Breast Augmentation with Natrelle® Silicone-Filled Breast ... - Allergan

Table of ContentsGlossary.................................................................................. 21. Considering Silicone Gel-Filled Breast Implant Surgery.... 101.1 what gives the breast its shape?.........................................111.2 What is a silicone filled breast implant?................................111.3 Are silicone gel-filled breast implants right for you?................. 121.4 What important factors should you consider in choosing siliconegel-filled implants?........................................................... 132. Breast Implant Complications......................................... 192.1 What are the potential complications?................................. 192.2 What are other reported conditions?................................... 293. Allergan’s Clinical Study Results........................................ 333.1 What are the overview findings of Allergan’s Core Study?......... 333.2 What are the 7-year follow-up rates?................................... 343.3 What are the benefits?..................................................... 343.4 What are the 7-year complication rates?.............................. 363.5 What are the main reasons for reoperation?......................... 393.6 What are the main reasons for implant removal?.................... 403.7 What are other clinical data findings?................................. 424. Surgical Considerations for Breast Augmentation......... 444.1 What are the alternatives to breast augmentation withsilicone gel-filled breast implants?....................................... 444.2 What are questions to consider whenchoosing a surgeon?........................................................444.3 What are other choices and optionsassociated with the surgery?..............................................454.4 What follow up examinations are important?.........................505. Additional Information...................................................... 535.1 What types of NATRELLE ® silicone-filled breast implantsare available from Allergan?..............................................535.2 What if I experience a problem?........................................545.3 What is device tracking?..................................................555.4 What are the ConfidencePlus ® warranties?...........................565.5 How can I receive more information?..................................56For Further Reading and Information....................................58Index ...................................................................................631

Breast massBreastreconstructionCalcificationCapsularcontractureA lump in the breast.A surgical procedure to replace breast tissue thathas been removed due to cancer or trauma or thathas failed to develop properly due to a severebreast abnormality.Process of hardening by calcium salts.A tightening of the tissue capsule surrounding animplant, resulting in firmness or hardening of thebreast and in squeezing of the implant if severe.capsular contracture is classified by Bakergrades. Baker Grades III or IV are the mostsevere. Baker Grade III often results in the need foradditional surgery (reoperation) because of painand possibly abnormal appearance. Baker GradeiV usually results in the need for additional surgery(reoperation) because of pain and unacceptableappearance. Capsular contracture Baker Grade IImay also result in the need for additional surgery.capsular contracture is a risk for implant rupture.Below is a description of each Baker Grade.• Baker Grade I – Normally soft and naturalappearance• Baker Grade II – A little firm, but breast looksnormal• Baker Grade III – More firm than normal, andlooks abnormal (change in shape)• Baker Grade IV – Hard, obvious distortion, andtenderness with painCapsuleCapsulectomyCapsulotomy (closed)Scar tissue which forms around the breast implant.sometimes this capsule squeezes the implant,resulting in capsular contracture.Surgical removal of the scar tissue capsule aroundthe implant.An attempt to break the scar tissue capsule aroundthe implant by pressing or pushing on the outsideof the breast. This method does not requiresurgery but is a known risk for rupture of theimplant and is contraindicated.3

Capsulotomy (open)CongenitalabnormalityAn attempt to break the scar tissue capsule aroundthe implant by surgical incision into the capsule.An abnormal development in part of thebody, present in some form since birth.Connective tissue A disease, group of diseases, or conditionsdisease/disorder (CTD) affecting connective tissue, such as muscles,ligaments, skin, etc., and/or the immune system.connective Tissue Diseases (“CTDs”) that involve theimmune system include autoimmune diseases suchas rheumatoid arthritis, lupus, and scleroderma.ContraindicationContralateralCore StudyDelayedwound healingDiffusionDisplacementDysmorphic disorderEpidemiologicalA use that is improper and should not be followed.Failure to follow contraindications identified in thelabeling could cause serious harm.Opposite side.The primary clinical study of augmentation,reconstruction, and revision (revision-augmentationand revision-reconstruction) patients thatsupported the approval of the premarket approval(PMA) application. Safety and effectiveness dataare collected yearly through 10 years, withthe follow-up from years 5 through 10 beingperformed as part of a postapproval Core Study.Delayed progress in the healing of anopened wound.Movement from one location to another.Movement of the implant from the usualor proper place.A psychological condition characterized byan obsession with a minor or an imaginedphysical flaw to the point that it can interferewith normal functioning.Relating to the science of explaining therelationships of factors that determine diseasefrequency and distribution.4

Extracapsular ruptureExtrusionFibromyalgiaFibrous tissuesGranulomaHematomaHypertrophicscarringImmune responseInfectionInflammationInframammaryInframammary foldInframammaryincisionInpatient surgeryIntracapsularruptureA type of rupture in which the silicone gel isoutside of the scar tissue capsule surroundingthe implant.Skin breakdown with the pressing out of theimplant through the surgical wound or skin.A disorder characterized by chronic pain in themuscles and soft tissues surrounding joints,with tenderness at specific sites in the body. It isoften accompanied by fatigue.Connective tissues composed mostly of fibers.A lump or mass made of inflammatory cellssurrounding a foreign substance due tolongstanding inflammation.A collection of blood within a space.An enlarged scar remaining after the healing ofa wound.A bodily response to the presence ofa foreign substance.Invasion with microorganisms (for example,bacteria, viruses). An infection usually results infever, swelling, redness, and/or pain.The response of the body to infection or injurythat is characterized by redness, swelling, warmth,pain, and/or loss of function.Below the breast.The crease at the base of the breast.An incision made in the fold below the breast.A surgical procedure in which the patient isrequired to stay overnight in the hospital.A type of rupture in which the silicone gel remainsinside the scar tissue capsule surrounding the implant.5

LactationLow molecularweight siliconesLymphadenopathyLymphedemaMRIMalpositionMammaryMammographyThe production and secretion of milk by thebreast glands.Small silicone molecules that might leak outof the implant.Enlargement of the lymph node(s).Swelling of the lymph nodes.Magnetic resonance imaging. A radiographicexamination that currently has the best abilityto detect rupture of silicone gel-filled breastimplants.Implant malposition or displacement is when theimplant is not in the correct spot in the breast.this could have been due to incorrect placementof the implant during the surgery or due to shiftingof the implant position over time.Pertaining to the breast.A type of X-ray examination of the breasts used fordetection of cancer.screening mammography – X-ray examination ofthe breast that is performed on women with nocomplaints or symptoms of breast cancer; the goalis to detect breast cancer when it is still too smallto be felt by a physician or the patient.diagnostic mammography – X-ray examination inorder to evaluate a breast complaint orabnormality detected by physical exam orscreening mammography; additional views of thebreast are usually taken.MammoplastyMastitisMastopexyMetastatic DiseasePlastic surgery of the breast.Inflammation of the breast.Plastic surgery to lift sagging breasts higher.Spreading of cancer cells from the original site toother parts of the body.6

MigrationNecrosisOutpatient surgeryPalpabilityPalpate/palpableParesthesisPectoralisPeriareolarPlastic surgeryPostoperativelyPrimary breastaugmentationPtosisReoperationRevisionaugmentationRheumatologicaldisease/disorderMovement of silicone materials outsidethe breast implant.Death of cells or tissues.A surgical procedure in which the patient is notrequired to stay in the hospital overnight.The ability to feel the implant.To feel with the hand.The feelings of pins and needles in a particulararea of your body (particularly the arms and legs).Major muscle of the chest.Around the darkened or pigmented areasurrounding the nipple of the breast.Surgery intended for the improvement ofappearance of the body.After surgery.The first time a breast implant is placedfor the purpose of breast augmentation.Breast sagging that is usually the result of normalaging, pregnancy, or weight loss.An additional surgery after your first breast implantation.Refers to the correction or improvement of aprimary augmentation. In the contextof this document, it refers to surgical removal andreplacement of breast implants that were placedoriginally for primary breast augmentation.A variety of diseases involving connective tissuestructures of the body, especially the jointsand fibrous tissue. These diseases are oftenassociated with pain, inflammation, stiffness, and/or limitation of motion of the affected parts.can include autoimmune diseases. Fibromyalgiais a rheumatological disorder.7

RosenbergSelf-Esteem ScaleRuptureSalineScar revisionSeromaSF-36 ScaleSilent ruptureSilicone elastomerSubglandularplacementSubmuscularplacementSurgical incisionSymptomSymptomaticA 10-item questionnaire intended to measureoverall self-esteem through statements related tofeelings of self-worth and self-acceptance.A tear or hole in the implant shell. Siliconeimplant ruptures may be with or without symptoms.ruptures can be intracapsular or extracapsular.A solution that is made up of water and a smallamount of salt.A surgical procedure to improve the appearanceof a scar.A build-up of the watery portion of the blood in atissue location.A 36-item questionnaire intended to measurepatient health in areas such as vitality, physicalfunctioning, bodily pain, general health, socialand emotional functioning, and mental health.A breast implant rupture without symptoms andwhich is not apparent except through appropriateimaging techniques such as MRI. Most siliconegel-filled breast implant ruptures are silent (seesymptomatic rupture next page).A type of silicone that has elastic propertiessimilar to rubber.Placement of a breast implant underneathand within the breast glands but on top ofthe chest muscle.Placement of a breast implant wholly or partiallyunderneath the chest muscle.A cut made to body tissue during surgery.Any perceptible change in the body or its functionsthat indicates disease or a phase of a disease.Any evidence or sign of disease or disorderreported by the patient.8

SymptomaticruptureSystemicTennesseeSelf-Concept ScaleToxic shocksyndromeTransaxillaryA breast implant rupture that is associatedwith symptoms (such as lumps, persistent pain,swelling, hardening, or change in implant shape).some silicone breast implant ruptures aresymptomatic, but most are silent.Pertaining to or affecting the body as a whole.A questionnaire intended to measure the patient’sview of her body and state of health, as well asher attitude about appearance, skills, andsexuality. The questionnaire administered in thecore Study consisted of 18 items.Infection from staphylococci, occurring most oftenin the vagina of menstruating women usingsuperabsorbent tampons but can also occurin other soft tissue infections. Symptoms includehigh fever, vomiting, diarrhea, rash, decreasedblood pressure and shock, which can result in death.Through the axilla (armpit); an incision madeunder the arm.9

1. CONSIDERING SILICONE GEL-FILLED BREAST IMPLANT SURGERYYou may be considering breast implant surgery to increasethe size of your breasts. This is referred to as breastaugmentation. Or you may need revision of a previousbreast augmentation, which is called revision-augmentation.Allergan has prepared this information to help you betterunderstand the breast implant procedure and assist you inmaking an informed decision about breast augmentation orrevision-augmentation surgery. It will help to answer someof the questions you may have about the surgery and aboutbreast implants in general. It will also provide you withspecific information about the risks and benefits of NATRELLE ®Silicone-Filled Breast Implants.This information cannot and should not replace discussingyour surgery with your plastic surgeon. Your decision whetheror not to get breast implants should be based on realisticexpectations of the outcome. There is no guarantee thatyour results will match those of other women. Your resultswill depend on many individual factors, such as your overallhealth (including age), chest structure, breast/nipple shapeand position, skin texture, healing capabilities (which may beslowed by radiation and chemotherapy treatment, smoking,alcohol, and various medications), tendency to bleed, priorbreast surgery, surgical team’s skill and experience, type ofsurgical procedure, and type and size of implant. Make sureyou speak with your surgeon about your expectations of theresults, as well as what you can expect regarding the lengthof the surgery, your recovery, and any risks and potentialcomplications of the surgery. Ask questions.As part of your decision, both you and your surgeon will berequired to sign Allergan’s consent to surgery form that confirmsyour understanding of what you have read. This Allerganconsent document will be provided to you by your surgeon.You should wait at least 1-2 weeks after reviewing andconsidering this information before deciding whether to haveprimary breast augmentation surgery. In the case ofa revision-augmentation, however, your surgeon may find itmedically necessary to perform surgery sooner.10

