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Breast Implant History and Evolution

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Presentation on theme: "Breast Implant History and Evolution"— Presentation transcript:

1 Advances in Breast Augmentation and Breast Reconstruction Physician-to-Physician Discussion Guide

2 Breast Implant History and Evolution
Historical Facts Timeline Silicone Moratorium Implants Today

3 We’ve come a long way since then……………..
History and Evolution 100’s of years ago Ivory, Bone, Glass, Metal, Bone and Liquid Paraffin were reportedly used In the 1940’s women in Japan were injected with Liquid Silicone 1950’s saw the introduction of the Ivalon Sponge…found to harden and disfigure the breast We’ve come a long way since then……………..

4 Evolutionary Timeline of Silicone Implants
21st Century Generation Form Stable in Clinical Trials 90’s Fourth Generation Refinements Continue 80’s Third Generation Dry Shells Cohesive Gels Textured Shells 70’s Second Generation Thin Shells Thin Gels Saline Implants 1962 First Silicone Breast Implant

5 Moratorium Timeline 1992 1994 1999 2006 Silicone Implants removed from U.S. Market U.S. gel implant advancements stall FDA sets guidelines for U.S. trials to study silicone implants European gel implant advancements continue with Form Stable Implants The 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 effective Approve sale of silicone implants outside clinical study to certified surgeons in U.S.

6 Cut implant showing cohesiveness
Breast Implants Today Options Fills Cohesive Gel: Follows industry standards for cohesivity. Delivers a soft feel closest to breast tissue. Saline: Allows for small incision sizes & fill flexibility Cut implant showing cohesiveness Surface Smooth: Pliable elastomer Textured: Offers greater tissue adhesion for controlled placement Shapes Round: Most commonly used for augmentation Anatomical Shapes: Helps adjust breast shape

7 NATRELLE® Implant Collection
Offering more Styles and Sizes than any manufacturer on the market today 8 Style Options 5 Profiles 143 Sizes Gel 7 Style Options 6 Profiles 103 Sizes Saline

8 Breast Augmentation

9 Breast Augmentation Statistics
Breast Augmentation Surgery was the #1 cosmetic surgical procedure in 2010 Silicone gel-filled implants were used in 60% of all breast augmentations in 2010 Between 2000 and 2010, the number of breast augmentation procedures has increased 39% Over 296,203 Breast Augmentation procedures were performed in 2010!* *Report of the 2010 Plastic Surgery Statistis. Annual SASPS Procedural Statistics represent procedures performed by ASPS member surgeons certified by The American Board of Plastic Surgery® as well as other physicians certifi ed by American Board of Medical Specialties-recognized boards. ©ASPS, 2011

10 Breast Augmentation can be performed different ways
The Procedure Breast Augmentation can be performed different ways First recommendation the surgeon will make is the incision site Under the breast in the fold: Inframammary In the armpit: Transaxillary Around the nipple areola: Peri-Areola

11 The second recommendation the surgeon will make is implant placement
Placement of implant The second recommendation the surgeon will make is implant placement Submuscular: Under the Pectoralis (chest) Muscle Subglandular: Under the breast tissue, above the muscle Breast Before & After Implantation Breast after subglandular augmentation Breast after submuscular augmentation Breast before augmentation

12 The final decision will be the type of implant
Gel implants feel more like breast tissue. Available to women 22 years and older for augmentation Saline implants involve a smaller incision. Available to women 18 years and older for augmentation. Gel Saline

13 Breast Reconstruction

14 Breast Reconstruction
Statistics A Women’s Right Options Two Stage Reconstruction Current Advancements About Silicone Breast Implants Autologous Reconstruction Time Line for Procedures Why?

15 Breast 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 :

16 Breast Reconstruction Statistics
Breast Reconstruction Surgery was the #5 reconstruction procedure in 2010 Between 2000 and 2010, the number of breast reconstruction procedures has increased 18% Over 93,000 Breast Reconstruction procedures were performed in 2010!* *Report of the 2010 Plastic Surgery Statistis. Annual SASPS Procedural Statistics represent procedures performed by ASPS member surgeons certified by The American Board of Plastic Surgery® as well as other physicians certifi ed by American Board of Medical Specialties-recognized boards. ©ASPS, 2011

17 and Cancer Rights Act of 1998 (WHCRA)
A Woman’s Right The Woman’s Health and 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 symmetry A Woman’s Right that is protected by law!

