Breast Augmentation - Mentor Worldwide LLC

Discover your
Breast
Augmentation
Options
We are prouD to Be the
ONLY BREAST IMPLANT
Company that
manufaCtures
in the uSA.
WHy Does THAT MATTer To you?
For over 25 years, Mentor has been
recognized worldwide as a leading
manufacturer of the highest quality
breast implants. An implant you can
trust, proudly made in the usA.
We’re here to help you
maKe a ConfiDent,
informeD DeCision.
This brochure contains the latest information
about breast implants for augmentation or
revision surgery to help you prepare for your process
ahead. inside you will find basic information about
breast augmentation and the different options
available from Mentor. clarifying your own
appearance goals and identifying the questions
you’ll want to ask along the way are important
steps in considering breast augmentation.
reADy To GeT sTArTeD?
For over 25 years, Mentor has been recognized
worldwide as a leading manufacturer of the
highest quality breast implants.
our rich history is filled with industry firsts,
innovative product designs, and groundbreaking
research. While other manufacturers have come and
gone, Mentor has a record of continually producing
leading-edge, FDA approved breast augmentation
products. We are dedicated to providing proven,
safe, and effective products and service.
Table of Contents
1
It All Begins With You
3
Breast Anatomy 101
Surgery: The Details
7Implant Sizes
11
Implant Types and Profile
12 Which type of Mentor®
Implant is right for you? 14 MENTOR® MemoryShape®
Breast Implants
16 MENTOR® MemoryGel®
Breast Implants
19 MENTOR® Saline Filled
Breast Implants
MENTOR® SPECTRUM®
Adjustable Saline Breast Implant
20 Facts about Silicone Gel Filled Breast Implants
24 Mentor Product Replacement
Policy and Limited Warranties
27 Selecting the Right
Surgeon for You
30 Frequently Asked Questions
About Breast Implants
37 Breast Augmentation Resources
it all Begins With you
How a woman feels about her body has a lot to do with
her overall self-confidence…that’s no secret. When
breast size or shape is an issue, many women turn to
breast augmentation to increase their confidence,
look better in their clothes, and…bottom line…
present the image they want to the world.
What is your reason for exploring
breast surgery?
• Do you want to enlarge your breasts to make
your body more proportional or your breasts
more balanced in size?
• is your goal to reshape and enlarge your breasts
because they have lost their shape due to
pregnancy and breastfeeding?
your reasons are as unique as you are.
That’s why it’s important to have a good understanding about your personal needs and expectations, and
be able to express them to your surgeon. Together
you can discuss the options available to you and
choose just the right implants for your body and desired outcome. Learning about the breast augmentation procedure is the first step in your journey to a
beautiful new you.
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THe TecHnicAL DeFiniTion
oF A BreAsT iMPLAnT:
A breast implant is a sack (implant shell)
made of silicone elastomer filled with
either silicone gel or saline, that is
surgically implanted under your breast
tissue or under your chest muscle.
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Breast anatomy 101
Pectoralis Major Muscle
Pectoralis Minor Muscle
Fatty Tissue
Milk Lobes, Glands
Milk Ducts
nipple and Areola
soft Tissue
ribs
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 cause
changes in your breasts over time.
implants are used to make breasts larger; however,
implants alone may not adequately lift the breast.
Additional procedures may be recommended to
achieve your goals. Procedures such as a mastopexy
may be suggested at the time of your breast
augmentation to lift the breast.
surgery: the Details
The surgical setting and anesthesia
Most often, augmentation surgery is performed on an
outpatient basis in a specialized operating room located
in a hospital, a surgery center, or a surgical suite in the
surgeon’s office. General anesthesia is commonly use
but local anesthesia with sedation is also an option.
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Important: Your surgeon should give you
specific instructions before surgery
Ask about any tests or presurgical examinations that
you’ll need prior to surgery. Also ask how long you need
to be without food or your routine medications prior to
surgery, and for any other directions you should follow.
Incision and placement options
Your surgeon will be your best guide when it comes
to the pros and cons of the incision site specifically
recommended for you. A few facts:
Size of incision
The incision size for a gel breast augmentation will
be larger than the incision size of a saline breast
augmentation.
Location of incision
There are three common incision sites:
• Around the nipple (periareolar)
• Within the breast fold (inframammary)
• Under the arm (axillary)
Axillary Incision
Periareolar Incision
Inframammary Incision
Types of incisions
• Periareolar – This incision is typically well
concealed, but since it also involves cutting
through the breast tissue, it is associated with
a higher likelihood of breastfeeding difficulties,
as compared to the other incision sites.1 Cutting
through the tissue may increase the chance that
there will be a change in breast or nipple sensation.
• Inframammary – This is the most commonly used
incision site at the present time. This incision is
1
Hurst, N.M. Lactation after augmentation mammoplasty.
Obstet. Gynecol. 1996;87(1):30-4.
{4}
generally less concealed than the periareolar and
may cause fewer breastfeeding difficulties than
the periareolar incision site.
• Axillary –This incision is less concealed than
the periareolar and may cause fewer breastfeeding
difficulties than the periareolar incision site. When
the incision is made under the arm, the surgeon may
use a probe fitted with a miniature camera, along
with minimally invasive, very small instruments, to
create a “pocket” for the breast implant.
• umbilical (belly button) – An incision made through
the umbilical channel. This incision site has not been
studied in the Mentor core study.