1.1 What Gives the Breast Its Shape?The breast consists of milk ducts and glands, surrounded byfatty tissue that provides its shape and feel. Beneath the breastis the chest muscle (pectoralis major muscle).Fatty tissueribspectoralis musclesmilk ductsand glandsFactors such as pregnancy (when milk glands are temporarilyenlarged), rapid weight loss, and the effects of gravity as youage combine to stretch the skin, which may cause the breast todroop or sag. However, it is important to realize that implantsare used to make the breast larger. The implants alone may notadequately lift the breast, or correct the effects of pregnancy,weight loss, or skin stretching. Your surgeon may suggestadditional procedures at the time of the breast augmentation,such as mastopexy, to help achieve improved breast lift.1.2 What Is a Silicone FilledBreast Implant?A silicone gel-filled breast implant is a sac (implant shell)of silicone elastomer (rubber) filled with silicone gel. It issurgically implanted either under your breast tissue or underyour chest muscle.11

1.3 Are Silicone Gel-Filled Breastimplants Right for You?NATRELLE ® Silicone-Filled Breast Implants are indicated forfemales for the following uses (procedures):• Breast augmentation for women at least 22 years old.Breast augmentation includes primary breastaugmentation to increase the breast size, as well asrevision surgery to correct or improve the result of aprimary breast augmentation surgery.• Breast reconstruction. Breast reconstruction includesprimary reconstruction to replace breast tissue that hasbeen removed due to cancer or trauma or that has failedto develop properly due to a severe breast abnormality.Breast reconstruction also includes revision surgery tocorrect or improve the result of a primary breastreconstruction surgery. (A separate patient brochure isavailable for those women considering breastreconstruction surgery and should be read prior toreaching a decision to undergo breast reconstruction).ContraindicationsBreast implant surgery should not be performed in:• Women with active infection anywhere in their body.• Women with existing cancer or pre-cancer of theirbreast who have not received adequate treatment forthose conditions.• Women who are currently pregnant or nursing.12

PrecautionsSafety and effectiveness have not been established in patientswith the following:• Autoimmune diseases(for example, lupus and scleroderma).• A weakened immune system (for example,currently taking drugs that weaken the body’snatural resistance to disease).• Conditions that interfere with wound healing andblood clotting.• Reduced blood supply to breast tissue.• Radiation to the breast following implantation.• Clinical diagnosis of depression or other mental healthdisorders, including body dysmorphic disorder andeating disorders. Please discuss any history of mentalhealth disorders with your surgeon prior to surgery.patients with a diagnosis of depression, or othermental health disorders, should wait until resolution orstabilization of these conditions prior to undergoingbreast implantation surgery.1.4 What Important Factors Should Youconsider in Choosing Siliconegel-Filled Implants?• Breast implants are not lifetime devices, andbreast implantation is likely not a one-time surgery.You will likely need additional unplanned surgeries onyour breasts because of complications or unacceptablecosmetic outcomes. These additional surgeries caninclude implant removal with or without replacement, orthey can include other surgical procedures. When youhave your implants replaced (revision-augmentation),your risk of future complications increases comparedto first time (primary) augmentation surgery, so youshould also review the complication rates for revisionaugmentationpatients to see what future risk rates youmay experience.13

KATELYNMother of FourNATRELLE ® Style 20ERICABookkeeperNATRELLE ® Style 20AMBERNurseNATRELLE ® Style 68QUYNHLawyer, Mother of TwoNATRELLE ® Style 15ROSEActress, MotherNATRELLE ® Style 363MINELAStudentNATRELLE ® Style 1514 14

• Many of the changes to your breast followingimplantation are irreversible (cannot be undone). Ifyou later choose to have your implant(s) removed andnot replaced, you may experience unacceptabledimpling, puckering, wrinkling, or other cosmeticchanges of the breast, which can be permanent.• Breast implants may affect your ability to breastfeed,either by reducing or eliminating milk production.• Rupture of a silicone gel-filled breast implant is mostoften without symptoms (silent). This means thatmost of the time neither you nor your surgeon willknow that your implants have a rupture. In fact, theability of a physical examination by a plastic surgeonwho is familiar with breast implants to detect siliconebreast implant rupture is 30% 3 compared to 89% forMRI. 4 You will need regular screening MRIexaminations over your lifetime in order to determine ifsilent rupture is present. You should have your firstmri at 3 years after your initial implant surgery andthen every 2 years, thereafter. The cost of MRIscreenings may exceed the cost of your initial surgeryover your lifetime. This cost, which may not becovered by your insurance, should be considered inmaking your decision.• If implant rupture is noted on MRI, you should havethe implant removed, with or without replacement.• With breast implants, routine screening mammographyfor breast cancer will be more difficult. If you are of theproper age for mammography screening, you shouldcontinue to undergo routine mammography screeningas recommended by your primary care physician. Theimplant may interfere with finding breast cancer duringmammography. Because the breast and implant aresqueezed during mammography, an implant may ruptureduring the procedure. More x-ray views are necessaryfor women with breast implants; therefore, you willreceive more exposure to radiation. However, the benefitof having the mammogram to find cancer outweighsthe risk of the additional X-rays. Be sure to inform themammography technologist that you have implants.15

KATELYNMother of FourNATRELLE ® Style 20ERICABookkeeperNATRELLE ® Style 20AMBERNurseNATRELLE ® Style 68HPQUYNHLawyer, Mother of TwoNATRELLE ® Style 15ROSEActress, MotherNATRELLE ® Style 363MINELAStudentNATRELLE ® Style 15KATELYNStyle 20ERICAStyle 20AMBERStyle 68HPQUYNHStyle 15ROSEStyle 363MINELAStyle 15ROBYNUnilateral ReconstructionNATRELLE ® 133V TissueExpanders and ImplantAMYBilateral ReconstructionNATRELLE ® 133V TissueExpanders and ImplantsJESSICABilateral PrimaryAugmentationNATRELLE ® Style FM270 NPHAEDRABilateral RevisionAugmentationNATRELLE ® Style FM47016

• You should perform an examination of your breastsevery month for cancer screening; however, this maybe more difficult with implants. You should ask yoursurgeon to help you distinguish the implant from yourbreast tissue.• You should perform an examination of your breastsfor the presence of lumps, swelling, hardening, orchange in implant shape, which may be signs ofsymptomatic rupture of the implant. Report any ofthese symptoms or persistent pain to your surgeon.Your surgeon may recommend an evaluation via MRIto screen for rupture.• After undergoing breast augmentation surgery (eitherprimary or revision), your health insurance premiumsmay increase, your insurance coverage may bedropped, and/or future coverage may be denied.Treatment of complications may not be coveredas well. You should discuss the complete extent ofyour insurance coverage with your insurance companybefore undergoing surgery.• You should inform any other doctor who treats you ofthe presence of your implants to minimize the risk ofdamage to the implants.• Allergan will continue its ongoing clinical Core Studythrough 10 years to further evaluate the long-termsafety and effectiveness of these products. In addition,Allergan has initiated a separate 10-year postapprovalstudy (the Breast Implant Follow-Up Study, or BIFS) toaddress specific issues for which the Allergan CoreStudy was not designed to fully answer, as well as toprovide a real-world assessment of some endpoints.The endpoints in the large postapproval study includelong-term local complications, connective tissuedisease (CTD), CTD signs and symptoms, neurologicaldisease, neurological signs and symptoms, offspringissues, reproductive issues, lactation issues, cancer,suicide, mammography issues, and MRI complianceand results. Allergan will update its labeling on aregular basis with the results of these two studies.You should also ask your surgeon for any availableupdated Allergan clinical information.17

• It is important that you read this entire brochurebecause you need to understand the risks and benefitsand to have realistic expectations of the outcome ofyour surgery.18

2. BREAST IMPLANT COMPLICATIONSUndergoing any type of surgical procedure involves risks(some serious) such as the effects of anesthesia, infection,swelling, redness, bleeding, pain, and even death, whichneed to be balanced against the benefits of the surgery itself.There are potential complications specific to breast implantsurgery and breast implants, as described below. Locatedat the end of this brochure is a list of the study reports usedto gather the information discussed in the sections below.These may be helpful to you if you wish to learn more abouta specific complication or condition. The reference list isnot complete because studies are being conducted all thetime; your physician may have other resources for furtherreading as well. It should be noted that the references includeaugmentation and/or reconstruction patients, as well asimplants of different types and from a variety of manufacturers.2.1 What Are the Potential Complications?• RuptureBreast implants are not lifetime devices. Breast implantsrupture when the shell develops a tear or hole. Ruptures canoccur at any time after implantation, but they are more likelyto occur the longer the implant is implanted. The followingthings may cause your implant to rupture: damage by surgicalinstruments; stressing the implant during implantation whichmay weaken it; folding or wrinkling of the implant shell;excessive force to the chest (for example, during closedcapsulotomy, which is contraindicated); trauma; compressionduring mammographic imaging; and severe capsularcontracture. Breast implants may also simply wear out overtime. Laboratory studies have identified some of the typesof rupture for Allergan’s product; however, it is not knownwhether these tests have identified all causes of rupture. Theselaboratory studies will continue post-approval.19

Silicone gel-filled breast implant ruptures are most often silent.(MRI examination is currently the best method to screen for silentrupture). This means that most of the time neither you nor yourplastic surgeon will know if the implant has a tear or hole in theshell. This is why MRI is recommended at 3 years and then every2 years, thereafter, to screen for rupture. However, sometimesthere are symptoms associated with gel implant rupture. Thesesymptoms include hard knots or lumps surrounding the implantor in the armpit, change or loss of size or shape of the breastor implant, pain, tingling, swelling, numbness, burning, orhardening of the breast.When MRI signs of rupture are found, or if your surgeondetermines you have signs or symptoms of rupture, you shouldhave the implant and any gel removed, with or withoutreplacement of the implant. It also may be necessary to removethe tissue capsule as well as the implant, which will involveadditional surgery, with associated costs. If you have symptomssuch as breast hardness, a change in breast shape or size, and/or breast pain, you should have an MRI to determine whetherrupture is present. 1,5There are also consequences of rupture. If rupture occurs, siliconegel may either remain within the scar tissue capsule surroundingthe implant (intracapsular rupture), move outside the capsule(extracapsular rupture), or gel may move beyond the breast (gelmigration). There is also a possibility that rupture may progress fromintracapsular to extracapsular and beyond. There have also beenhealth consequences reported in the literature. See below for details.Rupture Information on Allergan ImplantsIn Allergan’s Core Study, rupture was assessed for patients whohad scheduled MRIs to screen for silent rupture (i.e., part of theMRI cohort) and those who were not assessed for rupture byMRI (i.e., part of the non-MRI cohort). For primary augmentationpatients in the MRI cohort, the by-patient rupture rate was 8.6%and the by-implant rupture rate was 5.1% through 7 years. Forrevision-augmentation patients in the MRI cohort, the rupturerate was 0% through 7 years. This means that through 7 years,approximately 9 of every 100 primary augmentation womenhad at least one ruptured breast implant. For the non-MRI cohort,there were 3 primary augmentation and 2 revision-augmentationpatients who had reported rupture through 7 years.20

