Patient Counseling Information; Magnetic Resonance Imaging (Mri); Adverse Events - Boston Scientific AMS 800 Mode D'emploi

Patient-Related
• The implantation of this device should only be considered in patients whom the
physician determines are adequate surgical candidates.
• Tissue fibrosis, previous surgery, or previous radiation therapy in the area of the
implant may preclude implantation of a cuff.
• Trauma or injury to the pelvic, perineal, or abdominal areas, such as impact injuries
associated with sports, can result in damage to 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.
• Female patients of child-bearing age must be forewarned that pregnancy is
acceptable, but caesarean section may be indicated to minimize the risk of damage
to the bladder neck and its surrounding cuff. For those patients who become
pregnant, deactivation of the device during the third trimester is recommended
to reduce the risk of erosion. Patients contemplating pregnancy should consider
delaying implantation.
• Consideration should be given to the diameter of the implanted occlusive cuff
relative to catheters or other trans-urethral devices. When fully deflated, the inside
diameter of the smallest occlusive cuff (3.5 cm) generally exceeds 28F. Additional
clearance is required to accommodate the patient's urethral tissue between the
trans-urethral device and the occlusive cuff. Urethral tissue thickness is patient
specific and requires a physician's assessment to determine its impact on sizing.
InhibiZone -Related
™
• InhibiZone does not replace normal antibiotic protocols. Continue using any
prophylactic protocols normally used for urological surgical procedures.
• Components with InhibiZone are treated with a combination of rifampin and
minocycline HCl. The contraindications, warnings, and precautions regarding
these antimicrobial agents apply, and should be followed 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 methoxyflurane
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, or acetone, or other non-polar 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 into a sterile solution,
immediately prior to implant, if desired.

PATIENT COUNSELING INFORMATION

Although the prosthesis is designed to close the urethra, some patients continue to
have a degree of incontinence after this procedure.
Patients should be counseled in order to have a realistic expectation of the physical,
psychological, and functional outcomes 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.
An appropriate patient history, including history of personality disorders, and diagnostic
work-up should be a part of the patient decision making process. A discussion
concerning the patient's preference for which side of their body the pump should be
placed on may be appropriate.
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. Patients should also be aware that the
AMS 800 is not considered to be a lifetime implant.
™
It is also important that the physician discusses with the patient the possibility of an
allergic reaction to the materials in the device.
Patients should be counseled on expected postoperative pain including severity
and duration. Patients may experience pain when the device is activated in the
postoperative period and during periods of initial use. Cases of chronic pain associated
with the presence of the AMS 800 AUS device have been reported. Pain with a severity
or duration beyond what is expected may require medical or surgical intervention.
Black (K) ∆E ≤5.0
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.
Solid 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 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 800
AUS. 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
Non-clinical testing has demonstrated that the AMS 800 AUS is MR Conditional. The
device can be scanned safely 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 non-clinical testing, the AMS 800 AUS 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 +2.0°C.
Therefore, the MRI-related heating experiments for the AMS 800 AUS 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 +2.0°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 800 AUS. Therefore, optimization of MR
imaging parameters to compensate for the presence of this device may be necessary.
Table 2. Artifact Information
Pulse Sequence T1-SE
Signal Void Size 5,800 mm 2
Plane Orientation Parallel

ADVERSE EVENTS

Adverse Events – Males
A prospective clinical study was conducted to demonstrate the safety and efficacy of
the AMS 800 AUS. A total of 87 patients were enrolled in the study and 85 patients were
implanted with the device. The total device exposure was 143.1 patient years with a
mean of 1.7 patient years and a range of 0.03 to 3.4 patient years.
During the study, 26 patients experienced 43 device related adverse events. There were
3 patient deaths during the trial. No deaths that occurred during the duration of the
clinical study were attributed to the device implantation or use.
6
T1-SE GRE GRE
1,956 mm 2 6,096 mm 2 2,650 mm
Perpendicular Parallel Perpendicular
2