18 Why Inform Patients of Breast Reconstruction?
The Treatment of Breast Cancer consists of 3 parts Physiological Pharmacological Psychosocial 76% 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

19 So, A Complete Treatment Plan Includes A Discussion of Reconstruction Options…

20 Reconstruction Options
Alloplastic Procedure Single Stage: Using Expandable Implant or Implant alone Two Stage Reconstruction: Using Expanders and Implants Autologous Procedures TRAM flap: Tummy Tuck benefit DIEP flap: Similar to TRAM, without using Rectus muscle Latissimus Dorsi flap Procedures 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 Delayed Additional combinations: Expanders/Flaps/Implants

21 Alloplastic…Expander and Implant
Two Stage Reconstruction Utilizing a Tissue Expander followed by a Breast Implant Image Courtesy of P. Cordeiro and NEJM, October 9, 2008

22 NATRELLE® Two-Stage Reconstruction System

23 The First Stage The expander is filled with saline over a few weeks and allowed to rest for a period of 4-6 months NATRELLE® Style 133 Series Expanders with patented BIOCELL® texturing have integral ports and come in 42 different sizes and profiles

24 The Second Stage For expander to implant exchange the Plastic Surgeon has many options to customize the final result The NATRELLE® Implant Collection offers over 200 gel and saline implant choices in various shapes and sizes

25 Two Stage Reconstruction
Operative Result Two Stage Reconstruction Pre-Operative Expansion Complete Post-op with Implant

26 Recent Advancements in Two Stage
Skin Sparing/Nipple Sparing Mastectomies can lead to a more natural looking result This 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 implants Surgeons 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

27 What about the safety of Silicone Implants?
1992 1999 2006 The FDA imposes a moratorium on silicone implants while awaiting extensive studies The Institute of Medicine of the National Academies finds that silicone breast implants do not show a basis for health concern After 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.

28 Autologous Options TRAM Flap: Transverse Rectus Abdominus Musculocutaneous…. aka“tummy tuck” reconstruction DIEP Flap: Deep Inferior Epigastric Perforator…similar to a TRAM without the muscle Latissimus Dorsi Flap: Sometimes used with an expander & or a breast implant

29 The TRAM and DIEP Flap The TRAM Flap…1st performed in 1980 Can be performed as Immediate or Delayed

30 Latissimus Flap The latissimus flap is used in a variety of ways:
1. With an expander, followed by an implant 2. With an implant 3. As a muscle flap alone

31 Timeline for Procedures
Expander & Implant Latissimus dorsi Flap Pedicle Tram Flap Average Operation Time 1-2 hours 2-4 hours 3-6 hours Average Hospital Stay 0-2 days 2-3 days 2-5 days Blood Transfusion Unlikely maybe Average Time to Resume Daily Activity 2-3 weeks 6-8 weeks Characteristics Uses an implant May or may not use an implant No implant No additional scars Scar on back Scar on abdomen Muscle strength not impaired May have persistent muscle weakness in shoulder May have persistent muscle weakness in abdomen

32 Additional Reconstruction Procedures
Surgery on the Contralateral Breast for symmetry may consist of: Mastopexy to lift the breast Reduction to reduce the breast Augmentation to enhance the breast Nipple and Areola Reconstruction is then performed…first by grafting, then tattooing for color enhancement

33 More Options Better Outcomes
Surgeons today have More Options offering women Better Outcomes Today…..110 years after the first reconstruction was performed, breast reconstruction results can effectively restore what disease has taken away.

34 Brochures and Information
“Choices in Reconstruction” Brochure Informs Patients of autologous and alloplastic reconstruction options Available from your Allergan Surgical Sales Representative Visit the American Society of Plastic Surgeons (ASPS) website @

35 Important 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. 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 their breast who have not received adequate treatment for those conditions. • Women who are currently pregnant or nursing. Warnings Every 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 the implant during surgical insertion. • Care should be taken when using surgical instruments in proximity with the breast implant, including scalpel, sutures, and dissection instrumentation. .

36 Important 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 implant Do 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. Precautions Safety 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 events The 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 at Caution: Rx only.

37 Thank You! ©2010 Allergan, Inc. All rights reserved. ® and ™ marks owned by Allergan, Inc. APC44QJ12


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