The implantation of this device should only be considered for patients determined as suitable surgical candidates by the specialized physician.
Physicians implanting penile prostheses should be familiar with current practices in patient measuring techniques, implant size determination, and performing the surgery.
Removal of an implanted Inflatable Penile Prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or even may make it impossible.
• The physician should discuss with the patient all available ED treatment options and their risks and benefits and carry out an in-depth pre-operative consultation. Patients should be notified of probable future surgeries related with implanted Inflatable Penile Prosthesis (i.e. device revision).
• Proper device inflation and deflation requires dexterity and adequate strength from the patient.
• Mental or psychological conditions (e.g. dementia, Alzheimer’s disease) may hinder the patient’s ability to successfully manipulate the Inflatable Penile Prosthesis.
• The length and/or diameter expansion of the Infla10® cylinders may be limited by the contour, elasticity, and dimension of the patient’s tunica albuginea.
• Post-op trauma to the pelvic or abdominal areas can result in damage of the implanted device and/or surrounding tissues. This damage may result in the malfunction of the device and may necessitate surgical correction, including replacement of the device.
• Patients should not use injection therapy concurrently with the implanted Inflatable Penile Prosthesis. Injection therapy can damage the Inflatable Penile Prosthesis.
• Proper surgical technique, proper sizing, filling and anatomical placement of the device components are vital for successful outcomes.
• The device should be carefully examined prior to and during the surgical procedure to ensure the structural integrity of the device is not compromised. A damaged device or a device on which repairs have been attempted should not be implanted.
• Improper reservoir placement or filling technique can result in spontaneous unintended inflation or deflation of the cylinders that may result in unintended partial or full erections.
• Improperly sized cylinders, improper positioning of the pump or the reservoir, or incorrect tubing lengths can result in migration of the reservoir or the pump.
• Prostheses of incorrect length may result in voiding difficulties, inflammation, pressure necrosis and erosion into the urethra or through the tunica albuginea of the corpus cavernosum, SST deformity, buckling of the cylinders.
• Cylinder life may be reduced due to improper measurement technique, positioning or sizing.
• NarrowBody™ cylinders should only be used in patients with compromised corpora cavernosa and smaller anatomies. Do not use narrow cylinders in patients with normal anatomies.
• Extreme care should be taken when manipulating the device with blunt instruments and device components should not be handled with sharp-cornered instruments to avoid tearing, warping or nicking.
• Surface contaminants (e.g. talc, lint, fingerprints) can cause foreign body reactions. Contaminants should be avoided with utmost care. Any nick or split in the device creates a potential for mechanical failure and can serve as a collection point of debris which could cause foreign body reactions or be a locus for infection.
• Use sterile, isotonic or normal saline to fill the implant. Some patients may have a hypersensitivity to contrast media.
• The components of this device are manufactured and tested for assembly/use with their specified Rigicon® devices. The use of Rigicon® components with other manufacturers’ components has not been tested and is not recommended.
• Do not use product with damaged or open packaging, as sterility may be compromised.
• Due to the hydrophilic coating on all components of Infla10® (including connectors and Rear Tip Extenders) will be slippery when wet and care should be taken when handling them.