Contraindications; Warnings; Precautions; Patient Counseling Information - Boston Scientific AMS Ambicor Mode D'emploi

CONTRAINDICATIONS

The implantation of this device is contraindicated in patients who have active urogenital
infections or active skin infections in the region of surgery.

WARNINGS

• The implantation of this device will make latent natural or spontaneous erections as
well as other interventional treatment options, impossible.
• Men with diabetes, spinal cord injuries, or open sores may have an increased risk
of infection associated with a prosthesis.
• Failure to evaluate and promptly treat erosion may result in a substantial worsening
of the condition leading to infection and loss of tissue.
• Implantation of a penile prosthesis may result in penile curvature or scarring.
• This device contains solid silicone elastomer. The risks and benefits of implanting
this device in patients with documented sensitivity to silicone should be carefully
considered.
• Pre-existing abdominal or penile scarring or contracture may make surgical
implantation more complicated or impractical.

PRECAUTIONS

Surgery-Related
• Spontaneous unintended inflation or deflation of the cylinders may occur and may
result in unintended partial or full erections.
• Migration of the device components can occur if the cylinders are improperly sized,
or if the pump is not positioned properly.
• Removal of an implanted prosthesis without timely reimplantation of a new
prosthesis may complicate subsequent reimplantation or may make it impossible.
• Improper measurement technique, positioning, or sizing may reduce cylinder life.
• Unsuccessful outcomes have been reported due to improper surgical technique,
anatomical misplacement of components, improper sizing of components, or
tubing kinks.
Device-Related
• 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.
• Do not use product that has damaged or open packaging, as sterility may be
compromised.
Patient-Related
• Adequate patient manual dexterity and strength are required for proper device
inflation and deflation.
• Mental or psychological conditions, such as senile dementia, may inhibit the
patient's successful operation of the prosthesis.
• 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.
• The implantation of this device should only be considered in patients whom the
physician determines are adequate surgical candidates.
• Use of injection therapy concurrently with the penile prosthesis can damage the
prosthesis. Patients should not use injection therapy after they receive their implant.

PATIENT COUNSELING INFORMATION

Patients should be counseled in order to have a realistic expectation of the physical
(e.g., length and girth), psychological, and functional outcome of the implantation. The
risks, benefits, and potential adverse events of all available treatment options should be
discussed with the patient and considered by the physician and patient when choosing
a treatment option. A discussion concerning the patient's pump placement preference
may be appropriate.
An appropriate patient history, including history of personality disorders, and diagnostic
work-up should be a part of the patient decision making process. Some patients may
become dissatisfied by the presence of the prosthetic device in their body. This issue
should be discussed with the patient prior to the surgery. Patient dissatisfaction may
lead to device removal.
Implantation of a penile prosthesis may result in penile curvature or scarring. The
prosthetic erection may differ from the patient's original, natural erection in that it
may be shorter, less firm, have less girth, and reduced sensations. Realistic cosmetic
expectations should be communicated to the patient and should include the potential for
skin scarring, scrotal deformity, pump bulge in the scrotum, lack of concealability, and
other possible adverse events. Patients should also be aware that penile prostheses are
not considered to be lifetime implants.
Black (K) ∆E ≤5.0
Improper implantation of a penile prosthesis may not provide rigidity to the glans, which
may result in a floppy glans and in a lack of rigidity of the corpus spongiosum. Penile
flaccidity may be less than it was before implantation.
Patients who undergo revision surgery may notice a change in the character of
their erection compared to their previous implant, which may include differences in
sensation, length, girth, rigidity, and/or flaccidity. It is also important that the physician
discusses with the patient the possibility of an allergic reaction to the materials in the
device (See Silicone Information).

SILICONE INFORMATION

This device is composed of a number of materials, including solid silicone elastomers.
Silicone gel is not a component in the materials of this device. Silicone elastomers
have been commonly used in a variety of biomedical devices for over 40 years and are
used as a biocompatibility reference against which new materials are tested.
Scientific literature has included reports of adverse events and other observations
in patients with implantable silicone devices. As reported, these events/observations
indicate "allergic-like" symptoms and in other cases a symptom complex associated
with immunological disorders. No causal relationship has been established between
these events and silicone elastomer.
There are reports of malignant tumor formation in laboratory animals only, not humans,
associated with implants of relatively large size. Many different materials are associated
with this effect in animals, silicone elastomers among them. No such effect has been
described in humans.
Extensive testing has been conducted on all materials that comprise the AMS
Ambicor
™ Device. This testing has indicated no toxicological response attributable to
the materials. However, some of the materials caused minor irritation when implanted
in animals.
Silicone elastomer particulate shedding and particulate migrations to regional lymph
nodes have been reported in the literature on penile implants. There are no known
clinical sequelae to this phenomenon.

MAGNETIC RESONANCE IMAGING (MRI)

Important Safety Information
Nonclinical testing demonstrated that the AMS Ambicor Penile Prosthesis is MR
Conditional. The device can be safely scanned under the conditions shown in Table 2.
Table 2. Scanning Conditions
Static Magnetic Field 1.5 Tesla
Spatial Gradient Field 450 Gauss/cm or less
Maximum whole body 1.5 W/kg for 15 minutes of
averaged Specific scanning as assessed by
Absorption Rate (SAR) calorimetry

MRI-Related Heating

Nonclinical testing demonstrated that the AMS Ambicor Penile Prosthesis produced
the temperature rises shown in Table 3 during MRI performed for 15 minutes of scanning
in the respective MR systems which would not pose a hazard to the patient.
Table 3. Temperature Rises
Static Magnetic Field 1.5 Tesla
Highest Temperature Change ≤ + 0.4° C
(a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milwaukee, WI)
(b) 3.0T MR Excite, General Electric Healthcare, software version 14X.M5

Artifact Information

Nonclinical testing demonstrated that the AMS Ambicor Penile Prosthesis may
compromise the MR image quality if the area of interest is relatively close to the
implant. The maximum image artifact produced by a MR gradient echo pulse sequence
was a "moderate" localized signal void in the size and shape of the implant (Table 4).
Optimization of MR imaging parameters to compensate for the presence of the device
may be necessary.
Table 4. Signal Voids
Pulse Sequence T1-SE
Signal Void Size 6,244 mm
2
Plane Orientation Parallel
4
3.0 Tesla
a b
720 Gauss/cm or less
2.9 W/kg for 15 minutes of
scanning as assessed by
calorimetry
3.0 Tesla
a b
≤ + 1.9° C
T1-SE GRE GRE
1,589 mm 10,295 mm 2,779 mm
2 2
Perpendicular Parallel Perpendicular
2