Document 155846

We’re here to help you
make a confident,
informed decision.
For over 20 years,
Mentor Corporation
has been recognized
worldwide as a
leading manufacturer
of the highest quality
breast implants.
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
about Mentor MemoryGel™ and saline-filled
breast implant options. 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 20 years, Mentor Corporation has been
recognized worldwide as a leading manufacturer of the
highest quality breast implants. We offer two basic
types: MemoryGel™ and saline-filled 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. And, all of our
implants sold in the U.S. are manufactured
right here in the U.S.
Table of
Contents
1.
3.
5.
It All Begins With You
Breast Anatomy 101
Which type of Mentor breast implant is right for you? Silicone gel or saline?
11.
What about an implant’s size
and shape?
15.
19.
23.
25.
27.
Incision and Placement Options
Selecting the Right Surgeon for You
Surgery: The Details
Important Things to Consider
Mentor Product Replacement Policy and Limited Warranties
31.
Frequently Asked Questions About Breast Implants
It all begins with you
Your reasons are as
unique as you are.
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 then discuss the options
available to you and choose
just the right implants
for your body and desired
outcome. In addition to shape,
size, and texture, you also have a
choice between Mentor MemoryGel™
and saline-filled breast implants.
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BREAST ANATOMY 101
Pectoralis Major Muscle
Pectoralis Minor Muscle
Fatty Tissue
Milk Lobes, Glands
Milk Ducts
Nipple and Areola
Sof t 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.
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the technical definition of
a breast implant:
A breast implant is a sac (implant shell) made
of silicone elastomer filled with either silicone gel
or saline, which is surgically implanted under your
breast tissue or under your chest muscle.
Which type of
Mentor breast implant
is right for you?
Silicone Gel or saline?
MemoryGel ™ Breast Implants –
A trusted choice
MemoryGel™ implants have been successfully
used and trusted for 20 years by millions of women
worldwide. Why? Because our implants feel
more like natural breast tissue–without
compromising reliability or safety. After
decades of research and testing, MemoryGel™
breast implants are now FDA approved for women
in the U.S. 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.
Why this
picture
matters
to you:
We have cut a
MemoryGel™
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.
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The safety of silicone
breast implants
Smooth Round
Moderate Profile
Smooth Round
Moderate Plus Profile
Smooth Round
High Profile
Siltex ® Round
Moderate Profile
Siltex ® Round
Moderate Plus Profile
Siltex ® Round
High Profile
After reviewing years of research concerning
silicone gel-filled breast implants, the Institute of
Medicine (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.”
In November of 2006, the FDA approved
MemoryGel™ silicone breast implants for breast
augmentation and reconstruction.
Mentor Corporation is committed to conducting
long-term, far-reaching clinical studies.
beautiful Benefits:
MemoryGel™ breast implants are
FDA approved
Each implant is filled with Mentor’s
proprietary cohesive gel
The gel filler holds together uniformly and
looks and feels like natural breast tissue
The implants have a set fill volume for
predictable results
Over the years, Mentor has conducted rigorous
safety evaluations of both gel-filled and salinefilled breast implants. Mentor currently has three
10-year studies of silicone gel breast implants in
progress to provide even more clinical information
to patients and surgeons. As we have for many
years, Mentor will remain committed to providing
objective information about breast implant safety.
MemoryGel™ breast implants come in three
projection options: Moderate, Moderate
Plus and High Profile to give you the look
you want
They come in two shell surface options:
smooth and textured (Siltex®)
MemoryGel™ implants are covered by
Mentor’s Standard or Enhanced Limited
Warranty and Lifetime Replacement Policy
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saline implants:
Mentor Spectrum®
Adjustable Saline Implants
FDA approved
These implants are filled with a saltwater
solution similar to the fluid that makes up
most of the human body
Our saline implants have a slightly firmer
feel than gel
They have a flexible fill volume that can be
adjusted during surgery
Three projection options: Moderate,
Moderate Plus and High Profile
They come in two shell surface options:
smooth and textured (Siltex®)
Our saline implants are covered by Mentor’s
Standard or Enhanced Limited Warranty and
Lifetime Replacement Policy
Mentor Saline Breast Implants –
Another Option
Mentor’s 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. When the fill-tube is removed, the
implant will automatically seal itself.
An innovative line of adjustable implants
Often, the most difficult decision for most
women regarding breast augmentation is
choosing the breast size. Mentor’s innovative
line of Spectrum® Breast Implants makes the
decision-making process easier because the size
can be adjusted after surgery. In fact, Spectrum®
implants are the only post-operatively 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 ®
Siltex ®
Round
Spectrum ®
Siltex ®
Contour Profile ®
Spectrum ®
How do Mentor’s silicone
and saline implants compare?
