AMS 700® with MS Pump®

Penile Prosthesis Product Line

Instructions for Use

AMS 700® with MS Pump® page 1

Penile Prosthesis Product Line
Instructions for Use

CAUTION: Federal law (U.S.) restricts this device

to sale by or on the order of a physician.
European Union (EU) Authorized Representative:
American Medical Systems
Europe B.V.
Straatweg 66H
3621 BR Breukelen
The Netherlands
Tel: +31 (0) 346 258 100
Fax: +31 (0) 346 258 130

Contact List:
American Medical Systems U.S.A.
10700 Bren Road West
Minnetonka, MN 55343
U.S.A.
Tel: +952 930 6000
Fax: +952 930 6157
American Medical Systems Australia Pty Ltd.
Unit 39, Building F
16 Mars Road
Lane Cove NSW 2066
Australia
Tel: +61 2 9425 6800
Fax: +61 2 9427 6296
American Medical Systems Canada Inc.
P.O. Box 461
Guelph, Ontario N1H 6K9
Canada
Tel: +519 826 5333
Fax: +519 821 1356

American Medical Systems Deutschland GmbH

Voßstr. 20
D-10117 Berlin
Germany
Tel: +49 (0) 30 20 64390
Fax: +49 (0) 30 20 643999
American Medical Systems France
19 avenue de Norvège
Les Fjords - Bâtiment Nobel
91953 Courtaboeuf Cedex
France
Tel: +33 (0) 1 69 59 97 00
Fax: +33 (0) 1 69 59 97 29
American Medical Systems Ibérica S.L.
c/Joaquin Turina, 2 Planta primera - Oficina 6
28224 Pozuelo de Alarcón (Madrid)
Spain
Tel: +34 (0) 91 799 49 70
Fax: +34 (0) 91 715 75 26
American Medical Systems U.K. Ltd.
Capital Court
Capital Interchange Way
Brentford
TW8 0EX
United Kingdom
Tel: +44 (0) 20 8996 3100
Fax: +44 (0) 20 8995 3720
 English

AMS 700® with MS Pump®

Penile Prosthesis Product Line
Instructions for Use
NOTE: Refer to the Operating Room Manual for further
information on the AMS 700® product line
and their implantation.

DEVICE DESCRIPTION
The AMS 700® Series Inflatable Penile Prosthesis product
line includes the AMS 700 LGX® Preconnect, AMS 700®
CX Preconnect, AMS 700 LGX®, AMS 700® CX, AMS
700® CXM, and the AMS 700® CXR Penile Prosthesis.
These configurations are also available with InhibiZone®,
an antibiotic impregnation of rifampin (rifampicin) and
minocycline.* These prostheses are closed fluid-filled
systems consisting of a pair of cylinders, optional rear tip
extenders, a pump, and a fluid reservoir. All components
are connected by kink-resistant tubing. The cylinders are
inflated as fluid is pumped from the reservoir, creating an
erection. They are deflated as fluid is transferred back to
the reservoir, making the penis flaccid once again. This
device contains solid silicone elastomer. These devices are
for men who, after appropriate patient history and
diagnostic evaluations as well as discussions with the
urologist about other alternative treatment methods, are
determined to be suitable candidates for implantation
surgery.

INDICATIONS FOR USE

The AMS 700 Series Inflatable Penile Prosthesis product
line is intended for use in the treatment of chronic,
organic, male erectile dysfunction (impotence).

CONTRAINDICATIONS
The implantation of this device is contraindicated in
patients who have active urogenital infections or active
skin infections in the region of surgery.
The implantation of the InhibiZone version of this device
is contraindicated in patients with known allergy or
sensitivity to rifampin (rifampicin), or to minocycline, or
other tetracyclines.
The implantation of products with InhibiZone is
contraindicated in patients with systemic lupus
erythematosus because minocycline has been reported to
aggravate this condition.

* not available in all markets.

1
WARNINGS
1. Implantation of the device will make latent natural or
spontaneous erections, as well as other interventional
treatment options, impossible.
2. Men with diabetes, spinal cord injuries, or open sores
may have an increased risk of infection associated
with a prosthesis.
3. Failure to evaluate and promptly treat erosion may
result in a substantial worsening of the condition
leading to infection and loss of tissue.
4. Implantation of a penile prosthesis may result in
penile shortening, curvature or scarring.
5. 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.
6. Pre-existing abdominal or penile scarring or
contracture may make surgical implantation more
complicated or impractical.
7. If a hypersensitivity reaction develops to a device
coated with InhibiZone, the penile prosthesis should
be removed and the patient treated appropriately.

