Only Natrelle does gummy like this - Bridges to Beauty · Natrelle INSPIRA® Soft Touch Natrelle INSPIRA® A shell that protects Safety matters—from the outside in. The cohesive

Artistry becomes reality with the most complete portfolio of cohesive gel breast implants.2-4

Only Natrelle® does gummy like this

Please see inside for Indications and Important Safety Information.

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Three cohesivities. Countless possibilities.1,**Over 700 breast implant options.

Art. Science.

The implant you select is critical Designed for the shape you envisionWith the Natrelle ® Cohesive Collection, you can shape the breasts of patients based on their varying levels of available tissue coverage.

Your artistic vision relies on your ability to shape the breasts. Make your vision a reality with Natrelle ®.

The right implant can provide the upper pole fullness and contouring needed based on the desired breast shape. The amount of upper pole fullness and contouring your patient needs depends on available tissue. The amount of upper pole fullness and contouring an implant has depends on its cohesivity.

No two women are alike—from the amount of tissue they have to their breast-shaping needs.

Three cohesivities. Countless possibilities.1,*Natrelle ® offers the widest range of cohesivities for every breast, patient type, and aesthetic vision—

whether it’s a reconstruction, revision, or augmentation.5

Natrelle® Breast Implants Important InformationINDICATIONSNatrelle ® Breast Implants are indicated for women for the following:• Breast augmentation for women at least 22 years old for silicone-filled implants.

Breast augmentation for women at least 18 years old for saline-filled implants. Breast augmentation includes primary breast augmentation to increase 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.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONSBreast implant surgery should not be performed in:• Women with active infection anywhere in their body.• Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions.• Women who are currently pregnant or nursing.

Please see additional Natrelle ® Breast Implants Important Safety Information on following pages.

Natrelle INSPIRA® Soft Touch

Natrelle INSPIRA® Cohesive Natrelle® 410Natrelle INSPIRA®

55% more cohesivethan level 15,†

No breast tissuePotential reconstruction

Ample breast tissue/Needs shapingPotential augmentation

Three unique silicone gels feature cross-linking technology for 3 distinct cohesivities.

Highly cohesiveCohesiveCohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

*Over 700 breast implant options. † Methodology Breast implant gel was measured for material properties using the BTC-2000 ™. The BTC-2000 ™ applies a controlled vacuum, or negative pressure, to the gel while measuring the dynamic response of material deformation using a synchronized target laser. The gel for each device (n = 8 per group) was tested at 3 sites, all at or near the apex of the implant (anterior side). From those measurements, the gel cohesivity was calculated and the relative change was determined.

M. Duran M. Duran M. Duran M. Duran

Art. Science.

32

Value of Cohesivity

Designed to maintain upper pole fullness*

All Natrelle INSPIRA® Breast Implants are designed for upper pole fullness. How well that fullness is maintained when held upright depends on the implant’s cohesivity.

In vivo significance has not been established.

Natrelle ® Gel Breast Implants maintained upper pole fullness.6,†

Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION (continued) WARNINGS• Breast implants are not lifetime devices or necessarily a one-time surgery.• Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant.

Use care when using surgical instruments in proximity with the breast implant. For more information, please see the full Directions for Use.

PRECAUTIONSSafety and effectiveness have not been established in patients with the following:• Autoimmune diseases (eg, lupus and scleroderma).• A compromised immune system (eg, currently receiving immunosuppressive therapy).• Planned chemotherapy following breast implant placement.• Planned radiation therapy to the breast following breast implant placement.• Conditions or medications 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. Please

discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

† Methodology Breast implant devices (n = 6 per group) were placed in a horizontal orientation on a sliding stage; the width and maximum projections of the implants were measured using fixed calipers. The devices were then placed in a vertical-supported orientation using a 90º angle, and the width and maximum projections were measured again. From those measurements, the retention of dimension was calculated and the relative change was determined.

Images for visual representation only. In vivo significance has not been established.

*Based on implant performance testing. Clinical significance has not been established.

† Methodology Breast implant devices (n = 6 per group) were placed in a horizontal orientation on a sliding stage; the height of the implants was measured using fixed calipers. The devices were then placed in a vertical-supported orientation using a 90º angle, and the height was measured again. From those measurements, the retention of dimension was calculated and the relative change was determined.

Natrelle INSPIRA® Soft Touch

Natrelle INSPIRA® Cohesive

Natrelle INSPIRA®

84% upper pole retention6,*

91% upper pole retention6,*

97%upper poleretention6,*

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Designed for contouring that lasts*

Cohesivity determines how well an implant keeps its overall shape. An implant with highly cohesive gel will hold its contour more than an implant with responsive gel.6,†

Take creative control with 3 levels of cohesivity.

Natrelle INSPIRA® Cohesive and Natrelle® 410 feature the same highly cohesive gel.

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

ADVERSE EVENTSKey adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV.

Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling.

