Patient Counseling Information; Silicone Information; Magnetic Resonance Imaging (Mri); Mri-Related Heating - Boston Scientific AMS 700 Mode D'emploi

• 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.
• The stainless steel tubing plug(s) in the AMS 700™ Accessory Kit and Deactivation
Package contains nickel, which may cause an allergic reaction in individuals with
nickel sensitivity.
• Devices in the AMS 700 Penile Prothesis product line should be filled with sterile
normal saline. Some patients may have a hypersensitivity to contrast media.
• Do not use product that has damaged or open packaging, as sterility may be
compromised.
• CXR RTEs are not compatible with CX or LGX cylinders. CX/LGX RTEs are not
compatible with CXR cylinders.
• Verify proper attachment of RTEs by spinning them once seated. Properly attached
RTEs should spin freely without accidental disengagement or material bulging.
• Do not stack the CX, LGX, or CXR RTEs with the exception of the 1.5 cm RTE. The
locking ring will not engage with the smooth outer surface of the RTE, which may
result in the RTE disconnecting.
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 or abdominal areas, 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 contour, elasticity, and dimension of the tunica albuginea may limit the length
and/or diameter expansion of the AMS 700 Penile Prosthesis cylinders.
• 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.
InhibiZone™-Related
• InhibiZone does not replace normal antibiotic protocols. Continue using any
prophylactic protocols used when implanting an inflatable penile prosthesis.
• Because the products with InhibiZone are impregnated with a combination of
rifampin and minocycline HCl, the contraindications, warnings, and precautions
regarding the use of these antimicrobial agents apply and should be adhered to for
the use of this device, although systemic levels of minocycline HCl and rifampin in
patients receiving this device are unlikely to be detected.
• Use of products with InhibiZone should be carefully considered in patients with
hepatic or renal disease, as use of rifampin and minocycline HCl can cause
additional stress on the hepatic and renal systems.
• Patients who receive a device with InhibiZone and are also taking methoxyflourane
should be carefully monitored for signs of renal toxicity.
• Patients who receive a device with InhibiZone and are also taking warfarin should
have their prothrombin time monitored, because tetracyclines have been reported
to slow coagulation.
• Use of products with InhibiZone should be carefully considered in patients using
thionamides, isoniazid, and halothane, due to potential hepatic side effects that
have been reported in patients using these drugs and higher doses of rifampin.
• Devices with InhibiZone should not come into contact with ethyl alcohol, isopropyl
alcohol or other alcohols, acetone or other nonpolar solvents. These solvents may
remove the antibiotics from the device.
• InhibiZone components should not be soaked in saline or other solutions prior to
implantation. The components may be briefly rinsed or dipped in a sterile solution
immediately prior to implantation, if desired.

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 a 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.
Black (K) ∆E ≤5.0
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.
Improper implantation of a penile prosthesis may not provide rigidity to the glans, which
may result in a floppy glans and 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 and
a fluorosilicone lubricant. 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. Silicone fluids have an extensive history of use in medical devices.
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 or fluorosilicone lubricant.
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 was conducted on all materials that comprise the AMS 700 Penile
Prosthesis. This testing 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 700 Penile Prosthesis is MR Conditional.
A patient with this device can be safely scanned immediately after placement under the
following conditions:
Static Magnetic Field
-Static magnetic field of 3 Tesla (T) or less
-Maximum spatial gradient magnetic field of 720 Gauss/cm or less

MRI-Related Heating

In nonclinical testing, the AMS 700 Penile Prosthesis produced the following temperature
rise during MRI performed for 15 minutes of scanning (i.e., per pulse sequence) in the 3T
magnetic resonance (MR) system (3T/128 MHz, Excite, HDx, Software 14X.M5, General
Electric Healthcare, Milwaukee, WI):
Highest temperature change +1.9°C
Therefore, the MRI-related heating experiments for the AMS 700 Penile Prosthesis at 3T
using a transmit/receive radio frequency (RF) body coil reported a whole body averaged
specific absorption rate (SAR) of 2.9 W/kg (i.e., associated with a calorimetry measured
whole body averaged value of 2.7 W/kg) indicated that the greatest amount of heating that
occurred in association with these specific conditions was equal to or less than +1.9°C.

Artifact Information

MR image quality may be compromised if the area of interest is in the same area or
relatively close to the position of the AMS 700 Penile Prosthesis (Table 2). Therefore,
optimization of MR imaging parameters to compensate for the presence of this device
may be necessary.
Table 2. Signal Voids
Pulse Sequence T1-SE
Signal Void Size 6,244 mm
2
Plane Orientation Parallel
6
T1-SE GRE GRE
1,589 mm 10,295 mm 2,779 mm
2 2
Perpendicular Parallel Perpendicular
2