The rupture rate for the whole MRI cohort in the CoreStudy (including augmentation, revision-augmentation,reconstruction, and revision-reconstruction patients) through7 years was 7.3% for patients and 4.5% for implants. Acrossall patients in the Core Study, all ruptures were intracapsularwith 1 case of extracapsular gel (one rupture progressed toextracapsular gel following exploratory surgery to confirm therupture and then implant replacement was delayed). There wereno cases of migrated gel.Further rupture rate information on NATRELLE ® Silicone-FilledBreast Implants is provided from a published Europeanstudy known as the International MRI Study. 2 Silent rupturedata were collected via a single MRI on 77 augmentation,11 reconstruction, and 18 revision patients implanted withsmooth and textured NATRELLE ® implants by five surgeons.The average age of the implants was approximately 11years. Silent rupture was found in approximately 15% of thecombined group of augmentation, reconstruction, and revisionpatients and 8% of the implants. There was one possiblecase of extracapsular rupture with the remainder classified asintracapsular ruptures. No cases of gel migration were found.Additional information on rupture will be collected throughAllergan’s postapproval studies: the continuing Core Studyand Breast Implant Follow-Up Study (BIFS).Additional Information on Consequences of Rupturefrom LiteratureSince silicone implants were not available in the UnitedStates for many years but were used in Europe during thattime, some information on rupture rates comes from studiesconducted in Europe. Studies of Danish women evaluatedwith MRI involving a variety of manufacturers and implantmodels showed that about three-fourths of implant ruptures areintracapsular and the remaining one-fourth are extracapsular. 6Additional studies of Danish women indicate that over a2-year period, about 10% of the implants with intracapsularrupture progressed to extracapsular rupture as detected byMRI. 5 This means that for women with silicone gel rupturewithin the scar tissue capsule detected via MRI after 2 years,1 in 10 of these women had progression of the gel outside thescar tissue capsule. In about half of these cases of progressionfrom intracapsular to extracapsular rupture, the women hadexperienced trauma or mammography. In the other half, no21

cause was given. In the women with extracapsular rupture,after 2 years, the amount of silicone outside the scar tissuecapsule increased for about 14% of these women. This meansthat for 100 women with silicone gel rupture outside the scartissue capsule, the amount of gel outside the scar tissue capsuleincreased for 14 women 2 years later. This type of informationpertains to a variety of silicone implants from a variety ofmanufacturers and implant models, and it is not specific toAllergan implants.Below is a summary of information related to the healthconsequences of implant rupture, which have not been fullyestablished. These reports were in women who had implantsfrom a variety of manufacturers and implant models.• Local breast complications reported in the publishedliterature which were associated with rupture includebreast hardness, a change in breast shape or size,and breast pain. 5 These symptoms are not specific torupture, as they also are experienced by women whohave capsular contracture.• There have been rare reports of gel movement tonearby tissues such as the chest wall, armpit, or upperabdominal wall, and to more distant locations downthe arm or into the groin. This has led to nervedamage, granuloma formation and/or breakdown oftissues in direct contact with the gel in a few cases.There have been reports of silicone presence in theliver of patients with silicone breast implants. Movementof silicone gel material to lymph nodes in the axilla alsohas been reported, even in women without evidence ofrupture, leading to lymphadenopathy. 43• Concerns have been raised over whether rupturedimplants are associated with the development ofconnective tissue or rheumatic diseases and/orsymptoms such as fatigue and fibromyalgia. 11,12,18,19A number of epidemiology studies have evaluatedlarge populations of women with breast implants.These studies do not, taken together, support asignificant association of breast implants with atypical, diagnosed rheumatic disease. Other than onesmall study, 12 these studies do not distinguish whetherthe women had ruptured or intact implants.22

• Capsular ContractureThe scar tissue (capsule) that normally forms around theimplant may tighten over time and compress the implant,making it feel firm and leading to what is called capsularcontracture. Capsular contracture may be more commonfollowing infection, hematoma, and seroma, and the chanceof it happening may increase over time. Capsular contractureoccurs more commonly in revision-augmentation than inprimary augmentation. Because you may have your initialimplants replaced, you should be aware that your risk ofcapsular contracture increases with revision-augmentation.Capsular contracture is a risk factor for implant rupture, and itis the most common reason for reoperation.Symptoms of capsular contracture range from mild firmnessand mild discomfort to severe pain, distorted shape of theimplant, and palpability (ability to feel the implant). Capsularcontracture is graded into 4 levels depending on its severity.*Baker Grades III and IV are considered severe, and oftenadditional surgery is needed to correct these grades.Baker Grade I:Baker Grade II:Baker Grade III:Baker Grade IV:the breast is normally soft and looks naturalthe breast is a little firm but looks normalthe breast is firm and looks abnormalthe breast is hard, painful, and looks abnormalIn Allergan’s Core Study, for women receiving augmentationimplants for the first time, the risk of severe capsular contracturewas 16% through 7 years. This means that 16 out of every 100women who received Allergan implants for primary breastaugmentation had severe capsular contracture at least onceduring the first 7 years after receiving the implants.For women receiving revision-augmentation implants, the riskof severe capsular contracture was 20% through 7 years.Additional surgery may be needed in cases where pain and/or firmness are severe. This surgery ranges from removal of theimplant capsule tissue to removal and possible replacement ofthe implant itself. This surgery may result in loss of your breasttissue. Capsular contracture may happen again after theseadditional surgeries. Capsular contracture may increase the riskof rupture. 1* Baker, J.L. Augmentation mammaplasty. In: Owsley, J.Q. and Peterson, R.,Eds. Symposium on aesthetic surgery of the breast. St. Louis, MO: Mosby;1978:256-263.23

KATELYNMother of FourNATRELLE ® Style 20EBooNATREQUYNHLawyer, Mother of TwoNATRELLE ® Style 15RActreNATRELKATELYNStyle 20EStyQUYNHStyle 15RStylROBYN24Unilateral Reconstruction BilateralA

• Additional Surgeries (Reoperations)You should assume that you will need to have additionalsurgeries (reoperations). In Allergan’s Core Study, thereoperation rate was 30% for primary augmentation patientsand 41% for revision-augmentation patients, which means that30 out of every 100 women who received Allergan implants forprimary augmentation and 41 out of every 100 women whoreceived Allergan implants for revision-augmentation had areoperation during the first 7 years after receiving the implants.Patients may decide to change the size or type of theirimplants, requiring additional surgery. In addition, problemssuch as rupture, capsular contracture, hypertrophic scarring(irregular, raised scar), asymmetry, infection, and shifting canrequire additional surgery. Tables 3 and 4, which summarizethe main reasons for performing reoperations in the CoreStudy, are located in section 3.5. For women receivingprimary augmentation implants, the three most commonreasons for reoperations were capsular contracture, implantmalposition, and ptosis (sagging). For women receivingrevision-augmentation implants, the three most commonreasons for additional surgery were capsular contracture,hematoma/seroma, and implant malposition.• Implant RemovalBecause these are not lifetime devices, the longer youhave your implants the more likely it will be for you to havethem removed for any reason, either because of dissatisfaction,an unacceptable cosmetic result, or a complication suchas capsular contracture. Having your implants removedand replaced increases your chances of getting futurecomplications.For women receiving primary augmentation implants inAllergan’s Core Study, 14% had their implants removed atleast once through 7 years. Capsular contracture and patientrequest for style/size change were the most common reasonsfor implant removal. For women receiving revision-augmentationimplants in Allergan’s Core Study, 24% had their implantsremoved at least once through 7 years. The most commonreasons for implant removal were capsular contracture, patientrequest for style/size change, and implant malposition.25

Most women who have their implants removed have themreplaced with new implants, but some women do not.If you choose not to replace your implants, you may havecosmetically unacceptable dimpling, puckering, wrinkling,and/or other potentially permanent cosmetic changes of thebreast following removal of the implant. Even if you have yourimplants replaced, implant removal may result in loss of yourbreast tissue. Also, implant replacement increases your risksof future complications. For example, the risks of capsularcontracture and reoperation increase for patients with implantreplacement compared to first time placement. You shouldconsider the possibility of having your implants replaced andits consequences when making your decision to have implants.• Unsatisfactory ResultsUnsatisfactory results such as wrinkling, asymmetry, implantdisplacement (shifting), incorrect size, unanticipated shape,implant palpability, scar deformity, and/or hypertrophicscarring, may occur. Some of these results may causediscomfort. Pre-existing asymmetry may not be entirelycorrectable by implant surgery. Revision surgery may berecommended to maintain patient satisfaction, but carriesadditional considerations and risks. Selecting an experiencedplastic surgeon may minimize, but not necessarily prevent,unsatisfactory results.• PainPain of varying intensity and length of time may occur andpersist following breast implant surgery. In addition, impropersize, placement, surgical technique, or capsular contracturemay result in pain. You should tell your surgeon aboutsignificant pain or if your pain persists.• Changes in Nipple and Breast SensationFeeling in the nipple and breast can increase or decreaseafter implant surgery. The range of changes varies fromintense sensitivity to no feeling in the nipple or breastfollowing surgery. While some of these changes can betemporary, they can also be permanent, and may affect yoursexual response or your ability to nurse a baby. (See theparagraph on breastfeeding below.)26 26

• InfectionInfection can occur with any surgery or implant. Most infectionsresulting from surgery appear within a few days to weeks afterthe operation. However, infection is possible at any time aftersurgery. In addition, breast and nipple piercing procedures mayincrease the possibility of infection. Infections in tissue with animplant present are harder to treat than infections in tissue withoutan implant. If an infection does not respond to antibiotics, theimplant may have to be removed, and another implant maybe placed after the infection is resolved (cleared up). As withmany other surgical procedures, in rare instances, toxic shocksyndrome has been noted in women after breast implantsurgery, and it is a life-threatening condition. Symptoms includesudden fever, vomiting, diarrhea, fainting, dizziness, and/orsunburn-like rash. You should contact a doctor immediately fordiagnosis and treatment if you have these symptoms.• Hematoma/SeromaHematoma is a collection of blood within the space aroundthe implant, and a seroma is a build-up of fluid around theimplant. Having a hematoma and/or seroma followingsurgery may result in infection and/or capsular contracturelater on. Symptoms from a hematoma or seroma may includeswelling, pain, and bruising. If a hematoma or seromaoccurs, it will usually be soon after surgery. However, thiscan also occur at any time after injury to the breast. Whilethe body absorbs small hematomas and seromas, some willrequire surgery, typically involving draining and potentiallyplacing a surgical drain in the wound temporarily for properhealing. A small scar can result from surgical draining.Implant rupture also can occur from surgical draining if thereis damage to the implant during the draining procedure.• BreastfeedingBreastfeeding difficulties have been reported following breastsurgery, including breast reduction and breast augmentation.If your surgeon uses a periareolar surgical approach (anincision around the colored portion surrounding the nipple), itmay further increase the chance of breastfeeding difficulties.27

