Download Learn about reconstruction

Breast
Reconstruction
For over 20 years,
Mentor has been
recognised throughout
the world as a leading
manufacturer of the
highest quality breast
implants.
-2-
Be confident.
Be informed.
MAKE A GOOD DECISION.
There is a lot to learn when you are considering
breast reconstruction or breast replacement
surgery. This brochure is intended to help you
build a solid foundation of knowledge as you
begin this important process. It is packed
with facts about the surgery itself, the latest
information about MENTOR® MemoryGelTM
Silicone Gel-Filled and MENTOR® Saline-Filled
Breast Implant options…and more.
For over 20 years, Mentor has been recognised
throughout the world as a leading manufacturer of
the highest quality breast implants. We offer two
basic types: MemoryGel TM and Saline-Filled Breast
Implants.
2XUULFKKLVWRU\LVÀOOHGZLWKLQGXVWU\ÀUVWV
innovative product designs and groundbreaking
research. Mentor has a record of continually
producing leading-edge, FDA-approved (saline
and round-shaped gel) and CE-Marked breast
reconstruction products.
TABLE OF
CONTENTS
Introduction
1
Anatomy of the Breast
3
Breast Cancer Basics
4
Stages of Breast Cancer
7
What is a Mastectomy?
9
Breast Reconstruction Timing
10
Breast Reconstruction Options
11
About Breast Implants
18
MENTOR ® Tissue Expanders
25
Your Recovery
27
PatientSafe Coverage Limited Warranty
29
Breast Reconstruction Resources
34
Breast Implant Safety Study Information
35
Questions to Ask Your Plastic Surgeon
37
Glossary
39
Mentor—A Company That Cares
43
Important Safety Information
Back Cover
INTRODUCTION
There are many choices involved in the
breast reconstruction process. Perhaps the
most important question to ask is: Is breast
reconstruction right for you? For tens of
thousands of breast cancer survivors, the answer
has been yes.
Today, most women who have mastectomies
are good candidates for breast reconstruction.
After a mastectomy, women choose to have breast
reconstruction for many different reasons.
Some no longer feel whole, or they do not feel
as feminine. Others do not want to bother with
the day-to-day hassle of wearing an external
breast prosthesis. For many women, breast
reconstruction is a good way to feel better about
themselves and make a fresh new start in life.
Faster and Easier Breast Reconstruction
For women who choose breast reconstruction,
new surgical procedures are available that are
less time consuming and easier, while usually
providing good results. One of these new
surgical techniques is called single-stage
breast reconstruction, which is explained in
this brochure.
-1-
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ANATOMY OF THE BREAST
The breast consists of milk ducts and glands,
surrounded by fatty tissue that provides its shape
and feel. The chest muscle (pectoralis major
muscle) is located beneath the breast. Factors
such as pregnancy (when milk glands are
temporarily enlarged), rapid weight loss and the
effects of gravity as you age can combine to
stretch your skin, which may cause your breast to
droop or sag.
Pectoralis Major Muscle
Pectoralis Minor Muscle
Fatt y T issue
Milk Lobes, Glands
Milk Ducts
Nipple and Areola
Soft T issue
Ribs
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the shape of the breast to a greater or lesser
degree, depending on:
How much breast tissue is removed in a
partial or complete mastectomy;
How much skin is removed at the time of
your surgery; and
How much tissue reaction or scarring there is
in the remaining breast and skin in response to
chemotherapy or radiation therapy.
-3-
BREAST CANCER BASICS
Breast Cancer Facts
Simply stated, breast cancer is an uncontrolled
growth of breast cells. Breast cancer is a disease
in which malignant (cancer) cells form in the
tissues of the breast. It differs by individual, age
group, and even the kinds of cells within the
tumors themselves.
How Does Breast Cancer Occur?
Cancer is a result of mutations, or abnormal
changes, in the genes responsible for
regulating the growth of cells and keeping
them healthy. The genes are in each cell’s
nucleus, which acts as the “control room” of
each cell. Normally, the cells in our bodies
replace themselves through an orderly
process of cell growth: healthy new cells
take over as old ones die out. But over time,
mutations can “turn on” certain genes and
“turn off” others in a cell. That changed cell
gains the ability to keep dividing without
control or order, producing more cells just
like it and forming a tumor.
Breast Cancer is Caused by a Genetic
Abnormality
According to cancer societies, only 5 to
10% of cancers are due to an abnormality
inherited from your mother or father. About
90% of breast cancers are due to genetic
abnormalities that happen as a result of the
aging process and the strain of life in general.
-4-
-5-
Did you Know That Not All Tumors are
Cancerous?
A tumor can be benign (not dangerous
to health) or malignant (has the potential
to be dangerous). Benign tumors are not
considered cancerous: their cells are close
to normal in appearance, they grow slowly,
and they do not invade nearby tissues or
spread to other parts of the body. Malignant
tumors are cancerous.
The Term "Breast Cancer" Refers to a
Malignant Tumor that has Developed from
Cells in the Breast.
Usually breast cancer either begins in the
cells of the lobules, which are the milkproducing glands, or the ducts, the passages
that drain milk from the lobules to the nipple.
Less commonly, breast cancer can begin in
the stromal tissues, which include the fatty
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Over Time, Cancer Cells can Invade
Nearby Healthy Breast Tissue and Make
their way into the Underarm Lymph
Nodes, Small Organs that Filter out Foreign
Substances in the Body.
If cancer cells get into the lymph nodes,
they then have a pathway into other parts
of the body. The breast cancer’s stage refers
to how far the cancer cells have spread
beyond the original tumor.
-6-
STAGES OF BREAST CANCER
Determining the stage of your breast cancer is
fundamental for planning your treatment and
understanding the most likely outcome. If you
have been diagnosed with breast cancer, your
surgeon will decide what additional tests may
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outside the breast.
