AugmentationBREAST AUGMENTATIONWITH NATRELLE SILICONE-FILLEDAMBER IMPLANTSCRYSTALBREASTANDNurseNATRELLE Style 68HPSingerNATRELLE INSPIRA NATRELLE Style 20 BREAST IMPLANTSMINELACASEYStudentNATRELLE Style 15ParalegalNATRELLE Style 15AMBERCRYSTALStyle 68HPStyle 20MINELACASEYStyle 15Style 15JESSICAJACKIEBilateral PrimaryBilateral PrimaryAugmentationAugmentationNATRELLE Style FM270 NATRELLE Style MM280PHAEDRABilateral RevisionAugmentationNATRELLE Style FM470
Table of ContentsGlossary. 21. Considering Silicone Gel-Filled Breast ImplantSurgery. 111.1 What Gives the Breast Its Shape?.121.2 What Is a Silicone-Filled Breast Implant?.121.3 Who is eligible for NATRELLE Silicone-Filled Breast Implants andNATRELLE INSPIRA Breast Implants and what is theindication statement?.151.4 What Are the Contraindications?.151.5 What Are the Precautions?.171.6 Warnings.172.Breast Implant Benefits And Risks.182.1 What Are the Benefits?.182.2 What Are the Potential Risks?.192.3 What Causes Breast Implants to Rupture andHow Can I Tell if My Implants Are Ruptured?. 272.4 What Are Other Reported Conditions?. 293.Surgical Considerations For Breast Augmentation. 343.1 What are the Alternatives to Breast Augmentation with NATRELLE Silicone-Filled Breast Implants or NATRELLE INSPIRA Breast Implants?.343.2 What Are Questions to Consider WhenChoosing a Surgeon?. 343.3 What Are Choices and Options Associated with the Surgery?. 354.5.Follow-Up Examinations. 40Allergan’s Clinical Study Results.415.1 What Are the Overview Findings of Allergan’s Core Study?. 425.2 What Are the 10-Year Follow-Up Rates?. 425.3 What Are the Benefits?. 425.4 What Are the 10-Year Complication Rates?. 455.5 What Are the Main Reasons for Reoperation?. 475.6 What Are the Main Reasons for Implant Removal?. 495.7 What Are Other Clinical Data Findings?. 506.Additional Information. 536.1 What If I Experience a Problem?. 536.2 What Is Device Tracking?. 536.3 What Is the ConfidencePlus Limited Warranty?. 546.4 How Can I Receive More Information?. 55For Further Reading And Information. 56Index. 631
GlossaryAnaplastic large celllymphoma (ALCL)ALCL is not breast cancer; it is a rare typeof non-Hodgkin’s lymphoma, a cancerinvolving the cells of the immune system.AreolaThe pigmented or darker colored area ofskin surrounding the nipple of the breast.AsymmetryUneven appearance between a woman’sleft and right breasts in terms of size, shape,or breast level.AtrophyThinning or diminishing of tissues or muscle.Autoimmune diseaseAn autoimmune disease is a disease inwhich the body’s immune system attacksits own cells or tissues by mistake, causingdamage and dysfunction. Autoimmunediseases can affect connective tissue in thebody (the tissue that binds together bodytissues and organs). Autoimmune diseasescan affect many parts of the body, likenerves, muscles, glands, and the digestivesystem.BiocompatibleThe ability to exist along with living tissuesor systems without causing harm.BiopsyThe removal and examination of tissues,cells, or fluid from the body.Body DysmorphicDisorderA psychological condition characterized byexcessive worry about an imagined or minorphysical flaw to the point that it can interferewith normal daily activities.Body Esteem ScaleA questionnaire which asks about a person’sbody image.Breast augmentationA surgical procedure to increase breastsize. For this brochure, it refers to placementof a breast implant. The first time a breastimplant is placed for augmentation is called“primary augmentation.” Any time there isanother surgery to replace the implant, it isreferred to as “revision-augmentation.”Breast implantAny surgically implanted artificial deviceintended to replace missing breast tissue orto enhance a breast.Breast massA lump in the breast.2
Breast reconstructionA surgical procedure to replace breasttissue or reconstruct a breast after tissuewas taken out because of cancer or injury.Breast reconstruction also includes thesurgical correction of a breast that hasfailed to develop properly due to a severeabnormality or congenital defect. For thisbrochure, it refers to placement of a breastimplant.CalcificationProcess of hardening by calcium salts.Capsular contractureA tightening of the scar tissue (also calleda capsule) that normally forms around thebreast implant during the healing processafter surgery. In some women, the scar tissue(capsule) squeezes the implant. When thisoccurs, it is called capsular contracture. Thisresults in firmness or hardening of the breastand is a