Table des Matières
Publicité
The following are adverse events
associated with this product: Abscess,
Bleeding, Erosion, Excessive Fibrous
Capsular Growth, Exposure to
Biohazardous Material, Genital Changes,
Granulomas, Hemorrhage, Immune-
Related Connective Tissue Disorders,
Improper Size, Inguinal Hernia, Ischemia,
Necrosis, Pain (which may be prolonged or
severe), Perforation or Injury of Bladder,
Corpus Cavernosum, Nerve, Tunica, or
Urethra, Prolonged Procedure, Super Sonic
Transporter (SST) (as a result of improper
sizing), Ulceration, Unretrieved Device
Fragment, Vascular Compromise, Ventral
Chordee.
The following events occurred during this
clinical study but were classified by the
Investigators as not related to the device or
the implantation surgery: urethral stricture
(9 cases), prostate cancer (4 cases), BPH
(3 cases), incontinence (3 cases), urinary
retention (3 cases), urinary tract infection
(3 cases), abnormal prostate exam/
PSA (2 cases), ab nor mal sexual function
(2 cases), bala nitis (2 cases), hematuria
(2 cases), pain (2 cases), renal calculus
(2 cases), abnormal ejaculation (1 case),
bladder instability (1 case), bladder spasms
(1 case), blood in urine (1 case), dysuria (1
case), edema (1 case), epididymal cyst (1
case), eroded artificial sphincter (1 case),
erythema (1 case), infection (1 cases),
inguinal hernia (1 case), nocturia (1 case),
prostate nodule (1 case), prostatitis (1
case), pyuria (1 case), renal colic (1 case),
renal insufficiency (1 case), testicular cyst
(1 case), testicular hydrocele (1 case),
trichomonas (1 case), urethral mucosal
atrophy (1 case), urination impaired (1
case), urgency (1 case), and urosepsis (1
case).
There were four 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 14 patients underwent revision
surgeries in the study. Information on
device revisions is described in the "Clinical
Studies" section.
12
Publicité
Table des Matières