For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.Natrelle ® Breast Implants are available by prescription only.

Natrelle INSPIRA® Natrelle INSPIRA®

Soft TouchNatrelle INSPIRA®

CohesiveNatrelle ® 410

*Based on implant performance testing. Clinical significance has not been established.

54

Uppe

r Pol

e Fu

llnes

s &

Cont

ourin

gUpper Pole Fullness & Contouring

Natrelle INSPIRA® Soft Touch

Natrelle INSPIRA®

A shell that protectsSafety matters—from the outside in. The cohesive gel in Natrelle ® Gel breast implants is surrounded by a patented shell technology and a unique barrier layer.7

INTRASHIEL™ barrier shell technology minimizes diffusion through the silicone elastomer shell.7

High-performance silicone elastomer layers

Barrier layer

Cohesive gel fill

Natrelle ® 133Plus and 133 Tissue Expanders With/Without Suture Tabs and With MAGNA-SITE® Injection Sites Important Information INDICATIONSNatrelle ® 133Plus and 133 Tissue Expanders are indicated for: • Breast reconstruction following mastectomy.• Treatment of underdeveloped breasts. • Treatment of soft tissue deformities.

Natrelle ® knows safety is important—that’s why Allergan has been evaluating the long-term safety and effectiveness of Natrelle ® silicone-filled breast implants in patients since 1999.7

A gel that staysCohesive gel in all Natrelle ® Gel breast implants is designed to hold together.

When Natrelle ® Gel implants are cut ex vivo and compressed, the gel moves back into the shell.

Images for visual representation only. In vivo significance has not been established.

During vice compression

During vice compression

After vice compression

After vice compression

During vice compression After vice compression

Natrelle INSPIRA® Cohesive

extracapsular gel migration in round gel breast implants (N = 715)7

7.7%

< 1%

rupture rate at 10 years in round gel breast implants (n = 264)7

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

In vivo significance has not been established.

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNatrelle ® 133Plus and 133 Tissue Expanders SHOULD NOT be used in patients: • Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices, artificial

sensing devices).• Whose tissue at the expansion site is determined to be unsuitable.

Please see Natrelle ® 133Plus and 133 Tissue Expanders additional Important Safety Information on following pages.

76

Shel

l & G

el S

afet

yShell & Gel Safety

A more cohesive implant—what reconstruction patients may need

Natrelle ® 410 with highly cohesive gel has low wrinkling/rippling rates: 6.2% in primary reconstruction patients through 10 years (n = 225).8

Natrelle ® 133Plus and 133 Tissue Expanders IMPORTANT SAFETY INFORMATION (continued)CONTRAINDICATIONS (continued)• Who have an active infection or a residual gross tumor at the expansion site.• Undergoing adjuvant radiation therapy.• Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension,

chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications.

• Who are psychologically unsuitable.

WARNINGS• DO NOT use Natrelle ® 133Plus and 133 Tissue Expanders in patients who already have implanted devices that would be affected by

a magnetic field (see Contraindications), because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle ® 133Plus and 133 Tissue Expanders in place.

Please see additional Natrelle ® 133Plus and 133 Tissue Expanders Important Safety Information on following pages.

Primary Reconstruction With Natrelle ® 410Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

Revision Reconstruction With Natrelle INSPIRA® CohesiveCohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

“This patient came to me for a revision reconstruction and had very visible wrinkling/rippling. I could not have achieved these results without a more cohesive breast implant.”

Dr Alex N. Mesbahi

Implant selected: Natrelle INSPIRA® Cohesive Style TCM-405 Implant dimensions: 405 cc volume, 13.25 cm diameter, 4.4 cm projection

Photos provided by Dr Alex N. Mesbahi. Individual results may vary.

BEFORE AFTER

Now, the highly cohesive gel of Natrelle® 410 is available in a round gel.

Primary Reconstruction With Natrelle INSPIRA® CohesiveCohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

“My patient needed an implant designed for upper pole fullness—Natrelle INSPIRA® Cohesive delivered.” Dr Mark L. Venturi

Implant selected: Natrelle INSPIRA® Cohesive Style SCF-560Implant dimensions: 560 cc volume, 13.50 cm diameter, 5.7 cm projection

Photos provided by Dr Mark L. Venturi. Individual results may vary.

BEFORE AFTER

BEFORE 3 YEARS1 YEAR 7 YEARS

“My patient is happy with her look—and that’s after 7 years. The highly cohesive gel in Natrelle® 410 makes a difference.”

Dr Patricia McGuire

Implant selected: Natrelle ® 410 Style FF Implant dimensions: 475 cc volume, 13.5 cm base width, 14.0 cm height, 5.3 cm projection

Photos provided by Dr Patricia McGuire. Individual results may vary.

Art. Science.

98

Resu

lts T

hat L

ast

Results That Last

Look and feel—what augmentation patients say they want most9,*

Natrelle ® 133Plus and 133 Tissue Expanders IMPORTANT SAFETY INFORMATION (continued)WARNINGS (continued)• DO NOT alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE.