risk for implant rupture. Capsularcontracture is classified by Baker Grades.Capsular Contracture Baker Grades III or IVare the most severe. Baker Grade III oftenresults in the need for additional surgery(reoperation) because of pain and possiblyabnormal appearance. Baker Grade IVusually results in the need for additionalsurgery (reoperation) because of painand unacceptable appearance. Capsularcontracture Baker Grade II may also resultin the need for surgery. Each grade isdescribed below.11Baker Grade I – Normally soft and naturalappearanceBaker Grade II – A little firm, but breastlooks normalBaker Grade III – More firm than normal,and looks abnormal(change in shape)Baker Grade IV – Hard, obvious distortion,and tenderness with painCapsuleScar tissue which forms around the breastimplant.3
Capsulotomy (closed)An attempt to break the scar tissue capsulearound the implant by pressing or pushingon the outside of the breast. This methoddoes not require surgery but may rupture theimplant and is contraindicated.Capsulotomy (open)An attempt to break the scar tissue capsulearound the implant by surgical incision intothe capsule.Congenital abnormalityAn abnormal development in part of thebody, present in some form since birth.Connective tissuedisease/disorder (CTD)A disease, group of diseases, or conditionsaffecting connective tissue, such as muscles,ligaments, skin, etc., and/or the immunesystem. Connective tissue diseases (CTDs)that involve the immune system includeautoimmune diseases such as rheumatoidarthritis, lupus, and scleroderma.ContraindicationA use that is improper and should not befollowed. Failure to follow contraindicationsidentified in the labeling could cause seriousharm.ContralateralOpposite side.Core StudyThe primary clinical study of augmentation,reconstruction, and revision (revisionaugmentation and revision-reconstruction)patients that supported the approval of thepremarket approval (PMA) application.Safety and effectiveness data are collectedyearly through 10 years, with the follow-upfrom years 5 through 10 being performedas part of a post-approval Core Study.Delayed wound healingUnusually slow progress in the healing ofa wound; surgical incision site fails to healnormally or takes longer to heal.DisplacementMovement of the implant from the usual orproper place.ExtrusionSkin breakdown with the implant pressingthrough the skin or surgical incision.FibromyalgiaA disorder characterized by chronic painin the muscles and soft tissues surroundingjoints, with tenderness at specific sites in thebody. It is often accompanied by fatigue.4
Fibrous tissuesConnective tissues composed mostly offibers.Gel bleedWhen silicone gel leaks or “bleeds” ordiffuses through the implant shell.GranulomaA noncancerous lump that can form aroundany foreign material, such as silicone.Like any lump, it should be evaluated todistinguish it from a lump that might becancerous.HematomaA collection of blood within a space.Hypertrophic scarringAn enlarged scar remaining after a woundheals.IncisionA cut made to the tissue during surgery.InfectionThe growth in the human body ofmicroorganisms such as bacteria, viruses,or fungi. An infection usually results in fever,swelling, redness, and/or pain. It can occuras a result of any surgery.InflammationThe response of the body to infection orinjury that is characterized by redness,swelling, warmth, and/or pain.InframammaryBelow the breast.Inpatient surgeryA surgical procedure in which the patient isrequired to stay overnight in the hospital.LactationThe production and secretion of milk by thebreast glands.Low molecular weightsiliconesSmall silicone molecules that might leak outof the implant.Lymph nodesGlands that play an important part in thebody’s defense against infection. Theyproduce lymph, which travels throughoutthe body in the lymph system, and filtersimpurities from the body. Common areaswhere the lymph nodes can be felt with thefingers include: groin, armpit, neck, underthe jaw and chin, behind the ears, and onthe back of the head.LymphadenopathyEnlargement of the lymph node(s).LymphedemaSwelling of the lymph node(s).5