About Stages
The cancer stage—shown as a number
from 0 to IV—is based on the size of the
tumor and whether the cancer has spread
to the lymph nodes.
To determine your cancer stage, your
surgeon will ask questions about your
medical history, perform a careful physical
examination and review all prior tests as
well as the results from the biopsy of the
tumor or suspected area.
Additional tests, such as X-rays and blood
work, may be needed. In general, the
stage is not fully known until after the
operation to remove the tumor in your
breast and sample the lymph nodes under
your arm.
Breast cancer staging is complicated,
DQGWKHFODVVLÀFDWLRQV\VWHPVRPHWLPHV
changes as doctors learn more about
breast cancer.
Stages 0 to IV: What They Mean
Once the surgery is completed, your surgeon
can determine the stage of your cancer.
Breast cancer stages range from 0 to IV,
with many subcategories. Lower numbers
indicate earlier stages of cancer, while
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-7-
Stage 0
This stage describes noninvasive breast
cancer. It has not spread within the breast or
to other parts of the body.
Stage I
This stage is an early stage of invasive breast
cancer in which:
The tumor measures no more than 2 cm
in diameter
No lymph nodes are involved—the cancer
has not spread outside the breast
Stage II
This stage, subdivided into IIA and IIB,
describes invasive breast cancers in which
one of the following is true:
The tumor measures less than 2 cm but has
spread to lymph nodes under the arm
No tumor is found in the breast but cancer
is found in the axillary lymph nodes
The tumor is between 2 cm and 5 cm and
may have spread to lymph nodes under
the arm
The tumor is larger than 5 cm but has not
spread to any lymph nodes
Stage III
Stage III breast cancers are subdivided
into three categories—IIIA, IIIB, and IIIC—
based on a number of different criteria. By
GHÀQLWLRQVWDJH,,,FDQFHUVKDYHQRWVSUHDG
(metastasised) to distant sites.
For example, a stage IIIA tumor is larger
than 5 cm and has spread to one to three
lymph nodes under the arm. Other stage IIIA
tumors may be any size and have spread
into multiple lymph nodes. The lymph nodes
-8-
clump together and attach to one another
or to the surrounding tissue.
In stage IIIB breast cancer, a tumor of any
size has spread to tissues near the breast—
the skin and chest muscles—and may have
spread to lymph nodes within the breast
or under the arm. Stage IIIB also includes
LQÁDPPDWRU\EUHDVWFDQFHUDQXQFRPPRQ
but aggressive type of breast cancer.
Stage IIIC cancer is a tumor of any size that
has spread:
To 10 or more lymph nodes under the arm
To lymph nodes above or beneath the
collarbone and near the neck
To lymph nodes within the breast itself and
to lymph nodes under the arm
Stage IV
Stage IV breast cancer has spread to other,
distant parts of the body, such as the lungs,
liver, bones or brain.
WHAT IS A MASTECTOMY?
A mastectomy is when breast tissue is removed
due to the presence of a cancerous or precancerous growth. The amount
of tissue removed during a
mastectomy is not always the
same; it will vary based on the
size and stage of your cancer,
your body type and your
personal preferences.
Mastectomy
Incision
-9-
BREAST RECONSTRUCTION
TIMING
Breast reconstruction can be done during
the same operation as your mastectomy.
This is called immediate reconstruction. Or it
can be done weeks, months or even years
after your mastectomy. This is called delayed
reconstruction. Based on your personal
circumstances, you and your surgeon can
decide which method is best for you.
Immediate Reconstruction
The advantage of having immediate breast
reconstruction is that your breast is reconstructed
during the same operation as your mastectomy.
Therefore, you have only one operation and
recovery period. This means you can avoid the
experience of having only one or no breasts.
Delayed Reconstruction
The advantage of delayed reconstruction is
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from cancer and rebuild your strength. Delaying
breast reconstruction also gives you more time to
consider your options and make a well-informed
decision about breast reconstruction.
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BREAST RECONSTRUCTION
OPTIONS
There are different ways to reconstruct your
breast. The method you and your surgeon choose
will be based on several factors, including:
Your health and lifestyle
Your body type
Your breast size
Your personal choice
The amount of remaining skin and tissue
Breast reconstruction can be done using your
own body tissue, by using breast implants or by
using a combination of your own tissue with a
breast implant(s).
Using Your Own Tissue For Breast Reconstruction
Latissimus Dorsi Flap
One method for reconstructing your breast with
your own tissue is called the Latissimus Dorsi Flap.
During this procedure, a section of your skin and
muscle is removed from your back or from under
your arm and then moved to the breast area,
where it is used to reconstruct your breast. The skin
and muscle from your back area is normally quite
thin, this method is sometimes used with a breast
implant to give your new breast a fuller look and a
more natural shape.
Latissimus Dorsi Flap
With or Without Breast Implants
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2. The tissue is tunneled to the mastectomy and used to create a
breast mound.
3. An implant can also be used to create the breast mound.
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The TRAM Flap
Another way to reconstruct your breast using your
own tissue is called a TRAM Flap. This procedure
involves removing fat and muscle from the
stomach area and placing it in the chest area to
reconstruct your breast. Sometimes it’s possible for
the blood supply and connection to the stomach
area to be preserved. When it’s not, blood vessels
from the stomach tissue must be attached to the
chest area using microsurgery.
The TRAM Flap
(Pedicle or Free)
1. Mastectomy is performed and the donor site is marked.
2. 7KHÁDSRIUHFWXVPXVFOHDQGWLVVXHLVWXQQHOHGWRWKHEUHDVW
3. Final result.
Sample Tram Flap Reconstruction
Photos: Courtesy of Dr. Loren Eskenazi, San Francisco, California, USA
Before
After
By discussing all your options with your surgeon, you will
be able to make a decision that is right for you.
