For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you...
Transcript of For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you...
For over 20 years,
Mentor has been
recognised throughout
the world 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® MemoryGelTM Silicone Gel-
Filled and MenTor® Saline-Filled Breast Implant
options. Clarifying your own appearance goals
and identifying the questions you will want to
ask during this process are important steps when
considering breast augmentation.
Ready to get started?
For over 20 years , Mentor has been recognised throughout the world as a leading manufacturer of the highest quality breast implants . We of fer two basic types: MemoryGelTM and Saline-Filled Breast Implants .
Our rich history is filled with industry firsts,
innovative product designs and groundbreaking
research. Mentor has a record of continually
producing leading-edge, FDA-approved (saline
and round-shaped gel) and Ce-Marked breast
augmentation products.
make a confident, infoRmed decision.
We are here to help you
table of contents
It All Begins With You 1
Anatomy of the Breast 4
Your Surgery 5
About Breast Implants 5
Incision and Placement Choices 13
Your recovery 15
PatientSafe Coverage Limited Warranty 17
Breast Augmentation resources 22
Breast Implant Safety Study Information 23
Questions to Ask Your Plastic Surgeon 25
Glossary 27
Mentor—A Company That Cares 29
Important Safety Information Back Cover
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it all begins With You
For many women, feeling confident, alive and
vibrant goes hand-in-hand with looking their
best. For thousands of women, achieving such
confidence and personal satisfaction has come
from choosing breast augmentation. Following
their procedure, many women have gone on to
experience a transformation in how they feel
about themselves and their bodies.
There are many reasons women choose breast
augmentation. Some of them include:
ɶ enlarging their breasts to make their bodies
more proportional
ɶ reshaping and enlarging breasts that have
lost their shape due to breast-feeding
ɶ Balancing breasts that differ in size
or shape
Your reasons are very personal, and
your decisions about breast
augmentation should be made by
you and your surgeon based on
your personal needs, desires and
expectations.
Today, there are many options
available for women who
decide breast augmentation
is right for them.
This brochure is designed to
help you understand more
about breast augmentation
and all the options you have.
It is not intended to replace any
discussions between you and
your surgeon.
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anatomY of the breast
The breast consists of milk ducts and glands,
surrounded by fatty tissue that provides its shape
and feel. The chest muscle (pectoralis major
muscle) is located beneath the breast. Factors
such as pregnancy (when milk glands are
temporarily enlarged), rapid weight loss and the
effects of gravity as you age can combine to
stretch your skin, which may cause your breast to
droop or sag.
It is important to realise that implants are used to
make the breast larger. Implants alone may not
adequately lift the breast, or correct the effects
of pregnancy, weight loss or skin stretching. Your
surgeon may suggest additional procedures at
the time of your breast augmentation, such as a
mastopexy, to help achieve improved breast lift.
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Pectoral is Major Muscle
Pectoral is Minor Muscle
Fatty T issue
Milk Lobes, Glands
Mi lk Ducts
nipple and Areola
Soft T issue
ribs
© Mentor Wor ldwide LLC
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Mentor is proud of the quality
built into each of our breast
implants, and you can be
assured that behind your
decision to use our products is
a company that understands
your hopes and desires and a
company that truly cares.
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about breast implants
Your surgerY
Breast augmentation procedures are usually
performed in a hospital room or surgery center.
You normally can go home the same day as
your surgery. General anesthesia is typically used,
so you will be asleep during your procedure.
The surgery usually lasts one to two hours. Your
doctor will make an incision and form a pocket
in which the breast implant is placed. When the
implant is in its proper position, the incision will be
closed with stitches.
To achieve the best results and to make your
recovery as quick as possible, your surgeon will
discuss with you specific surgical techniques that
are best suited for your individual needs.
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Breast implant defined:
A breast implant is a sac
(implant shell) of silicone
elastomer, filled with
silicone gel or saline, that is
surgically implanted under
your breast tissue or under
your chest muscle. Mentor
makes two basic types:
Gel-filled and Saline-filled
Breast Implants.