• Calcium Deposits in the TissueAround the ImplantCalcium deposits can form in the tissue capsule surrounding theimplant. Symptoms may include pain and firmness. Deposits ofcalcium can be seen on mammograms and can be mistakenfor possible cancer, resulting in additional surgery for biopsyand/or removal of the implant to distinguish calcium depositsfrom cancer. If additional surgery is necessary to examineand/or remove calcifications, this may cause damage tothe implants. Calcium deposits also occur in women whoundergo breast reduction procedures, in patients who have hadhematoma formation, and even in the breasts of women whohave not undergone any breast surgery. The occurrenceof calcium deposits increases significantly with age.• ExtrusionExtrusion is when the breast implant comes through yourskin. This may occur, for example, when your wound has notclosed or when breast tissue covering your implants weakens.Radiation therapy has been reported to increase the likelihoodof extrusion. Extrusion requires additional surgery and possibleremoval of the implant, which may result in additional scarringand/or loss of your breast tissue.• NecrosisNecrosis is the death of cells or tissues. This may preventor delay wound healing and require surgical correction,which may result in additional scarring and/or loss of yourbreast tissue. Implant removal may also be necessary. Factorsassociated with increased necrosis include infection, use ofsteroids, smoking, chemotherapy/radiation, and excessiveheat or cold therapy.• Delayed Wound HealingSome patients may experience a prolonged wound healingtime. Delayed wound healing may increase the risk ofinfection, extrusion, and necrosis. Depending on the typeof surgery or the incision, wound healing times may vary.Smoking may interfere with the healing process. You shouldcontact your surgeon immediately if your wound does not healwithin the period of time he/she has discussed with you.28

• Breast Tissue Atrophy/Chest Wall DeformityThe pressure of the breast implant may cause breast tissuethinning (with increased implant visibility and palpability) andchest wall deformity. This can occur while implants are still inplace or following implant removal without replacement. Eitherof these conditions may result in additional surgeries and/orunacceptable dimpling/puckering of the breast.• LymphadenopathyLymphadenopathy is a chronic enlargement of the lymph nodes.A lymph node is a round mass of tissue which makes cells aspart of your immune system. The lymph nodes in the armpit(axilla) drain the breast area of fluid. Some patients with breastimplants report having enlarged lymph nodes in the armpit(s).Sometimes the enlarged lymph nodes are painful. If theybecome too large or painful, the lymph node(s) may need tobe surgically removed. Painful and/or enlarged lymph nodesshould be reported to your doctor.Literature reports associate lymphadenopathy with both intactand ruptured silicone breast implants. One study reportedthat armpit lymph nodes from women with both intact andruptured silicone gel implants had abnormal tissue reactions,granulomas, and the presence of silicone. 43 These reports werein women who had implants from a variety of manufacturersand implant models.2.2 What Are Other Reported Conditions?There have been reports in the literature of other conditionsin women with silicone gel-filled breast implants. Many ofthese conditions have been studied to evaluate their potentialassociation with breast implants. Although no cause-and-effectrelationship has been established between breast implantsand the conditions listed below, you should be aware ofthese reports. Furthermore, there is the possibility of risks,yet unknown, which in the future could be determined to beassociated with breast implants.• Connective Tissue Disease (CTD)Connective tissue diseases include diseases such as lupus,scleroderma, and rheumatoid arthritis. Fibromyalgia is adisorder characterized by chronic pain in the muscles and softtissues surrounding joints, with tenderness at specific sites in thebody. It is often accompanied by fatigue.29

There have been a number of published epidemiologicalstudies which have looked at whether having a breast implantis associated with having a typical or defined connectivetissue disease. 1,10-18 The published studies overall showthat breast implants are not significantly associated witha risk of developing a typical or defined connective tissuedisease. 1,13-15 However, the study size needed to conclusivelyrule out a small risk of connective tissue disease amongwomen with silicone gel-filled implants would need to bevery large. These studies do not distinguish between womenwith intact and ruptured implants. Only one study evaluatedspecific connective tissue disease diagnoses and symptoms inwomen with silent ruptured versus intact implants, but the studywas too small to rule out a small risk. 12• CTD Signs and SymptomsLiterature reports have also been made associating siliconebreast implants with various rheumatological signs andsymptoms such as fatigue, exhaustion, joint pain and swelling,muscle pain and cramping, tingling, numbness, weakness,and skin rashes. Scientific expert panels and literature reportshave found no evidence of a consistent pattern of signsand symptoms in women with silicone breast implants. 1,19-22Having these rheumatological signs and symptoms doesnot necessarily mean you have a connective tissue disease;however, you should be aware that you may experience thesesigns and symptoms after undergoing breast implantation. Ifyou notice an increase in these signs or symptoms, you shouldconsider seeing a rheumatologist to determine whether thesesigns or symptoms are due to a connective tissue disorder orautoimmune disease.• CancerBreast Cancer – Reports in the medical literature indicate thatpatients with breast implants are not at a greater risk than thosewithout breast implants for developing breast cancer. 23,25,27,30,35Some reports have suggested that breast implants may interferewith or delay breast cancer detection by mammography and/or biopsy; however, other reports in the published medicalliterature indicate that breast implants neither significantly delaybreast cancer detection nor adversely affect cancer survival ofwomen with breast implants. 23,28,31,34,3530 30

Brain Cancer – One recent study has reported an increasedincidence of brain cancer in women with breast implants ascompared to the general population. 24 The incidence of braincancer, however, was not significantly increased in womenwith breast implants when compared to women who hadother plastic surgeries. Another recently published reviewof four large studies of women with cosmetic implantsconcluded that the evidence does not support an associationbetween brain cancer and breast implants. 33Respiratory/Lung Cancer – One study has reported anincreased incidence of respiratory/lung cancer in women withbreast implants. 24 Other studies of women in Sweden andDenmark have found that women who get breast implants aremore likely to be current smokers than women who get breastreduction surgery or other types of cosmetic surgery. 26,29,32Cervical/Vulvar Cancer – One study has reported anincreased incidence of cervical/vulvar cancer in women withbreast implants. 24 The cause of this increase is unknown.Other Cancers – One study has reported an increasedincidence of stomach cancer and leukemia in women withbreast implants compared to the general population. 24 Thisincrease was not significant when compared to women whohad other types of plastic surgeries.• Neurological Disease, Signs, and SymptomsSome women with breast implants have complained ofneurological symptoms (such as difficulties with vision,sensation, muscle strength, walking, balance, thinking orremembering things) or diseases (such as multiple sclerosis),which they believe are related to their implants. A scientificexpert panel report found that the evidence for a neurologicaldisease or syndrome caused by or associated with breastimplants is insufficient or flawed. 1• SuicideIn several studies, a higher incidence of suicide was observedin women with breast implants. 36-39 The reason for theobserved increase is unknown, but it was found that womenwith breast implants had higher rates of hospital admissiondue to psychiatric causes prior to surgery, as comparedwith women who had breast reduction or in the generalpopulation of Danish women. 37 3131

• Effects on ChildrenAt this time, it is not known if a small amount of silicone maypass through from the breast implant silicone shell into breastmilk during breastfeeding. Although there are no currentestablished methods for accurately detecting silicone levelsin breast milk, a study measuring silicon (one component insilicone) levels did not indicate higher levels in breast milk fromwomen with silicone gel-filled implants when compared towomen without implants.In addition, concerns have been raised regarding potentialdamaging effects on children born to mothers with implants.Two studies in humans have found that the risk of birth defectsoverall is not increased in children born after breast implantsurgery. 41,42 Although low birth weight was reported in a thirdstudy, other factors (for example, lower pre-pregnancy weight)may explain this finding. 40 The author recommended furtherresearch on infant health.• Potential Health Consequences of Gel BleedSmall quantities of low molecular weight (LMW) siliconecompounds, as well as platinum (in zero oxidation state), havebeen found to diffuse (bleed) through an intact implant shell. 1,45The evidence is mixed as to whether there are any clinicalconsequences associated with gel bleed. For instance, studieson implants implanted for a long duration have suggested thatsuch bleed may be a contributing factor in the developmentof capsular contracture 1 and lymphadenopathy. 43 However,evidence against gel bleed being a significant contributingfactor to capsular contracture and other local complications isprovided by the fact that there are similar or lower complicationrates for silicone gel-filled breast implants than for saline-filledbreast implants. Saline-filled breast implants do not containsilicone gel and, therefore, gel bleed is not an issue for thoseproducts. Furthermore, toxicology testing has indicated that thesilicone material used in Allergan’s implants does not causetoxic reactions when large amounts are administered to testanimals. It should also be noted that studies reported in theliterature have demonstrated that the low concentration ofplatinum contained in breast implants is in the zero oxidation(most biocompatible) state. 44,46,47,49Allergan performed a laboratory test to analyze the siliconesand platinum (used in the manufacturing process), which maybleed out of intact implants into the body. Over 99% of the32 32

LMW silicones and platinum stayed in the implant. The overallbody of available evidence supports that the extremely lowlevel of gel bleed is of no clinical consequence.3. ALLERGAN’S CLINICALSTUDY RESULTSThis section of the brochure summarizes the results of theAllergan Core Study conducted on NATRELLE ® Silicone-FilledBreast Implants for primary augmentation and revision-augmentation.The Allergan Core Study is the primary clinicalstudy for this product. The results of the Core Study give youuseful information on the experience of other women withNATRELLE ® Silicone-Filled Breast Implants. While the resultscannot be used to predict your individual outcome, they canbe used as a general guide of what you may expect. Yourown complications and benefits depend on many individualfactors.As a note, supplemental safety information was alsoobtained from another Allergan clinical study (the AdjunctStudy), the Danish Breast Implant Registry, an internationalclinical MRI study, and the literature to help assess long-termrupture rate and the consequences of rupture for this product.The literature, which had the most available information onthe consequences of rupture, was also used to assess otherpotential complications associated with silicone gel-filledbreast implants. The key literature information was discussedthroughout the Breast Implant Complications section above,and the references can be found at the end of this brochure.3.1 What Are the Overview Findings ofallergan’s Core Study?The Allergan Core Study is a 10-year study to assess safetyand effectiveness in augmentation, reconstruction, andrevision (revision-augmentation and revision-reconstruction)patients. Patient follow-up is at 0-4 weeks, 6 months, 12months, 24 months, and annually through 10 years. Safetyis assessed by complications, such as implant rupture,capsular contracture, and reoperation. Benefit (effectiveness)is assessed by breast size change, patient satisfaction andmeasures of quality of life (QoL).The Allergan Core Study consists of 715 patients. Thisincludes 455 primary augmentation patients, 147 revision-33

augmentation patients, 98 primary reconstruction patients, and15 revision-reconstruction patients. Of these patients, 158 primaryaugmentation patients, 50 revision-augmentation patients, 51primary reconstruction patients, and 5 revision-reconstructionpatients are in the MRI cohort, which means that they areassessed for silent rupture by MRI at years 1, 3, 5, 7 and 9. Thestudy is currently ongoing, with the results through 7 years reportedin this brochure. Allergan will periodically update this brochureas more information becomes available. You should also ask yoursurgeon for any available updated Allergan clinical information.Allergan’s Core Study results indicate that the risk of at leastone occurrence of any complication (including reoperation)at some point through 7 years after implant surgery is 45% forprimary augmentation patients and 57% for revision-augmentationpatients. The information below provides more detailsabout the complications and benefits you may experience.More detailed data tables are found in the Appendix of thisbrochure. Please refer to the glossary for the definition of anycomplication you may not understand.3.2 What Are the 7-Year Follow-Up Rates?Follow-up rates from a clinical study show you how manywomen continue to provide information on their experiencewith breast implants.The Allergan Core Study enrolled 455 augmentation patients.Of the women expected to be seen at the 7-year follow-up visit,74% were seen.The Allergan Core Study enrolled 147 revision-augmentationpatients. Of the women expected to be seen at the 7-yearfollow-up visit, 72% were seen.3.3 What Are the Benefits?The benefits of NATRELLE ® Silicone-Filled Breast Implants wereassessed by a variety of outcomes, including bra cup size changeand assessments of patient satisfaction and quality of life. Datawere collected before implantation and at scheduled follow-upvisits at 1, 2, 4 and 6 years post-implant for those patients who stillhad their original implants and who came back for these visits.Breast Measurement: For primary augmentation patients, 396(87%) of the original 455 patients had a breast measurement within34

