Patient Guide
CONSIDERATIONS PRIOR TO SURGICAL REPAIR
If you are considering surgery for stress urinary incontinence your physician may ask you questions about your
medical history, to ensure you are a candidate for this type of procedure. Some of these contraindications,
warnings/potential complications, and post procedural events associated with surgery for stress urinary
incontinence are listed below as a reference for you. You should consult your physician for a complete
understanding of this information to determine whether this procedure is right for you.
Intended Use / Indications for Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence
resulting from hypermobility and/or intrinsic sphincter deficiency.
Contraindications
A mesh implant is contraindicated in the following patients:
• Pregnant patients, patients with the potential for future growth or patients who are considering future pregnancies.
• Any patients with soft tissue pathology into which the implant is to be placed.
• Patients with any pathology which would compromise implant placement.
• Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Warnings / Potential Complications
The risks and benefits of performing a suburethral sling procedure in the following should be carefully considered:
• Women planning future pregnancies.
• Overweight women (weight parameters to be determined by the physician).
• Patients with blood coagulation disorder.
• Patients with compromised immune system or any other conditions that would compromise healing.
• Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a
cystocele repair, it should be done prior to the suburethral sling placement.
• Vaginal and urinary tract infection should be treated prior to implantation.
• This product is intended for use only by clinicians with adequate training and experience in treatment of
female stress urinary incontinence (SUI).
The following complications have been reported due to suburethral sling placement, but are not limited to:
• As with all implants, local irritation at the wound site and/or a foreign body may occur.
• Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other
surrounding tissue, migration of the device from the desired location, fistula formation and inflammation.
The occurrence of these responses may require removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an existing infection.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device
migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due
to incomplete support or overactive bladder.
• In addition to the above listed potential complications, allergic reaction, abscess, detrusor instability, pain
(pelvic, vaginal, groin, dyspareunia), bleeding (vaginal, hematoma formation), vaginal discharge, dehiscence or
vaginal incision, nerve damage, edema and erythema at the wound site, have been reported due to suburethal
sling procedure.
• It has also been reported that orthostatic symptoms, fatigue and shortness of breath may occur due to the
potential development of bleeding, including occult bleeding.*
Post Procedure
• Should dysuria, bleeding or other problems occur, contact your physician immediately.
• In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
• Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
• Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure
through the urethra or other surrounding tissue, migration of the device from the desired location, fistula
formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal
or revision of the mesh.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion/
exposure, device migration, complete failure of the procedure resulting in incontinence due to incomplete
support or overactive bladder.
*For “Obtryx® Transobturator Mid-Urethral Sling System” procedure only
provide a ribbon of support under the urethra
to prevent it from dropping during physical
activity, which may include but is not limited
to: laughing or lifting. Providing support that
mimics the normal anatomy should prevent urine
from leaking or reduce the amount of leakage.
Q: What are the types of sling options?
Q: What should I expect after surgery?
A: Many surgical options have been developed, the difference being
how the mesh material is placed under the urethra. Your doctor will
recommend which anchoring location is right for you. As disease
state and anatomy differs for each patient, outcomes may vary.
Consult your physician for all available treatment options.
A: Before your discharge from
the hospital, you may be given a
prescription for an antibiotic and/
or pain medication to relieve any
discomfort you may experience. You
will be instructed on how to care for
your incision area. At the discretion of
your physician, most patients resume moderate activities within
2 to 4 weeks, with no strenuous activity for up to 6 weeks.
Sling Placement Options
most patients
resume moderate
activities within
2 to 4 weeks...
Q: When will I stop leaking?
Single Incision
Sling Placement
Pre-pubic
Sling Placement
A: Most women see results right
after the procedure. Talk with your
physician about what you should
expect. You are on your way!
Individuals depicted are models and included for illustrative purposes only.
© 2012 Boston Scientific Corporation or its affiliates. All rights reserved.
WH-119704-AA 30M 10/12
your guide to stress Urinary Incontinence
A: A mid-urethral sling system is designed to
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in use of
surgical mesh for repair of stress urinary incontinence. Refer to package insert provided with the product for
complete Instructions for Use, Contraindications, Potential Adverse Effect, Warnings and Precautions prior
to using this product.
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
incontinence
Q: How can a mid-urethral sling
system help my incontinence?