MalpositionWhen the implant is placed incorrectlyduring the initial surgery or when the implanthas shifted from its original position. Shiftingcan be caused by many factors, such asgravity, trauma, poor initial placement, andcapsular contracture.MammaryPertaining to the breast.MammographyA type of X-ray examination of the breastsused for detection of cancer.Screening mammography – x-rayexamination of the breast that is performedon women with no complaints or symptomsof breast cancer; the goal is to detect breastcancer when it is still too small to be felt bya physician or the patient.Diagnostic mammography – x-rayexamination in order to evaluate a breastcomplaint or abnormality detected byphysical exam or screening mammography;additional views of the breast are usuallytaken.MammoplastyPlastic surgery of the breast.MastitisInflammation of the breast.MastopexySurgical procedure to raise and reshapesagging breasts.Metastatic diseaseA stage of cancer after it has spread from itsoriginal site to other parts of the body.MigrationMovement of silicone materials outside thebreast implant to other parts of the body.MRI (MagneticResonance Imaging)A radiographic examination that currentlyhas the best ability to detect rupture ofsilicone gel-filled breast implants.NecrosisDeath of cells or tissues.Outpatient surgeryA surgical procedure in which the patient isnot required to stay in the hospital overnight.PalpabilityThe ability to feel the implant.PalpableFelt with the hand.PectoralisMajor muscle of the chest.PeriareolarAround the darkened or pigmented areasurrounding the nipple of the breast.6
Plastic surgerySurgery intended to enhance or improve theappearance of the body.PostoperativeAfter surgery.PrecautionsInformation that warns the reader of apotentially hazardous situation which, if notavoided, may result in minor or moderateinjury.Primary breastaugmentationThe first time a breast implant is placed forthe purpose of breast augmentation.PtosisSagging or drooping of the breast.ReoperationAn additional surgery after your first breastimplantation.Revision-augmentationRefers to the correction or improvement of aprimary augmentation. For this brochure, itrefers to surgical removal and replacementof breast implants that were placedoriginally for primary breast augmentation.Revision-reconstructionRefers to the correction or improvement of aprimary reconstruction. For this brochure, itrefers to surgical removal and replacementof breast implants that were placedoriginally for primary breast reconstruction.Rheumatologic disease/disorderA variety of diseases involving connectivetissue structures of the body, especially thejoints and fibrous tissue. These diseases areoften associated with pain, inflammation,stiffness, and/or limitation of motion of theaffected parts.Can include autoimmune diseases.Fibromyalgia is a rheumatological disorder.Rosenberg Self-EsteemScaleA questionnaire that measures overallself-esteem.Rowland ExpectationScaleA 16 item questionnaire intended tomeasure expectations and perceived resultsof implant surgery.RuptureA tear or hole in the shell of the implantthat allows silicone gel filler material to leakfrom the shell. Ruptures can be intracapsular(inside the scar tissue capsule surroundingthe implant) or extracapsular (outside thescar tissue surrounding the implant).SalineA solution made of water and a smallamount of salt.7
Scar revisionA surgical procedure to improve theappearance of a scar.SeromaSimilar to a bruise, a seroma occurs whenthe watery portion of the blood collectsaround a surgical incision or around abreast implant.SF-36 ScaleThe Short Form 36 Health Scale; aquestionnaire intended to measure physical,mental, and social health.Silent ruptureA breast implant rupture without symptomsor a visible change. Silent rupture cannot befelt by the woman or detected by a doctorthrough physical examination. Silent rupturecan only be discovered through appropriateimaging techniques such as MRI. Mostsilicone gel-filled breast implant ruptures aresilent (see symptomatic rupture below).Silicone elastomerA type of silicone that has elastic propertiessimilar to rubber.Subglandular placementPlacement of a breast implant underneathand within the breast glands but on top ofthe chest muscle.Submuscular placementPlacement of a breast implant wholly orpartially underneath the chest muscle.SymptomAny perceptible change in the body or itsfunctions that indicates disease or a phaseof a disease.SymptomaticExperiencing symptoms; any evidence orsign of disease or disorder.Symptomatic ruptureA breast implant rupture that is associatedwith symptoms (such as lumps, persistentpain, swelling, hardening, or change inimplant shape). Some silicone breast implantruptures are symptomatic, but most aresilent.SystemicPertaining to or affecting the body as awhole.Tennessee Self-ConceptScaleA questionnaire intended to measurethe patient’s view of her body and stateof health, as well as her attitude aboutappearance, skills, and sexuality. Thequestionnaire administered in the CoreStudy consisted of 18 items.8
