Presentation on theme: "Breast Implant History and Evolution"— Presentation transcript:
1Advances in Breast Augmentation and Breast Reconstruction Physician-to-Physician Discussion Guide
2Breast Implant History and Evolution Historical FactsTimelineSilicone MoratoriumImplants Today
3We’ve come a long way since then…………….. History and Evolution100’s of years ago Ivory, Bone, Glass, Metal, Bone and Liquid Paraffin were reportedly usedIn the 1940’s women in Japan were injected with Liquid Silicone1950’s saw the introduction of the Ivalon Sponge…found to harden and disfigure the breastWe’ve come a long way since then……………..
5Moratorium Timeline1992199419992006Silicone Implants removed from U.S. MarketU.S. gel implant advancements stallFDA sets guidelines for U.S. trials to study silicone implantsEuropean gel implant advancements continue with Form Stable ImplantsThe Institute of Medicine concluded: “a review of the studies of silicones and other substances known to be in breast implants does not provide a basis for health concerns”FDA finds silicone breast implants to be safe and effectiveApprove sale of silicone implants outside clinical study to certified surgeons in U.S.
6Cut implant showing cohesiveness Breast Implants TodayOptionsFillsCohesive Gel: Follows industry standards for cohesivity. Delivers a soft feel closest to breast tissue.Saline: Allows for small incision sizes & fill flexibilityCut implant showing cohesivenessSurfaceSmooth: Pliable elastomerTextured: Offers greater tissue adhesion for controlled placementShapesRound: Most commonly used for augmentationAnatomical Shapes: Helps adjust breast shape
7NATRELLE® Implant Collection Offering more Styles and Sizes than any manufacturer on the market today8 Style Options5 Profiles143 SizesGel7 Style Options6 Profiles103 SizesSaline
10Breast Augmentation can be performed different ways The ProcedureBreast Augmentation can be performed different waysFirst recommendation the surgeon will make is the incision siteUnder the breast in the fold: InframammaryIn the armpit: TransaxillaryAround the nipple areola: Peri-Areola
11The second recommendation the surgeon will make is implant placement Placement of implantThe second recommendation the surgeon will make is implant placementSubmuscular: Under the Pectoralis (chest) Muscle Subglandular: Under the breast tissue, above the muscleBreast Before & After ImplantationBreast after subglandular augmentationBreast after submuscular augmentationBreast before augmentation
12The final decision will be the type of implant Gel implants feel more like breast tissue. Available to women 22 years and older for augmentationSaline implants involve a smaller incision. Available to women 18 years and older for augmentation.GelSaline
14Breast Reconstruction StatisticsA Women’s RightOptionsTwo Stage ReconstructionCurrent AdvancementsAbout Silicone Breast ImplantsAutologous ReconstructionTime Line for ProceduresWhy?
15Breast Cancer Statistics Breast cancer accounts for 1 in every 4 cancers diagnosed in U.S. women*192,370 women were diagnosed with invasive breast cancer in 2009*Women with BRCA1 gene mutations are 57% likely to develop the cancer by age 70 (49% likely for BRCA2)** American Cancer Society, Breast Cancer Facts & Figures :
17and Cancer Rights Act of 1998 (WHCRA) A Woman’s RightThe Woman’s Healthand Cancer Rights Act of 1998 (WHCRA)Under WHCRA, group health plans, insurance companies and health maintenance organizations (HMOs) offering mastectomy coverage must also provide coverage for reconstructive surgery…including any adjustments to the opposite breast to get symmetryA Woman’s Right that is protected by law!
18Why Inform Patients of Breast Reconstruction? The Treatment of Breast Cancer consists of 3 partsPhysiologicalPharmacologicalPsychosocial76% of women receiving implants reported that reconstruction was important in helping them cope with cancer.*Breast Reconstruction is a woman’s right under the law and women should be informed of their options early in the treatment process.* Rowland, Julia H. “Psycological Impact of Treatments for Breast Cancer”, Surgery of the Breast, 2nd Edition, p. 382, 2006
19So, A Complete Treatment Plan Includes A Discussion of Reconstruction Options…
20Reconstruction Options Alloplastic ProcedureSingle Stage: Using Expandable Implant or Implant aloneTwo Stage Reconstruction: Using Expanders and ImplantsAutologous ProceduresTRAM flap: Tummy Tuck benefitDIEP flap: Similar to TRAM, without using Rectus muscleLatissimus Dorsi flapProcedures today are performed both immediate and delayed. Some strictly with an expander and an implant….some using Autologous tissue alone, some using Autologous tissue, expander and implant….some using Autologous tissue and an implant.All can be offered as Immediate or DelayedAdditional combinations: Expanders/Flaps/Implants
21Alloplastic…Expander and Implant Two Stage ReconstructionUtilizing a Tissue Expander followed by a Breast ImplantImage Courtesy of P. Cordeiro and NEJM, October 9, 2008
23The First StageThe expander is filled with saline over a few weeks and allowed to rest for a period of 4-6 monthsNATRELLE® Style 133 Series Expanders with patented BIOCELL® texturing have integral ports and come in 42 different sizes and profiles
24The Second StageFor expander to implant exchange the Plastic Surgeon has many options to customize the final resultThe NATRELLE® Implant Collection offers over 200 gel and saline implant choices in various shapes and sizes
25Two Stage Reconstruction Operative ResultTwo Stage ReconstructionPre-OperativeExpansion CompletePost-op with Implant
26Recent Advancements in Two Stage Skin Sparing/Nipple Sparing Mastectomies can lead to a more natural looking resultThis patient had a bilateral Skin and Nipple Sparing Mastectomy followed by bilateral 133V Tissue Expanders. Photo shows immediate post-op result after exchange to breast implantsSurgeons today are working closely with their General Surgeons to perform complete subcutaneous mastectomies…allowing for a more natural result.Photo courtesy of G. Patrick Maxwell, M.D., Nashville, TN
27What about the safety of Silicone Implants? 199219992006The FDA imposes a moratorium on silicone implants while awaiting extensive studiesThe Institute of Medicine of the National Academies finds that silicone breast implants do not show a basis for health concernAfter extensive study the FDA finds silicone implants safe and effective and approves use outside of clinical study for women 22 yrs & older in augmentation and women of any age in reconstruction.