Transobturator
Sling Placement
Retropubic
Sling Placement
Visit www.voicesforpfd.org for additional educational resources.
frequently asked questions
frequently asked questions, down-to-ear th answers
Q: What is stress
urinary incontinence?
Q: What type of stress urinary
incontinence do I have?
Q: What are the potential risks
and complications of surgery?
A: One condition is called hypermobility, (“hyper”
A: As with most surgical procedures, there are potential risks and
complications associated with surgery. Your physician can further
explain your specific risks based on your medical history and
surgical approach used. Some potential adverse reactions related to
surgical correction for stress urinary incontinence include:
means too much and “mobility” refers to movement) which
can result from childbirth, previous pelvic surgery or hormonal
changes. Hypermobility occurs when the normal pelvic floor
muscles can no longer provide the necessary support to the
urethra. This may lead to the urethra dropping when any
downward pressure is applied, resulting in involuntary leakage.
A: Urinary incontinence is defined
as the involuntary leakage of
urine. The problem afflicts
approximately 18 million adults
Another condition is called intrinsic sphincter
deficiency, usually called ISD. This refers to the weakening
in the United States, 85% of them being
of the urethral sphincter muscles or closing mechanism. As
a result, the sphincter does not function normally regardless
of the position of the bladder neck or urethra.
women. You are not alone! It usually
takes 4–6 years to see a healthcare
Pain/Discomfort/Irritation
n
Inflammation (redness, heat,
n
pain, or swelling resulting
from surgery), edema
(swelling caused by fluid
retention) and erythema
(redness of the skin)
Infection, including abscess
n
Bleeding (vaginal) and
n
professional for this condition.
n
with urination)
Vaginal discharge
n
Wound dehiscence (opening
n
of the incision after surgery)
Nerve damage
n
Detrusor stability (involuntary
n
construction of the detrusor
muscle while the bladder
is filling)
hematoma formation (pooling
of blood beneath the skin)
n
Q: What are some
of the symptoms?
A: Stress urinary incontinence is the
involuntary loss of urine during physical
activity, which may include but is not
limited to: coughing, laughing, or lifting.
Incontinence occurs when the muscles
You don’t
have to live
like this.
that support the urethra (the tube that
carries urine out of the body) are weakened or damaged.
This can happen as a result of childbirth, trauma, hormone
changes and many other reasons. You don’t have to live
like this. This type of incontinence can be treated both
surgically or nonsurgically.
of mesh material within
the organs surrounding
the vagina)
Q: What are some treatment options?
A: Stress urinary incontinence can be treated in several ways,
depending on the exact nature of the incontinence and its severity.
As disease state and anatomy differs for each patient, outcomes may
vary. Consult your physician for all available treatment options.
You and your physician may discuss:
n
Changes to your diet and fitness routine
n Physical therapy including pelvic floor
muscle training
n Vaginal pessaries
n Surgical options including traditional
mesh slings, single incision mini-slings,
retropubic colposuspension, and bulking.
This guide will focus on surgical procedures.
For more information, visit the FDA’s Urogynecologic Surgical Mesh website
at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
Normal functioning anatomy
A weakening of the muscles
supporting the urethra causes the
urethra to drop during physical
activity, resulting in urine leaking.
n
When your doctor is satisfied with the position of the mesh, he or
she will close and bandage the small incisions in the groin area
(if applicable for your sling type) and the top of the vaginal canal.
Fistula formation (a hole/
passage that develops
between organs or anatomic
structures that is repaired
by surgery)
Q: How will my surgery
be performed?
A small incision will be made in the vaginal area. Next, the synthetic
mesh is placed to create a “sling” of support around the urethra.
Mesh extrusion (presence
of mesh materials within
the vagina)
n
A: Your minimally-invasive sling procedure is estimated to
only take 30–45 minutes. Your doctor will determine the type
of anesthesia you will have during the procedure. Once the
anesthesia takes effect, your doctor will begin the procedure.
Mesh erosion (presence
n
Foreign body (allergic)
reaction to mesh implant
n
Urinary incontinence
(involuntary leaking of urine)
n
Urinary retention/obstruction
(involuntary storage of urine/
blockage of urine flow)
Voiding dysfunction (difficulty
n
Device migration, complete
failure of the device
n
Dyspareunia (pain during
intercourse)
frequently asked questions, down-to-ear th answers
Q: What is stress
urinary incontinence?