PRECAUTIONS
Surgery Related
1. Improper reservoir placement or filling technique can
result in spontaneous unintended inflation or
deflation of the cylinders that may result in
unintended partial or full erections.
2. Migration of the device components can occur if the
cylinders are improperly sized, if the pump or the
reservoir is not positioned properly, or if the tubing
lengths are incorrect.
3. Removal of an implanted prosthesis without timely
reimplantation of a new prosthesis may complicate
subsequent reimplantation or may make it
impossible.
4. Improper measurement technique, positioning or
sizing may reduce cylinder life.
5. Unsuccessful outcomes have been reported due to
improper surgical technique, anatomical
misplacement of components, improper sizing and
filling of components, or tubing kinks.
6. Implantation of AMS 700 LGX Cylinders in patients
with Peyroine's disease may not provide a satisfactory
result.
Device Related
1. AMS Quick Connect Sutureless Window Connectors
should not be used in revision procedures involving
previously implanted component tubing. In this
situation the Quick Connect Sutureless Window
Connectors may be less effective.

2
2. 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.
3. Devices in the AMS 700 product line should be filled
with sterile, normal saline. Some patients
may have a hypersensitivity to contrast media.
4. Do not use product that has damaged or open
packaging, as sterility may be compromised.
5. Devices with InhibiZone should not come into
contact with ethyl alcohol, isopropyl alcohol or other
alcohols, acetone or other non-polar solvents. These
solvents may remove the antibiotics from the device.
6. 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 implant, if
desired.
7. CXR RTEs are not compatible with CX or LGX
cylinders.
8. Verify proper attachment of RTEs by spinning them
once seated. Properly attached RTEs should spin
freely without accidental disengagement or material
bulging.
9. Do not stack the CX, LGX or CXR Snapcone RTEs
with the exception of the 1.5cm. The locking ring
will not engage with the smooth outer surface of the
RTE, which may result in the RTE disconnecting.
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 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.
5. The contour, elasticity and dimension of the tunica
albuginea may limit the length and/or diameter
expansion of the AMS 700 cylinders.
6. The implantation of this device should only be
considered in patients whom the physician
determines are adequate surgical candidates.

3
 7. Use of injection therapy concurently with the penile
prosthesis can damage the prosthesis. Patients should
not use injection therapy after they receive their
implant.
InhibiZone Related
1. InhibiZone does not replace your normal antibiotic
protocols. Continue using any prophylactic protocols
normally used when implanting an inflatable penile
prosthesis.
2. Because the products with InhibiZone are
impregnated with a combination of rifampin
(rifampicin) (a derivative of rifamycin B) and
minocycline (a derivative of tetracycline), 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 and rifampin
(rifampicin) in patients receiving this device are
unlikely to be detected.
3. Use of products with InhibiZone should be carefully
considered in patients with hepatic or renal disease, as
use of rifampin (rifampicin) and minocycline can
cause additional stress on the hepatic and renal
systems.
4. Patients who receive a device with InhibiZone and are
also taking methoxyflourane should be carefully
monitored for signs of renal toxicity.
5. 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.
6. 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 (rifampicin).

ADVERSE EVENTS
A clinical trial was conducted to determine the safety and
effectiveness of the AMS 700 Series of inflatable penile
prostheses. This trial involved only devices without
InhibiZone. A total of 300 patients were enrolled with
follow-up out to 5 years for 126 patients. The Adverse
Device Effects, detailed in the table below, were noted
during the duration of this clinical trial for all enrolled
patients.