Toxic shock syndromeA rare, but life-threatening bacterial infectionthat may occur after surgery. It occurs mostoften in the vagina of menstruating womenusing superabsorbent tampons. Symptomsinclude sudden high fever, vomiting,diarrhea, decreased blood pressure,fainting, dizziness, and sunburnlike rash.A doctor should be seen immediately fordiagnosis and treatment if toxic shocksyndrome is suspected.TransaxillaryUnder the arm.WarningStatement that alerts the reader about asituation which, if not avoided, could resultin serious injury or death.9
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1. Considering Silicone Gel-FilledBreast Implant SurgeryYou may be considering breast implant surgery to increase the sizeof your breasts. This is referred to as breast augmentation. Or youmay need to have a previous breast augmentation corrected orimproved, which is called revision-augmentation. Allergan has preparedthis information to help you better understand the breast implantprocedure and assist you in making an informed decision about breastaugmentation or revision-augmentation surgery. It will help to answersome of the questions you may have about the surgery and about breastimplants in general. It will also provide you with specific informationabout the risks and benefits of Allergan’s NATRELLE Silicone-FilledBreast Implants and NATRELLE INSPIRA Breast Implants. Similarinformation to help you understand breast reconstruction is available fromyour plastic surgeon, Allergan, or at www.natrelle.com.This information cannot and should not replace talking with your plasticsurgeon. Your decision whether or not to get breast implants should bebased on realistic expectations of the outcome. There is no guaranteethat your results will match those of other women. Your results will dependon many individual factors, such as your overall health (including age),chest structure, breast/nipple shape and position, skin texture, healingcapabilities (which may be slowed by radiation and chemotherapytreatment, smoking, alcohol, and various medications), tendency tobleed, prior breast surgery, surgical team’s skill and experience, type ofsurgical procedure, and type and size of implant. Make sure you speakwith your surgeon about your expectations of the results, as well as whatyou can expect regarding the length of the surgery, your recovery, andany risks and potential complications of the surgery. Ask questions.As part of your decision, both you and your surgeon will be requiredto sign Allergan’s “Acceptance of Risk and Consent to Surgery” formthat confirms your understanding of the risks and benefits of Allergan’sNATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants.Because breast implants will require monitoring and care for the restof your life, you should wait at least 1-2 weeks after reviewing andconsidering this information before deciding whether to have primarybreast augmentation surgery. In the case of a revision-augmentation,however, your surgeon may find it medically advisable to perform surgerysooner.11
1.1What Gives the Breast Its Shape?The breast consists of milk ducts and glands, surrounded by fatty tissuethat provides its shape and feel. Beneath the breast is the chest muscle(pectoralis major muscle).FATTY TI S S U ER IB SPEC TO R A L I S M U S C L E SM IL K D U C TSA ND G L A N D SImplants are used to make the breast larger or to restore/replace breasttissue. Factors such as pregnancy (when milk glands are temporarilyenlarged), rapid weight loss, and the effects of gravity as you agecombine to stretch the skin, which may cause the breast to droop orsag. However, it is important to realize that implants are used to makethe breast larger. The implants alone may not adequately lift the breast,or correct the effects of pregnancy, weight loss, or skin stretching. Yoursurgeon may suggest additional procedures at the time of the breastaugmentation, such as mastopexy, to help achieve improved breast lift.1.2 What Is a Silicone Filled Breast Implant?A silicone gel-filled breast implant is a sac (implant shell) of siliconeelastomer (rubber) filled with silicone gel. Allergan has approval for 2types of silicone gel fillers: cohesive silicone gel and highly cohesivesilicone gel. The focus of this brochure is cohesive silicone-filledbreast implants. A separate brochure is available for highly cohesivesilicone-filled implants from your plastic surgeon, from Allergan, or atwww.natrelle.com. Allergan offers two lines of cohesive silicone-filledbreast implants: NATRELLE Silicone-Filled Breast Implants andNATRELLE INSPIRA Breast Implants.12
NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants come in a variety of profiles and sizes. A number offactors will determine which style and size of breast implant is mostappropriate. These factors include your breast augmentation goals, yourbody size, your desired breast size, and the amount of breast skin youhave. Your plastic surgeon will discuss with you the implant options thatwill best help you achieve the result that is right for you.Example of a NATRELLE Silicone-Filled Breast ImplantExample of a NATRELLE INSPIRA Smooth Breast ImplantExample of NATRELLE INSPIRA Textured Breast Implant13
KATELYNERICAAMBERMother of FourNATRELLE Style 20BookkeeperNATRELLE Style 20QUYNHROSEMINELALawyer, Mother of TwoNATRELLE Style 15Actress, MotherNATRELLE Style 363StudentNATRELLE Style 15NurseNATRELLE Style 6814 14
Refer to Section 3.3 for more information on the different NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implantsavailable from Allergan.1.3 Who is eligible for NATRELLE Silicone-FilledBreast Implants and NATRELLE INSPIRA Breast Implants and what is the indicationstatement?NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants have been approved for females for the following uses(procedures): reast augmentation for women at least 22 years old. BreastBaugmentation includes primary breast augmentation to increase thebreast size, as well as revision surgery to correct or improve theresult of a primary breast augmentation surgery. Breast reconstruction. Breast reconstruction includes primaryreconstruction to replace breast tissue that has been removed dueto cancer or trauma or that has failed to develop properly due toa severe breast abnormality. Breast reconstruction also includesrevision surgery to correct or improve the result of a primary breastreconstruction surgery.A separate patient brochure is available for those women consideringbreast reconstruction surgery and should be read prior to reaching adecision to undergo breast reconstruction.1.4 What Are the Contraindications?A contraindication is a condition or circumstance that, if present, meansa procedure should not be done. Contraindications for breast implantsurgery are discussed in this section.Breast implant surgery should not be performed in: Women with active infection anywhere in their body, becausethe implant will make the infection much harder to treat should theinfection move into the breast. Women with existing cancer or pre-cancer of their breast who havenot received adequate treatment for those conditions, becauseradiation and chemotherapy treatments may increase the risk ofsome complications seen with breast implants. Also, breast implantsmay interfere with radiation or chemotherapy treatments. Women who are currently pregnant or nursing, because surgerymay interfere with the safety of the pregnancy/nursing. Since15
KATELYNERICAAMBERMother of FourNATRELLE Style 20BookkeeperNATRELLE Style 20NurseNATRELLE Style 68HPQUYNHROSEMINELALawyer, Mother of TwoNATRELLE Style 15Actress, MotherNATRELLE Style 363StudentNATRELLE Style 15KATELYNERICAAMBERStyle 20Style 20Style 68HPQUYNHROSEMINELAStyle 15Style 363Style 15ROBYNAMYJESSICAUnilateral Reconstruction Bilateral ReconstructionBilateral PrimaryNATRELLE 133V Tissue NATRELLE 133V TissueAugmentationExpanders and Implant Expanders and Implants NATRELLE Style FM270 NPHAEDRABilateral RevisionAugmentationNATRELLE Style FM47016
breast augmentation is an elective surgery, it should be postponeduntil you are no longer pregnant or nursing.1.5 What Are the Precautions?A precaution is information that warns the reader of a potentiallyhazardous situation which, if not avoided, may result in minor ormoderate injury. The following are precautions; safety and effectivenesshave not been established in patients with these conditions: Autoimmune diseases (for example, lupus and scleroderma) A weakened immune system (for example, currently taking drugsthat weaken the body’s natural resistance to disease) Planned chemotherapy following breast implant placement Planned radiation therapy to the breast following breast implantplacement Conditions that interfere with wound healing and blood clotting