Prefyx PPS™ System

Prescriptive Information

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.

• 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.

• 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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