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Mentor gel-filled breast implants are called MemoryGelTM Breast Implants
MemoryGelTM Breast Implants feature a unique
cohesive gel. This means that the gel filler acts
as a solid unit rather than a liquid. The gel holds
together uniformly, while retaining the natural
“give” that resembles actual breast tissue. The
gel-filled breast implant usually offers you a more
natural look and feel. MemoryGelTM Implants
are available in a wide range of shapes, sizes,
profiles, surface texture choices and cohesive
levels to fit different body types.
Breast Implant shapes and sizes
Depending on the desired shape you wish to achieve, you and your surgeon may choose either a round or contoured implant. Both shapes are available with gel-filled and saline-filled.
Mentor contoured gel-filled breast implants are called CONTOUR PROFILETM Gel (or CPGTM) Breast Implants. Contoured implants have a teardrop shape and can
provide patients with a more natural look and feel.
Breast implants are measured in cubic
centimeters, or cc’s, not in cup sizes. The size of
the implant used depends on the size and shape
of the individual woman’s chest
Your surgeon will also evaluate your existing breast and skin tissue to determine if you have enough to cover the breast implant you are considering, or in some cases such as after pregnancy, too much extra skin. If you desire a breast implant size that is too large for your tissue, your surgeon may warn you that the breast implant edges may be visible or palpable following your surgery. Also, excessively large breast implants may speed up the effects of gravity on the breast, and can result in droop or sag at an earlier age.
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A recent report indicates that larger sized implants (greater than 350 cc) may be too large for many women, increasing the risk of developing complications such as extrusion, hematoma, infection, palpable implant folds and visible skin wrinkling. Surgical intervention could be required to correct these complications1.
Mentor also offers an adjustable gel breast implant called (Round) SPECTRATM Adjustable Gel Breast Implant. The SPeCTrATM has the advantages of a silicone
gel breast implant with an adjustable saline
inner-lumen that can be adjusted both intra-and
post-operatively.
Implant profiles
In addition to size and shape, breast implants are available in different profiles (which refers to the amount of forward projection off the chest wall). Generally, the larger you want your cup size, the larger the breast implant your surgeon will consider. With respect to the profile you would like to achieve, you and your surgeon may choose a round or contoured implant.
1. Henriksen, T.F., et al. 2005. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann. Plast. Surg. 54(4): 343-51.
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MenTor® ConToUr ProFILeTM Gel Breast Implants, or CPGTM, offers 3 projections to match patient's unique physiology.
Implant surfaces
Breast implants are available with either a smooth or textured surface. mentor has a textured breast implant surface called SiLTeXTm.
Together with your surgeon, you can decide which implant shape, size, profile and surface texture is
right for you.
Photos courtesy of Dr. Fabian Weiller (Germany)
Before After
Photos courtesy of Dr. Claudio De Lorenzi (Canada)
Product Implanted: CPGTM Breast Implants
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All Cohesive, All the TimeTM
All of the MenTor® MemoryGelTM Breast Implants use a gel that is cohesive, safe and aesthetically pleasing. We offer three degrees of cohesive filling material, from soft to firm:
ɶ Cohesive ITM—the softest-feeling gel
ɶ Cohesive IITM—slightly firmer
ɶ Cohesvie IIITM—Mentor’s firmest gel
Smooth round MemoryGelTM Breast Implant
MenTor® ConToUr ProFILeTM Gel Breast Implants are filled with the most cohesive gel, Cohesive IIITM, to maintain their natural shape.
ConToUr ProFILeTM Gel (CPGTM)MemoryGelTM
Breast ImplantCohesive IIITM
SILTeXTM round MemoryGelTM Breast Implant
Smooth round SPeCTrATM Adjustable
Gel Breast Implant
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Why this picture matters to you: We have cut a MemoryGelTM Breast Implant in half to demonstrate how the gel material can hold together uniformly. It does this because of a cohesive, gelatin-like substance that acts as a solid rather than a liquid maintaining its shape.