4
AMS CLINICAL TRIAL ADVERSE DEVICE EFFECTS
ADE # Patient (%**) Mean Onset Time
in Days (Range in Days)
Urogenital Pain
(Typically Associated
with Healing Process) 160 (53.3%) 21 (0 – 876)
Urogenital Edema 106 (35.3%) 8 (0 – 722)
Urogenital Ecchymosis 30 (10.0%) 4 (0 – 150)
Reservoir Encapsulation
(persistent in 11/19 cases) 19 (6.3%) 275 (38 – 1731)
Patient Dissatisfaction
(With Length, Ability to Use
and Nonspecific Reasons) 18 (6.0%) 384 (0 – 1830)
Auto-Inflation 17 (5.7%) 141 (0 – 608)
Mechanical Malfunction
(Leaks, Incomplete Inflation/
Deflation, Kinking) 13 (4.3%) 905 (0 – 1915)
Urination Impaired
(Slow Stream, Split Stream,
Voiding Difficulties or
Obstructive Symptoms) 11 (3.7%) 239 (0 – 930)
Urogenital Erythema 10 (3.3%) 36 (0 – 320)
Joint Pain, Swelling, or Stiffness 9 (3.0%) 609 (1 – 1592)
Decreased Penile Sensation 7 (2.3%) 124 (0 – 214)
Urogenital Hematoma 7 (2.3%) 4 (0 – 25)
Abnormal Ejaculation
(Delayed, Burning, or
General Nonspecific Problems) 6 (2.0%) 409 (40 – 1797)
Infection 6 (2.0%) 216 (9 – 716)
Dysuria 5 (1.7%) 231 (2 – 684)
Penile Curvature 5 (1.7%) 144 (0 – 257)
Application Site Reaction
(Wound Separation, Delay in
Cutaneous Closure) 4 (1.3%) 14 (0 – 30)
Erosion/Extrusion (Pump/Cylinder) 4 (1.3%) 425 (72 – 1066)
Paresthesia 4 (1.3%) 490 (0 – 1897)
Urogenital Inflammation 4 (1.3%) 12 (0 – 27)
Adhesion of the Pump/Scrotum 3 (1.0%) 13 (10 – 19)
Device Malposition 3 (1.0%) 278 (43 – 574)
Device Migration (Pump/Cylinder) 3 (1.0%) 210 (40 – 548)
Transient Urinary Retention 3 (1.0%) 85 (3 – 248)
Urinary Frequency 3 (1.0%) 277 (99 – 409)
Weakness 3 (1.0%) 1072 (519 – 1592)
Abnormal Sexual Function 2 (0.7%) 239 (128 – 349)
Device Cylinder Aneurysm/Bulge 2 (0.7%) 945 (110 – 1780)
Dizziness 2 (0.7%) 929 (7 – 1850)
Dry Mouth 2 (0.7%) 1721 (1592 – 1850)
Hematuria 2 (0.7%) 902 (13 – 1791)
Low Grade Fever 2 (0.7%) 13 (7 – 18)
Memory Difficulties 2 (0.7%) 1318 (1107 – 1592)
Pelvic Pain 2 (0.7%) 270 (42 – 498)
Rheumatoid Arthritis 2 (0.7%) 281 (189 – 372)
Other 22 (7.0%) N/A
** Percentages based on total number of patients implanted (300).