Reduced blood supply to breast tissue Clinical diagnosis of depression or other mental health disorders,including body dysmorphic disorder and eating disorders. Pleasediscuss any history of mental health disorders with your surgeonprior to surgery. Patients with a diagnosis of depression, or othermental health disorders, should wait until these conditions haveresolved or stabilized prior to undergoing breast implantationsurgery.1.6 WarningsWarnings are statements that alert the reader about a situation which,if not avoided, could result in serious injury or death. Read this entirebrochure before having breast implant surgery. This is important so thatyou will understand the risks and benefits and have realistic expectationsof the outcome of your surgery. Breast implants are associated with manyshort-term and long-term risks.WARNING – Be aware that many of the changes to your breastfollowing implantation cannot be undone. If you later choose tohave your implant(s) removed and not replaced, you may experienceunacceptable dimpling, puckering, wrinkling, or other cosmetic changesto the breast, which can be permanent.WARNING – Before you decide to have breast implant surgery, youshould know that breast implants are not lifetime devices, and breastimplantation is likely not a one-time surgery. You will likely needadditional unplanned surgeries on your augmented breasts because ofcomplications or unacceptable cosmetic outcomes. These additional17
surgeries can include implant removal or replacement, or they caninclude other surgical procedures. Later surgeries to replace implants(revision-augmentation) carry higher risks of complications than the first(primary) augmentation surgery. Therefore, you should also consider thecomplication rates for revision-augmentation since you may experiencethese risks in the future.WARNING – Your NATRELLE Silicone-Filled Breast Implant or NATRELLEINSPIRA Breast Implant may rupture without any symptoms (silentrupture). This means that neither you nor your surgeon will know that yourimplants have ruptured. In order to detect silent rupture, you will needto have regular screening MRI examinations. You should have an MRI 3years after your breast implant surgery and then every 2 years after thatfor as long as you have your breast implants.2.Breast Implant Benefits And RisksUndergoing any type of surgical procedure involves risks (some serious)such as the effects of anesthesia, infection, swelling, redness, bleeding,pain, and even death. Some of these risks are serious, and all of theserisks need to be balanced against the benefits of the surgery itself. Atthe end of this brochure is a list of published studies used to gatherthe information discussed in the sections below. These studies may behelpful to you if you wish to learn more about a specific complicationor condition. The reference list is not complete because studies arebeing conducted all the time. Your physician may have other resourcesfor further reading. The information provided below focuses on womenundergoing Primary Augmentation and Revision-Augmentation withNATRELLE Silicone-Filled Breast Implants or NATRELLE INSPIRA Breast Implants. The studies in the list of references also include womenundergoing breast reconstruction and other types of implants from avariety of manufacturers. The risks and benefits of breast reconstructionmay differ from those of augmentation, and the risks of other typesof implants may differ from those of NATRELLE Silicone-Filled BreastImplants and NATRELLE INSPIRA Breast Implants.2.1 What Are the Benefits?Breast augmentation can change the size and proportion of the breast(s).In addition, revision-augmentation (replacement of an existing breastimplant) can correct or improve the result of a primary augmentationsurgery.Breast augmentation has the potential to offer both physical andpsychological benefits to women.1 The benefits of breast implants,therefore, relate to their ability to enhance breast volume and attainbody symmetry.1,3,5 Many studies have reported that a majority of breast18
