NATRELLE SILICONE-FILLED BREAST IMPLANTS AND
NATRELLE SILICONE-FILLEDBREAST IMPLANTS ANDNATRELLE INSPIRA BREAST IMPLANTSWITH SMOOTH SURFACEImportant Factors Breast Augmentation andReconstruction Patients Should ConsiderWARNING: Breast implants are not considered lifetime devices.The longer people have them, the greater thechances are that they will develop complications,some of which will require more surgery. Breast implants have been associated with thedevelopment of a cancer of the immune systemcalled breast implant-associated anaplastic largecell lymphoma (BIA-ALCL). This cancer occursmore commonly in patients with textured breastimplants than smooth implants, although ratesare not well defined. Some patients have diedfrom BIA-ALCL. Patients receiving breast implants have reporteda variety of systemic symptoms such as jointpain, muscle aches, confusion, chronic fatigue,autoimmune diseases and others. Individualpatient risk for developing these symptoms hasnot been well established. Some patients reportcomplete resolution of symptoms when theimplants are removed without replacement.The sale and distribution of this device is restricted tousers and/or user facilities that provide information topatients about the risks and benefits of this device inthe form and manner specified in the approved labelingprovided by Allergan.Important Factors
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IntroductionAllergan has prepared this brochure to provide you witha high-level overview of the facts about breast implantsurgery with Allergan’s FDA-Approved NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants with smooth surface. This brochure isnot intended to replace consultation with your surgeon.For a complete review of the benefits and risks of breastimplant surgery, please read the appropriate patient labelingpiece, Important Information for Women about BreastAugmentation/Reconstruction with NATRELLE Silicone-Filled Breast Implants and NATRELLEINSPIRA Breast Implants with Smooth Surface ,available online at www.allerganlabeling.com. To helpguide you, the locations of where you can find specificadditional information in the patient labeling are providedthroughout this brochure. A glossary of terms that you maybe unfamiliar with is located at the end.Because breast implants will require monitoring andcare for the rest of your life, you should wait 1-2 weeksafter reviewing and considering this information beforedeciding whether to have primary breast augmentation orreconstruction surgery. In the case of a revision surgery,however, your surgeon may find it medically necessary toperform surgery sooner.If you wish to speak to an Allergan Breast Implant SupportSpecialist to inquire about breast implants, discussany concerns, or request a copy of the patient labelingor physician Directions for Use, please call toll free at1.800.678.1605 (7 am to 5 pm Pacific Time).Important Factors 1
Figure 1:NATRELLE Silicone-Filled Breast ImplantFigure 2:NATRELLE INSPIRA Breast ImplantWho is eligible to getNATRELLE Silicone-FilledBreast Implants andNATRELLE INSPIRA Breast ImplantsNATRELLE Silicone-Filled Breast Implants andNATRELLE INSPIRA Breast Implants have been approvedfor women for the following uses (procedures): Breast augmentation for women at least 22 yearsold. 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.Important Factors
Breast reconstruction. Breast reconstruction includesprimary breast reconstruction to replace breast tissuethat has been removed due to cancer or trauma or thathas failed to develop properly due to a severe breastabnormality. Breast reconstruction also includes revisionsurgery to correct or improve the result of a primarybreast reconstruction surgery.Who should NOTget Breast Implants(CONTRAINDICATIONS)?Breast 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 treatmentfor those conditions Women who are currently pregnant or nursingPRECAUTIONSCaution: Notify your doctor if you have any of thefollowing conditions, as the risks of breast implantsurgery may be higher: Autoimmune Diseases (for example, lupus andscleroderma) A weakened immune system (for example, currentlytaking drugs that weaken the body’s natural resistanceto disease) Planned chemotherapy following breastimplant placement Planned radiation therapy to the breast following breastimplant placement Conditions that interfere with wound healing andblood clottingImportant Factors 3
Reduced blood supply to breast tissue 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 for resolution orstabilization of these conditions prior to undergoingbreast implantation surgery.What else should Iconsider (WARNINGS)?The following are warnings associated with NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants. There is a boxed warning for breastimplants. Please see the cover page. Breast implants are not lifetime devices, and breastimplantation is not necessarily a one-time surgery. Youwill likely need additional surgeries on your breasts dueto complications or unacceptable cosmetic results. Many of the changes to your breasts followingimplantation are irreversible. If you later choose tohave your implants removed and not replaced, youmay experience unacceptable dimpling, puckering,wrinkling, or other cosmetic changes of the breast,which may be permanent. Breast implants may affect your ability to breastfeed,either by reducing or eliminating milk production. Rupture of a silicone-filled breast implant is most oftensilent. This means that neither you nor your surgeonwill know that your implants have a rupture. Therefore,even if you have no symptoms, you should have yourImportant Factors