Another consideration: implant placement
The breast implant can be placed either partially under
the pectoralis major muscle (submuscular) or on top of
the muscle and under the breast glands (subglandular).
it is important to fully understand the advantages and
disadvantages of the implant’s placement. Take a look
at the benefits and negative features of each implant
placement option. Your surgeon will recommend the
approach best-suited to your body type and goals.
suBMuscuLAr PLAceMenT
•
•
•
•
•
surgery and recovery may be longer
recovery may be more painful
reoperation may be more difficult
Less visible and palpable implants
easier imaging during mammography
exam
• May be preferable if you have thin or
weakened breast tissue
suBGLAnDuLAr PLAceMenT
submuscular
Placement
• surgery and recovery may be shorter
• recovery may be less painful
• May provide easier access for
reoperation
• More visible and palpable implants
• More difficult imaging during
mammography exam
• May not be recommended if you have
thin or weakened breast tissue
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subglandular
Placement
PosToPerATive cAre
Give yourself time to relax and heal—
take care of yourself after surgery
Most women feel a bit tired and sore for several days
following surgery. your breasts may remain swollen
and sensitive to physical contact for a month or longer. you may also experience a feeling of tightness
in the breast area as your skin adjusts to your new
breast size. The feeling in the breasts and nipple area
also may be diminished during this time of swelling
and immediate postsurgery recovery. you should
talk to your surgeon about potential complications
that may follow your breast augmentation surgery.
Postoperative care can vary
you may be told to use a specific postoperative
bra, compression bandage, or jog bra for extra
support and positioning while you heal. some
surgeons may not want you to wear a bra at all
for a period of time following your surgery.
When can you resume your normal
activities?
Talk to your surgeon about your lifestyle and what
activities you may want to refrain from while your
body heals. you can probably return to work within
a few days. your surgeon will probably want you to
avoid strenuous activities for a couple of weeks that
could raise your pulse or blood pressure, or require
strenuous use of your arms and chest. your surgeon
may also recommend breast massage exercises.
Keep your breast implant iD card for later
reference
When you have breast augmentation, you will be
given a device identification card with the style and
serial number of your breast implant(s). This will be
given to you right after your surgery. it is important
that you keep a copy of this card because you may
need to refer to the information at a later date.
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What aBout an
implant’s size?
Breast implants are not measured in
bra cup sizes
Breast implants are measured in cubic centimeters,
or cc’s, not in cup sizes. This is because the size of the
implant used depends on the size and shape of the
individual woman’s chest.
your surgeon will evaluate your existing
breast and skin tissue
He or she needs to determine if you have enough
breast and skin tissue to cover the breast implant
you are considering, or in some cases such as after
pregnancy, too much extra skin. if you want a breast
implant size that is too large for your tissue, your
surgeon may warn you that the breast implant edges
may become visible following your surgery.
What else determines if the implant can be
detected by feel?
implant placement, size and the amount of skin
and tissue coverage over an implant also determine
how easily an implant can be felt. For example, implants
placed subglandularly (above the chest muscle) tend
to be more conspicuous than implants placed
submuscularly (below the chest muscle).
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hoW Will i KnoW WhiCh
size is right for me?
During your office consultation, your surgeon may
use different tools to help you select the right product for your new look. one such tool is the MenTor®
volume
sizing system.
These prosthetic sizing devices are uniquely designed to be placed onto your breast to create a
realistic preview of your new size. your surgeon may
also use the MenTor® BodyLogic® system to assist
in making informed product selection decisions
NATuRAL LOOK
AuGMENTED LOOK
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based on the precise measurements of your body. in
addition to measurements, your surgeon may use illustrations such as the ones below to better understand
the final look that you desire*.
TyPe 1 – A gentle filling out of the breast
in a way that is completely natural with no
excess fullness in the upper pole of the
breast. A larger implant could potentially
be used, but desired outcome is a
conservative augmentation.
TyPe 2 – Largest implant that can be used
without creating a breast which has an unnatural look. Desired outcome is to avoid
obvious look of a breast augmentation.
TyPe 3 - Large breast augmentation
resulting in a mildly unnatural look such as
a noticeably rounded contour in the upper
pole of the breast.
TyPe 4 – Largest implant possible,
knowing that it will create a distorted
unnatural look and obvious breast
augmentation.
*These tools are meant to assist you in selecting the right implant to achieve the patient’s desired
results. How you use these toolswill depend upon your personal preferences and experience. The
MENTOR® Volume Sizing System does not dictate a specific implant, but provides guidance in selecting a range of devices that will increase the likelihood of patient satisfaction. The MENTOR® Volume
Sizing System is not intended to replace your independent professional judgment.
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DECIDING ON an Implant
Type and profile is as
important as size
Round or Shaped? Gel or Saline? Smooth
or Textured?
The following pages provide detail about each type
of implant to help you understand your choices.
There are three basic types of implants: round gel,
shaped gel, and saline filled. In addition to shape,
breast implants are available in two shell surfaces,
smooth or SILTEX® Imprinted Texture, and a variety
of profiles. Profile refers to the amount of forward
projection of the implant off the chest wall. Higher
profile implants create a more prominent silhouette
than a lower profile breast implant.
SHAPED SILICONE GEL IMPLANTS are the newest
available option. MENTOR® MemoryShape® Breast
Implants are teardrop-shaped and made of a highly
cohesive silicone gel that maintains the implant’s
shape. Much like the silhouette of a natural breast,
they gently slope to a full projection point in the
lower portion of the implant. Also, a teardropshaped implant is thinner at the top, therefore it
gradually blends into the upper chest.
Round Silicone Gel implants are available as
MENTOR® MemoryGel® Breast Implants. These
implants are filled with a proprietary softer cohesive
gel, relative to MemoryShape® Breast Implants that
resembles the natural feel of breast tissue.
MemoryGel® Implants come in both smooth and
textured surfaces, and a range of profiles. High profile implants provide the greatest forward projection
for a more prominent silhouette, and are designed
for a narrower chest area.
Saline-Filled Implants are filled with a saltwater solution similar to the fluid that makes up most of
the human body. They have a slightly firmer feel than
gel implants. They are available in both smooth and
textured surfaces and a range of profiles.