The DIEP Flap
Another method for reconstructing your breast with
your own tissue is called DIEP Flap. DIEP (Deep Inferior
Epigastric Perforator) is similar to the TRAM Flap procedure, however, it does not remove muscles, only
skin, fat, and blood vessels are removed from the
stomach area.
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Breast Reconstruction with Implants
During a mastectomy, the surgeon removes skin
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and tight. Before a long-term implant can be
placed, the breast tissue needs to be stretched
to make space for it. This process is called tissue
expansion. It can typically be done in either
two
stages or in one stage (single-stage).
Two-Stage Breast Reconstruction
A two-stage breast reconstruction with implants
is a very popular option. This procedure can be
done either at the time of mastectomy or at a
later stage (delayed).
How It Works
Stage 1: A temporary breast tissue expander is
placed in the chest. Over a period of weeks,
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with saline, which is similar to saltwater. During
this process, your skin will gradually stretch
and grow to make room for the implant as it
expands. Your body will slowly adjust to the
growth of the implant in the same manner a
woman’s body adjusts to the gradual growth of
her abdomen when she is pregnant.
Stage 2: Once the breast-shaped pocket is
created, the tissue expander is removed and
the breast implant is placed in the pocket. In
reconstruction following a mastectomy, a breast
implant is most often placed sub-muscularly.
The surgery to replace the tissue expander with
a breast implant (implant exchange) is usually
done under general anesthesia in an operating
room. It may require a brief hospital stay or be
done on an outpatient basis.
Sample Two-Stage Breast Reconstruction Using a MENTOR®
Breast Tissue Expander Followed by a Round Saline Implant.
Photos: Courtesy of Dr. Gary Talbot, Little Rock, Arkansas, USA
After: 6 months post-op
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TWO-STAGE BREAST
RECONSTRUCTION
First Surgery
Second Surgery
The tissue expander is
placed in position.
The implant is then placed
in the expanded pocket.
The injection dome is
located. Expansion begins
by injecting saline through
the dome.
Completed procedure.
SILTEX ™ CONTOUR PROFILE TM
Tissue Expander
The tissue expander is now
removed.
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Single-Stage Breast Reconstruction
Mentor is one of the few companies that
manufactures breast implants that can be used
as both a tissue expander and a long-term breast
implant. These implants are used in single-stage
breast reconstruction. This procedure is becoming
more popular with surgeons as it means patients
only need to have one operation to reconstruct
their breast, instead of two or more.
How It Works
A combination expander/breast implant is
placed in the chest at the time of mastectomy.
7KHGHYLFHKDVDVPDOOÀOOWXEHDQGGRPHWKDW
is placed near the implant. Over a period of
weeks or months, saline is injected into the port
to expand the implant and grow tissue. When the
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EHUHPRYHGLQDVLPSOHRIÀFHSURFHGXUHDQGWKH
implant remains in place.
Single-Stage Reconstruction with Expander/Implant
Photos: Courtesy of Dr. Kay Young, San Francisco, California, USA
Before
After: 3 weeks
post-op
After: 1 year
post-op
SILTEX TM Round SPECTRUMTM
Breast Implant
SILTEX TM Round BECKER TM 25
Breast Implant
- 15 -
SINGLE-STAGE BREAST
RECONSTRUCTION
Expansion Procedure with BECKERTM
or SPECTRUMTM Adjustable Breast Implants
1.
2.
The expander/breast implant
is placed in position.
It is then expanded by
injecting saline through the
dome for up to 6 months.
4.
3.
Final volume is achieved.
The dome is then removed
LQDQRIÀFHSURFHGXUH
5.
Nipple reconstruction is
SHUIRUPHGDQGÀQDOUHVXOW
is achieved.
- 16 -
Mentor is proud of the quality
built into each of our breast
implants, and you can be
assured that behind your
decision to use our products is
a company that understands
your hopes and desires and a
company that truly cares.
- 17 -
ABOUT BREAST IMPLANTS
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A breast implant is a sac
(implant shell) of silicone
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silicone gel or saline, that is
surgically implanted under
your breast tissue or under
your chest muscle. Mentor
makes two basic types:
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Breast Implants.
®
MENTOR gel-filled breast implants
are called MemoryGel TM Breast
Implants
MemoryGelTM Breast Implants feature a unique
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as a solid unit rather than a liquid. The gel holds
together uniformly, while retaining the natural
“give” that resembles actual breast tissue. The
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natural look and feel. MemoryGelTM Implants
are available in a wide range of shapes, sizes,
SURÀOHVVXUIDFHWH[WXUHFKRLFHVDQGFRKHVLYH
OHYHOVWRÀWGLIIHUHQWERG\W\SHV
- 18 -
Breast Implant shapes and sizes
Depending on the desired shape you wish to
achieve, you and your surgeon may choose
either a round or contoured implant. Both shapes
DUHDYDLODEOHZLWKJHOÀOOHGDQGVDOLQHÀOOHG
MENTOR® contoured gel-filled breast implants are
called CONTOUR PROFILETM Gel (or CPGTM) Breast
Implants.
Contoured implants have a teardrop shape and can
provide patients with a more natural look and feel.
Breast implants are measured in cubic
centimeters, or cc’s, not in cup sizes. The size
of the implant used depends on the size and
shape of the individual woman’s chest.
Your surgeon will also evaluate your existing
breast and skin tissue to determine if you have
enough to cover the breast implant you are
considering. If you desire a breast implant size
that is too large for your tissue, your surgeon may
warn you that the breast implant edges may be
visible or palpable following your surgery. Also,
excessively large breast implants may speed up
the effects of gravity on the breast, and can
result in droop or sag at an earlier age.