5
RESOLUTION OF ADVERSE DEVICE EFFECTS
Method of Resolution

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Pa

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ADE

Su

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O
#
Urogenital Pain 160 (53.3%) 1% 31% 0% 68% 11%
Urogenital Edema 106 (35.3%) 0% 3% 11% 86% 2%
Urogenital Ecchymosis 30 (10.0%) 0% 0% 0% 100% 0%
Reservoir Encapsulation 19 (6.3%) 5% 0% 0% 95% 58%
Patient Dissatisfaction 18 (6.0%) 0% 0% 0% 100% 56%
Auto-Inflation 17 (5.7%) 0% 0% 0% 100% 35%
Mechanical Malfunction 13 (4.3%) 46% 0% 8% 46% 62%
Urination Impaired 11 (3.7%) 0% 64% 9% 27% 0%
Urogenital Erythema 10 (3.3%) 10% 30% 0% 60% 0%
Joint Pain, Swelling,
or Stiffness 9 (3.0%) 0% 11% 11% 78% 67%
Decreased
Penile Sensation 7 (2.3%) 0% 0% 0% 100% 72%
Urogenital Hematoma 7 (2.3%) 0% 0% 0% 100% 0%
Abnormal Ejaculation 6 (2.0%) 0% 17% 0% 83% 17%
Infection 6 (2.0%) 67% 33% 0% 0% 17%
Dysuria 5 (1.7%) 0% 60% 0% 40% 0%
Penile Curvature 5 (1.7%) 0% 0% 0% 100% 60%
Application
Site Reaction 4 (1.3%) 0% 25% 0% 75% 25%
Erosion/Extrusion 4 (1.3%) 100% 0% 0% 0% 0%
Paresthesia 4 (1.3%) 0% 0% 0% 100% 50%
Urogenital
Inflammation 4 (1.3%) 0% 50% 0% 50% 0%
Adhesion of
Pump/Scrotum 3 (1.0%) 0% 0% 0% 100% 33%
Device Malposition 3 (1.0%) 67% 0% 0% 33% 0%
Device Migration 3 (1.0%) 100% 0% 0% 0% 0%
Transient
Urinary Retention 3 (1.0%) 0% 0% 100% 0% 0%
Urinary Frequency 3 (1.0%) 0% 33% 0% 67% 67%
Weakness 3 (1.0%) 0% 0% 67% 33% 67%
Abnormal
Sexual Function 2 (0.7%) 0% 0% 0% 100% 100%
Device Cylinder
Aneurysm/Bulge 2 (0.7%) 50% 0% 0% 50% 50%
Dizziness 2 (0.7%) 0% 0% 0% 100% 50%
Dry Mouth 2 (0.7%) 0% 0% 0% 100% 100%
Hematuria 2 (0.7%) 0% 50% 0% 50% 50%
Low Grade Fever 2 (0.7%) 50% 50% 0% 0% 0%
Memory Difficulties 2 (0.7%) 0% 0% 0% 100% 0%
Pelvic Pain 2 (0.7%) 0% 0% 0% 100% 50%
Rheumatoid Arthritis 2 (0.7%) 0% 0% 0% 100% 100%
Other 22 (7.0%) N/A N/A N/A N/A N/A
1
Other treatments included back brace, physical therapy, urine culture, ice packs,
elevation, hot soaks, hot sitz bath, manual manipulation, patient education,
filliforms and followers, foley catheter, ultrasound/CT scan, and cystoscopy.

6
The following “Other” adverse device effects (in
alphabetical order) each occurred in less than 0.5% of the
patients: Alopecia, Back Pain, Cellulitis, Depression,
Diabetes Mellitus, Epigastric Pain, Eye Disorder, Eye Pain,
Fecal Incontinence, Fibrosis, Glans Hypermobile Dorsally,
Kidney Calculus, Libido Decreased, Migraine, Necrosis,
Pump Fixation, Phimosis, Photosensitivity Reaction,
Thickening of the Skin, Urinary Tract Infection, Urinary
Urgency, and Vertigo.
The following risks of inflatable penile implants or their
materials have been reported in the medical literature but
did not occur during the prospective study: granuloma
formation, non-rheumatoid arthritis immune-related tissue
disorders, ischemia, seroma, ulceration, vascular
compromise, and ventral chordee.
There were eighteen patient deaths during the course of
the trial. No deaths that occurred during the duration of
the clinical study were attributed to the device
implantation or use.
A total of 22 patients underwent revision surgeries in the
five year study period. Information on device revisions is
described in the “Clinical Studies” section.

CLINICAL STUDIES
A clinical trial was undertaken to demonstrate that the
AMS 700 product line provides an erection that is suitable
for intercourse and has acceptable rates of surgical revision
and of significant clinical events associated with the
implantation and use of these devices. This trial included
only devices without InhibiZone This trial was also
designed to demonstrate the implantation of these devices
does not negatively impact the sexual satisfaction,
psychological well being, self-esteem or quality of life of
patients who receive these devices. It was a prospective,
multi-center cohort trial in which the patients served as
their own control. The choice of device model implanted
(i.e. 700 CX, 700 CX Preconnect, 700 CXM, 700 Ultrex,
700 Ultrex Plus) was at the discretion of the patient and
implanting physician.
NOTE: The AMS 700 MS Pump was not available at the
time the clinical study was conducted. However, based on the
similarities between the AMS 700 MS Pump and the AMS
700 Inflate/Deflate Pump, the clinical results also apply to this
new model.
NOTE: The AMS 700 LGX Preconnect was not available at
the time the clinical study was conducted. However, since
providing the AMS 700 LGX in preconnected form is not
expected to affect the safety and effectiveness of the prosthesis,
these clinical results also apply to the new model.
NOTE: The AMS 700 CXR was not available at the time the
clinical study was conducted. However, based on the
similarities between the AMS 700 CXR and the AMS 700
CXM models, the clinical results also apply to this new model.

