MENTOR® ARTOURA® Breast Tissue Expanders

MENTOR® ARTOURA® Breast Tissue Expanders, available in smooth or SILTEX® Textured Shell Surface, are designed with Dynamic Control Technology™ to help surgeons achieve a desirable expansion profile and a precise pocket for breast reconstruction patients.1,2 The ARTOURA™ Breast Tissue Expander provides the surgeon with increased control of the breast pocket formation* and is engineered to create a more natural, teardrop breast shape.**

mentor artoura implant

Features & Benefits

mentor artoura implant

Engineering Precise Pocket Control

Only the MENTOR® ARTOURA® Breast Tissue Expander features Dynamic Control Technology™, which is designed for predictable expansion while reducing the need for distortion-related surgical corrections.3,4

mentor artoura implant

Contour Without Compromise

During expansion Dynamic Control Technology® is designed to create natural breast contours by shaping a pronounced lower pole while restraining the upper pole.5

Seamless Transition to MENTOR® Breast Implants

ARTOURA® Breast Tissue Expanders maintain a fixed base width, designed for a seamless transition to the full line of available MENTOR® Breast Implants.6, 7

Continuing Our Commitment to Safety and Reliability

ARTOURA® Expanders maintain key features fundamental to the MENTOR® Tissue Expander Portfolio to continue our legacy of predictability, stability and safety: Smooth and SILTEX® Microtexture Surface; Suture Tabs; Dacron® Patch; BufferZone® Self-Sealing Patch.8-10 ARTOURA® Expanders include an internal injection dome, which contains a magnet (Reference the Important Safety Information below for relevant contraindications and warnings).

Product Resources

MENTOR® ARTOURA® PLUS SMOOTH BREAST TISSUE EXPANDERS, HIGH PROFILE

Catalog #

Vol.

Width

Height

Proj.

SMXP100RH

225 cc

10.0 cm

10.0 cm

5.2 cm

SMXP110RH

300 cc

11.0 cm

11.0 cm

6.0 cm

SMXP120RH

375 cc

12.0 cm

12.0 cm

6.4 cm

SMXP130RH

475 cc

13.0 cm

13.0 cm

6.8 cm

SMXP135RH

500 cc

13.5 cm

13.5 cm

6.6 cm

SMXP140RH

600 cc

14.0 cm

14.0 cm

7.1 cm

SMXP150RH

750 cc

15.0 cm

15.0 cm

7.7 cm

SMXP155RH

850 cc

15.5 cm

15.5 cm

7.8 cm

MENTOR® ARTOURA® PLUS SMOOTH BREAST TISSUE EXPANDERS, ULTRA HIGH PROFILE

Catalog #

Vol.

Width

Height

Proj.

SMXP100RUH

350 cc

10.0 cm

10.0 cm

7.0 cm

SMXP110RUH

455 cc

11.0 cm

11.0 cm

7.6 cm

SMXP120RUH

535 cc

12.0 cm

12.0 cm

8.0 cm

SMXP130RUH

650 cc

13.0 cm

13.0 cm

8.2 cm

SMXP135RUH

700 cc

13.5 cm

13.5 cm

8.3 cm

SMXP140RUH

850 cc

14.0 cm

14.0 cm

8.9 cm

MENTOR® ARTOURA® SILTEX® Breast Tissue Expander, High Profile

Catalog #

Vol.

Width

Height

Proj.

TEXP100RH

225cc

10.0 cm

10.0 cm

5.2 cm

TEXP110RH

300cc

11.0 cm

11.0 cm

6.0 cm

TEXP120RH

375cc

12.0 cm

12.0 cm

6.4 cm

TEXP130RH

475 cc

13.0 cm

13.0 cm

6.8 cm

TEXP135RH

500 cc

13.5 cm

13.5 cm

6.6 cm

TEXP140RH

600 cc

14.0 cm

14.0 cm

7.1 cm

TEXP150RH

750 cc

15.0 cm

15.0 cm

7.7 cm

TEXP155RH

850 cc

15.5 cm

15.5 cm

7.8 cm

MENTOR® ARTOURA® SILTEX® Breast Tissue Expander, Ultra High Profile

Catalog #

Vol.

Width

Height

Proj.

TEXP100RUH

350 cc

10.0 cm

10.0 cm

7.0 cm

TEXP110RUH

455 cc

11.0 cm

11.0 cm

7.6 cm

TEXP120RUH

535 cc

12.0 cm

12.0 cm

8.0 cm

TEXP130RUH

650 cc

13.0 cm

13.0 cm

8.2 cm

TEXP135RUH

700 cc

13.5 cm

13.5 cm

8.3 cm

TEXP140RUH

850 cc

14.0 cm

14.0 cm

8.9 cm

Accessories

Aseptic Transfer System

Carton contains four sterile kits. Each kit contains the following:

Description

Catalog #

Aseptic Transfer System

350-8400

 

Includes:
• 60 cc syringe (sterile, disposable)
• Piercing spike
• 48” tubing (saline container to syringe)
• Dual check valve
• 10” tubing (syringe to implant fill tube)
• Luer connector (attaches to implant fill tube)

Injection Port Detector

Description

Catalog #

CENTERSCOPE® Magnetic Detection Device

350-4402

 

Miscellaneous

Description

Catalog #

Check Valve

200464-001

21-Gauge Winged Infusion Set

7B3050

Product Catalog

Product Catalog

Product Insert Data Sheet

Important Information for Your Patients to Consider

High Profile

Base Width(cm)

Height(cm)

Projection(cm)

Label Fill Volume(cc)

Catalog #

10.0

10.0

5.2

225

SDC-100H

11.0

11.0

6.0

300

SDC-110H

12.0

12.0

6.4

375

SDC-120H

13.0

13.0

6.8

475

SDC-130H

13.5

13.5

6.6

500

SDC-135H

14.0

14.0

7.1

600

SDC-140H

15.0

15.0

7.7

750

SDC-150H

15.5

15.5

7.8

850

SDC-155H

 

Ultra High Profile

Base Width(cm)

Height(cm)

Projection(cm)

Label Fill Volume(cc)

Catalog #

10.0

10.0

7.0

350

SDC-100UH

11.0

11.0

7.6

455

SDC-110UH

12.0

12.0

8.0

535

SDC-120UH

13.0

13.0

8.2

650

SDC-130UH

13.5

13.5

8.3

700

SDC-135UH

14.0

14.0

8.9

850

SDC-140UH

 

References

*As compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression
** As compared to Allergan 133® and CPX®4 Breast Tissue Expander
1. FM-0001306 SILTEX® Sizes and Styles Memo
2. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report
3. FM-0001306 v6 Flex Design Requirements Matrix
4. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report
5. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report
6. FM-0001306_v6 Flexa Design Requirements Matrix
7. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report
8. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report.
9. Maxwell GP et al. Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness Aesthetic Surgery Journal 2014, Vol. 34(6) 876–881 © 2014.
10. Mentor Worldwise, LLC, Internal Memo - Surface Area November 6, 2012

The third party trademarks used herein are the properties of their respective owners.

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. MENTOR® Breast Implants are also indicated for breast reconstruction.

Breast implant surgery should not be performed in women:

  • With active infection anywhere in their body
  • With existing cancer or pre-cancer of their breasts 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. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.

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. The most common complications for breast reconstruction with MENTOR® MemoryGel® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. The most common complications with MENTOR® MemoryShape® Breast Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation 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. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the incidence of worldwide cases.

Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures for both augmentation and reconstruction:

  • For Augmentation: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
  • For Reconstruction: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast 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.

ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA® Breast Tissue Expander and CONTOUR PROFILE® Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com

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