Smooth round MemoryGelTM Breast Implant,
Cohesive ITM
Here's a summary of MenTor® MemoryGelTM
Breast Implants product features:
ɶ Are Ce-Marked
ɶ Are approved by the United States Food
and Drug Administration (FDA)(round-
Shaped only)
ɶ Are filled with Mentor’s proprietary cohesive
gel
ɶ Our gel filler uniformly holds together and
retains a natural give that feels like breast
tissue
ɶ Come in round and ConToUr ProFILeTM
Implant shapes
ɶ Come in various projection options to give
you just the look you want
ɶ Are available with either a smooth or
textured surface (SILTeXTM)
ɶ Have a set fill volume for predictable results
ɶ Covered by the Mentor Lifetime Product
replacement Policy and our PatientSafe
Coverage Limited Warranty
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Saline Breast implants
Saline-filled breast implants are filled with a saltwater solution during surgery that is similar to the fluid that makes up most of the human body. For many women, deciding what breast size they want is the most difficult part about choosing implants. Saline comes in round and ConToUr ProFILeTM shape, in smooth and SILTeXTM surface.
mentor also offers an adjustable Saline Breast implant called the SPeCTRUmTm Adjustable Saline Breast implant.
MenTor® round and ConToUr ProFILeTM SPeCTrUMTM Implants are the only saline-filled breast Implants with a removable fill tube that lets your physician adjust the size of your implants for up to six months after your procedure by either adding or removing saline through the fill tube.
Smooth round Saline Breast Implant
SILTeXTM ConToUr ProFILeTM
Saline Breast Implant
SILTeX TM
ConToUr ProFILeTM
SPeCTrUMTM
Breast Implant
SILTeXTM round
Saline Breast Implant
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incision and placement choices
Per iareolar Incis ion
Inframammary Incis ion
Transaxi l lary Incis ion
Incisions
Breast augmentation is normally performed using one of three common incision sites: under the arm (transaxillary), around the nipple (periareolar), or within the breast fold (inframammary).
ɶ Transaxillary—This incision is less concealed, but it might be a good option for women who do not want any scars on their breasts.
ɶ 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 sites2. Cutting through the tissue may increase the chance that there will be a change in breast or nipple sensation.
ɶ Inframammary—This incision is generally less concealed and may cause fewer breastfeeding dificulties than the periareolar incision site.
Your surgeon will explain each incision choice to you in greater detail and help you make the decision that is right for you.
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2. Hurst, n.M. Lactation after augmentation mammoplasty. Obstet. Gynecol. 87(1):30-4.
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Placement
During a breast augmentation procedure, the
implants will either be placed under the chest
muscle (submuscular) or on top of the muscle
and under the breast glands (subglandular).
ɶ Submuscular Placement
may reduce the chances of your implants
being felt through your skin, and it may
help reduce the chance of scar tissue
hardening around your implants. It also will
make it easier to image your breast during
a mammogram. Possible disadvantages of
this placement choice could be a longer
surgery and recovery time.
ɶ Subglandular Placement
can make your augmentation surgery
shorter and reduce your recovery time.
A possible disadvantage could be
having your implant edges more visibly
noticeable under your skin. Imaging
during a mammogram can also be more
difficult when your implants are placed
subglandularly.
Your surgeon can speak with you regarding how
each placement option relates to your individual
needs. Then you can make a decision regarding
which option is right for you.
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Submuscular Placement
Subglandular Placement
Chest Muscle
Breast Implant
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Your recoverY
every woman’s recovery is different. In general,
you will probably feel a little sore for several days
following your breast augmentation surgery.
The first 24 to 72 hours after your procedure is
when you will experience the most discomfort.
Your breasts will be swollen and very tender.
Although every woman’s recovery is different,
you should be able to resume light activities in
approximately one week.
An important part of your recovery may involve
wearing a postoperative bra or compression
garment. These are designed to provide you with
extra support while you heal. Your doctor also
may have other specific suggestions for you to
follow while you recover. If any problems occur
after your breast implant surgery, contact your
surgeon immediately.
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patientsafe coveRAge limited WarRAntY
All MenTor® Breast Implants come with a Lifetime
Product replacement Policy3 at no additional
charge. Also, once you receive MenTor® Silicone
Gel-Filled Breast Implants, you are automatically
enrolled in the Mentor PatientSafe Coverage.
Lifetime Product replacement Policy
ɶ Automatically applies to all recipients of MenTor® Breast Implant products
ɶ Provides that regardless of the age of the implant, when confirmed rupture occurs, you are eligible for a no-charge replacement breast implant product of
any size in a similar style
A personal commitment to your wellbeing
Your decision to use MenTor®
Breast Implants for your breast
augmentation is a personal,
long-term decision. our
relationship with you does
not end with your surgery.
