Monarc-Patient-Broch..

LOSS OF BLADDER CONTROL
IS TREATABLE
TAKE CONTROL AND
RESTORE YOUR LIFESTYLE
TALKING ABOUT
STRESS INCONTINENCE (SUI)
Millions of women suffer from stress
incontinence (SUI). This condition results
in accidental loss of urine upon coughing,
laughing, sneezing, or simply getting up
from a chair.
SUI is frustrating and embarrassing, causing some
people to severely limit their activities and lifestyles.
Many treatment options for SUI are available. Monarc®
sling system is a simple procedure that corrects
the conditions that cause SUI and can free you from the
limitations associated with SUI.
HOW DO I KNOW IF I
HAVE INCONTINENCE?
Ask yourself the following questions:
• Do you leak urine unexpectedly?
• Is the urine leakage:
- Mild (a few drops)
- Moderate (wet underwear)
- Severe (wet outwear)
• Does the urine loss occur during coughing, sneezing,
laughing, bending or lifting?
• Does the urine loss occur when you change from a
sitting or lying position to a standing position?
• Do you leak urine continuously?
• Has this urine loss caused you to change your lifestyle?
If you answered “Yes” to any of these questions,
take the next step and talk with a doctor or other
healthcare professional.
1
CAUSES OF STRESS
URINARY INCONTINENCE (SUI)
Urinary incontinence in women can be caused by any
single condition or a combination of conditions. To
effectively diagnose and treat urinary incontinence, a
doctor must determine the cause.
Pregnancy and Vaginal Childbirth: Weakened or
damaged pelvic muscles and tissue can be the result
of pregnancy and childbirth, causing the bladder and
urethra to relax from their normal positions. The
bladder and urethra must be well supported by the
pelvic muscles and tissue to allow them to
work properly.
Aging and Genetic Factors: Aging tends to worsen all
forms of muscular injury. Changes in pelvic muscles can
contribute to urinary incontinence.
Medical Conditions: Certain medical and neurological
conditions, such as hysterectomies, spinal cord
problems (e.g., spina bifida, spinal cord injury,
malformation of the lower spine), multiple sclerosis,
Parkinson’s disease, stroke and diabetes can make
incontinence worse.
2
Infections and medications: Urinary tract infections can
cause temporary incontinence, and certain medications
may increase the likelihood of temporary incontinence.
Obesity: While obesity does not cause incontinence, it
does contribute to the condition due to the increased
abdominal pressure.
Smoking: While not a direct cause of incontinence,
smoking may aggravate urinary incontinence.
3
HOW MONARC® WORKS
In women with stress urinary incontinence, pelvic
muscles and tissue have been weakened by pregnancy,
childbirth, trauma, radiation, prior surgery, muscle
damage or hormonal changes, causing the bladder and
urethra to relax from their normal positions. The sudden,
added pressure from coughing, sneezing, laughing or
simple lifting can cause accidental loss of urine.
The Monarc sling system helps to correct the conditions
that cause stress urinary incontinence with a mesh sling
that supports the urethra. A narrow strip of polypropylene
mesh is surgically placed in your body to cradle your
urethra and give it a point of support. The self-fixating
mesh anchors itself to tissue and muscle in the space
surrounding the urethra.
YOUR BODY BEFORE INCONTINENCE
BLADDER
SPHINCTER AND
SUPPORTING TISSUE
When urethra is well
supported it prevents
urine leakage
4
YOUR BODY WITH INCONTINENCE
When pelvic floor
muscles are weak,
the urethra is no
longer supported,
allowing urine
to escape
YOUR BODY AFTER A MONARC SLING REPAIR
SLING
Placement of
Monarc sling
supports the
urethra and
prevents urine
leakage
Be sure to discuss all treatment
options with your physician.
5
MONARC’S PLACEMENT
INTO YOUR BODY
Placement of the sling system is usually performed
during an outpatient procedure in less than an
hour under local, regional, or general anesthesia,
depending on what you and your doctor choose.
Narrow mesh carriers are passed through an area
near the groin at the obturator of the pubic bone.
The mesh is then attached and pulled into place
under the urethra.
6
VIEW OF MONARC IN PLACE
7
WHAT TO EXPECT AFTER
MONARC PLACEMENT
Your doctor may insert a catheter through your
urethra to drain urine from your bladder. The
catheter is usually removed before you leave.
If your bladder does not empty properly, you may
have to wear your catheter for an extra day or two.
In some cases, you may have to use a catheter at
home until normal voiding resumes. In addition, your
doctor may prescribe antibiotics to prevent infection.
Most women see results as soon as the catheter
is removed, usually within a day or two after
the procedure.
Although many women have little or no pain after
the procedure, your doctor may prescribe an
analgesic for you.
Your incisions will be small and should heal quickly.
For approximately four to six weeks, you should avoid
sexual intercourse, heavy lifting, and rigorous exercise.
Your doctor will provide you with additional
information on your care after surgery for stress
urinary incontinence, including any other limitations
to activities.
Be sure to discuss all treatment
options with your physician.
8
WARNINGS AND PRECAUTIONS
As with most surgical procedures, potential adverse
reactions may occur. Some potential adverse reactions to
surgical procedures to correct urinary incontinence include:
• Pain/Discomfort/Irritation
• Inflammation (redness, heat, pain, or swelling
resulting from surgery)
• Infection
• Mesh erosion (presence of suture or mesh material
within the organs surrounding the vagina)
• Mesh Extrusion* (presence of suture or mesh
material within the vagina)
• Fistula formation (a hole/passage that develops
between organs or anatomic structures that is
repaired by surgery)
• Foreign body (allergic) reaction to mesh implant
• Adhesion formation (scar tissue)
• Urinary incontinence (involuntary leaking or urine)
• Urinary retention/obstruction (involuntary storage of
urine/blockage of urine flow)
• Voiding dysfunction (difficulty with urination or
bowel movements)
• Contracture (mesh shortening due to scar tissue)
• Wound dehiscence (opening of the incision
after surgery)
• Nerve damage
• Perforation (or tearing) of vessels, nerves, bladder,
ureters, colon, and other pelvic floor structures
• Hematoma (pooling of blood beneath the skin)
• Dyspareunia (pain during intercourse)
*Extrusion of the mesh into the vagina is one of the most common adverse events.
Most often, you may be able to be treated in your doctor’s office.
In some cases, treatment may occur in the operating room. If left untreated,
this complication may interfere with sexual intercourse.
*Data on file at AMS.
SOLUTIONS FOR LIFE® American Medical
Systems has been active in pelvic health since 1972
when it developed a cure of urinary incontinence.
More than 30 years later, we remain a leader in
offering cures for female incontinence and other
female conditions including prolapse. AMS also offers
products that treat incontinence, erectile dysfunction
and benign prostatic hyperplasia (BPH) in men.
For a complete list of indications, contraindications,
warnings and precautions consult your doctor.
If you have questions regarding the currency of
this information please contact AMS.
For more information on Stress Urinary Incontinence,
www.solutionsforurinaryincontinence.com
American Medical Systems, Inc.
World Headquarters
10700 Bren Road West
Minnetonka, MN 55343
USA
U.S. Toll Free:
800 328 3881
Phone:
952 930 6000
Fax:
952 930 6157
www.AmericanMedicalSystems.com
© 2010 American Medical Systems, Inc. All rights reserved.
601120-01 (03/10)
Photos are for illustrative purposes only. Subjects are
professional models and do not necessarily use or
endorse this product.