first ultrasound or MRI at 5-6 years after your initialimplant surgery and then every 2-3 years thereafter.If you have symptoms at any time or uncertainultrasound results for breast implant rupture, an MRIis recommended. The health consequences of a ruptured silicone gelfilled breast implant have not been fully established. With breast implants, a routine screeningmammography for breast cancer will be more difficult.The implant may interfere with breast cancer detectionduring mammography and because the breast andimplant are squeezed during mammography, animplant may rupture during the procedure. You should perform self-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. The presence of lumps, persistent pain,swelling, hardening, or changes in implant shape,may be signs of a rupture of the implant. These signsshould be reported to your surgeon and possiblyevaluated with imaging. After undergoing breast implant surgery (either primaryor revision), your health insurance premiums mayincrease, your insurance coverage may be dropped,and/or future coverage may be denied. Additionally,treatment of complications may not be covered. You should inform any other doctor who treats you ofthe presence of your implants to minimize the risk ofdamage to the implants.Important Factors 5
What are somecomplications withNATRELLE Silicone-FilledBreast Implants andNATRELLE INSPIRA Breast Implants(COMPLICATIONS)?Undergoing any type of surgery involves risks. There area number of local complications (problems at or near thebreast/surgical incision site) that may occur after yourbreast implant surgery. The following sections presentresults from Allergan’s Core clinical study conducted onNATRELLE Silicone-Filled Breast Implants. The AllerganCore Study assessed both BIOCELL textured and smoothbreast implants. BIOCELL textured breast implants wererecalled in July 2019 for their higher risk associated withBIA-ALCL and are no longer manufactured or marketed.Please refer to the Glossary at the end of this brochurefor the definition of terms and complications that you maynot understand.Allergan Core StudyTables 1 and 2 below present complication rates reportedin the Allergan Core Study through 10 years. Detailedinformation on complications reported in the Core Study,including information on complications reported within thefirst 3, 5, 7, and 10 years after implant surgery, can beImportant Factors
found online in the patient labeling, specifically in Sections2.2 What are the potential risks, 5.4 Allergan’s ClinicalStudy Results: What are the 10-Year Complication Rates,and 5.7 Allergan’s Clinical Study Results: What are OtherClinical Data Findings?In the Allergan Core Study, a group of patients hadscheduled MRIs to look for rupture independent ofwhether or not they had any symptoms. These patientsare called the MRI cohort. The remaining patients did nothave scheduled MRIs to look for rupture. These patientsare called the non-MRI cohort. (An MRI is a radiographicexamination that currently has the best ability to detectrupture of silicone gel-filled breast implants).One of the key complications reported is called “capsularcontracture.” Capsular contracture is a tightening of thescar tissue (also called a capsule) that normally formsaround the breast implant during the healing processafter surgery. In some women, the scar tissue (capsule)squeezes the implant. This results in firmness or hardeningof the breast, and it is a risk for implant rupture. Degreesof capsular contracture are classified by the Baker GradingScale.1 Capsular Contracture Baker Grades III and IV arethe most severe. Baker Grade III often results in the needfor additional surgery (reoperation) because of pain andpossibly abnormal appearance. Baker Grade IV usuallyresults in the need for reoperation because of pain andunacceptable appearance. Other reasons for reoperationsare discussed in the online patient labeling in Section5.5 Allergan’s Clinical Study Results: What are the MainReasons for Reoperation?1Baker, J.L. Augmentation mammoplasty. In: Owsley, J.Q. and Peterson, R., Eds. Symposium on aestheticsurgery of the breast. St. Louis, MO: Mosby, 1978:256-263.Important Factors 7