We make a long-term
commitment to our patients
and we stand behind the
integrity of our products.
3. Lifetime Product replacement Policy: Mentor will provide replacement MenTor® Breast Implants of any size in the same or similar style as the originally implanted product free of charge for the lifetime of the patient. Upon surgeon’s request, a different implant style may be selected (subject to a charge of the difference between product list prices).
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Additional benefits with PatientSafe coverage
The Mentor PatientSafe Coverage is free of charge
to all patients who are implanted with MenTor®
Silicone Gel-Filled Breast Implant products.
ɶ Automatic enrollment
ɶ In the case of confirmed implant rupture up to €1000 of financial assistance for operating room, anesthesia, and surgical charges incurred in any revision surgery carried out within 10 years of the date of the original implant not covered by
insurance will be provided4.
Products covered
The Mentor PatientSafe Coverage applies to
MenTor® Silicone Gel-Filled Breast Implants that
are implanted in the following countries:
Benelux, Denmark, France, Germany, Italy, Spain,
Sweden and the UK after October 1, 2005.
Czech republic and norway after February 1, 2007.
Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus,
Bulgaria, Burkina Faso, Croatia, Cyprus, egypt, estonia,
Finland, Georgia, Greece, Hungary, Iceland, Ireland,
Israel, Ivory Coast, Jordan, Kuwait, Latvia, Lebanon,
Lichtenstein, Lithuania, Macedonia, Malta, Morocco,
oman, Pakistan, Poland, Portugal, Qatar, reunion,
romania, russia, Saudi Arabia, Serbia & Montenegro,
Slovakia, Slovenia, South Africa, Switzerland, Tunisia,
Turkey, Ukraine, United Arab emirates (UAe) and Yemen
after June 1, 2011.
And provided implants have been:
ɶ Implanted in accordance with the Mentor package insert, current to the date of implantation, and other notifications or instructions published by Mentor
ɶ Used by appropriately qualified, licensed surgeons, in accordance with accepted
surgical procedures
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 formand the Patient claim form. Financial assistance does not imply a loan to the patient.
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events covered
The Mentor Lifetime replacement policy and
PatientSafe Coverage only apply to:
ɶ Cases of loss of shell integrity resulting in implant rupture that require surgical
intervention
Mentor reserves the right to determine if specific,
additional events should be covered.
events not covered
The Mentor Lifetime replacement policy and
PatientSafe Coverage do not apply to:
ɶ removal of intact implants due to capsular contracture, wrinkling, or rippling
ɶ Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures
ɶ removal of intact implants for size alteration
ɶ Surgery on the opposite breast to replace
an intact implant
You may also obtain a copy of the complete Mentor PatientSafe Coverage limited warranty by going to www.mentorwwllc.com or by writing to:
Mentor Medical Systems CVZernikedreef 22333 CL, LeidenThe netherlandsPhone +31-71-7513600
THIS IS A LIMITeD WArrAnTY onLY AnD IS SUBJeCT To THe TerMS AnD ConDITIonS SeT ForTH In THIS DoCUMenT AnD eXPLAIneD In GreATer DeTAIL In THe APPLICABLe MenTor LIMITeD WArrAnTY. ALL oTHer WArrAnTIeS, WHeTHer eXPreSSeD or IMPLIeD, BY oPerATIon oF LAW or oTHerWISe, InCLUDInG BUT noT LIMITeD To, IMPLIeD WArrAnTIeS oF MerCHAnTABILITY AnD FITneSS, Are eXCLUDeD, To THe eXTenT PerMITTeD BY LAW.
THe TerMS In eFFeCT WHen orIGInAL IMPLAnTATIon oCCUrS WILL APPLY AT THe TIMe oF CLAIM.
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PatientSafe claimform
In order to assess your eligibility for PatientSafe
Coverage for MenTor® Silicone Gel-filled Breast
Implants, Mentor Medical Systems CV needs
to collect the following information through its
local operations or from your surgeon. Please
ensure that you complete this form and return
it to your surgeon who will then forward it to the
appropriate local Mentor representative.
name:
Address:
Date and place of surgery:
name of surgeon:
Implant Style and Size used:
Lot#:
Serial#:
Data protectionMentor will use this information to communicate with you and to assess your eligibility for PatientSafe Coverage only. Mentor will not share this information with parties other than your health provider or local Mentor contact, unless required for legal or regulatory compliance or litigation. Mentor will retain the information for the duration of your use of the Silicone Gel-filled Breast Implants, or where a longer retention period is required or permitted by law.
