Patient Counseling Information - AMS 800 Instrucciones De Uso

(PIF Study n=12,713) on the AMS 800 and prospective clinical
study data (n=85) on the AMS 800. A log-normal distribution
fit the AMS historical data. Based on the log-normal model, it
was estimated that the five-year revision-free rate for the AMS
800 is approximately 73.8% with 95% CI ranging from 67.3%
to 79.6%. The results met the primary safety endpoint for the
clinical study of a five-year revision free rate at 75% using a 10%
delta with two-sided 95% lower bound greater than 65%.
1.00
0.80
0.60
0.40
0.20
0.00
0
Time in Months
Time in Months
Figure 1: Estimated Device Survival Rates for the AMS 800

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. 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 (See Silicone Information).
Antibiotic Information
The antibiotics present in InhibiZone, minocycline HCl and
rifampin, are well characterized and have been in use for years.
The dosage present on the artificial urinary sphincter is intended
to act on organisms that attempt to colonize on the device.
The AMS 800 components are treated with very low levels of
antibiotics. AMS provides numerous completed configurations
of the AMS 800 to individualize treatment, however, while the
AMS 800 PRB is not IZ treated, a complete device (PRB, pump,
and one or two cuffs), regardless of configuration, contains ≤ 6.5
mg rifampin and ≤ 8 mg minocycline HCl. This represents less
than 2% of oral dose exposure for a complete course of rifampin
or minocycline HCl with the maximum dose calculated from the
means and 95% tolerance interval.
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 artificial urinary sphincter implant
infections.
8
Estimated Survival Rates
6 12 18 24 36 48
- - - -
Prospective Survival Rate
Prospective Survival Rate
_____ Bayesian Survival Rate
Bayesian Survival Rate
60