18 months of surgery. Of these 396 patients, 41% increased by 1cup size; 45% increased by 2 cup sizes; 8% increased by morethan 2 cup sizes; and 6% had no increase or decrease. SeeFigure 1 below.Figure 11Cup Size Changes in Primary Augmentation PatientsCup Size Changes in Primary Augmentation Patients45% + 1 cup45% + 1 cup8%+ 2 cup8%+ 2 cup6%+ 3 or more cupsFigure + 3 or more cups41% 6% 1No ChangeCup Size Changes in Primary Augmentation Patients41%No ChangeRevision-augmentation patients did not undergo ameasurement of breast cup size change because they were45% + 1 cupundergoing replacement of an existing breast implant.Figure 28%+ 2 cupPrimary Augmentation and Revision-AugmentationPatient Satisfaction Through 7 Years6%+ 3 or more cups100Figure 2Primary 75 Augmentation 41% and Revision-Augmentation95% No of augmentation Changepatients were satisfiedPatient Satisfaction Through 7 YearsPatient Satisfaction: Allergan’s patient satisfaction was basedon a 5-point scale assessment of satisfaction with their implantsat the time of the follow-up visits. Of the original 455 primaryaugmentation patients, 317 (70%) provided a satisfaction ratingat 7 years after implantation, with 301 (95%) of these patients% Patients Satisfiedwith their implants50indicating 100 that they were satisfied with their breast implants.89% of revision patientswere satisified withtheir implants25Of the original 147 revision-augmentation patients, 91 (62%)7595% of augmentation0patients were satisfied1 2 3 4 5 6 7their implants81 (89%) 50 indicated that they Years were satisfied with their breastPrimary Revision89% of revision patientsimplants. See Figure 2 below.were satisified with25their implants% Patients Satisfiedprovided a satisfaction rating at 7 years. Of these 81 patients,Primary 0 Augmentation and Revision-Augmentation1 2 3 4 5 6 7Patient Satisfaction Years Through 7 Years100PrimaryFigure 2Revision% Patients Satisfied75502595% of augmentationpatients were satisfiedwith their implants89% of revision patientswere satisified withtheir implants01 2 3 4 5 6 7YearsPrimary Revision35

Quality of Life Assessments: Quality of life assessments wereobtained prior to implantation and at 1, 2, 4, and 6 yearspost-surgery. The 6-year data is provided here. For primaryaugmentation patients, the SF-36, which is a collection ofscales that measure mental and physical health, showed animprovement in one scale and a worsening in six scales after6 years compared to before breast implantation, althoughall scales remained higher than the general U.S. femalepopulation. For patient responses to questions regarding overallself-concept/self-esteem, there was a decrease in self-concepton the Tennessee Self-Concept Scale and no change in overallself-esteem on the Rosenberg Self-Esteem Scale 6 years afterreceiving implants. Patient responses to questions on theBody Esteem Scale regarding overall body image showedno changes, but a decrease in weight concern and physicalcondition, and increase with regard to sexual attractivenesswere shown.For revision-augmentation patients, the SF-36 showed nosignificant changes in all of the scales but one, which showeda decrease after 6 years. Patient responses to questions on theTennessee Self-Concept Scale and Rosenberg Self-Esteem Scaleshowed no changes 6 years after receiving implants. Patientresponses to questions on the Body Esteem Scale regardingoverall body image showed no changes, but a decrease withregard to physical condition was shown.3.4 What Are the 7-Year Complication Rates?The complications observed in primary augmentation andrevision-augmentation women through 7 years are presentedin Table 1 and Table 2, respectively. The rates reflect thepercentage of patients who experienced the listed complicationat least once within the first 7 years after their implantation. Somecomplications occurred more than once for some patients. Pleaserefer to the Glossary at the front of this brochure for the definition ofany complication you may not understand.The most common complications experienced within the first 7years of implantation for primary augmentation patients werereoperation (30% or approximately 30 patients out of 100) and36

capsular contracture (16% or 16 patients out of 100). The mostcommon complications experienced within the first 7 yearsof implantation for revision- augmentation patients were alsoreoperation (41%) and capsular contracture (20%).Table 17-Year Complication Rates for PrimaryAugmentation Patients N = 455 PatientsKey Complications 1%Reoperation 30.1%Capsular Contracture Baker Grade III/IV 15.5%Implant Removal with Replacement 11.0%Implant Rupture (MRI cohort) 8.6%Implant Removal Without Replacement 3.1%Other Complications Occurringin ≥ 1% of patients 2,3% %Breast Pain 11.4%Swelling 9.2%Nipple Complications 6.7%Implant Malposition 5.2%Scarring/Hypertrophic Scarring 3.7%Asymmetry 3.3%Ptosis 2.2%Breast/Skin Sensation Changes 1.6%Hematoma 1.6%Implant Palpability/Visibility 1.6%Seroma/Fluid Accumulation 1.6%Wrinkling/Rippling 1.2%Delayed Wound Healing 1.1%1Most events were assessed with severity ratings, and the rates shown in the table includeonly complications rated moderate, severe or very severe (excludes mild and very mildratings). All occurrences of reoperation, implant removal, implant rupture, implant extrusion andpneumothorax are included.2The following complications were reported at a rate less than 1%: bruising, infection, implantextrusion, lymphedema, other complications, redness, skin rash, and tissue/skin necrosis.3The following complications were reported at a rate of 0%: capsule calcification, gel migration,irritation, lymphadenopathy, and pneumothorax.37

Table 27-Year Complication Rates for Revision-Augmentation Patients N = 147 PatientsKey Complications 1 % %Reoperation 40.5%Capsular Contracture Baker Grade III/IV 20.4%Implant Removal with Replacement 20.9%Implant Removal without Replacement 4.3%Implant Rupture (MRI cohort) 0%Other Complications Occurringin ≥ 1% of patients 2,3%%Breast Pain 10.6%Swelling 8.4%Implant Palpability/Visibility 6.8%Implant Malposition 6.1%Seroma/Fluid Accumulation 6.1%Scarring/Hypertrophic Scarring 6.0%Ptosis 4.8%Wrinkling/Rippling 4.6%Asymmetry 3.7%Bruising 3.0%Breast/Skin Sensation Changes 2.2%Hematoma 2.1%Infection 1.4%1Most events were assessed with severity ratings, and the rates shown in the table includeonly complications rated moderate, severe or very severe (excludes mild and very mildratings). All occurrences of reoperation, implant removal, implant rupture, implant extrusion andpneumothorax are included.2The following complications were reported at a rate less than 1%: delayed wound healing,irritation, nipple complications, other complications, redness, and skin rash.3The following complications were reported at a rate of 0%: capsule calcification, gelmigration, implant extrusion, lymphadenopathy, lymphedema, pneumothorax, and tissue/skin necrosis.38

3.5 What Are the Main Reasonsfor Reoperation?The reasons for reoperation observed in primary augmentationand revision-augmentation women through 7 years are presentedin Table 3 and Table 4, respectively. There may be one or morereasons identified for having a reoperation (additional surgery afterthe primary or revision breast augmentation). Furthermore, theremay be multiple surgical procedures (for example, implant removalwith or without replacement, capsule procedures, incision anddrainage, implant reposition, scar revision, etc.) performed duringa reoperation.Table 3Main Reasons for Reoperation in PrimaryAugmentation Patients Through 7 YearsReason for ReoperationnCapsular Contracture 47Implant Malposition 24Ptosis 21Need for Biopsy 19Suspected Rupture 13Hematoma/Seroma 12Patient Request for Size/Style Change 9Scarring/Hypertrophic Scarring 8Asymmetry 6Breast Cancer 3Breast Pain 3Delayed Wound Healing 3Implant Palpability/Visibility 2Infection 2Wrinkling 2Implant Extrusion 1Necrosis 1Nipple Complications 1TOTAL 17739

The most common reason for reoperation through 7 yearsin primary augmentation patients was because of capsularcontracture (47 of 177 reoperations). In Allergan’s Core Study,there were 455 surgical procedures performed during 177reoperations involving 130 primary augmentation patients.Table 4Main Reasons for Reoperation in Revision-Augmentation Patients Through 7 YearsReason for ReoperationnCapsular Contracture 20Hematoma/Seroma 13Implant Malposition 11Ptosis 9Need for Biopsy 8Scarring/Hypertrophic Scarring 7Suspected Rupture 5Asymmetry 3Breast Cancer 3Infection 3Patient Request for Style/Size Change 3Nipple Complications 3Delayed Wound Healing 2Wrinkling 2Breast Pain, Breast Tissue Contour1 eachDeformity, Device Injury, ImplantPalpability/Visibility, Implant ExtrusionTOTAL 97The most common reason for reoperation through 7 years inrevision-augmentation patients was also because of capsularcontracture (20 of 97 reoperations). In Allergan’s Core Study,there were 267 surgical procedures performed during 97reoperations involving 56 revision-augmentation patients.3.6 What Are the Main Reasons forimplant Removal?The main reasons for implant removal observed in primaryaugmentation and revision-augmentation women through 740

years are presented in Figures 3 and 4, respectively.For primary augmentation, there were 107 implants removed in58 patients. Of these 107 implants, 85 were replaced. The mostcommon reason for implant removal was capsular contracture(35 of the 107 implants removed).For revision-augmentation there were 59 implants removed in32 patients. Of these 59 implants, 51 were replaced. The mostcommon reason for implant removal was also due to capsularcontracture (18 of the 59 implants removed).Figure 3. Main Reasons for Implant Removal Through YearsFigure 3. Main Reasons for Implant Removal Through 7 YearsPrimary Augmentation (n=107)Primary Augmentation (n=107)35 Capsular Contracture35 Capsular Contracture22 Patient Request for Style/Size Change22 Patient Request for Style/Size Change11 Implant Malposition11 Implant Malposition11 Suspected Rupture11 Suspected Rupture8 Asymmetry8 Asymmetry5 Ptosis5 Ptosis4 Breast Pain4 Breast Pain4 Wrinkling4 Wrinkling2 Breast Cancer2 Breast Cancer2 Infection2 Infection1 Breast Tissue Contour Deformity1 Breast Tissue Contour Deformity1 Implant Extrusion1 Implant Extrusion1 Need for Biopsy1 Need for BiopsyFigure Figure 4. 4. Main Main Reasons Reasons for for Implant Implant Removal Removal Through Through 7 Years YearsRevision-Augmentation (n=59) (n=59)18 Capsular Contracture18 Capsular Contracture10 Patient Request for Style/Size Change10 Patient Request for Style/Size Change10 Implant Malposition10 Implant Malposition6 Ptosis6 Ptosis4 Suspected Rupture4 Suspected Rupture3 Scarring/Hypertrophic Scarring3 Scarring/Hypertrophic Scarring2 Breast2 BreastCancerCancer2 Infection2 Infection2 Wrinkling2 Wrinkling1 Asymmetry1 Asymmetry1 Breast1 BreastPainPain41