Q: What type of stress urinary
incontinence do I have?
Q: What are the potential risks
and complications of surgery?
A: One condition is called hypermobility, (“hyper”
A: As with most surgical procedures, there are potential risks and
complications associated with surgery. Your physician can further
explain your specific risks based on your medical history and
surgical approach used. Some potential adverse reactions related to
surgical correction for stress urinary incontinence include:
means too much and “mobility” refers to movement) which
can result from childbirth, previous pelvic surgery or hormonal
changes. Hypermobility occurs when the normal pelvic floor
muscles can no longer provide the necessary support to the
urethra. This may lead to the urethra dropping when any
downward pressure is applied, resulting in involuntary leakage.
A: Urinary incontinence is defined
as the involuntary leakage of
urine. The problem afflicts
approximately 18 million adults
Another condition is called intrinsic sphincter
deficiency, usually called ISD. This refers to the weakening
in the United States, 85% of them being
of the urethral sphincter muscles or closing mechanism. As
a result, the sphincter does not function normally regardless
of the position of the bladder neck or urethra.
women. You are not alone! It usually
takes 4–6 years to see a healthcare
Pain/Discomfort/Irritation
n
Inflammation (redness, heat,
n
pain, or swelling resulting
from surgery), edema
(swelling caused by fluid
retention) and erythema
(redness of the skin)
Infection, including abscess
n
Bleeding (vaginal) and
n
professional for this condition.
n
with urination)
Vaginal discharge
n
Wound dehiscence (opening
n
of the incision after surgery)
Nerve damage
n
Detrusor stability (involuntary
n
construction of the detrusor
muscle while the bladder
is filling)
hematoma formation (pooling
of blood beneath the skin)
n
Q: What are some
of the symptoms?
A: Stress urinary incontinence is the
involuntary loss of urine during physical
activity, which may include but is not
limited to: coughing, laughing, or lifting.
Incontinence occurs when the muscles
You don’t
have to live
like this.
that support the urethra (the tube that
carries urine out of the body) are weakened or damaged.
This can happen as a result of childbirth, trauma, hormone
changes and many other reasons. You don’t have to live
like this. This type of incontinence can be treated both
surgically or nonsurgically.
of mesh material within
the organs surrounding
the vagina)
Q: What are some treatment options?
A: Stress urinary incontinence can be treated in several ways,
depending on the exact nature of the incontinence and its severity.
As disease state and anatomy differs for each patient, outcomes may
vary. Consult your physician for all available treatment options.
You and your physician may discuss:
n
Changes to your diet and fitness routine
n Physical therapy including pelvic floor
muscle training
n Vaginal pessaries
n Surgical options including traditional
mesh slings, single incision mini-slings,
retropubic colposuspension, and bulking.
This guide will focus on surgical procedures.
For more information, visit the FDA’s Urogynecologic Surgical Mesh website
at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
Normal functioning anatomy
A weakening of the muscles
supporting the urethra causes the
urethra to drop during physical
activity, resulting in urine leaking.
n
When your doctor is satisfied with the position of the mesh, he or
she will close and bandage the small incisions in the groin area
(if applicable for your sling type) and the top of the vaginal canal.
Fistula formation (a hole/
passage that develops
between organs or anatomic
structures that is repaired
by surgery)
Q: How will my surgery
be performed?
A small incision will be made in the vaginal area. Next, the synthetic
mesh is placed to create a “sling” of support around the urethra.
Mesh extrusion (presence
of mesh materials within
the vagina)
n
A: Your minimally-invasive sling procedure is estimated to
only take 30–45 minutes. Your doctor will determine the type
of anesthesia you will have during the procedure. Once the
anesthesia takes effect, your doctor will begin the procedure.
Mesh erosion (presence
n
Foreign body (allergic)
reaction to mesh implant
n
Urinary incontinence
(involuntary leaking of urine)
n
Urinary retention/obstruction
(involuntary storage of urine/
blockage of urine flow)
Voiding dysfunction (difficulty
n
Device migration, complete
failure of the device
n
Dyspareunia (pain during
intercourse)
CONSIDERATIONS PRIOR TO SURGICAL REPAIR
If you are considering surgery for stress urinary incontinence your physician may ask you questions about your
medical history, to ensure you are a candidate for this type of procedure. Some of these contraindications,
warnings/potential complications, and post procedural events associated with surgery for stress urinary
incontinence are listed below as a reference for you. You should consult your physician for a complete
understanding of this information to determine whether this procedure is right for you.