augmentation patients are satisfied with the results of their surgery. InAllergan’s Core Study through 10 years, approximately 9 out of 10women undergoing primary augmentation or revision-augmentation withNATRELLE Silicone-Filled Breast Implants are satisfied with their breastimplants. Section 5.3 provides more information on benefits seen inAllergan’s Core Study.2.2 What Are the Potential Risks?Table 1 describes some of the known risks of breast augmentation alongwith possible effects of those risks. This information is based on theresults of Allergan’s Core study of 455 Primary Augmentation patientsand 147 Revision-Augmentation patients. Additional useful informationrelated to these risks as well as risks occurring in less than 1% of patientsin the Core study is provided following Table 1. Sections 5.4 through5.7 as well as Tables 2 and 3 provide more information on risks seen inAllergan’s Core Study.19
Table 1Risks of Breast Augmentation Through 10 Years with NATRELLE Silicone-FilledBreast ImplantsEventLikelihood ofEvent Occurringin PrimaryAugmentationPatientsaLikelihood ofEvent Occurringin RevisionAugmentationPatientsaPossible Resulting Effectsof the EventAdditional Surgeries 36 out of 100(Reoperations)patients (36%)46 out of 100patients (46%) Implant Removalwith Replacement19 out of 100patients (19%)30 out of 100patients (30%) ImplantRemoval withoutReplacement3 out of 100patients (3%)4 out of 100patients (4%) CapsularContracture(Baker Grade III/IV)19 out of 100patients (19%)29 out of 100patients (29%) RuptureMRICohort9 out of 100patients(9%)5 out of 100patients (5%) Implant RemovalNonMRICohort14 out of 100patients (14%)10 out of 100patients (10%)Key RisksInfectionScarringHematoma or SeromaDelayed wound healingNecrosisPain or DiscomfortAnesthesia-relatedcomplications Loss of breast tissue Undesirable cosmetic resultInfectionScarringHematoma or SeromaDelayed wound healingNecrosisPain or DiscomfortAnesthesia-relatedcomplications Loss of breast tissue Undesirable cosmetic resultIn
NATRELLE Style 68HP CRYSTAL Singer NATRELLE Style 20 CASEY Paralegal NATRELLE Style 15 MINELA Student NATRELLE Style 15 ROSE Actress, Mother NATRELLE Style 363 QUYNH Lawyer, Mother of Two NATRELLE Style 15 AMY ROBYN Unilateral Reconstruction NATRELLE 133V Tissue Expanders and Implant Bilateral
augmentation can be integrated at both the image and class levels. Our proposed meta-specific data augmentation significantly improves the perfor-mance of meta-learners on few-shot classification benchmarks. 1. Introduction Data augmentation has become an essential part of the train-ing pipeline for image classifiers and similar systems, as it
( 0.7% positive labels). The objective of the data challenge is to develop a data augmentation approach for a binary labeled rare event multivariate time series data. A guideline for using the data and method develop-ment is provided. The e cacy of a method will be gauged based on the improvement in classi cation accuracy after data augmentation.
Gains of GT-Paste 4.4 8.3 -1.7 6.5 1.0 9.6 1.9 6.9 6.0 5.1 4.8 7.2 Table 1. Effectiveness of the GT-Paste data augmentation scheme. Applying GT-Paste data augmentation for LiDAR points achieves an improvement of 4.8%mAP. We use CenterPoint as baseline with 1/8 training data on the nuScenes dataset. Building Pole
The Institute for Safe Medication Practices (ISMP) designates IV oxytocin as a high- . Guidelines Related to Induction/Augmentation of Labor: Refer to handout . Preparation for Cervical Ripening, Induction, or Augmentation Topics to be covered:
Ear Surgery Eyelid Surgery Facelift Facial Bone Contouring Fat Grafting-face Neck Lift Rhinoplasty Total Face & Head Procedures 249.343 287.070 1.346.886 465.296 98.003 602.760 263.219 877.254 4.189.830 FACE & HEAD Breast Augmentation— saline Breast Augmentation—silicone Breast Augmentation—fat transfer Breast Implant Removal Breast Lift .
However, breast augmentation is an option that helps women improve the appearance of the breasts and cleavage, improve self-esteem, and help regain a feeling of femininity. Whatever your reasons for considering breast augmentation surgery, Dr. Hlavacek and everyone at Kansas City Surgical Arts want to support you in your journey.
Also known as augmentation mammaplasty, the procedure involves . using implants to fulfill your desire for fuller breasts or to restore breast volume lost after weight reduction or pregnancy. Implants also may be used to reconstruct a breast after mastectomy or injury. What it won't do. Breast augmentation does not correct severely drooping .
to a breast defect in a mastectomy patient. 2,3,6,7 In the 1930s, implantation of a glass ball into a patient's breast marked the fi rst implant-based breast augmentation. 6 By 1954, attempts at breast augmentation using local dermal-fat fl aps, adipose tissue, and even omentum were described. Alloplastic materials gained popular-