Advances in Breast Augmentation and Breast ReconstructionPhysician-to-Physician Discussion Guide

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Breast Implant History and Evolution

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Historical Facts

Timeline

Silicone Moratorium

Implants Today

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

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We’ve come a long way since then……………..

Evolutionary Timeline of Silicone Implants

21st CenturyGeneration

Form Stable

in ClinicalTrials

90’s Fourth Generation

Refinements

Continue

80’s ThirdGeneration

Dry Shells

Cohesive Gels

Textured Shells

70’s SecondGeneration

Thin Shells

Thin GelsSaline

Implants

1962

First SiliconeBreast Implant

Silicone Implants removed from

U.S. Market

U.S. gel implant advancements

stall

FDA setsguidelines forU.S. trials to

study silicone implants

European gel implant

advancements continue withForm Stable

Implants

The Instituteof Medicine concluded:

“a review of the studies of

silicones andother substances

known to be in breast implants

does not providea basis for

health concerns”

FDA finds silicone breast implantsto be safe and

effective

Approve saleof silicone

implants outside clinical study to

certified surgeonsin U.S.

Moratorium Timeline

1992 1994 1999 2006

Shapes Round: Most commonly used for augmentation

Anatomical Shapes: Helps adjust breast shape

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

NATRELLE® Implant Collection

Offering more Styles and Sizes than any manufactureron the market today

• 8 Style Options8 Style Options• 5 Profiles5 Profiles• 143 Sizes143 Sizes

GelGel

• 7 Style Options7 Style Options• 6 Profiles6 Profiles• 103 Sizes103 Sizes

SalineSaline

Breast Augmentation

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Breast Augmentation Statistics

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• 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

The Procedure

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

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Breast Augmentation can be performed different ways

Placement of implant

Submuscular: Under the Pectoralis (chest) Muscle

Subglandular: Under the breast tissue, above the muscle

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Breast Before & After Implantation

The second recommendation the surgeon willmake is implant placement

Breast aftersubglandular augmentation

Breast aftersubmuscular augmentation

Breast beforeaugmentation

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.

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The final decision will be the type of implant

GelGel SalineSaline

Breast Reconstruction

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Breast Reconstruction

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Statistics

A Women’s Right

Options

Two Stage Reconstruction

Current Advancements

About Silicone Breast Implants

Autologous Reconstruction

Time Line for Procedures

Why?

Breast Cancer Statistics

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* American Cancer Society, Breast Cancer Facts & Figures 2009-2010: http://www.cancer.org/Research/CancerFactsFigures/BreastCancerFactsFigures/f861009-final-9-08-09-pdf

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)*

Breast Reconstruction Statistics

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• 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 procedureswere 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

A Woman’s Right

Under WHCRA, group health plans, insurance companies and health maintenance organizations (HMOs) offering mastectomy coverage mustalso provide coverage for reconstructive surgery…including any adjustments to the opposite breast to get symmetry

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The Woman’s Healthand Cancer Rights Act

of 1998(WHCRA)

A Woman’s Right that is protected by law!

Why Inform Patients of Breast Reconstruction?

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* Rowland, Julia H. “Psycological Impact of Treatments for Breast Cancer”, Surgery of the Breast, 2nd Edition, p. 382, 2006

The Treatment of Breast Cancer consists of 3 parts

PharmacologicalPhysiological 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.

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

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Reconstruction Options

All can be offered as Immediate or DelayedAdditional combinations: Expanders/Flaps/Implants

Alloplastic ProcedureSingle Stage: Using Expandable Implant or Implant alone

Two Stage Reconstruction: Using Expanders and ImplantsAutologous ProceduresTRAM flap: Tummy Tuck benefit

DIEP flap: Similar to TRAM, without using Rectus muscle

Latissimus Dorsi flap

Alloplastic…Expander and Implant

Utilizing a Tissue Expander followed by a Breast Implant

Two Stage Reconstruction

Image Courtesy of P. Cordeiro and NEJM, October 9, 2008

NATRELLE®

Two-Stage Reconstruction System

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

The Second Stage

For expander to implant exchange the Plastic Surgeon has many options to customize the final result

The NATRELLE® Implant Collection offers over200 gel and saline implant choices in various shapes and sizes

Operative Result

Two Stage Reconstruction

Pre-OperativePre-Operative Expansion CompleteExpansion Complete Post-op with ImplantPost-op with Implant

Recent Advancements in Two Stage

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

Photo courtesy of G. Patrick Maxwell, M.D., Nashville, TN

Skin Sparing/Nipple Sparing Mastectomiescan lead to a more natural looking result

The FDA imposesa moratorium onsilicone 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 implantssafe and effectiveand approves use outside of clinical

study for women 22 yrs & older in

augmentationand women of

any age in reconstruction.

What about the safety of Silicone Implants?

1992 1999 2006

Latissimus Dorsi Flap:Sometimes used with an expander& or a breast implant

TRAM Flap: Transverse Rectus AbdominusMusculocutaneous….aka“tummy tuck”reconstruction

DIEP Flap: Deep Inferior EpigastricPerforator…similar to aTRAM without the muscle

Autologous Options

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The TRAM and DIEP Flap

The TRAM Flap…1st performed in 1980

Can be performed as Immediate or Delayed

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

Timeline for Procedures

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 AreolaReconstruction is thenperformed…first by grafting,then tattooing for colorenhancement

Surgeons today have

offering women

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 Societyof Plastic Surgeons (ASPS) website@ www.plasticsurgery.org

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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.

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Important Natrelle® Safety Information Continued

 

 

 

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•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. 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 www.natrelle.com or call Allergan Product Support at 1-800-433-8871.  Caution: Rx only.

Thank You!

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