Intended Use / Indications for Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence
resulting from hypermobility and/or intrinsic sphincter deficiency.
Contraindications
A mesh implant is contraindicated in the following patients:
• Pregnant patients, patients with the potential for future growth or patients who are considering future pregnancies.
• Any patients with soft tissue pathology into which the implant is to be placed.
• Patients with any pathology which would compromise implant placement.
• Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Warnings / Potential Complications
The risks and benefits of performing a suburethral sling procedure in the following should be carefully considered:
• Women planning future pregnancies.
• Overweight women (weight parameters to be determined by the physician).
• Patients with blood coagulation disorder.
• Patients with compromised immune system or any other conditions that would compromise healing.
• Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a
cystocele repair, it should be done prior to the suburethral sling placement.
• Vaginal and urinary tract infection should be treated prior to implantation.
• This product is intended for use only by clinicians with adequate training and experience in treatment of
female stress urinary incontinence (SUI).
The following complications have been reported due to suburethral sling placement, but are not limited to:
• As with all implants, local irritation at the wound site and/or a foreign body may occur.
• Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other
surrounding tissue, migration of the device from the desired location, fistula formation and inflammation.
The occurrence of these responses may require removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an existing infection.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device
migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due
to incomplete support or overactive bladder.
• In addition to the above listed potential complications, allergic reaction, abscess, detrusor instability, pain
(pelvic, vaginal, groin, dyspareunia), bleeding (vaginal, hematoma formation), vaginal discharge, dehiscence or
vaginal incision, nerve damage, edema and erythema at the wound site, have been reported due to suburethal
sling procedure.
• It has also been reported that orthostatic symptoms, fatigue and shortness of breath may occur due to the
potential development of bleeding, including occult bleeding.*
Post Procedure
• Should dysuria, bleeding or other problems occur, contact your physician immediately.
• In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
• Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
• Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure
through the urethra or other surrounding tissue, migration of the device from the desired location, fistula
formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal
or revision of the mesh.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion/
exposure, device migration, complete failure of the procedure resulting in incontinence due to incomplete
support or overactive bladder.
*For “Obtryx® Transobturator Mid-Urethral Sling System” procedure only
provide a ribbon of support under the urethra
to prevent it from dropping during physical
activity, which may include but is not limited
to: laughing or lifting. Providing support that
mimics the normal anatomy should prevent urine
from leaking or reduce the amount of leakage.
Q: What are the types of sling options?
Q: What should I expect after surgery?
A: Many surgical options have been developed, the difference being
how the mesh material is placed under the urethra. Your doctor will
recommend which anchoring location is right for you. As disease
state and anatomy differs for each patient, outcomes may vary.
Consult your physician for all available treatment options.
A: Before your discharge from
the hospital, you may be given a
prescription for an antibiotic and/
or pain medication to relieve any
discomfort you may experience. You
will be instructed on how to care for
your incision area. At the discretion of
your physician, most patients resume moderate activities within
2 to 4 weeks, with no strenuous activity for up to 6 weeks.
Sling Placement Options
most patients
resume moderate
activities within
2 to 4 weeks...
Q: When will I stop leaking?
Single Incision
Sling Placement
Pre-pubic
Sling Placement
A: Most women see results right
after the procedure. Talk with your
physician about what you should
expect. You are on your way!
Individuals depicted are models and included for illustrative purposes only.
© 2012 Boston Scientific Corporation or its affiliates. All rights reserved.
WH-119704-AA 30M 10/12
your guide to stress Urinary Incontinence
A: A mid-urethral sling system is designed to
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in use of
surgical mesh for repair of stress urinary incontinence. Refer to package insert provided with the product for
complete Instructions for Use, Contraindications, Potential Adverse Effect, Warnings and Precautions prior
to using this product.
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
incontinence
Q: How can a mid-urethral sling
system help my incontinence?
Transobturator
Sling Placement
Retropubic
Sling Placement
Visit www.voicesforpfd.org for additional educational resources.
frequently asked questions
CONSIDERATIONS PRIOR TO SURGICAL REPAIR
If you are considering surgery for stress urinary incontinence your physician may ask you questions about your
medical history, to ensure you are a candidate for this type of procedure. Some of these contraindications,
warnings/potential complications, and post procedural events associated with surgery for stress urinary
incontinence are listed below as a reference for you. You should consult your physician for a complete
understanding of this information to determine whether this procedure is right for you.
