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Device Related
1.
Some of the materials used in the
construction of this device have been
shown to cause minor irritation when
implanted in animals. Therefore,
implantation of this device may cause
minor irritation or discomfort in some
patients.
2.
Do not use product that has damaged
or open packaging, as sterility may be
compromised.
Patient Related
1.
A thorough preoperative consultation
should include a discussion between
patient and physician of all available
treatment options and their risks and
benefits.
2.
Adequate patient manual dexterity
and strength are required for proper
device inflation and deflation.
3.
Mental or psychological conditions,
such as senile dementia, may inhibit
the patient's successful operation of
the prosthesis.
4.
Trauma to the pelvic area, such as
impact injuries associated with sports
(e.g. bicycle riding), 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.
5.
The implantation of this device
should only be considered in patients
whom the physician determines are
adequate surgical candidates.
Adverse Events
A clinical trial was conducted to determine
the safety and effectiveness of the AMS
Ambicor inflatable penile prostheses. A
total of 179 patients were implanted with
follow-up out to 18 months or longer for
141 patients. The Adverse Device Effects,
detailed in the table below, were noted
during the duration of this clinical trial for
all enrolled patients.
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