Solyx™ SIS System

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. 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 Solyx SIS (Single Incision Sling) System is a sterile single use system consisting of one (1) delivery device and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with polypropylene carriers at each end of the distal mesh. The carrier is designed to be placed on the tip of the delivery device. The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle. This Product Contains No Detectable Latex.

INDICATIONS FOR USE
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 who 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 that would limit blood supply 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 physicians 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.

PROCEDURAL WARNING

• Cystoscopy can be done at the physician’s discretion.
• User should note the importance of placing the mesh tension free under the 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.

ADVERSE EFFECTS
The following adverse events have been reported due to suburethral sling placement, but are not limited to:

• Abscess
• Allergic reaction
• Bleeding
• Bruising/Hematoma
• Dehiscence of vaginal incision
• Detrusor Instability
• Dyspareunia
• Edema/Erythema
• Erosion/Exposure
• Extrusion
• Fistula
• Hemorrhage
• Incontinence
• Infection
• Inflammation
• Irritation
• Migration of device from desired location
• Organ perforation
• Overactive bladder
• Pain

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.
• 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.
• Physician should determine when it is suitable for each patient to return to normal activities. Patients should be counseled to refrain from heavy lifting, exercise, and intercourse after the procedure.
• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact their 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.
• Urinary Retention
• Urinary Tract Obstruction
• Vessel/Nerve Injury
• Vaginal Discharge
• Sexual Dysfunction