• Direct contact of surgical instruments to the malleable penile prosthesis may result in damage, rendering it unsuitable for implantation.
• During insertion, do not over bend cylinders beyond their natural U-shape as it may damage the malleable penile prosthesis and shorten its product life.
• Do not trim the distal or proximal ends of the cylinders, or the rear tip extenders. Trimming will damage the device.
• Careful intraoperative sizing is required to ensure proper device operation and to minimize the occurrence of sizing related complications such as migration and/or extrusion.
• Implantation of a malleable penile prosthesis that has been in previous contact with or contaminated by body tissue or fluid, regardless of intervening, cleaning, or sterilization, is prohibited.
• The device is presented in a double pouch package and inside a protective carton box. The package should be checked in terms of damaging, tearing and puncture. Do not use the damaged, teared and punctured packages.
• Before unpacking, the expiry date of the product should be checked. Do not use the products which have passed the expiration date. Sterilization of the products which have passed the expiration date is not being guaranteed.
• Products which are removed from patients should be disposed as medical waste within the framework of legal procedures.
• Before operation, the urologist should decide and evaluate whether the patient is available for treatment of erectile dysfunction or not.
• A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.
• Sufficient patient skill and strength are required for the appropriate device position.
• Uncircumcised patients may have an increased risk of postoperative complications with the sub-coronal approach. Surgeons may wish to discuss performing a circumcision to reduce the risks of post-operative complications associated with this approach.
• Some malleable penile prosthesis operations can be complex or unpractical for patients who have penile scarring or contractor.
• Some adverse events can be occurred like urethral bleeding, pain, phimosis not high several, hematoma after operation.
• If the patient had been done revision surgery, they can live differences such length, flaccidity, sensation and girth associated with using new malleable penile prosthesis.
• Physiology and psychology states can hinder the successful operation of the device.