3.7 What Are Other ClinicalData Findings?Below is a summary of clinical findings from the Allergan CoreStudy with regard to connective tissue disease (CTD), CTD signsand symptoms, cancer, lactation complications, reproductioncomplications, and suicide. These issues, along with others, arebeing further evaluated as part of an Allergan postapprovalstudy of a large number of patients followed through 10 years(Breast Implant Follow-Up Study, or BIFS).CTD DiagnosesFour primary augmentation patients (0.9%) were reported to havea new diagnosis of CTD; 2 with rheumatoid arthritis at 7 monthsand at 3 years, respectively, after implantation in the AllerganCore Study and 2 patients with fibromyalgia at 4.5 years afterimplantation for both. One revision-augmentation patient (0.7%)was reported to have a new diagnosis of fibromyalgia at 10months after implantation. It cannot be concluded that these CTDdiagnoses were caused by the implants because there was nocomparison group of similar women without implants.CTD Signs and SymptomsIn Allergan’s Core Study, numerous signs and symptomswere collected at 2, 4, and 6 years post-implant. For primaryaugmentation patients at 6 years after implantation, statisticallysignificant increases were found for the symptom category ofJoint (includes joint pain, stiff in morning, swelling in other joints,and swelling of hands), Muscular (includes back pain, musclepain, aches, or cramps, muscle weakness, neck pain, paralysisof arms or legs), Gastrointestinal (includes constipation, diarrhea,gastrointestinal pain, heartburn, loss of appetite, stomach painor cramps, and vomiting), Neurological (includes headaches,loss of balance, numbness/tingle of arms or legs, problems withmemory, problems with thinking, and ringing in ears), Urinary(includes problems with urination and urinating too often), andFibromyalgia (includes back pain, fatigue, neck pain, pain, andpain in the chest). No significant increases were found in thecategories of General, Global, Pain, Skin, Fatigue, and Othersymptoms. For revision-augmentation patients at 6 years afterimplantation, no statistically significant increases were found inany of the symptom categories.42

The Core Study was not designed to evaluate cause-andeffectassociations because there is no comparison group ofwomen without implants, and because other contributing factors,such as medications and lifestyle/exercise, were not studied.Therefore, it cannot be determined whether this increase wasdue to the implants or not, based on the Core Study. However,you should be aware that you may experience an increase inthese symptoms after receiving breast implants.CancerThere was 1 primary augmentation patient with a newdiagnosis of breast cancer through 7 years in the AllerganCore Study. There was a 13% benign breast disease rate anda 1% malignant breast disease rate through 7 years. In primaryaugmentation patients there was 1 report of thyroid cancer and1 report of brain cancer.For revision-augmentation patients, there was 1 patient with anew diagnosis of breast cancer. There was a 15% benign breastdisease rate and a 1% malignant breast disease rate through7 years. There were no reports of other cancers, such asrespiratory or cervical/vulvar, in revision-augmentation patients.Lactation ComplicationsSixteen (21%) of the 75 primary augmentation patients whoattempted to breastfeed following breast implantation in theAllergan Core Study through 7 years experienced difficulty withbreastfeeding. The most common difficulty was inadequatemilk production. For the 19 revision-augmentation patientswho attempted to breastfeed after receiving breast implants,6 (32%) had difficulty breastfeeding, 5 due to inadequate milkproduction and 1 due to pain.Reproduction ComplicationsTwenty-nine (6%) of the primary augmentation patients in theAllergan Core Study reported a reproduction problem through7 years, most commonly miscarriage. For the 5 (3%) revisionaugmentationpatients who experienced a reproduction problemthrough 7 years, the most common problem was infertility.SuicideThere was 1 report of suicide in the primary augmentationpatients and 2 reports of suicide in the revision-augmentationpatients in the Allergan Core Study through 7 years.43

4. SURGICAL CONSIDERATIONS FORBREAST AUGMENTATION4.1 What Are the Alternatives to Breastaugmentation with Siliconegel-Filled Breast Implants?For primary augmentation patients, alternatives may include:• Accepting your breasts as they are and havingno surgery.• Wearing a padded bra or external prostheses.• Having mastopexy surgery (breast lift)without an implant.• Having surgery with saline implants.For revision-augmentation patients, alternatives may include:• No revision.• Removal with or without replacement.4.2 What Are Questions to Considerwhen Choosing a Surgeon?When choosing a surgeon who is experienced with breastaugmentation, you should find out the answers to the followingtypes of questions:• How many breast augmentation implantationprocedures does he/she perform per year?• How many years has he/she performed breastaugmentation procedures?• Has he/she completed Allergan’s Physiciancertification Program for the use of its silicone-filledbreast implants?• Is he/she board certified, and if so, with which board?• In which state(s) is he/she licensed to practice surgery?(Note that some states provide information on disciplinaryaction and malpractice claims/settlements to prospectivepatients, either by request or on the internet.)• What is the most common complication he/sheencounters with breast augmentation?44

• What is his/her reoperation rate with breastaugmentation, and what is the most common type ofreoperation he/she performs?• Can he/she perform this surgery in a hospital, as wellas in the surgeon’s independent surgery center? (Notethat hospitals require evidence of appropriate trainingin specific procedures before allowing surgeons tooperate in their facilities.)4.3 What are Other Choices and Optionsassociated with the Surgery?There are two approved types of breast implant fillers, salineand silicone, which gives more options to you in terms ofthe type of implant to achieve the effect you desire. Yoursurgeon can discuss these options with you and may makerecommendations to you based upon the physical contours ofyour body. The focus of this brochure is silicone-filled breastimplants; a separate brochure is available for saline-filledimplants. Carefully review the section on complications and thesection on Allergan’s clinical study so that you may make aninformed choice. Be sure to ask your surgeon to see and touchsamples of both silicone and saline breast implants.Implant Shape and SizeDepending on the desired shape you wish to achieve, youand your surgeon have implants with different profiles, orstyles, from which to choose. Generally, the larger you wantyour cup size, the larger the breast implant the surgeon willconsider (measured in cubic centimeters, or cc’s, not in cupsizes, because cup size depends on the size and shape of theindividual woman’s chest).Your surgeon will also evaluate your existing breast and skintissue to determine if you have enough tissue to cover thebreast implant you are considering, or, in some cases such asafter pregnancy, too much extra skin. If you desire a breastimplant size that is too large for your tissue, the surgeon maywarn you that breast implant edges may be visible or palpablepostoperatively. Also, excessively large breast implants mayspeed up the effects of gravity on the breast, and can result indroop or sag at an earlier age. A recent report indicates thatlarger-sized implants (greater than 350 cc) may be too large formany women, increasing the risk of developing complications45

such as implant extrusion, hematoma, infection, palpable implantfolds, and visible skin wrinkling requiring surgical intervention tocorrect these complications. 7Surface TexturingSome studies suggest that surface texturing reduces the chanceof severe capsular contracture, 9 while other studies do not. 7,8Allergan’s Core Study did not show a difference in the likelihoodof developing capsular contracture with textured implantscompared to smooth implants.A textured implant may require a larger incision because therougher textured surface may make it harder to place into thepocket without undue stress, which might damage the implant ordecrease its durability.Implant PlacementThe breast implant can be placed either partially under thepectoralis major muscle (submuscular) or on top of the muscle andunder the breast gland (subglandular). You should discuss withyour surgeon the advantages and disadvantages of the implantplacement selected for you, as described in the table below.Breast Before & After ImplantationBreast beforeaugmentationBreast aftersubglandularaugmentationBreast aftersubmuscularaugmentation46

Comparison Between Submuscular VersusSubglandular PlacementSubmuscular PlacementSurgery may be longerRecovery may be longerMay be more painfulReoperation may bemore difficultLess visible andpalpable implantsLess likelihood ofcapsular contractureEasier imagingduring mammography examMay be preferable if you havehave thin or weakened breast tissueSubglandular Placementsurgery may be shorterrecovery may be shortermay be less painfulmay provide easier accessfor reoperationmore visible andpalpable implantsgreater likelihood ofcapsular contracturemore difficult imagingduring mammography examMay not be recommended if youhave thin or weakened breast tissueIncision SitesYou should discuss with your surgeon the pros and cons forthe incision site specifically recommended for you.The incision size will be larger than for a saline breastaugmentation. There are 3 common incision sites: under thearm (axillary), around the nipple (periareolar), or within thebreast fold (inframammary).Around nipple(periareolar)incisionUnder arm(transaxillary)incisionIn breast fold(inframammary)incision47

• 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 breastfeedingdifficulties, as compared to the other incision sites. Cuttingthrough the tissue may make a change in sensation orinfection more of a concern.• Inframammary - This incision is generally lessconcealed than periareolar and associated with fewerbreastfeeding difficulties than the periareolar incisionsite. It is also the most commonly used incision site atthe present time, and is felt to give the best access toand control of the breast implant pocket.• Transaxillary - This incision is less concealed thanperiareolar and associated with fewer breastfeedingdifficulties than the periareolar incision site. If theincision is made under the arm, the surgeon may usea probe fitted with a miniature camera, along withminimally invasive (very small) instruments, to createa “pocket” for the breast implant. This approach ismore difficult, and may increase the risk of damage to,and unexpected location of, the implant.• Umbilical (belly button) - This incision site has notbeen studied in Allergan’s Core Study and should notbe used for a wide variety of reasons, includingpotential damage to the implant shell.Additional Procedures at the Time of Breast AugmentationYour surgeon will examine your breasts and help you makedecisions to obtain the best result in your individual situation.In some cases, particularly after pregnancy or significantweight loss, implants alone may not address all of the issues,such as sagging or extra skin, affecting your breasts. This isparticularly true when there is extra skin remaining from whenthe breasts were engorged with milk, or when you might havebeen carrying more weight.In these situations, your surgeon may recommend a breastlift (mastopexy) to remove some of the extra skin, or to lift thebreasts, at the time of implant placement. Mastopexy involves48

emoving a strip of skin from under the breast or around thenipple to lift the nipple and breast location, and tighten theskin over the breast. Your surgeon will discuss the potentialrisks, and the location of the additional scars which might berequired to lift your breasts or to remove the extra skin.Implant PalpabilityImplants may be more palpable or noticeable if there is aninsufficient amount of skin/tissue available to cover the implantand/or when the implant is placed subglandularly.Surgical Setting and AnesthesiaAugmentation surgery is usually performed on an outpatient basis,in a specialized operating room which may be located in ahospital, a surgery center, or surgical suite in the surgeon’s office.General anesthesia is commonly used, and local anesthesia withsedation is also an option. You should be sure to check with yoursurgeon and with the facility where the surgery will take place, tobecome aware of the tests, presurgical examinations, and lengthof time you need to be without food or your routine medicationsprior to the surgical procedure.Postoperative CareYou will probably feel somewhat tired and sore for several daysfollowing the operation, and your breasts may remain swollenand sensitive to physical contact for a month or longer. Youmay also experience a feeling of tightness in the breast areaas your skin adjusts to your new breast size. The feeling in thebreasts and nipple area also may be diminished during thistime of swelling and immediate post surgery recovery. Otherpossible complications are described in the Breast ImplantComplications section.Postoperative care depends on each patient’s situation, may involvethe use of a special postoperative bra, compression bandage, orjog bra for extra support and positioning while you heal. Somesurgeons may not want you to wear a bra at all for a period of timefollowing the surgery. At your surgeon’s recommendation, you willmost likely be able to return to work within a few days, although forat least a couple of weeks you should avoid any strenuous activitiesthat could raise your pulse and blood pressure, or require strenuoususe of your arms and chest. Your surgeon may also recommendbreast massage exercises.49