Table 1: Key Complication Rates Reported through 10 YearsComplicationAny complication (including reoperation)Primary AugmentationN 45532.9%Key ComplicationsReoperation36.1%Implant removal with replacement18.6%Implant removal without replacement2.8%Implant ruptureMRI cohort9.3%Non-MRI cohort13.7%Capsular contracture (Baker Grade III/IV)18.9%Table 2: Other Complication Rates Reported through 10 YearsComplicationa,b,cPrimary AugmentationN 455Asymmetry3.3%Breast Pain11.5%Bruising 1%Breast/skin sensation changes1.6%Delayed Wound Healing1.1%Gel Migration 1%Hematoma1.6%Hypertrophic Scarring4.2%Implant extrusion 1%Implant malposition6.9%Implant palpability/visibility1.6%Infection 1%Irritation0Lymphedema 1%Nipple Complications6.3%Ptosis2.0%Redness 1%Seroma1.8%Skin Rash 1%Swelling9.2%Tissue/Skin Necrosis 1%Wrinkling/Rippling1.8%Other Complications c0.2%Most complications were assessed with severity ratings. This table only includes complications ratedmoderate, severe, or very severe (excludes mild and very mild ratings). For reoperation, implantremoval or replacement, implant rupture, implant extrusion, and pneumothorax all occurrences areincluded, regardless of severity.bThere were no reports of the following complications: capsule calcification, lymphadenopathy,pneumothoraxc Other complications include complications such as flexion of pectoral muscle, herniation following anauto accident, upper pole crescent deformityaImportant Factors
Revision-AugmentationN 147Primary ReconstructionN 98Revision-ReconstructionN vision-AugmentationN 147Primary ReconstructionN 98Revision-ReconstructionN 156.7%6.5%23.2%11.7%6.8%03.0%1.0%6.7%2.2%1.0%0 %6.4%6.7%1.4%3.2%0 1%000001.4%3.3%04.9%00 1%2.1%06.0%2.3%6.7% 1%2.0%6.7%8.2%7.1%002.3%05.4%10.2%00.7%1.0%0Other complications not listed above have also been reported inpatients with breast implants. These include: Breastfeeding difficulties Calcium deposits Breast tissue atrophy/chest wall deformity Connective TissueDisease (CTD) CTD signs and symptoms Neurological Disease Neurological Signsand Symptoms Cancer Lymphoma, includingBreast Implant-AssociatedAnaplastic Large CellLymphoma or BIA-ALCL Suicide Potential Effectson OffspringImportant Factors 9
Why are implantssometimes removed(IMPLANT REMOVAL)?Breast implants may be removed with or without replacementin response to a complication, or to improve a cosmeticresult. In the Allergan Core Study through 10 years, the mostcommon reason overall for implant removal was capsularcontracture in Augmentation and Revision-Augmentationpatients (32% and 36%, respectively). For Reconstructionpatients, through 10 years the most common reason forimplant removal was suspected implant rupture (26%).Among Revision-Reconstruction patients, 2 patients hadimplant removal due to asymmetry and one patient due tocapsular contracture.The main reasons Primary Augmentation and RevisionAugmentation patients had implants removed through 10years are presented in Figure 2 and Figure 3, respectively.The main reasons Primary Reconstruction women hadimplants removed through 10 years are presented inFigure 4. As stated above, 3 Revision-Reconstructionpatients had their implants removed through 10 years dueto asymmetry and capsular contracture (not presented in aseparate figure).Important Factors
Figure 2:Main Reasons for Implant Removal Through 10 YearsPrimary Augmentation (N 156 implants)Capsular Contracture32%Patient Request for Size/Style.20%Suspected Rupture17%Ptosis8%Implant Malposition7%Asymmetry5%Wrinkling/RipplingBreast Pain4%3%Breast Cancer1%Infection1%Breast Tissue Contour Deformity1%Implant Extrusion1%Need for Biopsy1%Figure 3:Main Reasons for Implant Removal Through 10 YearsRevision-Augmentation (N 78 implants)Capsular Contracture36%Implant Malposition18%Patient Request for Size/Style.14%Ptosis8%Suspected Rupture8%Breast ther3%Asymmetry1%Breast Pain1%Palpability/Visibility1%Figure 4:Main Reasons for Implant Removal Through 10 YearsPrimary Reconstruction (N 57 implants)Suspected Rupture26%Asymmetry21%Implant Malposition21%Capsular Contracture18%Patient Request for Style/Size Change7%Implant %Important Factors 11
How does thebreast implantationprocedure work?The sections below briefly describe some details of surgeryincluding where breast implants can be placed and incisionsites as well as what to expect after a breast implantsurgery. However, there are many factors to consider withbreast augmentation and breast reconstruction. Pleaseread the Section 3.0 Surgical Considerations for BreastAugmentation/Reconstruction in the appropriate patientlabeling piece available online.Implant PlacementThe breast implant can be placed either on top of themuscle and under the breast glands (subglandular) orpartially under the pectoralis major muscle (submuscular).You should discuss with your surgeon the advantages anddisadvantages of each implant placement.Figure 6:Implant PlacementBreast beforeaugmentationBreast after subglandularaugmentationBreast after submuscularaugmentationImportant Factors
