Patient Information - Promedon TUBE Serie Instruccion De Uso

Removal of the prosthesis is advisable in the case of surgical, physical,
psychological or mechanical failure.
The implant can damage or destroy the natural or spontaneous erectile
capacity, latent or in existence.
This product has been designed for single use. Therefore, DO NOT REUSE
or RESTERILIZE them, as this can potentially result in compromised device
performance and increased risk of inappropriate resterilization and cross
contamination.

PATIENT INFORmATION

The patient must know that erections produced with the penis implant will not
be like the previous experiences with normal erections.
It is the surgeon's responsibility to inform the patient and/or his
representatives, before surgery, about all possible complications related to
prosthesis implantation.
Promedon and its distributors delegate to the surgeon the responsibility
of informing the patient about all possible risks and advantages related to
prosthesis implantation and usage.
PRECAUTIONS
Careful patient selection is essential. Thorough diagnostic study should
precede this operation.
The prosthesis is supplied sterile and pyrogen free in a double-wrap packaging
system. This packaging is contained into a cardboard box wrapped with a
thermocontrible foil which must be undamaged. IF IT WAS DAMAGED WHEN
HANDLING, THE PROSTHESIS SHOULD NOT BE IMPLANTED.
It is difficult to determine penile size preoperatively; therefore, all diameter
prosthesis should be available for each case.
Operating Room Conditions: In general, operating rooms meet the
requirements for penile or testicular implant surgery. Nevertheless, we strongly
recommend checking the following parameters:
• Operating room asepsis.
• Adequate training for the surgical support personnel.
mAGNETIC RESONANCE (mR) ENVIORmENT
Non-clinical testing performed in the worst-case product has demonstrated
that Tube Malleable Penile prosthesis implants are MR conditional. A patient
with these devices can be safely scanned in an MR system meeting the
following conditions:
• Static magnetic field of 1.5 Tesla and 3 Tesla, with
• Maximum spatial field gradient of 12,800 G/cm (128 T/m)
• maximum force product of 231 T /m
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• Theoretically estimated maximum whole body averaged (WBA) specific
absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the Tube Malleable Penile prosthesis
implants are expected to produce a maximum temperature rise of less than
1.5°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a
background temperature increase of ≈ 1.3°C (2 W/kg, 1.5 Tesla) 0.6°C
(2 W/kg, 3 Tesla) RF-related temperature increase with a background
temperature increase of ≈ 0.6°C (2 W/kg, 3 Tesla) after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the device extends
approximately 3.74 mm from the Tube Malleable Penile prosthesis implants
when imaged with a spin echo pulse sequence and a 3 Tesla MR system.
COmPLICATIONS
Possible complications associated with the use of this prosthesis must be
discussed with the patient prior to surgery.
Complications which may result from the use of this prosthesis include the
risks associated with the medication and methods utilized in the surgical
procedure, as well as the patient's degree of intolerance to any foreign object
implanted in the body. Some complications may demand prosthesis removal.
Infections that do not respond to therapy with antibiotics demand prosthesis
removal.
Some patients may feel pain in the gland or the scrotum immediately after
surgery.
Reported complications of penile prostheses include:
• Erosion, perforation or extrusion of the implant through the corona glandis,
corpus cavernosum and urethra.
• Wound infection, including secondary necrosis and extrusion of the implant.
Serious infection cannot be resolved in the presence of the prosthesis.
•Mild to severe interference with blood flow to the corpora cavernosa.
• Superficial to severe lymphedema of the penis.
• Penile or perineal hematoma.
• Malposition of the prosthesis.
• Paraphimosis.
• Mechanical failure of the implant due to fracture or separation of the
component parts.
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