7
NOTE: The Conceal ™ Low Profile Reservoir* was not
available at the time the clinical study was conducted.
However; based on similarities between the Conceal Low
Profile Reservoir and the spherical reservoir, the clinical results
also apply to this new model.
* not available in all markets

Three hundred male patients, over 21 years of age, were

enrolled in this study. All patients with diagnosed organic
erectile dysfunction were eligible for enrollment, if they
did not present with a history of allergy/sensitivity to
silicone, pre-existing autoimmune or connective tissue
diseases or active urogenital infection.
All safety-related data, diagnoses and health status
evaluations were captured on detailed case report forms.
The Investigators’ professional evaluation of the erections
provided by the IPPs after implantation and their
suitability for intercourse was the primary efficacy
endpoint. The number of surgical revisions performed and
reported by the Investigators was the primary safety
endpoint. Patient self-evaluations on four validated
outcome instruments were the secondary efficacy
endpoints (concerning quality of life, self-esteem, and
sexual satisfaction and functioning).
This clinical trial provided the following results through
the five-year evaluation for the first 126 patients to reach
this post-surgical follow-up.
Physician Assessment of Device Function
One hundred twenty-six devices were evaluated at the five-
year follow-up, of which 123 (97.6%) could be inflated.
Of these 123 devices, all (100%) were determined to
provide an erection suitable for intercourse. However,
it should be noted that this analysis does not include the
following information regarding device malfunctions:
(i) 3 of the 123 devices found to be functioning properly
at the five-year exam were surgically revised prior to
this exam to correct a mechanical malfunction, and
(ii) 3 additional devices not evaluated at the five-year
follow-up exam were also surgically revised due to
mechanical malfunction. These cases of device revision are
discussed further in the next section.
Surgical Revisions
The incidence of revisions was evaluated in the 126
patients with follow-up out to five years, as well as 16
additional patients who experienced one or more revision
surgery and did not reach the five-year follow-up exam. (A
revision is considered any urogenital surgical intervention
that is related to the function, placement or site reaction
to the implanted device.) Of these 142 patients, 22
(15.5%; 95% confidence interval = 21.5%) experienced a
total of 26 revision surgeries, and 120 (84.5%) were not
revised.
The average time to the first revision surgery was
15 months (Ranging from 0.9 months to 60.1 months).
Of the twenty-six revision surgeries, there were five
(5) revisions due to “Infection”; two (2) for “Infection/
Erosion”; two (2) for “Migration/Malposition”, two

8
(2) for “Erosion”, two (2) for “Malposition”; seven (7) for
“Mechanical Malfunction”, two (2) for “Fibrous Capsular
Complication”, two (2) for “Reimplantation Following
Previous Revision”, and two (2) due to reasons listed
as “Other”. The “Other” reasons included Cylinder
kink/auto-inflation (1), Corporal body aneurysm (1). In
five of these revision surgeries, no device components were
explanted or replaced. The components were
manipulated/repositioned but were not removed.
Patient Evaluation of Quality of Life, Self-esteem,
Psychological and Sexual Well-Being
In accordance with the study protocol, overall health-
related quality of life (using the Medical Outcomes Study
Health Survey, MOS-20), self-esteem (using the
Rosenberg Self-Esteem Scale), psychological well-being
(using the Brief Symptom Inventory), and sexual
functioning and satisfaction (using the Sexual History
Form) were evaluated in patients through two years post-
implantation. Throughout the two-year follow-up period,
patient quality of life, self-esteem, and psychological well
being were determined to be equivalent to the pre-implant
state. Sexual functioning and sexual satisfaction, on the
other hand, was significantly improved over the pre-
implant state.

SUPPLEMENTARY CLINICAL INFORMATION

Although it is not feasible to predict exactly how long an
implanted penile prosthesis will function in a particular
patient, American Medical Systems, Inc. has assembled a
set of data on device removals and revisions to help gain
insight into the product performance over time.
The following two tables provide an estimate of the long-
term rates of device removals and revisions for Ultrex and
CX models. The first data set comes from Patient
Information Forms (PIFs) submitted to AMS by
physicians for surgical procedures requiring parts
replacement under AMS warranty (Table 1). All forms
reporting devices implanted between January 1993 and
December 2000 were included in a life table analysis that
was used to calculate the revision rates for each category.
Revision surgeries may not be reported to AMS.
Therefore, the incidence of surgeries after original implant
would likely be underreported, if one were to rely solely
on the PIF data. AMS also assembled a second set of data
directly from a retrospective review of physicians’ medical
records (Table 2). These medical records capture each
surgery performed by that physician after original implant
for any reason.
NOTE: These analyses did not include the AMS 700 with MS
Pump, snapcone cylinders, or parylene coated components.
NOTE: These analyses did not include the AMS Conceal Low
Profile Reservoir.