Note: If you experience fever, do not feel well, or see noticeableswelling and/or redness or drainage in your implanted breast(s),you should contact your surgeon immediately.Other Factors to Consider InRevision-Augmentation SurgerySome revision surgeries require removal of an intact implant(for example, capsulotomy and pocket adjustments), whileothers do not require removal of the implant. Any devicethat has been removed during revision surgery should not bereimplanted. Allergan breast implants are “for single use only.”4.4 what Follow-Up Examinationsare Important?Breast Self-ExaminationsFollowing breast augmentation, you should continue to performa breast self-examination monthly. This may be more difficultwith a breast implant in place. To continue to perform amonthly breast self examination efficiently, you should ask yoursurgeon to help you identify the difference between the implantand your breast tissue. Being able to identify the implantfrom breast tissue will decrease the necessity of excessivesqueezing of the implant during examination. Any new lumpsshould be evaluated with a biopsy, as appropriate. If a biopsyis performed, be sure to inform the medical professionalperforming the biopsy that you have breast implants so thatcare will be taken to avoid injuring the implant.50

SCREENING FOR SILENT RUPTUREBecause most ruptures of silicone-filled breast implants are silent,in most cases neither you nor your surgeon will be able to findevidence of rupture. Therefore, evaluation of your implantsis needed to screen for implant rupture. The best method ofscreening is currently MRI at a center with a breast coil, witha magnet of at least 1.5 Tesla. The MRI should be read by aradiologist who is familiar with looking for implant rupture.It is recommended that your first MRI evaluation take placestarting at 3 years after implant surgery and then every 2 years,thereafter, even if you are experiencing no problems with yourimplant. If signs of rupture are seen on MRI, then you shouldhave your implant removed, with or without replacement. Yourdoctor should assist you in locating a radiology/screeningcenter, as well as a radiologist who is familiar with the techniqueand equipment for proper MRI screening for silent rupture ofyour breast implant.Symptomatic RuptureSymptoms associated with rupture may include hard knots orlumps surrounding the implant or in the armpit, loss of sizeof the breast or implant, pain, tingling, swelling, numbness,burning, or hardening of the breast. If you notice any ofthese changes, see your plastic surgeon so that he or she canexamine the implants and determine whether you need to havean MRI examination to find out if your symptoms are due torupture of the implant. If rupture has occurred, you should haveyour implant removed. Consult with your doctor regarding thisand any other medical decisions related to your implants. Moreinformation on rupture is provided in section 3 of this brochure.51

MammographyThe current recommendations for getting screening/preoperative mammograms are no different for womenwith breast implants than for those without implants.Mammography exams should be interpreted by radiologistsexperienced in the evaluation of women with breast implants.It is essential that you tell your mammography technologistbefore the procedure that you have an implant. You shouldrequest a diagnostic mammogram rather than a screeningmammogram, because more pictures are taken withdiagnostic mammography. The technologist can use specialtechniques to reduce the possibility of rupture and to get thebest possible views of the breast tissue.52

5. ADDITIONAL INFORMATION5.1 what Types of NATRELLE ®silicone-Filled Breast Implants Areavailable from Allergan?NATRELLE ® Silicone-Filled Breast Implants come in a varietyof profiles and sizes with either a textured shell or smoothsurface shell. Your plastic surgeon will discuss with you theimplant design that will best help you achieve the result that isright for you.Examples of NATRELLE ® Smooth and Textured Implant StylesSmooth Implanttextured ImplantThe following diagram may help you to understand the projectionsof implants as your surgeon discusses the variousoptions with you.Moderate Profile Moderate-Plus Profile High Profile Extra-High ProfileA=Width, B=Projection53

Approved Allergan Implant StylesStyle Number Breast Implant Description Size RangeStyle 10 Smooth shell surface, moderate profile 120cc–800ccStyle 15 Smooth shell surface, moderate-plus profile 155cc–752ccStyle 20 Smooth shell surface, high profile 120cc–800ccStyle 40 Smooth shell surface, moderate profile 80cc–560ccStyle 45 Smooth shell surface, extra-high profile 120cc–800ccStyle 110 BIOCELL ® textured shell surface, 90cc–510ccmoderate profileStyle 115 BIOCELL ® textured shell surface, 150cc–716ccmoderate-plus profileStyle 120 BIOCELL ® textured shell surface, 180cc–650cchigh profile5.2 what If I Experience a Problem?You will be given a device identification card with the styleand serial number of your breast implant(s). This card is foryour permanent record and should be kept in a safe place. Inthe event you have a concern or problem with your implant,you can use this card to describe the implant to your healthcare provider or to Allergan.You should immediately report any problems that you noticewith your implants to your plastic surgeon. If you believe thatyou have experienced a serious problem(s) related to yourbreast implants, you should have your health professionalreport the problem(s) to the Food and Drug Administration(FDA) and/or to Allergan. You may also report any seriousproblem directly through the FDA’s MedWatch voluntaryreporting system. An adverse event is considered seriousand should be reported when it results in a hospitalization,disability, congenital problem with your child, or othermedical or surgical intervention. The information reported toMedWatch is entered into databases to be used to followsafety trends (patterns) of a device and to determine whetherfurther follow-up of any potential safety issues related to thedevice is needed.54

To report, use MedWatch form 3500, which may beobtained through FDA’s website athttp://www.fda.gov/medwatch/index.html. You mayalso call 1.888.463.INFO.FDA (1.888.463.6332), from10am-4pm Eastern Time, Monday through Friday, to receivean additional FDA MedWatch Package. Keep a copy of theMedWatch form completed by your surgeon for your records.5.3 what Is Device Tracking?Silicone gel-filled breast implants are subject to DeviceTracking by Federal regulation. This means that your physicianwill be required to submit to Allergan the serial number ofthe implant(s) you receive, the date of surgery, informationrelating to the physician’s practice and information on thepatient receiving the implant(s). Your surgeon will writethis information on the Device Tracking Form suppliedby Allergan with each silicone-filled breast implant. Yoursurgeon will return the top portion of the form to Allerganfollowing surgery. The bottom portion of the form will beprovided to you following surgery. You have the right toremove your personal information from Allergan’s DeviceTracking program. If you choose NOT to participate inDevice Tracking, please check the appropriate box on theDevice Tracking form and return to Allergan. You also havethe right to have your personal information withheld fromdisclosure to third parties who may request information fromAllergan, such as the FDA. If you choose to participate in theDevice Tracking program but do NOT want your personalinformation to be released to third parties, please also checkthe appropriate box.Allergan strongly recommends that all patients receivingNATRELLE ® Silicone-Filled Breast Implants participate inAllergan’s Device Tracking program. This will help ensure thatAllergan has a record of each patient’s contact informationso that all patients, including you, can be contacted in thecase of a recall or other problems with your implants that youshould be made aware of.You are encouraged to complete the Device Tracking Formyou received following surgery and return it to Allergan inthe postage paid business reply envelope provided. Pleaseinform Allergan whenever your contact information changes.55 55

Assessment of Information EffectivenessThe “Required Information” section of the Device Tracking Formalso has a question designed to assess the effectiveness of theBreast Augmentation with NATRELLE ® Silicone-Filled BreastImplants patient planner provided prior to your surgery. Thisquestion asks you to verify that you received and had adequatetime to review this patient labeling information. Please checkeither yes or no. When the Required Information section iscomplete, return it to Allergan in the postage-paid businessreply envelope provided.5.4 what are the ConfidencePlus ®limited Warranties?The ConfidencePlus ® Limited Warranties provide lifetimereplacement and limited financial reimbursement in the event ofshell leakage or breakage resulting in implant rupture, subjectto certain conditions as fully discussed in the ConfidencePlus ®literature. Allergan offers two levels of coverage under itswarranty program. Our standard ConfidencePlus ® LimitedWarranty program applies automatically to every Allerganbreast implant recipient subject to the conditions discussed inthe ConfidencePlus ® literature. The optional ConfidencePlus ®Premier Limited Warranty program is available for a lowenrollment fee and increases the financial benefit in the eventof implant rupture, subject to the conditions discussed in theConfidencePlus ® literature. For more information, please visitwww.cppwarranty.com or contact Allergan’s Product SupportDepartment at 1.800.362.4426.5.5 how Can I Receive More Information?Upon request, you will be provided with a copy of thepackage insert (Directions for Use; NATRELLE ® Silicone-FilledBreast Implants document). You can request a copy from yoursurgeon or from Allergan. It can also be found onwww.NATRELLE.com. The package insert has many undefinedmedical and technical terms because it contains informationdirected only to the surgeon.56

For more detailed information on the preclinical and clinicalstudies conducted by Allergan, you are referred to theSummary of Safety and Effectiveness Data (SSED) for thisproduct which may be accessed athttp://www.fda.gov/cdrh/breastimplants.If, after reading this information, you have additionalquestions about breast implants or breast implant surgery,there are a number of resources available to you.TOLL-FREE NUMBERIf you are a patient or a prospective patient and wish tospeak to an Allergan Breast Implant Support Specialist toinquire about breast implants, discuss any concerns, orrequest a copy of the patient labeling or package insert(Directions for Use), call toll free at 1.800.362.4426 (7 am to5 pm Pacific Time).ADDITIONAL RESOURCESAllergan1.800.624.4261www.NATRELLE.comwww.allergan.comwww.breastimplantanswers.comInstitute of Medicine Report on the Safety of Silicone Implantswww.nap.edu/catalog/9618.htmlFood and Drug Administration1.888.INFO.FDA or 1.240.276.3103www.fda.gov/cdrh/breastimplants57