28Autologous OptionsTRAM Flap: Transverse Rectus Abdominus Musculocutaneous…. aka“tummy tuck” reconstructionDIEP Flap: Deep Inferior Epigastric Perforator…similar to a TRAM without the muscleLatissimus Dorsi Flap: Sometimes used with an expander & or a breast implant
29The TRAM and DIEP FlapThe TRAM Flap…1st performed in 1980 Can be performed as Immediate or Delayed
30Latissimus Flap The latissimus flap is used in a variety of ways: 1. With an expander, followed by an implant2. With an implant3. As a muscle flap alone
31Timeline for Procedures Expander & ImplantLatissimus dorsi FlapPedicle Tram FlapAverage Operation Time1-2 hours2-4 hours3-6 hoursAverage Hospital Stay0-2 days2-3 days2-5 daysBlood TransfusionUnlikelymaybeAverage Time to Resume Daily Activity2-3 weeks6-8 weeksCharacteristicsUses an implantMay or may not use an implantNo implantNo additional scarsScar on backScar on abdomenMuscle strength not impairedMay have persistent muscle weakness in shoulderMay have persistent muscle weakness in abdomen
32Additional Reconstruction Procedures Surgery on the Contralateral Breast for symmetry may consist of:Mastopexy to lift the breastReduction to reduce the breastAugmentation to enhance the breastNipple and Areola Reconstruction is then performed…first by grafting, then tattooing for color enhancement
33More Options Better Outcomes Surgeons today haveMore Optionsoffering womenBetter OutcomesToday…..110 years after the first reconstruction was performed, breast reconstruction results can effectively restore what disease has taken away.
34Brochures and Information “Choices in Reconstruction” BrochureInforms Patients of autologous and alloplastic reconstruction optionsAvailable from your Allergan Surgical Sales RepresentativeVisit the American Society of Plastic Surgeons (ASPS) website @
35Important Natrelle® Safety Information Indications:• Breast Augmentation. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.• Breast Reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.NOTE: the FDA has determined that patients seeking breast augmentation with silicone-filled implants must be at least 22 years of age. Patients seeking breast augmentation with saline implants must be at least 18 years of age. There is no age restriction for reconstruction patients with either implant type.ContraindicationsBreast implant surgery should NOT be performed in:• Women with active infection anywhere in their body.• Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.• Women who are currently pregnant or nursing.WarningsEvery effort should be made to avoid damage to the breast implants during surgery.• Care should be taken to avoid the use of excessive force and to minimize handling of theimplant during surgical insertion.• Care should be taken when using surgical instruments in proximity with the breastimplant, including scalpel, sutures, and dissection instrumentation..
36Important Natrelle® Safety Information Continued Use care in subsequent procedures such as open capsulotomy, breast pocket revision,hematoma/seroma aspiration, and biopsy/lumpectomy to avoid damage to the implantDo not contact the implant with disposable, capacitor-type cautery devices.Do not alter the implants or attempt to repair or insert a damaged prosthesis.Do not immerse the implant in Betadine solution.Do not re-use or resterilize any product that has been previously implanted. Breast implants are intended for single use only.Do not place more than one implant per breast pocket.Do not use the periumbilical approach to place the implant.Do not use microwave diathermy in patients with breast implants, as it has been reported to case tissue necrosis, skin erosion, and implant extrusion.PrecautionsSafety and effectiveness have not been established in patients with the following:• Autoimmune diseases (for example, lupus and scleroderma)• A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease)• Conditions that interfere with wound healing and blood clotting• Reduced blood supply to breast tissue• Radiation to the breast following implantation• Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery.Adverse eventsThe most commonly reported adverse events for Natrelle® Silicone Filled Breast Implants are: reoperation, implant removal with replacement, grade III/IV capsular contracture, implant malposition, and asymmetry, The most commonly reported adverse events for Natrelle® Saline Filled Breast Implants are: reoperation, grade III/IV capsular contracture, implant removal, and implant deflation.Other potential complications include: rupture, unsatisfactory results, pain, changes in nipple sensation, infection, hematoma/seroma, breastfeeding difficulties, calcium deposits in tissue around the implant, necrosis, delayed wound healing, chest wall deformity, and lymphadenopathy.Important: For full safety information please visit or call Allergan Product Support atCaution: Rx only.