RHIS 2021 Exhibitor Flipbook by TEAM

Exhibitor Flipbook

We listened to what matters to you...that’s why we offer the

DIFFERENCE 3 cohesivities. 5 profiles. 300 options.1,* HIGH FILL RATE

100% gel fill rate †

*†

2,3, ,

Per predefined product specification criteria.

HIGH PROJECTION

Up to

UPPER POLE RETENTION

97% Natrelle INSPIRA® Cohesive * 91% Natrelle INSPIRA® SoftTouch *

6.7 cm * 1,

4, ,‡,§ 4, ,‡,§

‡

In vivo significance has not been established.

10 YEARS of proven data2 LOW RUPTURE RATE

7.7% at 10 years

HIGH PATIENT SATISFACTION

94% for augmentation at 10 years 91% for reconstruction at 10 years

2,||,¶

Combined MRI cohort only (n = 264).

2,§

Primary augmentation cohort (n = 279), primary reconstruction cohort (n = 43).

Natrelle® offers the most comprehensive smooth implant portfolio.1,5,6 *Natrelle INSPIRA® Collection. § 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 90° 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. || The Allergan® core study MRI cohort included women who received implants for breast augmentation, revision augmentation, reconstruction, and revision reconstruction (n = 264) through 10 years. ¶ Kaplan-Meier risks rates for key complications in the Allergan® core study through 10 years for the primary augmentation cohort (n = 455) included reoperation (36.1%); implant removal (20.9%); capsular contracture III/IV (18.9%); non-MRI cohort implant rupture (13.7%); and MRI cohort implant rupture (9.3%); and for the primary reconstruction cohort (n = 98) included reoperation (71.5%); implant removal (53.5%); MRI cohort implant rupture (35.4%); capsular contracture III/IV (24.6%); and asymmetry (23.2%). # Patient satisfaction based on primary augmentation patients using round implants (n = 279, 86% definitely satisfied and 8% somewhat satisfied) and primary reconstruction patients using round implants (n = 43, 67.4% definitely satisfied and 23.3% somewhat satisfied).

Natrelle ® Breast Implants Important Information INDICATIONS Natrelle ® 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 CONTRAINDICATIONS Breast 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. 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. Please see additional Important Safety Information on back.

The desired smooth look your PATIENTS WANT

19%

61%

11%

Fullest look with a very rounded look on top

Fuller look with more roundness on top

Full look with slight roundness on top

Very little fullness on top

30%

40%

14%

17%

of prospective AUGMENTATION patients surveyed preferred this look7,*

of prospective RECONSTRUCTION patients surveyed preferred this look8,† *Based on a survey of 141 prospective breast augmentation patients. † Based on a survey of 125 prospective breast reconstruction patients.

Visit NatrelleSurgeon.com to learn more. @NatrelleBreastReconstruction @NatrelleBreastAugmentation

IMPORTANT SAFETY INFORMATION (continued) PRECAUTIONS Safety 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.

ADVERSE EVENTS Key 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 /products. To report a problem with Natrelle ® Breast Implants, please call Allergan at 1-800-433-8871. Natrelle ® Breast Implants are available by prescription only.

References: 1. Data on file, Allergan, January 2020. 2. Natrelle ® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2017. 3. Data on file, Allergan. 4. Data on file, Allergan, February 2017. 5. Mentor ® Product Catalog: Tissue Expanders, Breast Implants and Sizers, January 2020. 6. Sientra ® Round Breast Implant Product Catalog, July 2019. 7. Data on file, Allergan, October 2017. 8. Data on file, Allergan, May 2018. NATRELLE ® and its design are trademarks of Allergan, Inc., an AbbVie company. All other trademarks are the property of their respective owners. © 2020 AbbVie. All rights reserved. Natrelle.com NAT141348 11/20 008132

A reliable alternative to permanent mesh With rapid tissue ingrowth and long-lasting strength, bioresorbable Phasix™ Mesh provides a strong, reliable repair when patients need it most. 1

Composed of biologically-derived 1 material, poly-4-hydroxybutyrate (P4HB) Organized and functional collagen 1 at the repair site 3x the strength of the native 1 abdominal wall at 52 weeks

Backed by 5-year data In a longitudinal 5-year follow up of 73 complex abdominal wall reconstruction patients, Phasix™ Mesh demonstrated lower recurrence, SSI and complication rates compared to Strattice™ Tissue Matrix.3

Improved healing from the start Predictable strength for the long run. Phasix™ Mesh provides critical strength during the initial healing phase with rapid tissue ingrowth and vascularization through its open-pore monofilament structure, then gradually and predictably degrades within 12 to 18 months leaving behind a durable, functional repair.1 Clinically proven long-term outcomes3 Phasix™ Mesh

Strattice™ Tissue Matrix

Total recurrence

12.9%

38.1%

Postoperative infections

12.9%

31.0%

Complications

19.4%

45.0%

$10,595 cost savings associated with Phasix™ Mesh compared to Strattice™ Tissue Matrix3

Committed partner. Full portfolio. Proven outcomes. As the category leader for hernia repair and bioresorbable mesh, BD is committed to providing an innovative hernia portfolio that focuses on improving clinical outcomes for better patient care.