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WhiCh type of mentor®
Breast implant is right
for you?
Here is a summary look at some of the features of
MenTor® MemoryGel® Breast implants, MenTor®
Memoryshape® Breast implants, and saline-Filled
implants. This side-by-side comparison can help you
determine which implant type is right for you. your
plastic surgeon is another excellent resource with
whom to discuss your options.
HoW Do MenTor’s
MenTor® MeMorysHAPe®
BreAsT iMPLAnT
FDA approved
YES
Made in the uSA
YES
Fill
Filled with a highly cohesive gel for
durable shape retention
designed to give a youthful feel.
Volume
set fill volume for predictable results.
Projection options
Teardrop-shaped to match the natural
slope of a breast with full projection point at the lower portion of the
implant.
Shell surface options
Warranty
imprinted with MenTor® siLTeX®
Texture designed to keep your
implants in place.
covered by the Mentor replacement Policy, Mentor Warranty, and
enhanced Warranty.
{ 12 }
seeing is believing.
cross section of a MenTor® Memoryshape®
Breast implant illustrating cohesive gel fill.
siLicone AnD sALine iMPLAnTs coMPAre?
MenTor® MeMoryGeL®
BreAsT iMPLAnT
sALine FiLLeD
BreAsT iMPLAnT
YES
YES
YES
YES
Filled with a proprietary cohesive
gel that holds together uniformly
while retaining the natural give
that resembles breast tissue.
Filled with a saltwater solution
similar to the fluid that makes up
most of the human body;
slightly firmer feel than gel.
set fill volume for predictable
results.
Flexible fill volume, allowing the
surgeon to adjust the volume
during the procedure.
Four projection options:
Moderate classic, Moderate Plus,
High and ultra High Profiles.
Three projection options:
Moderate, Moderate Plus, and
High Profiles.
Two shell surfaces available:
smooth and textured (MenTor®
siLTeX® Texture).
Two shell surfaces available:
smooth and textured (MenTor®
siLTeX® Texture).
covered by the Mentor replacement Policy, Mentor Warranty, and
enhanced Warranty.
covered by the MenTor
standard & enhanced Advantage
Limited Warranties and
Lifetime replacement Policy.
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MENTOR® MemoryShape®
Breast Implants
A new addition to our family of products
Our MemoryShape® Implants give your surgeon
an additional choice to help you achieve a naturallooking silhouette.
Trusted and Proven
With over 10 years of surgical use, and available in
more than 70 countries worldwide*, MemoryShape®
Breast Implants are a leading choice for women who
could benefit from an implant that helps create the
natural shape of the breast. 2
Youthful firmness
The cohesive gel that Mentor uses is formulated
unlike any other to give your breasts a youthful feel.
Gentle texture
Each MemoryShape® Implant features SILTEX®
Texture, a gentle imprinting process designed
to help keep your implants in place.
Are MemoryShape® Implants
right for you?
As with all breast implant choices, you and your
surgeon will take into consideration your unique
features, as well as your desired outcomes in order
to give you the beautiful result you’re looking for.
Following are some of the factors that may guide
you and your surgeon’s decision to choose
MemoryShape® Implants.
* Referred to as MENTOR® CPG™ Gel Breast Implants outside the United States.
2
Data on file at MENTOR Worldwide LLC.
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If you’re considering augmentation
with MemoryShape® Breast Implants:
Do you have a certain look in mind? Teardrop-shaped
implants are made to match the silhouette of a
natural breast with more fullness at the bottom than
at the top. If this is the look you want, MemoryShape®
Implants may be right for you. If you want a look that
is more “round” at the top of your breast, you should
discuss MemoryGel® Round Breast Implants with
your surgeon.
Is the feel of the breast implant most important
to you? MemoryShape® Implants are filled with a
highly cohesive silicone gel that helps the implant
create a natural breast silhouette. Although this gel
is pliant, it may feel firm. If it is a top priority that
your implant have a soft feel, ask your surgeon about
MemoryGel® Breast Implants. They are a round breast
implant option with a slightly softer feel.
15} }
{ {15
Do you have sufficient tissue coverage? An important
consideration in determining if Memoryshape® Breast
implants may be a good choice for you is the amount
of breast tissue coverage you have. During your
consultation, your surgeon will evaluate your breast
tissue to determine if Memoryshape® implants are
well suited to you.
Do you have an incision site preference? When
placing a breast implant, there are three common
incision sites: around the nipple (periareolar), within
the breast fold (inframammary), and underneath
the arm (axillary). Memoryshape® implants may be
placed using any of these incision sites. However, the
most common incision site is within the breast fold.
Teardrop-shaped implants may require a larger incision
than round implants.
mentor® memorygel®
Breast implants
smooth round Moderate
classic Profile implant
smooth round Moderate
Plus Profile implant
smooth round ultra
High Profile implant
smooth round
High Profile implant
siLTeX® roundModerate
classic Profile implant
siLTeX® roundModerate
Plus Profile implant
siLTeX® round ultra
High Profile implant
siLTeX® round
High Profile implant
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A trusted choice
After decades of research and testing,
MemoryGel® Breast implants were approved by the
FDA for women in the us. MemoryGel® implants
have now been successfully used and trusted for
over 25 years by millions of women worldwide.
Why? Because our implants feel like natural breast
tissue—without compromising reliability or safety.
MemoryGel® implants come in either a textured
or smooth surface shell and are available in a wide
range of sizes and profiles to fit your body.
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A PicTure is WorTH A
THousAnD WorDs
We have cut a MenTor® MemoryGel®
Breast implant in half to demonstrate
how the gel material holds together
uniformly. MemoryGel® silicone Gel
is a cohesive, gelatin-like
substance that does not
pour or separate like a
liquid, but acts more
like a solid.
our adherence to strict quality
manufacturing requirements
has resulted in silicone shells that
have been tested and shown to possess
excellent strength, resilience and elasticity.