9
PIF Study
Table 1: Revision rates based on PIF data:*

Reason for 700 CX Revision Rate 700 Ultrex Revision Rate

Removal or (5 YRS) (5 YRS)
Replacement Surgery n=12,080 n=20,438

Mechanical Revision 5.6% 4.8%

Removal for Infection 2.2% 2.0%

Removal for Erosion 1.4% 1.0%

Migration/Malposition 0.5% 0.5%
of Component

Cylinder Aneurysm 0.5% 0.5%

Other Reasons 3.6 % 2.9%

ALL REASONS** 11.6% 9.8%

* Interpretations of the PIF data may be limited by a number of factors:

• Statistics are based only on surgery data voluntarily reported to AMS by hospitals
and physicians in the U.S. as part of the AMS Product Replacement. Because
surgeries may not be reported to AMS, the number of patients implanted and
the incidence of removal/replacement surgery may actually be higher.
• These statistics pertain only to the incidence of removal/replacement surgery
and not to the current functioning of devices which have not been removed.
** The total may be less than the sum of the category percentages because more
than one reason can be reported for any revision.

Medical Records Study

Table 2: Revision rates based on medical records data**

Reason for 700 CX Revision Rate 700 Ultrex Revision Rate

Removal or (5 YRS) (3 YRS)
Replacement Surgery n=512 n=155

Mechanical Revision 9.4% 3.2%

Removal for Infection 2.9% 2.0%

Removal for Erosion 2.4% 1.6%

Migration/Malposition 2.8% 0.7%

of Component

Cylinder Aneurysm 0.6% 0.0%

Other Reasons 2.1% 4.0%

ALL REASONS 18.1% 10.4%

** Interpretations of the medical record data may be limited by several factors:

• These percentages reflect the known revisions performed by the original
implant physicians.
• These statistics pertain only to the incidence of removal/replacement surgery
and not to the current functioning of devices which have not been removed.

NOTE: The amount for “ALL REASONS” is lower than the

total of the individual percentages due to the incidence of
multiple reasons for removal/replacement surgery.

10
ANTIBIOTIC INFORMATION
The antibiotics present in InhibiZone, minocycline and
rifampin (rifampicin), are well characterized and have been
in use for years. The dosage present on the penile
prostheses is intended to act on organisms that attempt to
colonize the device. The AMS 700 components are treated
with very low levels of antibiotics. AMS provides numerous
completed configurations of the AMS 700 to individualize
treatment; however, a complete device (reservoir, pump and
two cylinders), regardless of configuration, represents less
than 2% of oral dose exposure for a complete course of
rifampin (rifampicin) or minocycline. Although the quantity
of antibiotics on individual AMS 700 componenets may
vary, average quantities on the most common device
configurations have approximately 27mg (SD plus or minus
6) rifampin (rifampicin) and 11mg of minocycline (SD plus
or minus 1). The following in vitro data are available, but
their clinical significance is unknown. No clinical studies
have been performed to evaluate the effect of the
antibiotic surface treatment on reducing the incidence of
penile implant infections, but early published data is
promising. (Ref. Carson, CC. Efficacy of antibiotic
impregnation of inflatable penile prostheses in decreasing
infection in original implants. J Urol. 2004; 171: 1611-
1614.) (Ref. Droggin, D, Shabsigh, R, Anastasiadis, AG,
Anitibiotic coating reduces penile prosthesis infection.
J Sex Med 2005; 2: 565-568.)
Table 3: In vitro Zones of Inhibition for Device Samples*
with InhibiZone Treatment
Mean S. D Number of
Organism (mm) (mm) Isolates

Staphylococcus epidermidis 22.6 2.9 21

Staphylococcus aureus 17.5 5.0 25

Escherichia coli** 6.5 2.6 24

Enterococcus faecalis** 4.8 6.7 21

Candida albicans** 0.1 0.4 21

Proteus mirabilis** 0.6 1.0 17

* obtained using standardized KRT test samples containing
12 µg minocycline and 26 µg rifampin (rifampicin)
** the isolates tested were not susceptible to
rifampin (rifampicin) and/or minocycline control disks

An animal infection study was conducted using 11 rabbits.