FOR FURTHER READING AND INFORMATIONOverall Safety Assessment1. Bondurant, S., Ernster, V., and Herdman, R., Eds. 2000. Safety ofsilicone breast implants. Committee on the Safety of Silicone BreastImplants, Division of Health Promotion and Disease Prevention,Institute of Medicine. Washington, D.C.: National Academy Press.Implant Rupture2. Hedén, P., et al. 2006. Prevalence of rupture in Inamed siliconebreast implants. Plast. Reconstr. Surg. 118:303-8.3. Hölmich, L.R., et al. 2005. The diagnosis of silicone breast implantrupture. Clinical findings compared to findings at MRI. Ann. Plast.Surg. 54(6):583-9.4. Hölmich, L.R., et al. 2005. The diagnosis of breast implant rupture:MRI findings compared to findings at explantation. 2005. Eur. J.Radiol. 53:213-25.5. Hölmich, L.R., et al. 2004. Untreated silicone breast implant rupture.Plast. Reconstr. Surg. 114:204-14.6. Hölmich, L.R., et al. 2001. Prevalence of silicone breast implantrupture among Danish women. Plast. Reconstr. Surg.108(4):848-58.Capsular Contracture7. Henriksen, T.F., et al. 2005. Surgical intervention and capsularcontracture after breast augmentation: a prospective study of riskfactors. Ann. Plast. Surg. 54(4):343-51.8. Kulmala, I., et al. 2004. Local complications after cosmetic breastimplant surgery in Finland. Ann. Plast. Surg. 53(5):413-9.9. Seify, H., et al. 2005. Preliminary (3 years) experience with smoothwall silicone gel implants for primary breast augmentation. Ann.Plast. Surg. 54(3):231-5.Connective Tissue Disease (CTD)10. Brinton, L.A., et al. 2004. Risk of connective tissue disorders amongbreast implant patients. Am. J. Epidemiol. 160(7):619-27.58

11. Brown, S.L., et al. 2001. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.J. Rheumatol. 28:996-1003.12. Hölmich, L.R., et al. 2003. Self-reported diseases and symptoms byrupture status among unselected Danish women with cosmetic silicone breast implants. Plast. Reconstr. Surg. 111:723-32.13. Janowsky, E.C., et al. 2000. Meta-analyses of the relation betweensilicone breast implants and the risk of connective-tissue diseases.N. Engl. J. Med. 342(11):781 90.14. Lipworth, L., et al. 2004. Silicone breast implants and connectivetissue disease: An updated review of the epidemiologic evidence.Ann. Plast. Surg. 52:598-601.15. Tugwell, P., et al. 2001. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 44(11):2477-84.16. Weisman, M.H., et al. 1988. Connective-tissue disease followingbreast augmentation: A preliminary test of the human adjuvant tissuehypothesis. Plast. Reconstr. Surg. 82(4):626-30.17. Williams, H.J., et al. 1997. Breast implants in patients with differentiated and undifferentiated connective tissue disease. ArthritisRheum. 40(3):437-40.18. Wolfe, F. and Anderson, J. 1999. Silicone filled breast implantsand the risk of fibromyalgia and rheumatoid arthritis. J. Rheumatol.26:2025-28.CTD Signs and Symptoms19. Berner, I.,et al. 2002. Comparative examination of complaints ofpatients with breast-cancer with and without silicone implants.Eur. J. Obstet. Gynecol. Reprod. Biol. 102:61-6.20. Breiting, V.B., et al. 2004. Long-term health status of Danish womenwith silicone breast implants. Plast. Reconstr. Surg. 114:217-26.21. Fryzek, J.P., et al. 2001. Self-reported symptoms among womenafter cosmetic breast implant and breast reduction surgery. Plast.Reconstr. Surg. 107:206-13.22. Kjøller, K., et al. 2004. Self-reported musculoskeletal symptomsamong Danish women with cosmetic breast implants. Ann. Plast.Surg. 52(1):1-7.59

Cancer23. Brinton, L.A., et al. 2000. Breast cancer following augmentationmammoplasty (United States). Cancer Causes Control. 11(9):819-27.24. Brinton, L.A., et al. 2001. Cancer risk at sites other than the breastfollowing augmentation mammoplasty. Ann. Epidemiol. 11:248-56.25. Bryant, H., and Brasher, P. 1995. Breast implants and breastcancer–reanalysis of a linkage study. N. Engl. J. Med.332(23):1535-9.26. Cook, L.S. 1997. Characteristics of women with and without breastaugmentation. JAMA. 20:1612-7.27. Deapen, D.M., et al. 1997. Are breast implants anticarcinogenic?A 14-year follow-up of the Los Angeles Study. Plast. Reconstr. Surg.99:1346-53.28. Deapen, D., et al. 2000. Breast cancer stage at diagnosis andsurvival among patients with prior breast implants. Plast. Reconstr.Surg. 105:535-40.29. Fryzek, J.P., et al. 2000. Characteristics of women with cosmeticbreast augmentation surgery compared with breast reduction surgerypatients and women in the general population of Sweden. Ann.Plast. Surg. 45(4):349-56.30. Herdman, R.C., et al. 2001. Silicone breast implants and cancer.Cancer Invest. 19(8):821-32.31. Jakubietz, M.G., et al. 2004. Breast augmentation: Cancerconcerns and mammography–A literature review. Plast. Reconstr.Surg. 113:117e 22e.32. Kjøller K., et al. 2003. Characteristics of women with cosmeticbreast implants compared with women with other types of cosmeticsurgery and population-based controls in Denmark. Ann. Plast. Surg.50(1):6-12.33. McLaughlin, J.K. and Lipworth, L. 2004. Brain cancer and cosmeticbreast implants: A review of the epidemiological evidence. Ann.Plast. Surg. 52(2):15-17.34. Miglioretti, D.L., et al. 2004. Effect of breast augmentation onthe accuracy of mammography and cancer characteristics. JAMA.291(4):442-50.60

35. Pukkala, E., et al. 2002. Incidence of breast and other cancersamong Finnish women with cosmetic breast implants, 1970-1999.J. Long Term Eff. Med. Implants. 12(4):271-9.Suicide36. Brinton, L.A., et al. 2001a. Mortality among augmentation mammoplasty patients. Epidemiol. 12(3):321-6.37. Jacobsen, P.H., et al. 2004. Mortality and suicide among Danishwomen with cosmetic breast implants. Arch. Int. Med.164(22):2450-5.38. Koot, V., et al. 2003. Total and cause specific mortality amongSwedish women with cosmetic breast implants: prospective study.BMJ. 326(7388):527-8.39. Pukkala, E., et al. 2003. Causes of death among Finnish womenwith cosmetic breast implants, 1971-2001. Ann. Plast. Surg.51(4):339-42.Effects on Breastfeeding/Children40. Hemminki, E., et al. 2004. Births and perinatal health of infantsamong women who have had silicone breast implantation in Finland,1967-2000. Acta Obstet. Gynecol. Scand. 83(12):1135-40.41. Kjøller, K., et al. 2002. Health outcomes in offspring of Danishmothers with cosmetic breast implants. Ann. Plast. Surg. 48:238-45.42. Signorello, L.B., et al. 2001. Offspring health risk after cosmeticbreast implantation in Sweden. Ann. Plast. Surg. 46:279-86.Silicone Gel Migration43. Katzin, W.E., et al. 2005. Pathology of lymph nodes from patientswith breast implants: a histologic and spectroscopic evaluation.Am. J. Surg. Pathol. 29(4):506 11.Gel Bleed44. Chandra, G., et al. 1987. A convenient and novel route tobis(alkyne)platinum(0) and other platinum(0) complexes from Speier’shydrosilylation catalyst. Organometallics. 6:191-2.45. Flassbeck, D.B., et al. 2003. Determination of siloxanes, silicon,and platinum in tissues of women with silicone gel-filled implants.Anal. Bioanal. Chem. 375(3):356-62 (for example, data fromPatients B & C).61

46. Lappert, M.F. and Scott, F.P.A. 1995. The reaction pathway fromSpeier’s to Karstedt’s hydrosilylation catalyst. J. Organomet. Chem.492(2):C11-C13.47. Lewis, L.N., et al. 1995. Mechanism of formation of platinum(0)complexes containing silicon-vinyl ligands. Organometallics.14:2202-13.48. Lugowski, S.J., et al. 2000. Analysis of silicon in human tissues withspecial reference to silicone breast implants. J. Trace Elem. Med.Biol. 14(1):31-42.49. Stein, J., et al. 1999. In situ determination of the active catalyst inhydrosilylation reactions using highly reactive Pt(0) catalystprecursors.J. Am. Chem. Soc. 121(15):3693-703.62

INDEXAlternatives............................................................................................. 44Anesthesia.............................................................................................. 49Breast Implant Follow-Up Study, or BIFS........................................................ 17Breast measurement.................................................................................. 34Breast reconstruction................................................................................. 12Breast self-examination.............................................................................. 50Breast tissue atrophy................................................................................. 29Breastfeeding.............................................................................. 27, 32, 43Calcium deposits...................................................................................... 28Cancer............................................................................................. 30, 43Capsular contracture................................................................................. 23Chest wall deformity................................................................................. 29Complications................................................................................... 19, 36ConfidencePlus ® ....................................................................................... 56Connective tissue disease (CTD).................................................................. 29Contraindications..................................................................................... 12Core Study.............................................................................................. 33CTD....................................................................................................... 42CTD signs and symptoms..................................................................... 30, 42Delayed wound healing............................................................................ 28Device identification card.......................................................................... 54Device tracking........................................................................................ 55Effects on children.................................................................................... 32Extrusion................................................................................................. 28Food and Drug Administration (FDA)............................................................ 54Gel diffusion............................................................................................ 32Hematoma/seroma.................................................................................. 27Implant palpability.................................................................................... 49Implant placement.................................................................................... 46Implant removal................................................................................. 25, 40Implant Shape and Size............................................................................ 45Incision Sites............................................................................................ 47Indications.............................................................................................. 1263

Infection.................................................................................................. 27Inframammary.......................................................................................... 48Lactation complications.............................................................................. 43Lymphadenopathy.................................................................................... 29Mammography.................................................................................. 15, 52Mastopexy.............................................................................................. 48MedWatch............................................................................................. 54MRI....................................................................................................... 51Necrosis................................................................................................. 28Neurological disease................................................................................ 31Nipple and breast sensation....................................................................... 26Pain....................................................................................................... 26Patient satisfaction.................................................................................... 35Periareolar.............................................................................................. 48Postoperative care.................................................................................... 49Precautions.............................................................................................. 13Quality of life assessments.......................................................................... 36Reoperation............................................................................................. 39Reoperations........................................................................................... 25Reproduction complications........................................................................ 43Rupture............................................................................................. 15, 19Rupture from literature................................................................................ 21Rupture Information on Allergan Implants....................................................... 20Screening............................................................................................... 51Silent Rupture........................................................................................... 51Suicide............................................................................................. 31, 43Summary of Safety and Effectiveness Data (SSED)........................................... 57Surgeon.................................................................................................. 44Surgical setting........................................................................................ 49Symptomatic Rupture................................................................................. 51Transaxillary............................................................................................ 48Umbilical................................................................................................ 48Unsatisfactory Results................................................................................. 2664

.comALLERGAN71 South Los Carneros Road, Santa Barbara, CA 931171.800.624.4261www.allergan.comv018© 2012 Allergan, Inc. ® and marks owned by Allergan, Inc. M1209 Rev. 07