We’re proud of our MemoryGel® implants
and it’s easy to see why:
•
MemoryGel® Breast implants are one of
the most studied medical devices in the world
•
We conduct rigorous, multi-level
testing at every step of manufacturing
•
The uniquely formulated cohesive gel
creates the soft, natural feel preferred
by millions of women
{ 18
{ 18} }
mentor® saline Breast
implants— another option
MenTor® saline Filled Breast implants also come in
a variety of shapes, sizes, profiles, and surface textures.
saline implants are inserted into the body without fluid.
once placed, the implant is filled to the predetermined
size.
smooth
round Moderate
Profile implant
smooth
round Moderate Plus
Profile implant
smooth
round High Profile
implant
siLTeX®
round Moderate
Profile implant
siLTeX®
conTour ProFiLe®
Moderate implant
siLTeX®
conTour ProFiLe®
High implant
mentor® speCtrum®
aDJustaBle saline Breast
implants
An innovative line of adjustable implants
often, the most difficult decision for most women
regarding breast augmentation is choosing the breast
size. The innovative line of sPecTruM® implants
makes the decision-making process easier because the
size can be adjusted after surgery. in fact, sPecTruM®
implants are the only postoperatively adjustable saline
filled breast implants that allow your surgeon to adjust
the size of your implant for up to six months after your
procedure.
smooth round
sPecTruM® implant
siLTeX® round
sPecTruM® implant
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siLTeX®
conTour ProFiLe®
sPecTruM® implant
faCts aBout siliCone gel
filleD Breast implants
The History of silicone
Did you know silicone has been used in
hundreds of thousands of medical devices
for over 50 years?
catheters, heart valves, pacemakers, artificial joints
and tissue expanders…just to name a few you are familiar with. surgeons have trusted silicone for years
because they know it is reliable, easy to sterilize,
biocompatible, and flexible when used in both
implantable and nonimplantable medical devices.
MenTor® silicone Gel Filled Breast implants first
became available in the united states in April 1984.
in 1992, the Food and Drug Administration called
for a moratorium (removal from the marketplace)
to the sale and use of silicone filled breast implants,
limiting patient access to silicone filled breast
implants and requiring implant manufacturers to
collect clinical study data. shortly after the start of
the moratorium the FDA decided to allow breast reconstruction patients as well as women with existing
breast implants the option to receive silicone filled
breast implants through a clinical study – the Mentor
Adjunct study–to collect data about device performance and safety from 1992-2006. This study
has been one of the largest clinical device studies
conducted in the world, with more than 150,000
patients participating.
in september 2000, the core study to demonstrate
long-term safety and effectiveness of the silicone
gel breast implants began enrollment. This was
designed to follow women undergoing primary augmentation, primary reconstruction, or revision for
10 years after initial implantation.
Based on the pivotal core study data, and supported
by the Adjunct study data, the FDA approved the
Premarket Application (PMA) for MemoryGel® Breast
implants in november 2006. The same silicone breast
implant material was used in both studies.
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a major study of silicone breast implants
sponsored by the us government found:
“no evidence for health concerns”
in 1997, the Department of Health and Human
services requested the institute of Medicine (ioM)
of the national Academy of sciences to conduct a
comprehensive evaluation of the safety of breast
implants. The ioM panel of independent scientific experts included members of the medical, scientific and
educational communities with experience in radiology,
women’s health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology internal
medicine, and plastic surgery.
The results
After reviewing years of evidence and research
concerning silicone gel filled breast implants, the
ioM found that “Evidence suggests diseases or
conditions such as connective tissue diseases,
cancer, neurological diseases or other systemic
complaints or conditions are no more common in
women with breast implants than in women
without implants.”
The complete ioM report is available online at
http://books.nap.edu/catalog/9602.html.
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siLicone useD ToDAy versus
siLicone oF THe PAsT
silicone gel filled breast implants have undergone
changes over time to meet increasingly sophisticated
consumer expectations. The very first silicone breast
implants used thick shells and contained firm gel. The
second generation of implants introduced in the late
1970’s had thinner shells and used less firm gel to address concerns of patients and surgeons who believed
that implants were too firm, palpable and visible.
in the mid 1980s, concerns related to rupture rates of
the second generation thinner-shelled implants led
manufacturers to introduce a third generation of
implants. The shell and gel of these third generation
implants were slightly thicker but still soft.
Today these third generation silicone gel filled
breast implants are typically referred to as
cohesive gel implants.
Fourth generation implants, including MemoryGel®
Breast implants were introduced in the mid 1990s
with further refinements in the manufacturing
process. Today newer, fifth generation implants are
available, such as with Memoryshape® Breast
implants, which are filled a uniquely formulated
cohesive gel that provides shape retention.
An APProvAL BAseD on science:
The FDA said “Approved”
in november of 2006, the FDA approved
MenTor® MemoryGel® Breast implants for
breast augmentation and reconstruction.
After nearly two decades of research and testing
with surgeons and patients all over the world,
MenTor® MemoryGel® Breast implants became
available to women in the us.
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AnoTHer iMPorTAnT reAson To
TrusT MenTor:
MenTor® Breast implants are the only breast
implants made in the us. Their strict quality
manufacturing requirements exceed the
us standards.
nothing could be more important than the
quality of the breast implant that you and your
surgeon choose
Mentor is the world leader in breast implant
manufacturing, research, and testing. For over 35
years, we have adhered to the highest standards of
safety in manufacturing, testing, and clinical trials
for saline and silicone
breast implants for use in
both breast augmentation
and breast reconstruction.
