2
5. The implantation of products with InhibiZone is
contraindicated in patients with systemic lupus
erythematosus because minocycline has been reported to
aggravate this condition.
Warnings
1. Patients with urinary tract infections, diabetes, spinal cord
injuries, open sores, or skin infections in the region of the
surgery have an increased risk of infection associated with a
prosthesis. Appropriate measures should be taken to reduce
the likelihood of infection.
Infection that fails to respond to antibiotic therapy may
result in removal of the prosthesis. Infection followed by
explantation of the device may result in scarring which may
make subsequent reimplantation more difficult.
2. Erosion may be caused by infection, pressure on the tissue,
improper cuff sizing, improper balloon selec tion, tissue
damage, and component mis place ment. The cuff may erode
around the urethra or bladder neck. The control pump may
erode through the scrotum. The pressure-regulating balloon
may erode into the bladder. Acute urinary tract infection
can interfere with proper functioning of the device and
may lead to erosion of the urethra in the cuff area. Failure
to evaluate and promptly treat the erosion may result in a
substantial worsening of the condition leading to infection
and/or loss of tissue.
3. Poor bladder compliance or a small fibrotic bladder may
require some measure of intervention including, in some
cases, augmentation cystoplasty before implanting the
prosthesis.
4. Patients with urge incontinence, overflow incontinence,
detrusor hyperreflexia or bladder instability should have
these conditions treated and controlled (or resolved) prior
to implantation of the device.
5. Do not pass a catheter or any other instrument through the
urethra without first deflating the cuff and deactivating the
device to prevent potential damage to the urethra or the
AMS 800.
6. This device contains solid silicone elastomers. This device
does not contain silicone gel. The risks and benefits of
implanting this device in patients with documented
sensitivity to silicone should be carefully considered.
7. Surgical, physical, psychological, or mechanical
complications, if they occur, may necessitate revision or
removal of the prosthesis. Removal of the device without
timely reimplantation of a new device may complicate
subsequent reimplantation. The timing of reimplantation
should be determined by the treating physician based on
the patient’s medical condition and history.
8. Product wear, component disconnection or other
mechanical problems may lead to surgical interven tion.
Mechanical complications may include mal func tioning
of the components and leakage of fluid. Any mechani cal
malfunction that does not permit the transfer of fluid from
the cuff to the balloon may result in overflow obstruction.
Mechanical events should be evaluated carefully by the
treating physi cian and the patient should consider risks and
bene fits of treatment options, including revision surgery.
9. Previous patient history of adverse reaction(s) to radiopaque
solution precludes its use as a filling medium for the
prosthesis. Instead, saline should be used to fill the device.
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