Please confirm that the information above is accurate and that you agree with the collection and use of your personal information as described above, by signing below. If you have any questions, or if you wish to request access, correction, or deletion of any personal information, please contact us directly at:
Mentor Medical Systems CVZernikedreef 22333 CL, LeidenThe netherlandsPhone +31-71-7513600
Date
Signature
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breast augmentation resources
The following list of resources may help
you to find more information about breast
augmentation and a certified plastic surgeon
in your area.
American Society of Plastic Surgeons www.plasticsurgery.org
British Association of Plastic Surgeons www.baps.co.uk
French Society of Plastic Surgeons www.plasticiens.org
German Association of Plastic Surgeons www.vdpc.de
Italian Society of Plastic Surgeons www.sicpre.org
Spanish Society of Plastic Surgeons www.cirugia-plastica.org
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breast implant safetY studY information
For the past several years, there have been
many reports in the media about women with
breast implants who have autoimmune disease
or breast cancer. Also during this time, many
respected medical professionals and institutions
have conducted scientific studies about the
safety of breast implants. Mentor is pleased to
be able to provide the public with up-to-date
information about breast implant studies.
Institute of Medicine
In June 1999, the national Academy Institute
of Medicine issued a report that included the
following conclusion: In an overall consideration
of the epidemiological evidence, the committee
noted that because there are more than 1.5
million adult women of all ages in the United
States with silicone breast implants, some of
these women would be expected to develop
connective tissue diseases, cancer, neurological
diseases or other systemic complaints or
conditions. evidence suggests that such
diseases or conditions are no more common
in women with breast implants than in women
without implants. The full text of the publication,
Information for Women About the Safety of
Silicone Breast Implants—A report of a Study by
the Institute of Medicine5, is available online at
www.nap.edu.
5. Bondurant, Stuart; ernster, Virginia L.; Herdman, roger; The Safety of Silicone Breast Implants. (US). Committee on the Safety of Silicone Breast Implants national Academies Press, 2000—Medical reference can be found: http://books.google.com/books?id=h1owCkaIg-oC&dq=isbn:0309065321.
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Independent review Group
The Independent review Group (IrG) on Silicone
Breast Implants was assembled by the Chief
Medical Officer of the UK to review the possible
health issues associated with silicone gel breast
implants. Members of the IrG were selected for
their independent views, their knowledge and
understanding of the issues, and lack of any
financial interest in the conclusions they reached.
Led by Professor roger D. Sturrock, MD, FrCP,
the IRG reported in 1998 that there is no scientific
evidence of an association between silicone
gel-filled breast implants and any established
connective tissue disease. The complete report is
available online at www.silicone-review.gov.uk6.
european Committee on Quality Assurance
In July 1998, the european Committee on Quality
Assurance and Medical Devices in Plastic Surgery
released a report that contained the following
conclusions: There are conclusive scientific,
clinical, immunological, epidemiological data,
that silicone gel-filled breast implants do not
cause any autoimmune nor connective tissue
diseases. Their report also stated, Updated studies continue to show that silicone gel-filled implants do not cause cancer nor other malignant disease. The
entire declaration can be found online at www.
ibir.org/equam/archive/consdecjune2000final.
doc7.
7. The european Committee on Quality Assurance and Medical Devices in Plastic Surgery Website. www.ibir.org/equam/archive/consdecjune2000final.doc. Accessed June 22, 2011.
6. MHrA Website. www.mhra.gov.uk. Accessed June 22, 2011.
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Questions to ask Your plastic surgeon
ɶ How many years have you performed
breast augmentation procedures?
ɶ How many breast augmentation
procedures do you perform each year?
ɶ What are the possible risks and
complications associated with breast
augmentation surgery?
ɶ What are all my options for breast
augmentation?
ɶ What shape, size, surface texturing,
incision site and placement site is
recommended for me?
ɶ How will my ability to breast-feed be
affected?
ɶ How can I expect my implanted breasts
to look over time?
ɶ Do you have before-and-after photos
that I can look at?