Incision SitesYou should discuss with your surgeon the pros and consfor the incision site specifically recommended for you.Breast augmentation with Responsive silicone implantsrequires a larger incision than saline implants. Breastaugmentation with SoftTouch silicone implants or HighlyCohesive silicone implants requires a larger incision thanResponsive silicone implants. There are 3 common incisionsites: around the nipple (periareolar), within the breast fold(inframammary), or under the arm (axillary or transaxillary).In reconstructive surgery, your surgeon will decide on theincision placement and length, largely based on the typeof cancer surgery you will receive. Most implants used forbreast reconstruction are placed through an incision at themastectomy scar, either during the mastectomy procedureor after tissue expansion.Figure 7:Incision SitesUnder arm(transaxillary)incisionIn breast fold(inframammary)incisionAround nipple(periareolar)incisionImportant Factors 13
Postoperative CareYou will probably feel somewhat tired and sore for severaldays following the operation, and your breasts may remainswollen and sensitive to physical contact for a month orlonger. You may also experience a feeling of tightness in thebreast area as your skin adjusts to your new breast size.The breasts and nipple area also may have less feelingduring this time of swelling and immediately after surgery.Other possible complications have been described above.Postoperative care depends on each patient’s situation andmay involve using a special postoperative bra, compressionbandage, or jog bra for extra support and positioning whileyou heal. Some surgeons may not want you to wear a braat all for a period of time following the surgery.At your surgeon’s recommendation, you will most likely beable to return to work within a few days. However, for atleast a couple of weeks you should avoid any strenuousactivities that could raise your pulse and blood pressure,or require strenuous use of your arms and chest.What if I experiencea problem?You will be given a device identification card with the styleand serial number of your breast implant(s). This card isyour permanent record and should be kept in a safe place.In the event you have a concern or problem with yourimplant you can use this card to describe the implant toyour health care provider or to Allergan.Important Factors
Where can I getadditional information?It is important that you read the entire patient labeling,entitled Breast Augmentation/Reconstruction with NATRELLE Silicone-Filled Breast Implants and NATRELLEINSPIRA Breast Implants, because you need tounderstand the risks and benefits and have realisticexpectations for your surgery. The patient labeling isavailable online at www.allerganlabeling.com, or apaper copy can be obtained by calling Allergan ProductSurveillance at 1.800.624.4261. Additional information isalso available on the FDA website athttp://www.fda.gov/breastimplants.What is Device Tracking?Breast implants are subject to Device Tracking by federalregulation. This means that your physician will be requiredto submit to Allergan the serial number of the implant(s)you receive, the date of surgery, information relating tothe physician’s practice and information on the patientreceiving the implant(s). You have the right to removeyour personal information from Allergan’s Device Trackingprogram. You also have the right to have your personalinformation withheld from disclosure to third parties whomay request information from Allergan, such as FDA.However, Allergan strongly recommends that all patientsreceiving NATRELLE Silicone-Filled Breast Implantsand NATRELLE INSPIRA Breast Implants participate inAllergan’s Device Tracking Program. This will help ensurethat Allergan has a record of each patient’s contactinformation so that all patients can be contacted in the caseof a recall or other problems with the implants. Please seeSection 6.2 Device Tracking of the online patient labelingfor more information on Device Tracking.Important Factors 15
Acknowledgement ofInformed Decision andPatient Decision ChecklistThe review and understanding of the patient informationdocuments is a critical step in deciding whether youshould choose breast implant surgery. You should learnabout breast implants and then carefully consider thebenefits and risks associated with breast implants andbreast implant surgery before you make your decision.At the end of the electronic patient labeling document(available at http://www.allerganlabeling.com), there is aform (Acknowledgement of Informed Decision and PatientDecision Checklist) that lists important risks, including thoseknown or reported to be associated with the use of thedevice, based on information from clinical trials, scientificliterature, and reports from patients who have undergonedevice placement.After reviewing the information in the patient informationdocuments, read and discuss the items in the PatientDecision Checklist carefully in consultation with yoursurgeon. Your surgeon can provide a copy for you to placeyour initials next to each item to indicate that you haveread and understood the item. Your full signature at theend of the document will confirm that you have read thematerials and that your surgeon has answered all questionsto your satisfaction. In order to formally record a successfulinformed decision process, the Acknowledgement ofInformed Decision and Patient Decision Checklistdocument (available separately and within the patientlabeling document at: www.allerganlabeling.com) shouldbe signed by both you and the surgeon. A copy should beprovided to you.Important Factors