A recent report indicates that larger sized implants
(greater than 350 cc) may be too large for
many women, increasing the risk of developing
complications such as extrusion, hematoma,
infection, palpable implant folds and visible skin
wrinkling. Surgical intervention could be required
to correct these complications1.
1. Henriksen, T.F., et al. 2005. Surgical intervention and capsular contracture after breast
augmentation: a prospective study of risk factors. Ann. Plast. Surg. 54(4): 343-51.
- 19 -
Mentor also offers an adjustable gel breast implant called
(Round) SPECTRATM Adjustable Gel Breast Implant.
The SPECTRATM has the advantages of a silicone
gel breast implant with an adjustable saline
inner-lumen that can be adjusted both intraand postoperatively.
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In addition to size and shape, breast implants are
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amount of forward projection off the chest wall).
Generally, the larger you want your cup size,
the larger the breast implant your surgeon will
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like to achieve, you and your surgeon may
choose a round or contoured implant.
Implant sufaces
Breast implants are available with either a
smooth or textured surface.
Mentor has a
textured breast implant surface called SILTEXTM
Together with your surgeon, you can decide
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texture is right for you.
- 20 -
All Cohesive, All the TimeTM
All of the MENTOR® MemoryGelTM Breast Implants
use a gel that is cohesive, safe and aesthetically
pleasing. We offer three degrees of cohesive
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Cohesive ITM—the softest-feeling gel
Cohesive IITM³VOLJKWO\ÀUPHU
Cohesvie IIITM³0HQWRU·VÀUPHVWJHO
SILTEX
SILTE
SILT
E X TM Roun
Round
d
MemoryGel
M
G l TM
Breast Implant
Smooth Round
MemoryGel TM
Breast Implant
Sm
Smooth
Round
TM
SPECTRA
SP
SPECT
SP
Adjustable
Gel Breast Implant
MENTOR® CONTOUR PROFILETM Gel Breast
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Cohesive IIITM, to maintain their natural shape.
CONTOUR PROFILE TM Gel
(CPG TM)MemoryGel TM
Breast Implant
Cohesive III TM
- 21 -
WHY THIS
PICTURE
MATTERS
TO YOU:
Smooth Round
MemoryGel TM Breast Implant,
We have cut a
Cohesive I
MemoryGelTM
Breast Implant in half to demonstrate how the
gel material can hold together uniformly. It
does this because of a cohesive, gelatin-like
substance that acts as a solid rather than a
liquid maintaining its shape.
TM
Here's a summary of MENTOR® MemoryGelTM
Breast Implants product features:
Are CE-Marked
Are approved by the United States Food and
Drug Administration (FDA)(Round-Shaped Only)
$UHÀOOHGZLWK0HQWRU·VSURSULHWDU\FRKHVLYHJHO
2XUJHOÀOOHUXQLIRUPO\KROGVWRJHWKHUDQGUHWDLQV
a natural give that feels like breast tissue
Come in round and CONTOUR PROFILETM
Implant shapes
Come in various projection options to give you
just the look you want
Are available with either a smooth or textured
surface (SILTEXTM)
+DYHDVHWÀOOYROXPHIRUSUHGLFWDEOHUHVXOWV
Covered by the Mentor Lifetime Product
Replacement Policy and our PatientSafe
Coverage Limited Warranty
- 22 -
- 23 -
Saline Breast Implants
Saline-filled breast implants are filled with a
saltwater solution during surgery that is similar
to the fluid that makes up most of the human
body. For many women, deciding what breast
size they want is the most difficult part about
choosing implants. Saline comes in round and
CONTOUR PROFILE TM shape, in smooth and
SILTEX TM surface.
Mentor also offers an adjustable Saline Breast
Implant called the SPECTRUM TM Adjustable
Saline Breast Implant.
MENTOR ® Round and CONTOUR PROFILE TM
SPECTRUMTM Implants are the only salinefilled breast Implants with a removable fill
tube that lets your physician adjust the size of
your implants for up to six months after your
procedure by either adding or removing saline
through the fill tube.
SILTEX TM Round
Saline Breast Implant
Smooth Round
Saline Breast Implant
SI LTE
LT E X TM
CONTOUR PROFILE TM
SPECTRUMTM
Breast Implant
- 24 -
SILTEX TM
CONTOUR PROFILE TM
Saline Breast Implant
MENTOR® TISSUE EXPANDERS
CONTOUR PROFILETM Breast Tissue
Expander
The CONTOUR PROFILETM Breast Tissue Expander is
used in a two-stage breast reconstruction procedure to
expand the skin and create a shaped pocket for
implantation. This product is designed to expand
primarily in the lower portion of the breast, so the
resulting pocket will accommodate the implant
and slope like a mature breast. It also has an
integral injection dome that allows your surgeon
to add saline solution to the expander and
gradually stretch the breast tissue over several
months. Expansion is typically performed in an
RIÀFHSURFHGXUH
For some patients, the secondary surgery for
the expander/breast implant exchange can
be avoided by using a breast implant that is
postoperatively adjustable, or is a combination
W\SHH[SDQGHUEUHDVWLPSODQW,QDVLPSOHRIÀFH
SURFHGXUHDIWHU\RXUVXUJHU\WKHÁXLGYROXPH
of postoperatively adjustable implants can be
increased or reduced. This helps you to achieve
WKHÀQDOEUHDVWVL]H\RXGHVLUH
- 25 -
SILTEXTM BECKERTM Tissue Expander/Breast
Implants
The BECKERTM is the only gel product that gives
you the option of a
single or two-stage breast
reconstruction. These unique products have an
inner lumen containing saline that allows for
tissue expansion and an outer lumen of gel that
is designed to provide a softer feeling implant.
The remote injection dome makes volume
adjustments simple and are easily removed
when expansion is complete.