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glossarY
Aspiration: The withdrawing of a fluid from the body by
means of suction.
Biocompatible: Being biologically compatible by not
producing a toxic response in living tissue.
Breast Augmentation: A surgical procedure which
enlarges the breast through implantation of a prosthesis.
Breast Implant: A soft, silicone envelope with various
fillers that can be placed in the body for simulated
breast tissue.
Capsular Contraction: A tightening of the scar tissue
surrounding an implant.
CPGTM: MenTor® ConToUr ProFILeTM Gel Breast
Implant.
envelope: The outer lining of an implant which traps
the inner filling, sealing it in.
expander/Mammary Implant: A breast implant that
also acts as a tissue expander, stretching the tissues,
but then also remains in place as a breast implant.
Fibrous Tissues: Connective tissues composed mainly
of fibers.
Glandular: relating to a gland.
Hemorrhage: Abnormal internal or external discharge
of blood.
Inpatient Surgery: A surgical procedure in which the
patient is required to stay overnight in a hospital.
Mastopexy: Breast lift to tighten the breast by removing
skin that the forces of gravity and the effects of aging
have caused to sag.
MemoryGelTM Breast Implants: MenTor® gel-filled
breast implants.
Milk Ducts: Tubes for the passage of secreting milk.
opaque: not transparent; impenetrable by visible light
rays and x-rays.
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outpatient Surgery: A surgical procedure in which the
patient is not required to stay overnight in a hospital.
Pectoralis Major: A muscle located in the upper chest
which provides support for the breasts and is necessary
for arm movements.
Postoperatively Adjustable Implant: An implant that
allows the volume to be adjusted, after implantation,
within a specified range.
Prosthesis: Any artificial body part.
Ptosis: Sagging. Breast ptosis is usually the result of
normal aging and the pull of gravity or changes
caused by pregnancy or weight loss.
Saline: A solution that is made up of water and a small
amount of salt. Approximately 71% of an adult's body
weight consists of this saltwater solution.
Sensory nerves: The nerves that conduct afferent impulses
from sensory receptors to the brain or spinal cord.
Sepsis: The presence of various microorganisms, their
poisonous products or their toxins in the blood or tissue.
Silicone: A material that is widely used in medical
implants, composed primarily of silicon, carbon,
hydrogen and oxygen.
Silicone gel: Silicone produced in a semi-solid, semi-
liquid state, used as a filling in breast implants, similar in
consistency to a normal breast.
SILTeXTM: Mentor's textured breast implant surface.
SPeCTrATM: MenTor® adjustable gel breast implant.
Thrombosis: The formation or development of a blood clot.
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mentor— a companY that cares
Founded in 1969, Mentor is a leading supplier
of medical products in over 100 countries
throughout the world. As the world’s leading
maker of high-quality breast implants, our years
of experience result in quality products that you
can rely on.
MenTor® MemoryGelTM Breast Implants are
made at our state-of-the-art manufacturing
plant in Leiden, The netherlands. This advanced
manufacturing facility is the largest of its kind
in the world. It features many groundbreaking
engineering advances that are new to the
breast implant industry.
Mentor conducts research, development and
manufacturing at several facilities throughout
europe and the United States. The company
also has sales and distribution outlets around the
world. In 1995, Mentor became the first breast
implant manufacturer to achieve Ce-marking
for its products.
Mentor is proud of the quality built into each of
our breast implants, and you can be assured
that behind your decision to use our products is
a company that understands your hopes and
desires and a company that truly cares.
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important safetY information:MenTor® MemoryGelTM and MenTor® Saline-Filled Breast Implants are indicated for breast augmentation—in women who are at least 18 years old—or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or precancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. You may need additional unplanned surgeries on your breast because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
The most common complications with MemoryGelTM Breast Implants include reoperation, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent (meaning neither you nor your doctor will know you have a rupture). The health consequences of a ruptured silicone gel-filled breast implant have not been fully established. Screenings such as mammography, MrI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture.
The most common complications with MenTor® Saline-Filled Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.
Patients are reminded to discuss the indications, contraindications, warnings, precautions and the risks and benefits associated with MenTor® Breast Implants with their surgeons or review detailed risk information on line at www.mentorwwllc.com.
It is important that you understand the risks associated with breast implant surgery when considering MenTor® Breast Implants.
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