbable meshes.
• This product is intended for use only by clinicians with adequate training and experience in treatment of female stress urinary incontinence (SUI). The physician is advised to consult the medical literature regarding techniques, complications and hazards associated with the intended procedures.
• Good surgical practices should be followed for management of contamination or infected wounds.

PROCEDURAL WARNING:

• Cystoscopy is not required, but can be done at the surgeon’s discretion.
• User should note the importance of placing the mesh without tension under mid-urethra.

POST PROCEDURAL WARNING:

• If subsequent infection occurs, follow appropriate medical intervention practices.
• The patient should be advised that future pregnancies may negate the effects of this procedure and the patient may again become incontinent.

Potential Adverse Effects

The following complications have been reported due to suburethral sling placement, but are not limited to:

• As with all implants, local irritation at the wound site and/or a foreign body response may occur.
• Tissue responses to the implant could include vaginal erosion/extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an existing infection. Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.
• In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dyspareunia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema, and erythema at the wound site, have been reported due to suburethral sling procedures.
• Sexual dysfunction is a potential risk with this procedure.

Cautions

• Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.
• The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.
• Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.
• Ensure the mesh is placed with minimum tension under the mid-urethra.
• Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.
• Patients should be counseled to refrain from heavy lifting, exercise, and intercourse for a minimum of four weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
• Do not use any mechanical means of contact with the mesh (such as clips, staples, etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.
• Avoid excessive tension on the mesh during handling.

CAUTION: Federal law (USA) restricts the device to sale, distribution and use by or on the order of a physician. Refer to the Directions for Use provided with this product for complete instructions, warnings and precautions prior to using this product.

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