TITAN® AND TITAN® TOUCH
INFLATABLE PENILE PROSTHESIS -
IMPORTANT SAFETY INFORMATION
A penile implant, also called a penile
prosthesis, is concealed entirely within
the body to address erectile dysfunction
(impotence). The implant requires some
degree of manipulation before and after
intercourse to make the penis erect or flaccid.
Indications: The Titan and Titan Touch
Inflatable Penile Prosthesis is indicated
for male patients suffering from erectile
dysfunction (impotence) who are considered
to be candidates for implantation of a
penile prosthesis.
Contraindications: The Titan and Titan Touch
Inflatable Penile Prosthesis is contraindicated
in patients who have one or more of the
following: (1) Patients with an active infection
present anywhere in the body, especially
urinary tract or genital infection. (2) Patients
with a documented sensitivity to silicone.
(3) Patients with unresolved problems
affecting urination, such as an elevated
residual urine volume secondary to bladder
outlet obstruction or neurogenic bladder.
(4) Patients unwilling to undergo any further
surgery for device revision.
Warnings: Implantation of the device may
make latent natural erections, as well as
other interventional treatment options,
impossible. Men with diabetes or spinal cord
injuries, as well as immunocompromised
patients, may have an increased risk of
infection associated with a prosthesis.
Implantation of a penile prosthesis may result
in penile shortening, curvature or scarring.
Precautions: Removal of an implanted
prosthesis without timely reimplantation of a
new prosthesis may complicate subsequent
reimplantation or may make it impossible.
MRI quality may be compromised if the
area of interest is in the exact same area or
relatively close to the position of the Titan,
and Titan Touch IPP. Be sure to consult
with your physician. Patients should discuss all
available treatment options and their risks and
benefits with their physician. Health conditions
which hamper sexual activity, such as severe
chest pain (angina), may prevent successful
use of this device. The prosthesis should not
be implanted in patients who lack the manual
dexterity or strength necessary to operate the
device. 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. The device may be
used in the presence of Peyronie’s Disease.
Potential Complications: Penile implants are
surgical solutions requiring a healing period
that have risks associated with surgery such
as scrotal swelling, auto-inflation, discomfort,
angulation/curvature, swelling (edema),
device malfunction, chronic pain, difficulty
with ejaculation, transient urinary retention,
fever, migration, patient dissatisfaction,
infection at surgical site or wound, deflation,
swelling of clotted blood or clear fluid
(hematoma/seroma), wound leakage,
bleeding, delayed wound healing, narrowing
of the opening of the foreskin (phimosis),
sensory loss, cylinder malfunction, formation
of thick tissue (fibrous capsule formation),
over/under inflation, erosion, scrotal
reddening (erythema), genital change,
and inguinal hernia.
This treatment is prescribed by your physician.
Discuss the treatment options with your
physician to understand the risks and benefits
of the various options to determine if a penile
implant is right for you.
Caution: Federal law (USA) restricts this device
to sale by or on the order of a physician.
PM-15451 03.2021
Coloplast Corp. Minneapolis, MN 55411 / Interventional Urology Surgical Support 1-800-258-3476
www.coloplast.com The Coloplast logo is a registered trademark of Coloplast A/S. © 2022-11. All rights reserved Coloplast A/S. PM-08241