MemoryGel™ Breast Implants
Feel more like natural breast tissue
Moderate, Moderate Plus and High profiles
Smooth
Round Moderate
Profile
Smooth
Round Moderate Plus
Profile
Smooth
Round High
Profile
Smooth and textured surfaces available in
a range of sizes
Saline Breast Implants
Various profiles
Intra-operative sizing flexibility
Self-sealing valve
Siltex
Round Moderate
Profile
®
Siltex
Contour Profile ®
Moderate
®
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Siltex
Contour Profile ®
High
®
Post-operative adjustability with the
Spectrum® Implant
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What about an Implant’s
size and shape?
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.
Your surgeon may use a system such as
BodyLogic.™ Mentor’s BodyLogic™ system is
designed to assist surgeons and their staff to
make more informed product selection decisions
for their patients.
Deciding on implant profile
is as important as size.
Round or Contoured?
In addition to size and shape, breast implants are
available in different profiles. Profile refers to the
amount of forward projection of the implant off
the chest wall.
Round implants are the most popular
choice, and are available as MemoryGel™
or saline-filled breast implants. Both types of
implants come in a variety of profiles: Moderate,
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The most popular choice
Moderate Plus and High. High profile implants
provide the greatest forward projection for a more
prominent silhouette, and are designed for a
narrower chest area.
Our saline-filled contoured implants provide
a more mature, sloped breast shape, and come
in Moderate and High Profile styles. However, it’s
important to know that when contoured implants
are placed beneath the chest muscle, they may
assume a round shape.
Currently, smooth-surfaced breast implants
are the most popular choice among women
and surgeons.
A textured implant may require a larger incision
because the rougher textured surface makes it harder
to place into the pocket without undue stress, which
might damage the implant or decrease its durability.
What else determines if the implant
can be detected by feel?
Smooth
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 sub-glandularly (above the chest muscle)
tend to be more conspicuous than implants placed
sub-muscularly (below the chest muscle).
Siltex ®
Some studies suggest
Product Implanted: Round Moderate Profile Gel
Before
that surface texturing may reduce the chance of
severe capsular contracture1
Mentor’s Core study did not show a difference
in the likelihood of developing capsular
contracture with textured implants compared
to smooth-surfaced implants. Capsular
contracture occurs when the scar tissue or
capsule that normally forms around the implant
tightens and squeezes the implant.
Af ter
Photos courtesy of Dr. Ram Kalus (Columbia, South Carolina)
Product Implanted: Round High Profile Saline
Before
Af ter
Photos courtesy of Dr. Louis L. Strock (Fort Worth, Texas)
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1
Seify, H., et al. 2005. Preliminary (3 years) experience with smooth wall
silicone gel implants for primary breast augmentation.
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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.
Your surgeon will be your
best guide when it comes
Location of incision
to the pros and cons of
There are three common incision sites:
the incision site specifically
Around the nipple (periareolar)
Within the breast fold (inframammary)
Under the arm (axillary)
recommended for you.
A xillar y Incision
Periareolar Incision
Inframammar y Incision
Types of incisions
Periareolar–This incision is typically more
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.2 Cutting through the tissue
may increase the chance that there will be a
change in breast or nipple sensation.
2
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Hurst, N.M. 1996. Lactation after augmentation mammoplasty.
Obstet. Gynecol. 87(1):30-4.
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Inframammary–This is the most commonly
used incision site at the present time.
This incision is 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.
sub-muscular and
sub-glandular placement
Sub-muscular placement
Surgery and recovery may be longer
Recovery may be more painful
Re-operation 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
Sub-glandular placement
Surgery and recovery may be shorter
Another consideration:
Implant placement
Recovery may be less painful
The breast implant can be placed either partially
under the pectoralis major muscle (sub-muscular)
or on top of the muscle and under the breast
glands (sub-glandular). 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 on the next page. Your surgeon
will recommend the approach best-suited to
your body type and goals.
More visible and palpable implants
Sub-muscular
Placement
May provide easier access for re-operation
More difficult imaging during
mammography exam
May not be recommended if you have thin
or weakened breast tissue
Sub-glandular
Placement
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selecting the right
surgeon for you
The surgeon will expect
you to ask questions–
even sensitive ones.
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.
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Here are some questions you may want to ask:
How many breast augmentation procedures do
you perform each year?
What shape, size, surface texturing, incision site
and placement site do you recommend for me?
How will my ability to breastfeed be affected?
How many years have you been doing these
procedures?
How can I expect my implanted breasts to look
over time?
Have you obtained training certification from
Mentor to use MemoryGel™ breast implants?
How can I expect my implanted breasts to look
after pregnancy or after breastfeeding?
Are you board certified, and if so, with
which board?
