For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you...

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Transcript of For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you...

Page 1: For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you and your surgeon based on your personal needs, desires and expectations. Today,
Page 2: For over 20 years, · 2015-12-04 · your decisions about breast augmentation should be made by you and your surgeon based on your personal needs, desires and expectations. Today,

For over 20 years,

Mentor has been

recognised throughout

the world as a leading

manufacturer of the

highest quality breast

implants.

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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

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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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- 29 - - 30 -

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.

Corporate Headquarters

Santa Barbara, CA 93111 USA

Tel: +1 805 879 6000

www.mentorwwllc.com

© Mentor Worldwide LLC 2011 0210025 Rev J 9/13

NOT FOR DISTRIBUTION IN USA. APPROveD FOR eMeA RegION.

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