2021 Allergan. All rights reserved.All trademarks are the property of their respective owners.3889-01rev03 11/2021Important Factors 17
GlossaryListed below is an abbreviated glossary of terms that youmay be unfamiliar with. A full glossary can be found onlinein the patient labeling.AsymmetryUneven appearance between a woman’s left and rightbreasts in terms of size, shape, or breast level.Breast Implant Associated Anaplastic large celllymphoma (BIA-ALCL)BIA-ALCL is not breast cancer; it is a rare type ofnon‑Hodgkin’s lymphoma, a cancer involving the cells ofthe immune system.Capsular contractureA tightening of the scar tissue (also called a capsule)that normally forms around the breast implant during thehealing process after surgery. In some women, the scartissue (capsule) squeezes the implant. When this occurs,it is called capsular contracture. This results in firmness orhardening of the breast and is a risk for implant rupture.Capsular contracture is classified by Baker Grades.Capsular Contracture Baker Grades III and IV are themost severe. Baker Grade III often results in the needfor additional surgery (reoperation) because of pain andpossibly abnormal appearance. Baker Grade IV usuallyresults in the need for additional surgery (reoperation)because of pain and unacceptable appearance. CapsularContracture Baker Grade II may also result in the need forsurgery. Each grade is described below. Baker Grade I – Normally soft and natural appearance Baker Grade II – A little firm, but breast looks normal Baker Grade III – More firm than normal, and may lookabnormal (change in shape) Baker Grade IV – Hard, obvious distortion, andtenderness with painImportant Factors
CapsuleScar tissue which forms around the breast implant.Delayed wound healingUnusually slow progress in the healing of a wound; surgicalincision site fails to heal normally or takes longer to heal.ExtrusionSkin breakdown with the implant pressing through the skinor surgical incision.HematomaA collection of blood within a space.InfectionThe growth in the human body of microorganisms suchas bacteria, viruses, or fungi. An infection usually resultsin fever, swelling, redness, and/or pain. It can occur as aresult of any surgery.MalpositionWhen the implant is placed incorrectly during the initialsurgery or when the implant has shifted from its originalposition. Shifting can be caused by many factors,such as gravity, trauma, poor initial placement, andcapsular contracture.NecrosisDeath of cells or tissues.PtosisSagging or drooping of the breast.RuptureA hole or tear in the shell of the implant that allows siliconegel filler material to leak from the shell. Ruptures can beintracapsular (inside the scar tissue capsule surroundingthe implant) or extracapsular (outside the scar tissuesurrounding the implant).SeromaSimilar to a bruise, a seroma occurs when the wateryportion of the blood collects around a surgical incision oraround a breast implant.Important Factors 19
2021 Allergan. All rights reserved.All trademarks are the property of their respective owners.3889-01rev03 11/2021
The following are warnings associated with NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants. There is a boxed warning for breast implants. Please see the cover page. Breast implants are not lifetime devices, and breas
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Round TruForm 1 Gel Breast Implants, and MemoryGel Breast Implants. These core clinical studies DID NOT include NATRELLE Inspira Round TruForm 1 Gel Breast Implants, NATRELLE 410 TruForm 2 Gel Breast Implants, or NATRELLE 510 Dual Gel Anatomical Breast Implants. Only clinical studies with 10 year data were considered.
Round TruForm 1 Gel Breast Implants, and MemoryGel Breast Implants. These core clinical studies DID NOT include NATRELLE Inspira Round TruForm 1 Gel Breast Implants, NATRELLE 410 TruForm 2 Gel Breast Implants, or NATRELLE 510 Dual Gel Anatomical Breast Implants. Only clinical studies with 10 year data were considered.
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Page 1 INTRODUCTION Directions to the Physician The information supplied in this Directions for Use document is intended to provide physicians an overview of essential information about NATRELLE Silicone-Filled Breast Implants and NATRELLE INSPIRA Breast Implants, including the indications for use, contraindications, warnings, precautions, important factors for a patient to consider .
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ACCOUNTING 0452/22 Paper 2 May/June 2019 1 hour 45 minutes Candidates answer on the Question Paper. No Additional Materials are required. READ THESE INSTRUCTIONS FIRST Write your Centre number, candidate number and name on all the work you hand in. Write in dark blue or black pen. You may use an HB pencil for any diagrams or graphs. Do not use staples, paper clips, glue or correction fluid. DO .