What are my options if I’m dissatisfied with the
cosmetic outcome of my implanted breasts?
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 alternate procedures or products are
available if I choose not to have breast implants?
What is the most common complication you
encounter with breast augmentation?
What is your re-operation rate with breast
augmentation, and what is the most common
type of re-operation 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.)
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.)
Do you have before and after photos I can look
at 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)
The American Academy of Cosmetic
Surgeons (AACS)
Your local medical society
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?
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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 used but local anesthesia
with sedation is also an option.
Important: Your surgeon should give you
specific instructions before surgery
Ask about any tests or pre-surgical 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.
Post-operative 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.
Post-operative care can vary
You may be told to use a specific post-operative
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.
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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.
IMPORTANT THINGS
TO CONSIDER
There are some age restrictions on who
can and can’t use breast implants
Mentor’s saline-filled breast implants for breast
augmentation surgery are intended for women who
are at least 18 years old.
Women having breast augmentation surgery with
MemoryGel™ breast implants must be at least 22
years old. If you are considering augmentation
surgery with saline implants, please read Mentor’s
brochure entitled, Saline-Filled Implant Surgery:
Making An Informed Decision.
When considering MemoryGel™ implants be sure
to read: Important Information for Augmentation
Patients about Mentor MemoryGel™ Silicone GelFilled Breast Implants.
Both brochures contain current information about
breast implants. After reading and signing the
Acknowledgment of Informed Decision page in each
brochure, your surgeon will help you decide which
implant type is the right choice for you.
Breast implants are not lifetime devices, and
breast implantation is likely not a one-time
surgery. You may need additional unplanned
surgeries on your breasts because of complications
or unacceptable cosmetic outcomes. These
additional surgeries can include implant removal
with or without replacement, or they can include
other surgical procedures. When you have your
implants replaced (revision-augmentation), your risk
of future complications may increases compared to
first time (primary) augmentation surgery.
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Many of the changes to your breasts following
implantation are irreversible (cannot be
undone). If you later choose to have your implant(s)
removed and not replaced, you may experience
dimpling, puckering, wrinkling, or other cosmetic
changes of the breast which can be permanent.
Breast implants may affect your ability to
breastfeed, either by reducing or eliminating
milk production.
Breast Augmentation Resources
Mentor (or your surgeon) will be happy to
provide you with a copy of the package insert
(directions for use).
For more detailed information on the pre-clinical and
clinical studies conducted by Mentor, please refer
to the summary of safety and effectiveness data
(SSED) for this product at www.fda.gov/cdrh/
breastimplants/.
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.
MENTOR PRODUCT
REPLACEMENT POLICY AND
LIMITED WARRANTIES
Mentor proudly stands behind the
products we manufacture with a product
replacement policy and two limited
warranty programs. It’s important to
understand that when undergoing breast
augmentation, breast implantation may not
be a one-time surgery.
Mentor’s Lifetime Product
Replacement Policy provides
for the free lifetime product
replacement of its
MemoryGel™ 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.
The Mentor Standard Advantage
Limited Warranty is free of charge to all
patients who are implanted with Mentor
MemoryGel™ and saline-filled breast
implants in the United States and Puerto Rico.
The Mentor Enhanced Advantage Limited
Warranty is available for women who are
implanted with Mentor MemoryGel™ and
saline-filled breast implants in the United
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States and Puerto Rico. You must pay a
$100.00 enrollment fee within 45 days of
your breast implantation. Your surgeon will
provide you with a copy of Mentor’s Product
Replacement and Limited Warranty program for
breast implants. However, it is not intended to
replace any discussion between you and your
surgeon. Prior to your surgery, your surgeon
should advise you about possible risks and
complications associated with breast implant
surgery, including deflation or rupture.
Please retain your records
With both the Mentor Standard Advantage and
Mentor Enhanced Advantage Limited Warranties,
it’s important for you to also maintain your own
records to ensure validation of your enrollment.
This is necessary because it’s possible your
surgeon may only be required to retain your records
for a limited period of time depending upon the laws
of your state.
Study results
Mentor’s saline-filled breast implants have been
demonstrated to be effective for augmentation
patients in a prospective 36-month study of
1,264 patients. In addition to an increase in
bra cup size reported by 6% of patients, other
statistically significant implant surgery benefits were
demonstrated, as described below.
Increased satisfaction with breast size, shape
and firmness3
Increased comfort with appearance3
Important Information
For additional information or questions
about Mentor breast implants, please call
1-800-MENTOR-8. Here are additional resources
that can provide more information:
Mentor Brochures
Important Information for Augmentation Patients
about Mentor MemoryGel™ Silicone Gel-Filled
Breast Implants
Saline-Filled Implant Surgery: Making An
Informed Decision
Mentor Corporation
1-800-Mentor-8
www.mentorcorp.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/
Increased satisfaction with physical appearance4
Improved self-esteem5
3
As assessed by the Breast Evaluation Questionnaire.