Five rabbits were implanted subcutaneously with 6 test
samples each and five rabbits were implanted
subcutaneously with 6 control samples each. One rabbit
received three test samples and three control samples. The
test samples were portions of an InhibiZone treated AMS
700 Pump and the control samples were portions of a
standard AMS 700 Pump without InhibiZone. All samples
were soaked in a 103-104 CFU solution of staphylococcus
aureus, Sheretz strain for 8 hours. Samples were then
allowed to dry for 30 minutes prior to surgical placement
in the rabbit. After 2 days, all samples were removed and
observed for growth on the samples. The number of
coated samples that were infected was statistically
significantly lower than the number of control samples
that were infected. 11
PATIENT COUNSELING INFORMATION
Patients should be counseled in order to have a realistic
expectation of the physical, 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.
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
shortening, 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 may result 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 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
biocompatability 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
casual relationship has been established between these
events and silicone elastomer or fluorosilicone lubricant.

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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 prostheses in the AMS 700. 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)

INFORMATION
Several studies regarding MRI and the AMS 700
product line (or similar AMS products) have concluded
that the presence of an AMS prosthesis will not produce
harmful effects during scanning. These studies were
conducted by Robert C. Lange, Ph.D., Yale University and
Frank G. Shellock, Ph.D., Cedars-Sinai Medical Center,
Los Angeles. Dr. Lange produced his study for American
Medical Systems and Dr. Shellock produced his studies
independently for publication in American Journal of
Roentgenology (AJR) and Radiology.1-3
In these studies, the metallic components in AMS implants
were subjected to magnetic field strengths up to 1.5 Tesla and
showed no unsafe magnetic interaction. The small stainless
steel components in AMS prostheses may distort the uniform
magnetic field in the vicinity of the implant; though it is
unlikely that these components will interfere with normal
MRI. However, the complete compatibility profile of these
products within a MRI field has not been established.
1
Shellock F, MR Imaging of Metallic Implants and Materials: A Compilation of
the Literature, AJR, October 1988.
2
Shellock F, MR Imaging and Biomedical Implants, Materials and Devices:
An Updated Review, Radiology, 1991, Vol 180, pp. 541-550.
3
Shellock F, MR Procedures and Biomedical Implants, Materials and Devices:
1993 Update, Radiology, 1993, Vol. 189, pp. 587-599.

INVENTORY RETURNS AND PRODUCT

REPLACEMENT INFORMATION
In the United States
Before returning any components, whether explanted
or unused (sterile or nonsterile), customers must fill out
the Return Goods Form located on the last page of the
Patient Information Form.
Follow all of the instructions on the form carefully, and be
sure that the components have been thoroughly cleaned
before returning them to AMS.

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In all cases, obtaining credit or percentage of credit for
a returned component is subject to approval under the
terms of the AMS Return Goods Policy and the AMS
Product Warranty Policy. For complete information
regarding these policies, contact the AMS Customer
Service Department.
Outside the United States
Customers outside of the United States should contact
their local AMS Representative prior to returning any
product.
This document is written for professional medical
audiences. Contact American Medical Systems for lay
publications.
American Medical Systems periodically updates product
literature. If you have questions about the currency of this
information, contact American Medical Systems.

HOW SUPPLIED AND STORAGE

WARNING: Contents supplied STERILE. Do not use if
sterile barrier is damaged. If damage is found, call your
AMS representative.
For single patient use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient
injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission
of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or
death of the patient. After use, dispose of product and
packaging in accordance with hospital, administrative
and/or local government policy.

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Manufactured by:
American Medical Systems, Inc.
10700 Bren Road West
Minnetonka, MN 55343
USA
U.S. Toll Free: 800-328-3881
Tel: + 952 930 6000
Fax: + 952 930 6157
www.AmericanMedicalSystems.com

EU Authorized Representative:
American Medical Systems
Europe B.V.
Straatweg 66H
3621 BR Breukelen
The Netherlands
Tel: +31 (0) 346 258 100
Fax: +31 (0) 346 258 130

©2010 American Medical Systems, Inc.

All rights reserved. Printed in USA.
230127-01 (06/10)