Intended Use / Indications for Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence
resulting from hypermobility and/or intrinsic sphincter deficiency.
Contraindications
A mesh implant is contraindicated in the following patients:
• Pregnant patients, patients with the potential for future growth or patients who are considering future pregnancies.
• Any patients with soft tissue pathology into which the implant is to be placed.
• Patients with any pathology which would compromise implant placement.
• Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Warnings / Potential Complications
The risks and benefits of performing a suburethral sling procedure in the following should be carefully considered:
• Women planning future pregnancies.
• Overweight women (weight parameters to be determined by the physician).
• Patients with blood coagulation disorder.
• Patients with compromised immune system or any other conditions that would compromise healing.
• Take special care in cases of bladder prolapse because of anatomical distortion. If the patient requires a
cystocele repair, it should be done prior to the suburethral sling placement.
• Vaginal and urinary tract infection should be treated prior to implantation.
• This product is intended for use only by clinicians with adequate training and experience in treatment of
female stress urinary incontinence (SUI).
The following complications have been reported due to suburethral sling placement, but are not limited to:
• As with all implants, local irritation at the wound site and/or a foreign body may occur.
• Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other
surrounding tissue, migration of the device from the desired location, fistula formation and inflammation.
The occurrence of these responses may require removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an existing infection.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device
migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due
to incomplete support or overactive bladder.
• In addition to the above listed potential complications, allergic reaction, abscess, detrusor instability, pain
(pelvic, vaginal, groin, dyspareunia), bleeding (vaginal, hematoma formation), vaginal discharge, dehiscence or
vaginal incision, nerve damage, edema and erythema at the wound site, have been reported due to suburethal
sling procedure.
• It has also been reported that orthostatic symptoms, fatigue and shortness of breath may occur due to the
potential development of bleeding, including occult bleeding.*
Post Procedure
• Should dysuria, bleeding or other problems occur, contact your physician immediately.
• In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
• Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
• Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure
through the urethra or other surrounding tissue, migration of the device from the desired location, fistula
formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal
or revision of the mesh.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion/
exposure, device migration, complete failure of the procedure resulting in incontinence due to incomplete
support or overactive bladder.
*For “Obtryx® Transobturator Mid-Urethral Sling System” procedure only
provide a ribbon of support under the urethra
to prevent it from dropping during physical
activity, which may include but is not limited
to: laughing or lifting. Providing support that
mimics the normal anatomy should prevent urine
from leaking or reduce the amount of leakage.
Q: What are the types of sling options?
Q: What should I expect after surgery?
A: Many surgical options have been developed, the difference being
how the mesh material is placed under the urethra. Your doctor will
recommend which anchoring location is right for you. As disease
state and anatomy differs for each patient, outcomes may vary.
Consult your physician for all available treatment options.
A: Before your discharge from
the hospital, you may be given a
prescription for an antibiotic and/
or pain medication to relieve any
discomfort you may experience. You
will be instructed on how to care for
your incision area. At the discretion of
your physician, most patients resume moderate activities within
2 to 4 weeks, with no strenuous activity for up to 6 weeks.
Sling Placement Options
most patients
resume moderate
activities within
2 to 4 weeks...
Q: When will I stop leaking?
Single Incision
Sling Placement
Pre-pubic
Sling Placement
A: Most women see results right
after the procedure. Talk with your
physician about what you should
expect. You are on your way!
Individuals depicted are models and included for illustrative purposes only.
© 2012 Boston Scientific Corporation or its affiliates. All rights reserved.
WH-119704-AA 30M 10/12
your guide to stress Urinary Incontinence
A: A mid-urethral sling system is designed to
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in use of
surgical mesh for repair of stress urinary incontinence. Refer to package insert provided with the product for
complete Instructions for Use, Contraindications, Potential Adverse Effect, Warnings and Precautions prior
to using this product.
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
incontinence
Q: How can a mid-urethral sling
system help my incontinence?
Transobturator
Sling Placement
Retropubic
Sling Placement
Visit www.voicesforpfd.org for additional educational resources.
frequently asked questions
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