DO NOT expose to contaminants.• DO NOT expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance.

Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed.• Active infection anywhere may increase risk of periprosthetic infection. Postoperative infections should be treated aggressively.

Unresponsive or necrotizing infection may require premature removal.

WARNINGS (continued)• Natrelle ® 133Plus and 133 Tissue Expanders are temporary, single-use only devices, and are not to be used for permanent implantation

or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months.• When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs.

Please see additional Natrelle ® 133Plus and 133 Tissue Expanders Important Safety Information on back.

96% of primary augmentation patients were satisfied through 10 years with Natrelle ® 410 (n = 292).8

“I wanted to look like me—just with more volume.”Patient

BEFORE 10 YEARS

Implant selected: Natrelle ® 410 Style FM-395 Implant dimensions: 395 cc volume, 13.0 cm base width, 13.5 cm height, 4.8 cm projection

Photos provided by Dr Bradley P. Bengtson. Individual results may vary.

Primary Augmentation With Natrelle ® 410Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

“My breasts looked deflated after having kids. Now they have a full, contoured look that I love.”Patient

Implant selected: Natrelle INSPIRA® Cohesive Style SCM-310 Implant dimensions: 310 cc volume, 12.00 cm diameter, 4.0 cm projection

Photos provided by Dr Allen Gabriel. Individual results may vary.

Augmentation With Natrelle INSPIRA® Cohesive

BEFORE AFTER

“I wanted fullness—especially at the top of my breasts. I’m so happy with my results.”Patient

Implant selected: Natrelle INSPIRA® Soft Touch Style TSM-345 Implant dimensions: 345 cc volume, 12.50 cm diameter, 4.2 cm projection

Photos provided by Dr Charles Randquist. Individual results may vary.

Primary Augmentation With Natrelle INSPIRA® Soft TouchCohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

*N = 300.

AFTER

Cohe

sivity Level

Cohe

sivity Level

Cohe

sivity Level

1 2 3

BEFORE

Art. Science.

1110

Resu

lts T

hat L

ast

Shaping the future with youNatrelle® is the #1 plastic surgery portfolio.10,11,*,†

© 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Natrelle.com NAT106165 03/17 163956

References: 1. Data on file, Allergan, January 2017; Allergan Plastic Surgery Order Form. 2. More of Everything: Natrelle ® Product Catalog. Irvine, CA: Allergan; 2015. 3. Our products: breast implants. Mentor Worldwide LLC website. http://www.mentorwwllc.com /global-us/Breast.aspx. Updated April 2016. Accessed February 13, 2017. 4. Sientra ® HSC & HSC+ Breast Implant Product Catalog. Santa Barbara, CA: Sientra, Inc., 2015. http://sientra.com/Content/pdfs/MDC-0177%20R2%20HSCHSC%2B%20Breast%20Implants%20Product%20Catalog.pdf. Accessed February 13, 2017. 5. Data on file, Allergan, February 8, 2017; Study Report MD16075-DV2. 6. Data on file, Allergan, February 3, 2017; Study Report MD16075-DV1. 7. Natrelle ® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2016. 8. Natrelle ® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Directions for Use, 2014. 9. Data on file, Allergan, March 2016; Plastic Surgery A&Us: PLS and Patients. 10. Data on file, Allergan, December 2016; Plastic Surgery Monthly Tracker: Breast Implants & Tissue Expanders. 11. Data on file, Allergan, November 2016; Breast Implant + Tissue Expander Share Tracker. 12. Kline & Company, Inc. Professional Skin Care: US Market Analysis and Opportunities. Parsippany, NJ: Kline & Company, Inc.; January 19, 2017. 13. Data on file, Allergan, 2016; EAME Brand Share. 14. Data on file, Allergan, February 2016; US Neurotoxin Market Share Report.

Natrelle ® 133Plus and 133 Tissue Expanders IMPORTANT SAFETY INFORMATION (continued)PRECAUTIONSActive infections may need to be treated and resolved before surgery. Allergan relies on the surgeon to know and follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.

ADVERSE REACTIONSDeflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.

For more information, please visit www.allergan.com/labeling/usa.htm. To report a problem with Natrelle ®, please call Allergan at 1-800-433-8871.Natrelle ® 133Plus and 133 Tissue Expanders are available by prescription only.

From Allergan—the leader in medical aesthetics12-14

Natrelle INSPIRA® Collection #1 selected round gel implant collection in the US.10,*

Natrelle® 410#1 selected anatomical implant in the US.11,†

Natrelle ® 133 Series#1 selected tissue expander in the US.11,†

Natrelle INSPIRA® CohesiveMost cohesive round gel breast implant in the US.5

*Based on surgeon survey data, December 2016 (N = 100).†Based on US market share data through November 2016 (N = 67).

Art. Science.