Smooth and SILTEXTM Round SPECTRUMTM
Breast Implants
The SILTEXTM SPECTRUMTM Implant functions as
both a tissue expander or a long-term saline
breast implant and it also gives you the option
of a
single or two-stage breast reconstruction. It
can be placed with minimal volume during your
LQLWLDOVXUJHU\ZLWKWKHÁXLGYROXPHJUDGXDOO\
being increased over time, which expands the
EUHDVWWLVVXH7KLVLPSODQWFRQWDLQVDÀOOWXEHDQG
remote injection dome that will be removed
ZKHQWKHÀQDOYROXPHLVUHDFKHG7KHH[SDQGHU
remains in place as the long-term breast implant.
SILTEX TM Round SPECTRUMTM
Breast Implant
SILTEX TM Round BECKER TM 25
Breast Implant
SILTEX TM CONTOUR PROFILE TM
Breast Tissue Expander
- 26 -
YOUR RECOVERY
Every woman’s recovery is different. In general,
you will probably feel a little sore for several days
following your breast reconstruction surgery.
7KHÀUVWWRKRXUVDIWHU\RXUSURFHGXUHLV
when you will experience the most discomfort.
Your breasts will be swollen and very tender.
Although every woman’s recovery is different,
you should be able to resume light activities in
approximately one week.
An important part of your recovery may involve
wearing a postoperative bra or compression
garment. These are designed to provide you with
extra support while you heal. Your doctor also
PD\KDYHRWKHUVSHFLÀFVXJJHVWLRQVIRU\RXWR
follow while you recover. If any problems occur
after your breast implant surgery, contact your
surgeon immediately.
- 27 -
- 28 -
PATIENTSAFE COVERAGE
LIMITED WARRANTY
A personal commitment to
your wellbeing
Your decision to use MENTOR®
Breast Implants for your breast
reconstruction is a personal,
long-term decision. Our
relationship with you does
not end with your surgery.
We make a long-term
commitment to our patients
and we stand behind the
integrity of our products.
All MENTOR® Breast Implants come with a Lifetime
Product Replacement Policy2 at no additional
charge. Also, once you receive MENTOR® Silicone
Gel-Filled Breast Implants, you are automatically
enrolled in the Mentor PatientSafe Coverage.
Lifetime Product Replacement Policy
Automatically applies to all recipients of
MENTOR ® Breast Implant products
Provides that regardless of the age of
WKHLPSODQWZKHQFRQÀUPHGUXSWXUH
occurs, you are eligible for a no-charge
replacement breast implant product of
any size in a similar style
2. Lifetime Product Replacement Policy: Mentor will provide replacement
MENTOR® Breast Implants of any size in the same or similar style as the originally
implanted product free of charge for the lifetime of the patient. Upon surgeon’s
request, a different implant style may be selected (subject to a charge of the
difference between product list prices).
- 29 -
$GGLWLRQDOEHQHÀWVZLWK3DWLHQW6DIHFRYHUDJH
The Mentor PatientSafe Coverage is free of charge
to all patients who are implanted with MENTOR®
Silicone Gel-Filled Breast Implant products.
Automatic enrollment
,QWKHFDVHRIFRQÀUPHGLPSODQWUXSWXUH
XSWR½RIÀQDQFLDODVVLVWDQFHIRU
operating room, anesthesia, and surgical
charges incurred in any revision surgery
carried out within 10 years of the date
of the original implant not covered by
insurance will be provided3.
Products covered
The Mentor PatientSafe Coverage applies to
MENTOR® Silicone Gel-Filled Breast Implants that
are implanted in the following countries:
Benelux, Denmark, France, Germany, Italy, Spain,
Sweden and the UK after October 1, 2005.
Czech Republic and Norway after February 1, 2007.
Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus,
Bulgaria, Burkina Faso, Croatia, Cyprus, Egypt, Estonia,
Finland, Georgia, Greece, Hungary, Iceland, Ireland,
Israel, Ivory Coast, Jordan, Kuwait, Latvia, Lebanon,
Lichtenstein, Lithuania, Macedonia, Malta, Morocco,
Oman, Pakistan, Poland, Portugal, Qatar, Reunion,
Romania, Russia, Saudi Arabia, Serbia & Montenegro,
Slovakia, Slovenia, South Africa, Switzerland, Tunisia,
Turkey, Ukraine, United Arab Emirates (UAE) and Yemen
after June 1, 2011.
And provided implants have been:
Implanted in accordance with the Mentor
package insert, current to the date of
LPSODQWDWLRQDQGRWKHUQRWLÀFDWLRQVRU
instructions published by Mentor
8VHGE\DSSURSULDWHO\TXDOLÀHGOLFHQVHG
surgeons, in accordance with accepted
surgical procedures
3. Operating room and anesthesia charges to be given payment priority. In order
WRTXDOLI\IRUÀQDQFLDODVVLVWDQFH\RXZLOOQHHGWRVLJQD5HOHDVHIRUPDQGWKH
Patient claim form. Financial assistance does not imply a loan to the patient.
- 30 -
Events covered
The Mentor Lifetime Replacement policy and
PatientSafe Coverage only apply to:
Cases of loss of shell integrity resulting
in implant rupture that require surgical
intervention
0HQWRUUHVHUYHVWKHULJKWWRGHWHUPLQHLIVSHFLÀF
additional events should be covered.
