Migration of the prosthesis may occur if the prosthesis is not sutured in place.
Use of an oversized prosthesis for the existing scrotal pocket may result in necrosis and subsequent extrusion.
The implantation of this prosthesis should only be considered in patients whom the physician determines are adequate surgical candidates.
A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.
Careful patient selection is essential, as well as a thorough diagnostic study before the surgery.
The prosthesis must be checked prior to and during the surgery, so as to monitor the structural integrity of the implant.
The prosthesis should be handled carefully, avoiding pointed, toothed, or sharp instruments, as any nick or damage may be the cause of subsequent complications of the implant.
Dirt, fingerprints, talc or any other substances that can contaminate the surface of the prosthesis may be the cause of reactions to foreign objects.
Extreme preventive measures must be taken to avoid contamination.
Any hole or mark in the prosthesis is a possible cause of failure, since it may serve as a surface to keep materials that may cause reactions to foreign objects or infections in the patient.
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 in accordance with hospital, administrative and/or local government policy.