Because of this, we are
consistently recognized
by surgeons for
outstanding product
integrity. Millions of
women worldwide have
used MenTor® MemoryGel® Breast implants.
Mentor is committed to conducting long-term,
far-reaching clinical studies.
Mentor is committed to conducting its own longterm, far-reaching clinical studies. Throughout the
years, Mentor has done extensive safety evaluations
of both saline filled breast implants and gel filled
breast implants. Mentor is and will remain committed to providing objective, clinical information about
breast implant safety.
{ 23 }
mentor proDuCt
replaCement poliCy
anD limiteD Warranties
Mentor proudly stands behind the products we
manufacture with a product replacement policy
and Mentor warranty. it’s important to understand
that when undergoing breast augmentation, breast
implantation may not be a one-time surgery.
MenTor ProDucT
rePLAceMenT PoLicy
Mentor Product replacement Policy provides for the
free lifetime product replacement of its MemoryGel®
Breast implants, Memoryshape® Breast implants,
and saline Filled Breast implants, worldwide. When
implant replacement is required, and the Mentor
Product replacement Policy applies, Mentor will
provide, throughout the patient’s lifetime, the same
MenTor® Breast implant at no cost. if a more
expensive product is requested, Mentor will
invoice your surgeon for the price difference.
MenTor® MeMoryGeL® BreAsTiMPLAnTs AnD MeMorysHAPe®
BreAsT iMPLAnTs
THe MenTor WArrAnTy
Offers up to $3,500 in financial assistance.
Here’s what’s included:
• Automatic enrollment in our Product
Replacement Policy*
• Applies to certain expenses occurring from a
confirmed, qualifying rupture for up to 10 years
from the date of implant surgery
• Pays up to $3,5004 financial assistance for certain
operating room, anesthesia, and surgical charges
not covered by insurance and applies only to implant
surgeries conducted on or after october 6, 2014
• replacement product for up to 3 years following a
primary5 implant surgery, whether augmentation or
reconstruction, in the event of capsular contracture
Baker Grade iii & iv, double capsule, and late-forming seroma. see full warranty for additional details
{ 24 }
• Free contralateral (opposite side) implant
replacement upon surgeon request
• Plus, this warranty coverage is Free
THe MenTor enHAnceD WArrAnTy
Offers up to $3,500 in financial assistance plus more.
Requires enrollment within 45 days.
Here’s what’s included:
• Automatic enrollment in our Product
Replacement Policy*
• Applies to certain expenses occurring from a confirmed, qualifying rupture for up to 10 years from
the date of implant surgery
• Pays up to $3,5004 financial assistance for certain
operating room, anesthesia, and surgeon fees not
covered by insurance for replacement surgery
resulting from a Baker Grade iii capsular contracture, Baker Grade iv capsular contracture, double
capsule, or late-forming seroma for up to 10 years
from the date of primary implant surgery occurring
on or after date of implant october 6, 2014
• replacement product for up to 10 years following a
primary5 implant surgery, whether augmentation or
reconstruction, in the event of capsular contracture
Baker Grade iii & iv, double capsule, and late-forming seroma. see full warranty for additional details
• Free contralateral (opposite side) implant
replacement upon surgeon request
• Must be purchased for an enrollment fee of $200
within 45 days from implantation
For full program details including
qualifications, visit www.mentorwwllc.com
* Product replacement Policy for MenTor® Gel-filled
Breast implants: in the event of unexpected rupture
(loss of shell integrity), Mentor will provide replacement of a MenTor ® Product of any size in the same
style as the implant being replaced) free of charge for
the lifetime of the patient. upon the surgeon’s request,
a different implant style may be selected (subject to a
charge of the difference between product list prices).
4
operating room and anesthesia charges to be given
payment priority. in order to qualify for financial
assistance, you will need to sign a release before
Mentor will make payment to you or on your behalf.
5
Primary means the very first original implantation
of the MenTor® MemoryGel® Breast implant or
Memoryshape® Breast implant. Prior implant(s),
regardless of type, style, or manufacturer, preclude
inclusion in the Mentor enhanced Warranty for both
replacement product and financial assistance. in the
event of primary reconstruction with use of a tissue
expander, the temporary tissue expander does not
qualify as an implant.
{ 25 }
MenTor® sALine FiLLeD
BreAsT iMPLAnTs
MenTor sTAnDArD ADvAnTAGe
LiMiTeD WArrAnTy
Offers up to $1,200 in financial assistance.
This warranty is free of charge to all patients who
are implanted with MenTor® saline Filled Breast
implants. Here is an overview of the details:
• Automatic enrollment in our Lifetime Product
Replacement Policy1
• coverage for 10 years (qualified deflation)
and up to $1,200 financial assistance for certain
operating room, anesthesia, and surgical charges
not covered by insurance2
• Free contralateral (opposite side) implant
replacement upon surgeon request
• enrollment in this warranty is Free and
automatic; registration is encouraged
MenTor enHAnceD ADvAnTAGe
LiMiTeD WArrAnTy
Offers up to $2,400 financial assistance
This optional warranty is available for saline filled
breast implant products and, to be eligible, must be
purchased for an enrollment fee of $100 within 45
days from implantation.3 Here is an overview of the
details:
• Automatic enrollment in our Lifetime Product
Replacement Policy1
• coverage for 10 years (qualified deflation)
and up to $2,400 financial assistance for certain
operating room, anesthesia, and surgical charges
not covered by insurance2
• Free contralateral (opposite side) implant
replacement upon surgeon request
1
Lifetime Product replacement Policy for MenTor® saline Breast implants: in
the event of a deflation, Mentor will provide replacement MenTor® Product
of any size in the same style (as the implant being replaced) 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). refer to the Mentor Limited Warranty for eligibility and program details.
2
operating room and anesthesia charges to be given payment priority. in order
to qualify for financial assistance, you will need to sign a release before Mentor will make payment to you or on your behalf.