Events not covered
The Mentor Lifetime Replacement policy and
PatientSafe Coverage do not apply to:
Removal of intact implants due to
capsular contracture, wrinkling, or rippling
Loss of implant shell integrity resulting
from reoperative procedures, open
capsulotomy, or closed compression
capsulotomy procedures
Removal of intact implants for size
alteration
Surgery on the opposite breast to replace
an intact implant
You may also obtain a copy of the complete Mentor
PatientSafe Coverage limited warranty by going to
www.mentorwwllc.com or by writing to:
Mentor Medical Systems CV
Zernikedreef 2
2333 CL, Leiden
The Netherlands
Phone +31-71-7513600
THIS IS A LIMITED WARRANTY ONLY AND IS SUBJECT
TO THE TERMS AND CONDITIONS SET FORTH IN THIS
DOCUMENT AND EXPLAINED IN GREATER DETAIL IN
THE APPLICABLE MENTOR LIMITED WARRANTY. ALL
OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED,
BY OPERATION OF LAW OR OTHERWISE, INCLUDING
BUT NOT LIMITED TO, IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS, ARE EXCLUDED, TO THE
EXTENT PERMITTED BY LAW.
THE TERMS IN EFFECT WHEN ORIGINAL IMPLANTATION
OCCURS WILL APPLY AT THE TIME OF CLAIM.
- 31 -
PatientSafe claimform
In order to assess your eligibility for PatientSafe
Coverage for MENTOR®6LOLFRQH*HOÀOOHG%UHDVW
Implants, Mentor Medical Systems CV needs
to collect the following information through its
local operations or from your surgeon. Please
ensure that you complete this form and return
it to your surgeon who will then forward it to the
appropriate local Mentor representative.
Name:
Address:
Date and place of surgery:
Name of surgeon:
Implant Style and Size used:
Lot#:
Serial#:
Data protection
Mentor will use this information to communicate
with you and to assess your eligibility for PatientSafe
Coverage only. Mentor will not share this information
with parties other than your health provider or local
Mentor contact, unless required for legal or regulatory
compliance or litigation. Mentor will retain the
information for the duration of your use of the Silicone
*HOÀOOHG%UHDVW,PSODQWVRUZKHUHDORQJHUUHWHQWLRQ
period is required or permitted by law.
3OHDVHFRQÀUPWKDWWKHLQIRUPDWLRQDERYHLVDFFXUDWH
and that you agree with the collection and use of your
personal information as described above, by signing
below. If you have any questions, or if you wish to
request access, correction, or deletion of any personal
information, please contact us directly at:
Mentor Medical Systems CV
Zernikedreef 2
2333 CL, Leiden
The Netherlands
Phone +31-71-7513600.
Date
Signature
- 32 -
- 33 -
BREAST RECONSTRUCTION
RESOURCES
The following list of resources may help you to
ÀQGPRUHLQIRUPDWLRQDQGVXSSRUWIRU\RXUEUHDVW
reconstruction decision.
Cancerworld
www.cancerworld.org
France
Breast Cancer Information
www.cancerdusein.org
French Society of Plastic Surgeons
www.plasticiens.org
Germany
Breast Cancer Information
www.brustkrebs.de
German Association of Plastic Surgeons
www.vdpc.de
Italy
Breast Cancer Information
www.senologia.it
Italian Society of Plastic Surgeons
www.sicpre.org
Spain
Spanish Cancer Association
www.aecc.es
Spanish Society of Plastic Surgeons
www.cirugia-plastica.org
United Kingdom
Breast Cancer Care
www.breastcancercare.org.uk
British Association of Plastic Surgeons
www.baps.co.uk
For the most comprehensive information
about reconstructive surgery,
we invite you to visit
www.YourBreastOptions.com
- 34 -
BREAST IMPLANT SAFETY
STUDY INFORMATION
For the past several years, there have been
many reports in the media about women with
breast implants who have autoimmune disease
or breast cancer. Also during this time, many
respected medical professionals and institutions
KDYHFRQGXFWHGVFLHQWLÀFVWXGLHVDERXWWKH
safety of breast implants. Mentor is pleased to
be able to provide the public with up-to-date
information about breast implant studies.
Institute of Medicine
In June 1999, the National Academy Institute
of Medicine issued a report that included the
following conclusion: In an overall consideration
of the epidemiological evidence, the committee
noted that because there are more than 1.5
million adult women of all ages in the United
States with silicone breast implants, some of
these women would be expected to develop
connective tissue diseases, cancer, neurological
diseases or other systemic complaints or
conditions. Evidence suggests that such
diseases or conditions are no more common
in women with breast implants than in women
without implants. The full text of the publication,
Information for Women About the Safety of
Silicone Breast Implants—A Report of a Study by
the Institute of Medicine4, is available online at
www.nap.edu.
4. Bondurant, Stuart; Ernster, Virginia L.; Herdman, Roger; The Safety of Silicone
Breast Implants. (US). Committee on the Safety of Silicone Breast Implants National
Academies Press, 2000—Medical Reference can be found: http://books.google.com/
books?id=h1owCkaIg-oC&dq=isbn:0309065321.
- 35 -
Independent Review Group
The Independent Review Group (IRG) on Silicone
Breast Implants was assembled by the Chief
0HGLFDO2IÀFHURIWKH8.WRUHYLHZWKHSRVVLEOH
health issues associated with silicone gel breast
implants. Members of the IRG were selected for
their independent views, their knowledge and
understanding of the issues, and lack of any
ÀQDQFLDOLQWHUHVWLQWKHFRQFOXVLRQVWKH\UHDFKHG
Led by Professor Roger D. Sturrock, MD, FRCP,
WKH,5*UHSRUWHGLQWKDWWKHUHLVQRVFLHQWLÀF
evidence of an association between silicone
JHOÀOOHGEUHDVWLPSODQWVDQGDQ\HVWDEOLVKHG
connective tissue disease. The complete report is
available online at www.silicone-review.gov.uk5.
European Committee on Quality Assurance
In July 1998, the European Committee on Quality
Assurance and Medical Devices in Plastic Surgery
released a report that contained the following
conclusions: 7KHUHDUHFRQFOXVLYHVFLHQWLÀF
clinical, immunological, epidemiological data,
WKDWVLOLFRQHJHOÀOOHGEUHDVWLPSODQWVGRQRW
cause any autoimmune nor connective tissue
diseases. Their report also stated,
Updated studies
continue to show that silicone gel-filled implants do
not cause cancer nor other malignant disease. The
entire declaration can be found online at www.