1190808

1/cs

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3" x 3" (8 cm x 8 cm)

1190616

1/cs

Rectangle

2.4" x 6.3" (6 cm x 16 cm)

1/cs Rectangle 1190816Over 153,000

implants

3" x 6.3" (8 cm xMore 16 cm)than 950

patients studied2

1190820

1/cs

Rectangle

3" x 8" (8 cm x 20 cm)

1191010

1/cs

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4" x 4" (10 cm x 10 cm)

1/cs 10 Rectangle 1190200More than

clinical studies

clinical 4" x 6" (10.2 cm Proven x 15.2 cm) outcomes2

1191020

1/cs

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4" x 8" (10 cm x 20 cm)

1191025

1/cs

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4" x 10" (10 cm x 25 cm)

1190300

1/cs

Rectangle

6" x 8" (15.2 cm x 20.3 cm)

PhasixTM Mesh

1191525

1/cs

Rectangle

6" x 10" (15 cm x 25 cm)

Ventral hernias; Onlay, retrorectus, or preperitoneal placement

1192020

1/cs

Square

8" x 8" (20 cm x 20 cm)

Product code Qty.

Shape

Dimensions

1191530

1/cs

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6" x 12" (15 cm x 30 cm)

1190100

1/cs

Round

3" (7.6 cm)

1190400

1/cs

Rectangle

8" x 10" (20.3 cm x 25.4 cm)

1190011

1/cs

Round

4.5" (11 cm)

1192030

1/cs

Rectangle

8" x 12" (20 cm x 30 cm)

1190808

1/cs

Square

3" x 3" (8 cm x 8 cm)

1192040

1/cs

Rectangle

8" x 16" (20 cm x 40 cm)

1190616

1/cs

Rectangle

2.4" x 6.3" (6 cm x 16 cm)

1190500

1/cs

Rectangle

10" x 12" (25.4 cm x 30.5 cm)

1190816

1/cs

Rectangle

3" x 6.3" (8 cm x 16 cm)

1193030

1/cs

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12" x 12" (30 cm x 30 cm)

1190820

1/cs

Rectangle

3" x 8" (8 cm x 20 cm)

1192540

1/cs

Rectangle

10" x 16" (25 cm x 40 cm)

1191010

1/cs

Square

4" x 4" (10 cm x 10 cm)

1193045

1/cs

Rectangle

12" x 18" (30 cm x 45 cm)

1190200

1/cs

Rectangle

4" x 6" (10.2 cm x 15.2 cm)

1193535

1/cs

Square

14" x 14" (35 cm x 35 cm)

1191020

1/cs

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4" x 8" (10 cm x 20 cm)

1194040

1/cs

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16" x 16" (40 cm x 40 cm)

1191025

1/cs

Rectangle

4" x 10" (10 cm x 25 cm)

1194545

1/cs

Square

18" x 18" (45 cm x 45 cm)

1190300

1/cs

Rectangle

6" x 8" (15.2 cm x 20.3 cm)

1195050

1/cs

Square

19.5" x 19.5" (50 cm x 50 cm)

1191525 1/cs Rectangle 6" x 10" (15 cm x 25 cm) References 1. Data on file. Preclinical results may not correlate to clinical performance. 2. Publications available upon request. 3. Buell JF, Flaris AN, Raju S, Hauch A, Darden M, Parker GG. Long-term outcomes in complex abdominal wall reconstruction repaired with absorbable biologic polymer scaffold (Poly-4-Hydroxybutyrate). Annals of Surgery Open. 2021;2(1). doi:10.1097/ as9.0000000000000032. 4. Data on file at BD. Phasix™ Mesh, 1192020 1/cs Square 8" x 8" (20Phasix™ cm x ST 20Mesh, cm)Phasix™ Plug, Phasix™ ST Mesh with Open Positioning System and Phasix™ ST Mesh with Echo 2™ Positioning System. Indications Phasix™ Mesh is indicated to reinforce soft tissue, where weakness exists in patients 1191530plastic and1/cs Rectangle x 12" (15 cm x 30involving cm) soft tissue undergoing reconstructive surgery, 6" or for use in procedures repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

1190400

1/cs

Rectangle

8" x 10" (20.3 cm x 25.4 cm)

Contraindications Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required. 1192030 1/cs Rectangle 8" x 12" (20 cm x 30 cm) Warnings 1. Phasix™ Mesh must not be put in direct contact with bowel or viscera.