3
one warranty payout per enrollment fee; enrollment in the program for
replacement device will require additional $100 enrollment fee.
Please note: if you had breast surgery prior to May 1, 2009, your warranty
coverage is what was offered at the time of your original surgery.
{ 26 }
selecting the right
surgeon for you
What could be more important? Gather names;
do your research into each surgeon’s training,
experience and results; schedule consultations with
surgeons; ask questions; see before-and-after
photos; and then use your own best judgment to
make your choice.
Do you relate to the surgeon?
Do you feel at ease?
In addition to medical experience, a surgeon’s
communication skills can be an important factor
in choosing the right surgeon for you. After the
consultation, ask yourself: Did he or she take
the time to answer your questions or did you feel
rushed? Was the staff courteous, helpful
and genuinely caring? Your questions and
considerations are valid. You may want to meet
with more than one surgeon.
The surgeon will expect you to ask questions—
even sensitive ones. A tip—bring your questions
in writing so you don’t forget anything important.
{ 27 }
Here are some questions you may
want to ask:
• How many breast augmentation procedures
do you perform each year?
• How many years have you been doing these
procedures?
• Have you obtained training certification
from Mentor to use MemoryGel® Breast Implants
and MemoryShape® Breast Implants?
• Are you board certified, and if so, with which board?
• In which state(s) are you licensed to practice
surgery? (Note that some states provide information on disciplinary action and malpractice claims/
settlements to prospective patients, either by
request or on the Internet.)
• What is the most common complication you
encounter with breast augmentation?
• What is your reoperation rate with breast
augmentation, and what is the most common type of
reoperation you perform?
• Do you perform this surgery in a hospital or at an
independent surgery center?
(Note that hospitals require the demonstration
of evidence of appropriate training in specific
procedures before allowing surgeons to operate in
their facilities.)
{ 28 }
You’ll also want to ask questions about the
procedure itself during your initial consultation:
• What are the risks and complications
associated with having breast implants?
(Highlight any risks and complications in
this brochure and bring a copy with you.)
• How many operations can I expect over my lifetime
on my implanted breasts?
• If I choose to have the implants removed at a later
date, how will my breasts look?
• What shape, size, surface texturing, incision site
and placement site do you recommend for me?
• How will my ability to breastfeed be affected?
• How can I expect my implanted breasts to look
over time?
• How can I expect my implanted breasts to look
after pregnancy or after breastfeeding?
• What are my options if I’m dissatisfied with the
cosmetic outcome of my implanted breasts?
• What alternate procedures or products are
available if I choose not to have breast implants?
• Do you have before and after photos for each
procedure?
• I’d like to be a size B (or C or D) cup size. Do
you think that’s appropriate for my body type?
• What results are reasonable for me to expect?
Turn to Mentor
www.loveyourlook.com provides a list of qualified
surgeons in your area. Just click on “find a surgeon”
and in minutes you’ll have several surgeons to
contact. You can also find a list of surgeons by
contacting a number of respected professional
organizations, such as:
• The American Society of Plastic
Surgeons (ASPS)
• The American Society for Aesthetic
Plastic Surgery (ASAPS)
• Your local medical society
{ 29} }
{ 29
FREQUENTLY ASKED
QUESTIONS ABOUT BREAST
IMPLANTS
For the most comprehensive information about
breast implant surgery, we invite you to visit the
Mentor aesthetic website: www.loveyourlook.com
What is a breast implant?
When someone says “breast implant,” they are describing a silicone shell that is filled with either silicone gel
or saline solution. Breast augmentation and reconstruction surgeons insert these implants under breast
tissue or under the chest muscle to create a fuller looking and feeling bust line.
What is silicone?
Silicone is derived from silicon, a semi-metallic or
metal-like element that in nature combines with
oxygen to form silicon dioxide, or silica. Beach sand,
crystals and quartz are silica. Silica is the most common substance on earth. Heating silica with carbon at a
high temperature can produce silicon. Further processing can convert the silicon into silicone, which can be a
liquid, a gel or a rubbery substance. Various silicones
are used in lubricants and oils, as well as in silicone
elastomers. Silicone can be found in many common
consumer items, such as chewing gum, nail polishes,
suntan and hand lotions, antiperspirants, bath soaps
and processed foods.
Are silicone gel-filled implants safe?
After decades of research and testing, MemoryGel®
Breast Implants and MemoryShape® Breast Implants
are FDA approved for augmentation and reconstruction. Mentor has conducted rigorous safety evaluations of our gel filled breast implants, including two
10-year Core studies to provide even more information to patients and surgeons.
Each Core study is a prospective, 10-year, multicenter clinical study conducted to examine the
safety and effectiveness of MENTOR® Silicone Gel
Breast Implants. As we have for many years, Mentor
will remain committed to providing objective
information about breast implant safety.
{ 30 }
What are MENTOR® MemoryGel® Breast Implants?
MemoryGel® Breast Implants are Mentor’s most
popular line of breast implants. They are pre-filled with
Mentor’s proprietary cohesive silicone gel. MemoryGel®
Breast Implants hold safely and uniformly together to
deliver a natural feel that closely resembles natural
breast tissue.
How do MemoryShape® Breast Implants differ from
MemoryGel® Breast Implants? MemoryShape® Implants,
are teardrop-shaped and made of a more highly cohesive
silicone gel, designed to impart a natural silhouette and
give you a youthful feel. In comparison MemoryGel®
Implants are round and made of a slightly less cohesive
silicone gel which resembles the natural give of breast
tissue.
What is gel cohesiveness and why is it important?
Gel cohesiveness is determined by the amount of
cross-linking within the silicone gel filler. The more
cross-linking, the more cohesive the gel and the more
it helps to maintain its shape. As such, highly cohesive
silicone gel filled breast implants are able to retain their
molded, teardrop-shape whereas MemoryGel® Implants
(round) are more pliable.