LELURUJHTXDPDUFKLYHFRQVGHFMXQHÀQDO
doc6.
5. MHRA Website. www.mhra.gov.uk. Accessed June 22, 2011.
6. The European Committee on Quality Assurance and Medical Devices in Plastic
Surgery Website. ZZZLELURUJHTXDPDUFKLYHFRQVGHFMXQHÀQDOGRF
Accessed June 22, 2011.
- 36 -
QUESTIONS TO ASK YOUR
PLASTIC SURGEON
What are all my options for breast reconstruction?
What are the possible risks and complications for
each type of breast implant surgery, and how
common are they?
What if my cancer recurs or occurs in the other breast?
Will reconstruction interfere with my cancer treatment?
How many steps are there in each procedure,
and what are they?
How long will it take to complete my reconstruction?
How much experience do you have
with each procedure?
Do you have before-and-after photos I can
look at for each procedure? What results are
reasonable for me?
What will my scars look like?
What kind of changes in my implanted breast can
I expect over time?
What kind of changes in my implanted breast can
I expect with pregnancy?
:KDWDUHP\RSWLRQVLI,·PGLVVDWLVÀHGZLWKWKH
cosmetic outcome of my implanted breast?
Can I talk with other patients about their experience?
For staged reconstruction, what is the estimated
total cost of each procedure?
How much will my health insurance carrier cover,
especially any complication that may require
surgery?
How much pain or discomfort will I feel, and for
how long?
Will I need to replace my implant at some point?
How long will I be in the hospital?
Will I need blood transfusions, and can I donate
my own blood?
When will I be able to resume my normal activities
(sexual activity or athletic activity)?
Who is the manufacturer of my breast implant?
Does the manufacturer have a product warranty?
- 37 -
- 38 -
GLOSSARY
Aspiration:7KHZLWKGUDZLQJRIDÁXLGIURPWKHERG\E\
means of suction.
BECKERTM: The BECKERTM Adjustable Breast Implant is the
only gel product that gives you the option of a single or
two-stage breast reconstruction. This unique product has
an inner lumen containing saline that allows for tissue
expansion and an outer lumen of gel that is designed
to provide a softer feeling implant. The remote injection
dome makes volume adjustments simple and are easily
removed when expansion is complete.
Biocompatible: Being biologically compatible by not
producing a toxic response in living tissue.
Breast Implant:$VRIWVLOLFRQHHQYHORSHZLWKYDULRXVÀOOHUV
that can be placed in the body for simulated breast tissue.
Breast Reconstruction: A surgical procedure that
rebuilds a removed breast.
Buttocks Flap Reconstruction: A breast reconstruction
RSHUDWLRQWKDWXVHVDÁDSIURPWKHEXWWRFNVWKDWLV
transferred to the chest to create a breast mound.
Capsular Contraction: A tightening of the scar tissue
surrounding an implant.
CPGTM: MENTOR® CONTOUR PROFILETM Gel Breast
Implant.
Delayed Reconstruction: Breast reconstruction that
takes place weeks, months or years after a mastectomy.
A DIEP Flap: is a type of Breast reconstruction in which
blood vessels called Deep Inferior Epigastric Perforators
(DIEP), and the skin and fat connected to them are
removed from the lower abdomen and transferred to
the chest to reconstruct a breast after mastectomy
ZLWKRXWWKHVDFULÀFHRIDQ\RIWKHDEGRPLQDOPXVFOHV
7KH',(3ÁDSLVVLPLODUWRWKHPXVFOHVSDULQJIUHH75$0
ÁDSEXWRQO\UHTXLUHVWKHUHPRYDORIVNLQDQGIDW
Envelope: The outer lining of an implant which traps
WKHLQQHUÀOOLQJVHDOLQJLWLQ
Expander/Mammary Implant: A breast implant that
also acts as a tissue expander, stretching the tissues,
but then also remains in place as a breast implant.
- 39 -
Fibrous Tissues: Connective tissues composed mostly of
ÀEHUV
Flap: A portion of tissue, which may include muscle, fat
and skin, with its blood supply moved from one part of
the body to another.
Flap Reconstruction: Rebuilding of a removed breast
XVLQJDÁDSWRIRUPWKHEUHDVWPRXQG
Glandular: Relating to a gland.
Hemorrhage: Abnormal internal or external discharge
of blood.
Immediate Reconstruction: Breast reconstruction that
takes place during the same surgical procedure as a
mastectomy.
Inpatient Surgery: A surgical procedure in which the
patient is required to stay overnight in a hospital.
Latissimus Dorsi Flap Reconstruction: Breast
reconstruction that utilises the patient's own tissue
transferred from the latissimus dorsi muscle, located in
the back, to build a breast mound.
Lumpectomy: Surgical removal of a cancerous tumor
along with a small margin of surrounding tissue.
Lymph Nodes: Structures in the lymphatic system that
DFWDVÀOWHUVFDWFKLQJEDFWHULDDQGFDQFHUFHOOVDQG
that contribute to the body's immune system.
Mastectomy: The removal of breast tissue due to the
presence of a cancerous or precancerous growth.
Mastopexy: Breast lift to tighten the breast by removing
skin that the forces of gravity and the effects of aging
have caused to sag.
MemoryGelTM Breast Implants: 0HQWRU
VJHOÀOOHGEUHDVW
implant.
Milk Ducts: Tubes for the passage of secreting milk.
0RGLÀHG5DGLFDO0DVWHFWRP\Surgical removal of the
breast, some fat and most of the lymph nodes in the
armpit, leaving the chest wall muscles largely intact.