4
As assessed by the Multidimensional Body-Self Relations Questionnaire.
5
As assessed by the Tennessee Self-Concept Scale.
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FREQUENTLY ASKED
QUESTIONS ABOUT
BREAST IMPLANTS
For the most comprehensive information about
breast implant surgery, we invite you to visit
Mentor’s 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.
MemoryGel™ breast implants
MemoryGel™ breast implants are the next
generation of silicone implants. They are prefilled with Mentor’s propriety cohesive silicone
gel. MemoryGel™ breast implants hold safely and
uniformly together to deliver a “natural feel”
that closely resembles natural breast tissue.
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.
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.
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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?
The FDA has determined that Mentor’s breast
implants are safe and effective. To ensure ongoing
quality, the FDA has required that we continue to
monitor our gel-filled implants by conducting a postapproval study of approximately 42,000 women
over the course of 10 years. Mentor welcomes
the opportunity to conduct this study to continue
to further the science and information regarding
silicone safety and efficacy.
Good news from the scientific community
The Institute of Medicine, in a highly respected
study, concluded that, “There is no evidence that
silicone implants are responsible for any major
diseases of the whole body. Women are exposed
to silicone constantly in their daily lives.”
Do Mentor breast implants include latex?
No. Because latex allergies are so common,
Mentor never uses latex 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.
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™ 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.
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.
*source: www.fda.gov/cdrh/breastimplants/platinum.html
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What is the average life expectancy
of a breast implant?
Will getting breast implants cause stretch
marks on my breasts?
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.
Rarely, but it can happen. If you want to take every
precaution to avoid stretch marks you have a few
options that can reduce their likelihood.
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?
You can choose a smaller size breast implant to
minimize the stretching of your skin or choose a
Spectrum® adjustable 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 post-surgery.
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.
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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 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
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 Mentor’s
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.
In addition, the
Mentor Standard
Advantage Limited
Warranty is free of charge
to all patients who are implanted
with Mentor gel-filled or saline-filled
breast implants in the United States
and Puerto Rico.
The Mentor Enhanced Advantage Limited
Warranty is an optional limited warranty
available for women who are implanted with
Mentor gel-filled or saline-filled breast implants
in the United States and Puerto Rico.
more visible.
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Please visit www.mentorcorp.com/
breastsurgery/augmentation/cs_ba_warranty.
html to learn more about the terms of our Limited
Warranty and Product Replacement Policy.
You can enroll in the Enhanced
Advantage Limited Warranty by visiting
www.mentorcorp.com/enhancedadvantage.
Please review the complete limited warranties
for details and limitations of coverage. You may
receive a copy of the complete Mentor Advantage
and Enhanced Advantage Limited Warranties for
MemoryGel™ and saline-filled breast implants by
writing or calling:
It is very important that you take time to read
and fully understand your brochure, and ask your
surgeon any questions you may have.
If you receive MemoryGel™ breast implants, you will
be asked to sign the Acknowledgement of Informed
Decision form in the brochure. After you read and
sign the Informed Decision form in your brochure,
your surgeon will help you decide which breast
implant is the right choice for you.
Consumer Affairs Department
Mentor
201 Mentor Drive
Santa Barbara, CA 93111
(866) 250-5115 Option 3
You may also obtain a copy of Mentor’s Breast
Augmentation Owner’s Manual from your surgeon,
or by visiting www.mentorcorp.com.
To receive a detailed explanation about the benefits
and risks associated with breast implants, please
read the following patient brochure that applies to
your procedure:
Important Information for Augmentation Patients
About Mentor MemoryGel™ Silicone Gel-filled
Breast Implants
Important Information for Reconstruction
Patients About Mentor MemoryGel™ Silicone
Gel-filled Breast Implants
Saline-filled Breast Implant Surgery: Making an
Informed Decision
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Implant Safety Information:
There are risks associated with Breast Implant Surgery.
Please read the appropriate patient brochure entitled
Important Information for Augmentation Patients about Mentor
MemoryGel™ Silicone Gel-Filled Breast Implants or Important
Information for Reconstruction Patients about Mentor
MemoryGel™ Silicone Gel-Filled Breast Implants. These
educational brochures provide you with information about
the risks and benefits of silicone breast implants. It is very
important that you take the time to read and fully understand
the brochure; ask any questions you may have; and then wait
at least one to two weeks prior to scheduling surgery with
MemoryGel™ silicone gel breast implants. After reading and
signing the Acknowledgement of Informed Decision Form in
your brochure, and after the consultation, your surgeon will
help you decide which implant is the right choice for you.
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