Why are MemoryShape® Implants teardrop-shaped?
They are shaped to match the silhouette of a natural
breast with more fullness at the bottom than at the top.
Also, a teardrop-shaped implant is thinner at the top,
therefore it gradually blends into the upper chest.
I’ve heard it’s okay for round implants to shift,
but not shaped implants. How do shaped implants
stay in the proper position? MemoryShape® Breast
Implants have orientation marks to help your surgeon
place them correctly during surgery, and their textured
surface is specially designed to help keep them in place.
Choose a surgeon you feel comfortable with and who is
experienced at placing shaped implants.
Why Choose MemoryShape® Implants? Our greatest
satisfaction is our patients’ satisfaction. Women who
had breast augmentation or reconstruction procedure
with MemoryShape® Implants reported a three-fold
increase in satisfaction scores, with improvements in
self-esteem, appearance and quality of life.2
2
Data on file at MENTOR Worldwide LLC.
{ 31 }
We’re proud to provide our surgeons with the product
innovation and training support to help make this
possible.
What are Saline Filled Breast Implants?
Saline Filled Breast Implants are silicone shells filled
with saline (a saltwater solution) that is very similar
to the bodies natural fluid which makes up most of
the human body. Saline implants are inserted into the
body without fluid and then filled with the saline fluid
through a fill tube during the surgery to adjust and
achieve optimal volume. Certain MENTOR® Saline
Filled Breast Implants also allow for adjustments
after surgery.
Do MENTOR® Breast Implants include latex?
No. Because latex allergies are so common, Mentor®
Breast Implants are not made with natural rubber in
the manufacturing of any of its breast implants.
Is there active platinum in breast implants?
The manufacture of silicone breast implant shells
and gel-filling materials uses platinum as a catalyst.
{ 32 }
Because very small amounts of platinum remain in the
product following its manufacture, concerns have been
raised that platinum may enter the body and cause
adverse effects—either by diffusing through the intact
shell, or through an implant rupture. However, in 2006,
the United States Food and Drug Administration (FDA)
released the following conclusion about platinum:
“Based on the existing literature, FDA believes that
the platinum contained in breast implants is in the
zero oxidation state, which would pose the lowest risk,
and thus that the small amounts of platinum that leak
through the shell do not represent a significant risk to
women with silicone breast implants.”
How much do breast implants weigh?
You can use this formula to estimate the weight of
your MemoryGel® Breast Implants and Saline Filled
Breast Implants:
1 ounce = 30 cc’s.
Example: A 300 cc implant = 10 ounces
Implant weight will vary with implant size.
How do cc’s compare to cup size?
cc volumes do not accurately translate to bra cup sizes.
{ 33 }
How do breast implants affect mammography?
With breast implants, routine mammography screening may be more difficult. The implant may interfere
with finding breast cancer during mammography and
generally requires additional x-rays and more potential exposure to radiation. If you are of the proper age
for mammography screening, you should continue to
undergo routine mammography screenings as recommended by your primary care surgeon. When you do, be
sure to inform the mammography technician that you
have implants.
What is the average life expectancy of a breast
implant?
It’s important to know that breast implants don’t last
a lifetime. While implant duration varies from woman
to woman, implants need to be replaced at some time.
Replacement is often prompted by choice, such as a
desired size change, or implant style change. Some
women undergo breast implant replacement because of
a complication, such as saline deflation or gel rupture.
Do implants influence the occurrence of breast cancer?
Patients with breast implants have not been found to
be at a greater risk of developing breast cancer than
those without breast implants.
Should I be at my ideal weight before I have a breast
implant procedure?
You should be close to your ideal weight when you have
breast implant surgery. Why? Because women who lose
or gain a significant amount of weight after receiving
breast implants sometimes alter the results in unpredictable and/or undesirable ways.
Will my breasts still move like normal breasts?
The goal is to create soft and natural moving breasts.
Achieving this depends upon multiple factors. For
some women, implants are firmer and more fixed in
their position than their natural breasts.
I’m over 50 years of age. Am I too old to get breast
implants?
Your general health is far more important than your
age. Women over the age of 50 can and do get implants.
You are never too old to look your best.
Will getting breast implants cause stretch marks on my
breasts?
Rarely, but it can happen. If you want to take every
precaution to avoid stretch marks you have a few
{ 34 }
options that can reduce their likelihood. You can choose
a smaller size breast implant to minimize the stretching
of your skin or choose a SPECTRUM® Adjustable Saline
Breast Implant so you can slowly stretch your skin
over time.
Will I lose nipple sensation?
There can be an increase or decrease in nipple
sensation after your breast implant surgery. A small
number of women experience intense sensitivity and
others, no feeling. These effects can be temporary
or permanent.
What will happen during pregnancy?
Every woman has different results with breast implants
before or after a pregnancy. If you become pregnant
after receiving breast implants, your breasts will grow
and go through all the usual changes associated with
pregnancy. The amount of enlargement will vary from
woman to woman, and the size of your implants will be
a factor.
Will I be able to breastfeed?
Many women with breast implants successfully breastfeed their babies. Some breastfeeding difficulties have
been reported following breast surgery particularly
when a surgeon uses a periareolar (around the nipple)
incision. It is important that you let your surgeon know
if you are planning or considering getting pregnant
postsurgery.
How long should I wait to resume exercise and other
strenuous activities after breast implant surgery?
Because recovery periods vary from woman to woman,
your surgeon will determine how much recovery time
you may need and when to resume normal activities.