Opaque: Not transparent; impenetrable by visible light
rays and x-rays.
- 40 -
Outpatient Surgery: A surgical procedure in which the
patient is not required to stay overnight in a hospital.
Pectoralis Major: A muscle located in the upper chest
which provides support for the breasts and is necessary
for arm movements.
Postoperatively Adjustable Implant: An implant that
allows the volume to be adjusted, after implantation,
ZLWKLQDVSHFLÀHGUDQJH
Prosthesis$Q\DUWLÀFLDOERG\SDUW
Ptosis: Sagging. Breast ptosis is usually the result of
normal aging and the pull of gravity or changes
caused by pregnancy or weight loss.
Radical Mastectomy: Removal of the breast,
underlying muscles and underarm lymph nodes.
Saline: A solution that is made up of water and a small
amount of salt. Approximately 71% of an adult's body
weight consists of this saltwater solution.
Sensory Nerves: The nerves that conduct afferent impulses
from sensory receptors to the brain or spinal cord.
Sepsis: The presence of various microorganisms, their
poisonous products or their toxins in the blood or tissue.
Silicone: A material that is widely used in medical
implants, composed primarily of silicon, carbon,
hydrogen and oxygen.
Silicone Gel: Silicone produced in a semisolid,
VHPLOLTXLGVWDWHXVHGDVDÀOOLQJLQEUHDVWLPSODQWV
similar in consistency to a normal breast.
SILTEXTM: Mentor's textured breast implant surface.
Simple Mastectomy: Removal of the breast only.
SPECTRATM: Mentor's adjustable gel breast implant.
Thrombosis: The formation or development of a blood clot.
Tissue Expander: An adjustable implant that can be
LQÁDWHGZLWKVDOWZDWHUWRVWUHWFKWKHWLVVXHVDWWKH
mastectomy site.
Tram Flap Reconstruction: Breast reconstruction that
utilises the patient's own lower abdominal tissue and
muscle to build a breast mound.
- 41 -
MENTOR—
A COMPANY THAT CARES
Founded in 1969, Mentor is a leading supplier
of medical products in over 100 countries
throughout the world. As the world’s leading
maker of high-quality breast implants, our years
of experience result in quality products that you
can rely on.
MENTOR® Gel-Filled Breast Implants are made
at our state-of-the-art manufacturing plant
in Leiden, The Netherlands. This advanced
manufacturing facility is the largest of its kind
in the world. It features many groundbreaking
engineering advances that are new to the
breast implant industry.
Mentor conducts research, development and
manufacturing at several facilities throughout
Europe and the United States. The company
also has sales and distribution outlets around the
ZRUOG,Q0HQWRUEHFDPHWKHÀUVWEUHDVW
implant manufacturer to achieve CE-marking
for its products.
Mentor is proud of the quality built into each of
our breast implants, and you can be assured
that behind your decision to use our products is
a company that understands your hopes and
desires and a company that truly cares.
- 42 -
IMPORTANT SAFETY
INFORMATION:
MENTOR® MemoryGelTM and MENTOR® Saline-Filled Breast Implants are
indicated for breast augmentation—in women who are at least 18 years
old—or for breast reconstruction. Breast implant surgery should not be
performed in women with active infection anywhere in their body, with
existing cancer or precancer of their breast who have not received
adequate treatment for those conditions or are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are
not lifetime devices and breast implantation is likely not a one-time surgery.
You may need additional unplanned surgeries on your breast because of
complications or unacceptable cosmetic outcomes. Many of the changes
to your breast following implantation are irreversible (cannot be undone)
and breast implants may affect your ability to breastfeed, either by
reducing or eliminating milk production.
The most common complications with MemoryGelTM Breast Implants
include reoperation, capsular contracture, asymmetry, and breast pain.
A lower risk of complication is implant rupture, which is most often silent
(meaning neither you nor your doctor will know you have a rupture).
7KHKHDOWKFRQVHTXHQFHVRIDUXSWXUHGVLOLFRQHJHOÀOOHGEUHDVWLPSODQW
have not been fully established. Screenings such as mammography, MRI,
or ultrasound are recommended after initial implant surgery to assist in
detecting implant rupture.
The most common complications with MENTOR® Saline-Filled Breast
Implants include reoperation, implant removal, capsular contracture,
ZULQNOLQJEUHDVWSDLQDQGGHÁDWLRQ
CONTOUR PROFILETM Tissue Expanders and Smooth Round Tissue
Expanders with Remote Dome are used for breast reconstruction following
mastectomy. These expanders are intended for temporary subcutaneous
or submuscular implantation and are not intended for use beyond six
months. You should not have an MRI while the CONTOUR PROFILETM Tissue
Expander or Smooth Tissue Expander with Remote Dome is implanted.
The device could be moved by the MRI causing pain or displacement,
potentially resulting in a revision surgery. The incidence of extrusion of the
expander has been shown to increase when the expander has been
placed in injured areas: scarred, heavily irradiated or burned tissue,
crushed bone areas or where severe surgical reduction of the area has
previously been performed.
Patients are reminded to discuss the indications, contraindications,
ZDUQLQJVSUHFDXWLRQVDQGWKHULVNVDQGEHQHÀWVDVVRFLDWHGZLWK
MENTOR® Breast Implants with their surgeons or review detailed risk
information on line at www.mentorwwllc.com.
It is important that you understand the risks associated with breast implant
surgery when considering MENTOR® Breast Implants.
Corporate Headquarters
Santa Barbara, CA 93111 USA
Tel: +1 805 879 6000
www.mentorwwllc.com
Local Address Here
© Mentor Worldwide LLC 2011 0210009 Rev G 9/13
NOT FOR DISTRIBUTION IN USA. APPROVED FOR EMEA REGION.