1192040

1/cs

Rectangle

8" x 16" (20 cm x 40 cm)

2. Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device with known to tetracycline hydrochloride or 1190500 1/cs in patients Rectangle 10" allergies x 12" (25.4 cm x 30.5 cm) kanamycin sulfate should be avoided.

fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. 6. This mesh has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the mesh and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the mesh may lead to injury, illness or death of the patient or end user. Precautions 1. Please read all instructions prior to use 2. Only physicians qualified in the appropriate surgical techniques should use this device. User should be familiar with mesh strength and size requirements. Improper selection, placement, positioning and fixation of the device can cause subsequent undesirable results.

4. If an infection develops, treat the infection aggressively. Consideration should be given 1192540 1/cs theRectangle 10" infection x 16" (25 x 40 cm) of the mesh. regarding the need to remove mesh. An unresolved maycm require removal

Adverse Reactions In preclinical testing, Phasix™ Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

5. To prevent recurrences when repairing hernias, the Phasix™ Mesh must be large enough to provide sufficient overlap the margins of thexdefect. Careful 1193045 1/csbeyond Rectangle 12" 18" (30 cm xattention 45 cm)to mesh

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

3.1193030 The safety and effectiveness of Phasix™ Mesh in the following applications has not been 1/cs Square 12" x 12" (30 cm x 30 cm) evaluated or established: pregnant women, pediatric use, neural and cardiovascular tissue

1193535 14" x 14" (35(844.823.5433) cm x 35 cm) BD, Warwick, RI, 1/cs 02886,Square U.S. 1.844.8.BD.LIFE 1194040

1/cs

Square

16" x 16" (40 cm x 40 cm)

bd.com 1194545

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18" x 18" (45 cm x 45 cm)

1195050

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19.5" x 19.5" (50 cm x 50 cm)

For Healthcare Professionals

MemoryGel Breast Implant ®

10 year Core Study data demonstrate safety and high patient satisfaction1

MILLION

Women with MENTOR® Breast Implants

MemoryGel Core Study Highlights ®

Highest 98% Lowest Patient

Satisfaction† 1-3

Patients highly satisfied and would make the same decision at 10 years

Reported Kaplan-Meier estimated cumulative incidence of key complications at 10 years for round gel implants among the primary augmentation cohort§ 1,2,4-6

Wrinkling: 1.3% | Explantation: 11.6% | Capsular Contracture: 12.1% | Reoperation: 25.5%

1% Malposition

0% Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

9.8% Kaplan-Meier estimated rate of confirmed rupture

† Based on patient survey at 10 years in the Mentor® MemoryGel® Breast Implant 10-Year Core Gel Clincial Study Final Report.

§ Not a head to head clinical study. Based on a comparison of 10 year core clinical study data for Primary Augmentation, Revision Augmentation, and Primary Reconstruction for MENTOR® MemoryGel® Breast Implants and NATRELLE™ Round TruForm1 Gel Breast Implants. It is important to note that study protocols were different for each manufacturer, and therefore, the results are not comparable across studies. The third party trademarks used herein are the properties of their respective owners.

1. S ummary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013. 2. Spear S, Murphy DK. Natrelle Round Silicone Breast Implants: Core Study Results at 10 Years. June 2014;133:6:1354-1361. 3. Stevens W, Calobrace MB, Alizadeh K, et al. Ten-year Core Study Data for Sientra’s Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. April 2018. Vol. 141, Number 4S. 4. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Highly Cohesive Silicone-Filled Breast Implants. Application No. 88573. License No.72262. Date Issued: 2014/01/17. 5. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Silicone-Filled Breast Implants-Smooth Shell With Barrier and Natrelle(TM) Silicone Filled Breast Implants - Textured Shell with Barrier Layer. Application No. 61865 and 60524 License No License No 72264 and 72263. Date Issued: 2012/09/25. 6. FDA: Sientra, Inc. Summary of Safety and Effectiveness Data (SSED). Santa Barbara, Calif: Sientra; 2012. IMPORTANT SAFETY INFORMATION The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel® Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least 18 years old for MENTOR® Saline Breast Implants.Breast implant surgery should not be performed in women: With active infection anywhere in their body; With existing cancer or precancer of their breast who have not received adequate treatment for those conditions; Who are currently pregnant or nursing. Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. 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. There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production. Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures. For MemoryGel® Implants: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. For MemoryShape® Implants: Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. For MENTOR® Saline-filled Implants: Saline-Filled Breast Implants: Making an Informed Decision. These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR® Breast Implants. Important information: Prior to use, refer to the instructions for use supplied with this device for indications,contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician. © Mentor Worldwide LLC 2020 136310-200406