As a rule of thumb, the first few days are the most
uncomfortable. Most women return fully to their
regular lives after four to six weeks. Be careful about
resuming strenuous activities that could raise your
pulse and blood pressure, or require strenuous use
of your arms and chest through the entire recovery
process. Be sure to check with your surgeon before
returning to your workouts.
What affect does smoking have on the healing process
following surgery?
Smoking can compromise recovery by causing blood
vessels to constrict, reducing blood flow and the
oxygen it carries to the surgical area. Your tissues need
{ 35 }
this blood and oxygen supply to heal properly. When
your blood supply is reduced, tissues heal more slowly
and irregularly. That’s why many surgeons ask patients
to refrain from smoking for one to five weeks prior
to and after surgery. It is important that you ask your
surgeon what his or her specific recommendation for
you would be.
When can I wear an underwire bra again?
Most surgeons ask women to wait three months
before wearing underwire bras after breast implant
surgery because the body continues to form scar
tissue around the implant for that time. Be sure to
ask your surgeon for a recommendation.
Can I go to tanning salons, infrared saunas or sunbathe
if I have breast implants?
These activities will not hurt the breast implants in
any way, however, they may make scar tissue more
visible.
When can I fly and/or scuba dive?
Once fully recovered, you can feel free to scuba dive
and fly in airplanes with some minor considerations
since there may be slight expansion and contraction
of the shell with changes in pressure. With saline-filled
implants, this may result in a minimal amount of air
bubbles in the implant, and you may feel or hear fluid
sounds (gurgling). This should correct itself within
24 to 48 hours.
Are MENTOR® Breast Implants covered by
a warranty?
Your peace of mind is important to us. All MENTOR®
Products come with the Mentor Lifetime Product
Replacement Policy which provides for the free
lifetime product replacement of our gel filled and
saline filled breast implants, worldwide. When
implant replacement is required, and the Mentor
Product Replacement Policy applies, Mentor will
provide, throughout the patient’s lifetime, the same
or similar MENTOR® Breast Implant at no cost. If a
more expensive product is requested, Mentor will
invoice your surgeon for the price difference.
Please visit http://www.loveyourlook.com/
Breast-Implants/breast-implant-warranty.aspx to
learn more about the terms of our Limited
Warranties and Product Replacement Policy.
{ 36 }
Breast Augmentation
Resources
For additional information or questions about
MENTOR® Breast Implants, please call
1-800-MENTOR-8. Here are additional
resources that can provide more information:
www.mentorwwllc.com/breastsurgery/
augmentation/downloads.htm
Mentor Brochures:
•
Important Information for Augmentation
Patients About MENTOR® MemoryGel®
Breast Implants
•
Patient Educational Brochure - Breast
Augmentation with MENTOR® MemoryShape®
Breast Implants
•
Quick Facts about Breast Augmentation &
Reconstruction with MENTOR® MemoryShape®
Breast Implants
•
Saline filled Breast Implant Surgery:
Making an Informed Decision
Mentor Worldwide, LLC
1-800-Mentor-8
www.mentorwwllc.com
www.loveyourlook.com
Institute of Medicine Report
on the Safety of Silicone Implants
www.nap.edu/catalog/9602.html
Food and Drug Administration
1-888-INFO-FDA or 301-8230
www.fda.gov/cdrh/breastimplants
You can find important information in the FDA
breast implant consumer handbook, which is
available through the phone number or web site
provided above.
American Society of Plastic Surgeons
www.plasticsurgery.org
{ 37
{ 37
} }
IMPORTANT SAFETY INFORMATION
The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel®
Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least
18 years old for MENTOR® Saline Breast Implants.
Breast implant surgery should not be performed in women:
•
With active infection anywhere in their body
•
With existing cancer or pre-cancer of their breast who have not received
adequate treatment for those conditions
•
Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune
system, conditions that interfere with wound healing and blood clotting, or
reduced blood supply to breast tissue. Patients with a diagnosis of depression,
or other mental health disorders, should wait until resolution or stabilization of
these conditions prior to undergoing breast implantation surgery.
There are risks associated with breast implant surgery. You should be aware
that breast implants are not lifetime devices and breast implantation may not
be a one-time surgery. You may need additional unplanned surgeries on your
breasts 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.
Breast implants are not lifetime devices and breast implantation may not be a
one-time surgery. The most common complications for breast augmentation
with MemoryGel® Implants include any reoperation, capsular contracture,
nipple sensation changes, and implant removal with or without replacement.
The most common complications with MENTOR® MemoryShape® Implants for
breast augmentation include reoperation for any reason, implant removal with
or without replacement, and ptosis. A lower risk of complication is rupture. The
health consequences of a ruptured silicone gel breast implant have not been
fully established. MRI screenings are recommended three years after initial
implant surgery and then every two years after to detect silent rupture.
The most common complications for breast augmentation with MENTOR®
Saline-filled Breast Implants include reoperation, implant removal, capsular
contracture, breast pain, and implant deflation.
Detailed information regarding the risks and benefits associated with
MENTOR® Breast Implants is provided in several educational brochures. For
MemoryGel® Implants: Important Information for Augmentation Patients about
MENTOR® MemoryGel® Breast Implants. For MemoryShape® Implants: Patient
Educational Brochure – Breast Augmentation with MENTOR® MemoryShape®
Breast Implants and Quick Facts about Breast Augmentation & Reconstruction
with MENTOR® MemoryShape® Breast Implants. For MENTOR® Saline-filled
Implants: Saline-Filled Breast Implants: Making an Informed Decision. These
brochures are available from your surgeon or visit www.mentorwwllc.com. It
is important that you read and understand these brochures when considering
MENTOR® Breast Implants.
201 Mentor Drive
santa Barbara, cA 93111 usA
(805) 879-6000
customer service: (800) 235-5731
Fax: (805) 967-7108
www.mentorwwllc.com
© Mentor Worldwide LLc 2014 017280-141007